CLINICAL FEATURE
Studying Nursing Interventions in Acutely Ill, Cognitively Impaired Older Adults Lessons learned from conducting research in real-world settings on a vulnerable population.
OVERVIEW: Although it increases the risk of poor outcomes and raises the costs of care, cognitive impairment in hospitalized older adults is often neither accurately identified nor well managed. In conducting a two-phase, comparative-effectiveness clinical trial of the effects of three nursing interventions—augmented standard care, resource nurse care, and the transitional care model—on hospitalized older adults with cognitive deficits, a team of researchers encountered several challenges. For example, in assessing potential subjects for the study, they found that nearly half of those assessed had cognitive impairment, yet many family caregivers could not be identified or had no interest in participating in the study. One lesson the researchers learned was that research involving cognitively impaired older adults must actively engage clinicians, patients, and family caregivers, as well as address the complex process of managing postdischarge care. Keywords: cognitive impairment, evidence-based intervention, family caregivers, older adults, research participation, transitional care
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eventy-eight-year-old Mattie Gilpin has not been taking her medications as prescribed and is consequently hospitalized with worsening symptoms of heart failure. (This is the case of a patient involved in our research; we have changed her name and other identifying details.) After admission she is stabilized quickly and found to have intact orientation and recall but significant limitations in executive function—a form of cognitive impairment that affects the ability to undertake complex tasks such as medication management. A widow, Ms. Gilpin has four sons who care for her but who appear to be unaware of her difficulties in handling her health problems and treatment. During the hospitalization, Ms. Gilpin and her sons are approached and agree to participate in a study of the effects of various nursing interventions on rates of rehospitalization in older adults with cognitive impairment. She is assigned to an advanced practice nurse (APN) who visits Ms. Gilpin in the hospital within 24 hours of enrollment. 44
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During the meeting with Ms. Gilpin and her sons, the APN learns that the sons are sports fans and uses baseball analogies to get them involved. The APN has frank conversations with the Gilpin sons about their need to “step up to the plate” and “take their turn at bat.” But will they be able to ensure that their mother adheres to her medication regimen, attends her medical appointments, and has access to foods that fit her dietary restrictions? The APN explains that to “hit the ball out of the park,” they will need to work together to help their mother meet her goal of continuing to live independently in her apartment. The need for research in this vulnerable population is great. Cognitive deficits in older adults can result from neurodegenerative conditions such as Alzheimer’s disease,1 as well as from progressive chronic diseases such as heart failure2 or acute multifactorial syndromes such as delirium.3 And hospitalization itself can impair cognition in the elderly. A 2012 study, in which older adults were interviewed at three-year intervals for up to 12 years, found that in this population cognition ajnonline.com
By Kathleen McCauley, PhD, RN, FAAN, FAHA, Christine Bradway, PhD, CRNP, FAAN, Karen B. Hirschman, PhD, MSW, and Mary D. Naylor, PhD, RN, FAAN
declines considerably after hospitalization, “even after controlling for illness severity and prehospital cognitive decline.”4 Regardless of their cause, cognitive deficits affect an estimated 8% to 43% of hospitalized older adults and can affect health and quality of life and increase total annual health care costs.3-9 Notably, many hospitalized older patients who have cognitive deficits have no documented history of dementia.5 However, these patients are especially vulnerable to health care systems that ignore or inadequately address their needs.5, 10-12 Too often, cognitive deficits in older adults go unrecognized or, even if identified, are poorly managed. This can set off a cascade of A patient performs the CLOX 1, a clock-drawing task used to assess patients for cognitive impaircostly and often preventable adverse ment. Photo by Ed Eckstein. events during and after hospitalization, including falls, malnutrition, incontinence, functional decline, prolonged or repeated hospitalization, nursing home admission, a 2013 systematic review by Rennke and colleagues and death.3, 5-7, 9, 13-18 found that cognitive impairment or dementia was the Improving the care of such patients may involve most common exclusion criteria in studies on transithe early detection and management of cognitive imtional care.31 19-21 pairment during hospitalization, but the nature Therefore, since current literature suggests that simand intensity of the interventions needed are not ply detecting problems is insufficient to ensure that known. Nor is it certain that universal screening for patients receive the care they need, in 2006 we and delirium in hospitals is the answer; disadvantages can our multidisciplinary colleagues set out to study include “misclassification, subsequent treatment of which of several nursing interventions might improve non-delirious patients or misdiagnosis of those with outcomes in hospitalized older adults suffering from delirium,” according to a 2011 systematic review.22 cognitive impairment, building on our experience in Strategies have been proposed to improve hospital managing transitions in cognitively intact, high-risk and postdischarge outcomes, including systematic asolder patients. Our objective was to compare the efsessment and reporting of patients’ cognitive status to fects of three evidence-based interventions on several health team members, although such interventions primary outcomes involving patients, caregivers, and have not been shown to improve outcomes.23, 24 The costs. We also wanted to test whether well-educated use of hospital resource nurses with special training staff nurses (in an in-hospital intervention) could be in the clinical management of this high-risk patient as effective as transitional care (in a hospital-to-home group has been found to improve nursing staff’s unintervention). derstanding of the older patient’s needs,25 decrease Here, we summarize our methods for testing the delirium (the number and length of episodes),20 and three interventions in our two-phase, comparativeimprove patient function during hospitalization.26 effectiveness clinical trial (a report on the first phase Approaches that focus on episodes of acute illness of this study was published in May 201432) and defrom hospital to home, such as the transitional care scribe the facilitators and barriers found in conducting model (TCM),27-29 have demonstrated benefits among this research. We conclude with our recommendahigh-risk older adults, but until recently these care tions based on lessons learned in implementing this management models have not been tested in those with complex study in real-world clinical settings. cognitive deficits. In fact, Naylor and colleagues’ 2011 systematic review of transitional care interventions on OVERVIEW OF STUDY METHODS rates of hospital readmission found that studies exWe designed a multisite randomized clinical trial to cluded cognitively impaired older adults.30 Similarly, compare three interventions of varying intensities, [email protected]
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each designed to capitalize on nursing’s central role in the care and outcomes of hospitalized cognitively impaired older adults and their family caregivers. Since each of the interventions required changes in care processes that might affect more than the enrolled patients, we were unable to randomly assign patients at each given site. Thus, we elected to test the interventions at three different hospitals, all part of one system that shares standards of care. Also, to minimize threats to the internal validity, we conducted the study in two phases. In phase 1, we tested the three interventions at three different hospitals; interventions were randomly assigned to each site. In phase 2, we implemented the TCM at each site. This design enabled us to provide both cross-site (phase 132) and within-site (phase 1 versus phase 2) comparisons. Eligibility. Inclusion criteria were hospitalized older adults, 65 years of age or older, living in the community within 30 miles of the admitting hospital, who spoke English, had family caregivers willing to participate, and had a preexisting diagnosis of dementia or had been found to have cognitive impairment during hospitalization through our in-person assessments. Exclusion criteria were patients enrolled in Medicare’s hospice or end-stage renal disease programs, patients undergoing treatment for cancer, or those with unmanaged psychiatric conditions or a primary diagnosis of stroke. Cognitive assessments. Prior to cognitive assessment, research assistants—nurses or social workers with bachelor’s degrees—completed an orientation on the standardized instruments as well as the chartabstraction and documentation protocols. Also, each assistant completed online training in research ethics and in the Health Insurance Portability and Accountability Act (HIPAA) (the mean orientation time per research assistant was 40 hours). At weekly meetings, the research assistants and the project manager reviewed data and discussed quality improvement. Daily, the research assistants and the project manager received an electronic list of patients ages 65 and older who had been admitted to each hospital in the prior 24 hours. Data were stored in password- protected files on HIPAA-compliant computer servers. The University of Pennsylvania institutional review board (IRB) approved the screening of patients without requiring their enrollment; we made the case that such cognitive assessment should be but was not the standard of care. Initial patient screenings (that is, chart abstractions for documentation of preexisting diagnoses or assessments for cognitive deficits) were conducted by research assistants within 24 hours of hospitalization, and information from the screening was used to determine eligibility for study participation. For patients without a preexisting diagnosis of dementia, research assistants used the Six-Item Screener (SIS),33 and the CLOX 1, a clock-drawing task,34 to assess for cognitive deficits. In earlier studies, the SIS 46
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(consisting of three orientation and three recall questions) was effective in screening similar patients for cognitive impairment.35, 36 Patients with two errors were considered impaired (a score of 4 or lower in a range of 0 to 6).33 Patients with fewer than two errors were further assessed using the CLOX 1, a subscale of a two-part clock-drawing assessment. This clock-drawing task is strongly associated with executive function, defined as cognitive processes (decision making, memory, attention, focus) that enable planning, problem solving, and completion of daily tasks; it is used for basic assessment but not diagnosis of cognitive impairment. Patients with five or more errors on the CLOX 1 (a score of 10 or lower in a range of 0 to 15) were considered to have cognitive deficits.34 Cognitive findings were verbally communicated to patients’ assigned nurses and physicians (and discharge planners for the higher-dose TCM group) and, within four hours, were documented in patients’ records (and discharge planning system). Documentation for all patients with positive findings from the assessment consisted of a 4" × 4" blue-andwhite sticker containing information about the research and specific findings from chart review and assessment. (The screening protocol can be found at http://bit.ly/1vtb2L1; click the hyperlink for “Documentation and communication of assessment.”) (Editor’s note: For more on assessing cognitive dysfunction, see AJN’s How to Try This series, at http:// bit.ly/HTTT_AJN.) Approximately half the patients identified from chart review were further evaluated for eligibility (N = 5,398) (see Figure 1). Among this group, 1,062 patients (20%) were unable to be approached because of poor health (such as coma or intubation); an additional 553 (11%) refused or were unable to be assessed because of physical impairments (such as hearing or vision deficits). Of the remaining 3,783 patients, 1,884 (50%) had either a diagnosis of dementia (12%) or deficits in orientation or recall based on the SIS or deficits in executive function based on the CLOX 1 (88%). Among those with signs of cognitive deficits, 638 (34%) did not meet other eligibility criteria. Of the final eligible 1,246 patients, 536 (43%) were enrolled, along with 536 family caregivers. Primary reasons for refusals were patients’ or caregivers’ insufficient interest in research. Enrollment. Patients with a prior diagnosis of dementia or whose cognitive impairment was detected by assessment were given information about the study that was reviewed with them and with a family member (usually, the legally authorized representative). Since all patients had some cognitive impairment, the IRB approved that patients could provide assent (indicate willingness) to participate and family caregivers could provide informed consent that would cover both themselves and the patient. These procedures were similar to those recently published in an article ajnonline.com
Figure 1. Enrollment for Study Phases 1 and 2
9374 Patient charts reviewed 3976 Did not meet inclusion criteria 5398 Eligible for further evaluation
3783 Assessed for presence of cognitive deficits
1062 Unable to screen (comatose, intubated, unconscious) 553 Refused or unable to complete screening (injured hand, vision problems)
1899 No cognitive impairment 1884 Met cognitive impairment eligibility criteria 1650 Had deficits in orientation, recall, or executive function 234 Had diagnosis of dementia
638 Did not meet other eligibility criteria 266 Unable to reach a caregiver 127 Unable to identify a caregiver 122 Patient discharged 123 Change in diagnosis, prognosis, or discharge plan
1246 Met all eligibility criteria
536 Enrolled at hospital and provided site-specific dose intervention
[email protected]
710 Not enrolled 271 Patient not interested in research 217 Caregiver not interested in research 63 Patient/caregiver felt they did not need the services 38 Patient refused to give permission to contact caregiver 6 Patient stated “too ill” to participate 115 No reason given for refusal
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on recruitment of dementia patients into research.37 Enrolled patients’ health status, quality of life, and resource use (such as rehospitalization) and family caregivers’ care burden were assessed at two-, six-, 12-, and 26-week intervals after discharge.
THE THREE PROTOCOLS AND FINDINGS
In phase 1 (2006–2008), enrolled patients received care at one of three sites: patients at site 1 received augmented standard care (ASC; the low-dose intervention); at site 2, ASC plus resource nurse care (RNC; medium dose); and at site 3, ASC plus the TCM (high dose). Interventions were randomly assigned to the three participating hospitals. In phase 2 (2008–2010), the same clinical sites were used, but all patients received the TCM protocol (phase 1 enrollees were not eligible for participation in phase 2). Site 1: The ASC protocol sought to determine whether notifying team members of patients’ cognitive deficits would influence care plans and outcomes.38 Once patient assent and caregiver informed consent were obtained, the 4" × 4" sticker was updated to indicate the patient’s enrollment. By design, no additional contact was made between the study team and enrolled patients’ primary nurses, physicians, or discharge planners. Assessment of fidelity to this protocol was maintained by the project manager via quarterly review of patients’ medical records and monthly calculation of time to assessment and enrollment of patients. The ASC protocol was completed in a mean time of 22 minutes per patient. Site 2: The RNC protocol sought to determine what effect preparing hospital RNs to care for or to coach others to care for cognitively impaired older adults would have on patients’ care plans and outcomes.25, 39, 40 The RNC protocol extended from each patient’s enrollment through the index hospital discharge. First, a research assistant implemented the ASC protocol as described above. Next, the assistant notified the unit’s nurse manager of the patient’s enrollment. The nurse manager was asked to assign a resource nurse to the enrolled patient throughout the index hospitalization (if not already assigned). In preparation for their role, resource nurses completed an online education program developed by APNs with expertise in working with cognitively impaired older adults and knowledgeable in the TCM. The content was independently reviewed by two external clinical experts in the care of cognitively impaired older adults (see Table 1 for program topics). This learning experience was designed using written case narratives to improve nurses’ knowledge and decision-making skills in managing hospitalization and discharge of cognitively impaired older adults. (Go to http://bit.ly/1mGSC49 for the RNC training modules.) Nurse managers invited 69 RNs, 57 with bachelor’s or master’s degrees in nursing, to complete the online program; 86% (59 of 69) did so and earned a test 48
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score of 80% or higher—required to be designated a “resource nurse”—in a mean of six hours. Throughout the study, resource nurses were invited to monthly seminars led by study team members on issues relevant to the RNC protocol, but few attended those sessions. Fidelity to the ASC component of this protocol was assessed as described earlier. Similarly, timely assignment of enrolled patients to resource nurses was monitored, but nurses’ contributions to patients’ care plans were not documented consistently, nor was the time devoted to direct care or coaching measured. Site 3: The TCM protocol extended from the index hospitalization through an average of two months after discharge, complementing care delivered in the hospital and substituting for post–acute skilled care provided by nurses in patients’ homes. Adapted from prior studies,27-29 the protocol sought to address the particular needs of this patient group and their family caregivers. APNs with master’s degrees in nursing and at least one year of clinical experience in the team-based care of older adults completed the RNC modules, as well as TCM-specific modules and individualized learning experiences guided by clinical experts. Over a one-month period, each APN spent a mean of 100 hours in orientation. Within 24 hours of patient enrollment, including application of the ASC protocol, an APN assigned by the project manager completed in-person assessment of the patient’s and family caregiver’s needs and goals; the APN visited the patient daily while hospitalized and collaborated with team members to implement care plans aimed at improving management of acute conditions complicated by cognitive impairment and preventing adverse events. The same APN visited the patient’s home within 24 hours of discharge, at least weekly during the first month, and at least every other week through completion of the intervention. APNs accompanied patients and family caregivers to their first postdischarge primary care visits to promote continuity of care. APNs also conducted telephone outreach and were available by phone seven days per week, working collaboratively with primary care clinicians to ensure smooth transitions following completion of this protocol.41 APNs documented assessments, patient and caregiver high-priority problems, and interventions and wrote case narratives.41 APNs met bimonthly with two clinical experts to review cases. The mean number of visits per patient was 11 and calls was 10. Fidelity to the TCM intervention protocol was also assessed. Results of phase 1 were published earlier this year.32 Of the 202 patients and family caregivers (a subset of the final 536 patients and caregivers) enrolled at the three sites, 65 received ASC, 71 RNC, and 66 the TCM. We found that 25% of patients were rehospitalized or died by day 33 in the ASC group, by day 58 in the RNC group, and by day 83 in the TCM group. The TCM protocol also showed lower ajnonline.com
Table 1. Training for Resource Nurse Certification Module Section
Content
Introduction
•• Enhancing care coordination in the presence of memory and thinking problems
Understanding cognitive impairment
•• What is dementia? •• What is delirium? •• Complicating factors
Assessing your patient with cognitive impairment (memory and thinking problems)
•• Neuropsychological screening and assessment •• Nursing assessment in the presence of cognitive impairment •• Physical assessment in the presence of cognitive impairment
Providing education and support from hospital to home
•• Discharge planning •• Understanding and managing common behaviors associated with cognitive impairment in the elderly •• From hospital to home: educating families on day-to-day issues •• Advance care planning and assessing capacity
Enhancing care coordination
•• Interactive case study
Building on the foundation
•• Managing memory impairment
Source: Transitional Care Model. Expanding TCM for cognitively impaired older adults and their family caregivers. University of Pennsylvania School of Nursing; 2013.
er-patient 30-day rehospitalization rates than either p the RNC or ASC protocols. We found no significant differences in functional status between groups. These are the first findings to suggest that the TCM may decrease costs and improve postdischarge outcomes in cognitively impaired older adults and their caregivers. Also, rather than comparing the TCM to a similar group receiving standard care, this study examined the performance of the TCM relative to other evidence-based interventions of varying intensities. Evidence suggests that ASC should be the standard of care.38 RNC capitalized on the critical role of hospital nurses in anticipating and responding to the clinical challenges posed by high-risk patient groups with complex physical and cognitive needs. This study’s phase 1 findings may have a role in determining how systems may better engage complex patients and their family caregivers. Along the way we encountered several challenges in testing new care models in a health care system where the primary commitment is not research but rather the care of patients—and where these can be seen as competing priorities. How might research be better aligned to real-world practice?
FACILITATORS AND BARRIERS TO EMPLOYING THE PROTOCOLS
We assessed multiple data sources in determining the facilitators and barriers we encountered in implementing the three interventions, including minutes from study-team meetings; notes from APN meetings [email protected]
with clinical experts; and recollections from investigators, research assistants, and APNs. An analysis of the specifics of the TCM intervention based on the use of APNs’ written case narratives is published elsewhere.41 Overall facilitators. Several factors influenced our ability to achieve the study’s aims. The health care system involved has long been dedicated to interdisciplinary, innovative care of older adults. At each hospital, nurse champions helped in establishing the relationships needed to launch the study and deploy team members (such as the research assistants). When the study began, hospital leaders expressed their commitment to enhancing patient safety and preventing adverse events such as avoidable rehospitalizations. Indeed, enhancing care transitions became a systemwide priority during the study period. The tools used to assess cognitive status were easy to administer, posing limited burden on patients or nurses. Also easing communication among clinicians at all sites were interprofessional patient rounds, documentation in integrated progress notes, and an online discharge-planning system. Overall barriers. We encountered some problems with recruitment. This study required the participation of family caregivers because the risk of poor outcomes increases if cognitively impaired patients have inadequate social support.42 Nearly half (1,884 of 3,783) of patients assessed in both phases of our study were found to have cognitive deficits, but despite the use of multiple strategies, some caregivers (393 of 1,884, or 21%) could not be identified or reached during the hospital stay, while others (217 of AJN ▼ October 2014
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1,246, or 17%) were unwilling to participate. Cognitive assessments across all three sites revealed previously unidentified deficits in 46% (1,650 of 3,549) of the hospitalized older adults assessed in our study. Understandably, some patients and caregivers found this upsetting. Research assistants had been prepared for a range of responses and assured the patients, the family members, and the health care team that the assessment findings signaled a deficit at one moment in time but was not diagnostic. Even after research assistants made many efforts (often over multiple visits) to explain the meaning of these assessment results and their potential implications for plans of care, some patients and family caregivers could not acknowledge deficits, presenting challenges to the research team in enrolling dyads. In addition, 20% of patients were not screened owing to poor health. Thus, patients with a possibly higher risk of poor outcomes did not receive the potential benefits of the protocols.
Partnerships result in better research and better practice. RNC facilitators. Based on prior testing of the RNC model, we knew that a voluntary process would engage more nurses. Nurse champions at Site 2 initially promoted the study and assisted in identifying potential nurses to participate. Designation as a resource nurse was acknowledged through a variety of modest mechanisms (such as a certificate). We focused on two units, where nurses were given time during the workday at a computer lab to complete the training, and many were excited to further their education. The evidence-based modules encouraged nurses to learn at their own pace. Nurses had various levels of expertise in caring for cognitively impaired older adults, and we asked for intermittent self-assessment of their progress during the modules. RNC barriers included inadequate resources. In retrospect, we realize that our use of a voluntary model did not account for the day-to-day pressures on the nursing leadership team and the bedside nurses. Specifically, the study design and funding did not adequately support, recognize, or reward resource nurses. Early on, we realized it was not possible to recruit enough nurses to cover all shifts on all units that might admit eligible patients. In response, and in collaboration with the nursing leaders, the team focused on recruitment of resource nurses from two highvolume units and invested study funds to reimburse the hospital for the time required for nurses to complete the modules. Nurses’ initial enthusiasm waned over time, but we persevered and, with the support of the nurse champions, achieved the modest engagement of staff nurses. 50
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Also, in order to approximate a real-world model of influencing nursing practice, we did not monitor the ongoing implementation of the RNC intervention. While we assessed that nurses acquired the knowledge needed to be resource nurses, we made no further effort to influence their care or coaching practices. Consequently, we acquired little data on how this training affected the care delivered to enrolled patients receiving the RNC protocol. TCM facilitators. Acceptance of the importance of the APN role in the TCM facilitated implementation of this protocol. Our history of multidisciplinary collaboration with the health system led to positive working relationships. The involvement of APNs with the same older adults and family caregivers from hospital to home fostered the subsequent collaborations between patients, caregivers, and clinicians.41, 43 APNs also encouraged relationships with community organizations that fostered sustainable plans of care. During biweekly one-hour case conferences, two of us (KM and CB) conducted root-cause analyses of positive and negative outcomes. This mentoring of the APNs facilitated problem solving. Consultation with other experts (gerontology–psychiatric nurse specialists, nutritionists, and a pharmacologist) also addressed knowledge gaps. As highly skilled providers, the APNs promoted care coordination and interprofessional collaboration, assisting care in the hospital and in the community. For example, collaboration with home care and palliative care programs eased the transition of patients to these services. TCM barriers. Study personnel needed to negotiate their roles within established inpatient and outpatient teams. This required that APNs and investigators teach clinical colleagues about the APNs’ potential contributions, including facilitating team effectiveness in managing the patient. Distrust emerged when other clinicians on the team perceived the APN as interfering with or usurping their role. The TCM APNs routinely participated in patient care rounds and discussed the enrolled patients with the nurses and physicians responsible for their care. It was part of the APNs’ research role to ensure that the care provided was evidence based and consistent with recognized strategies to decrease delirium and manage each patient’s health concerns. While the APNs were credentialed as APNs in the health system, they were not employees of these hospitals and had to negotiate their role on the health care team. Conflicts sometimes arose when APNs sought a balance between a patient’s readiness for discharge and the caregiver’s readiness to manage care at home. In most such cases, the APN supported families through this transition. On a few occasions, however, the APN identified safety issues and negotiated an additional day or two of hospitalization to ensure that needed community resources were in place. Most of the time, such dilemmas were amicably resolved, but they ajnonline.com
r equired of the APN a high level of communication skill and clinical acumen, as well as established trust among team members.
LESSONS LEARNED
Our experience provides important lessons that we hope can inform the conduct of complex studies, especially in vulnerable populations. Lesson 1: Make cognitive assessment of hospitalized older adults a standard of care. Because 46% of the older adults assessed in our study showed signs of previously undetected cognitive impairment, we recommend that all older adults hospitalized for an acute condition be assessed for signs of cognitive impairment. We do not advocate the use of any single screening tool in hospitals but rather encourage detection of cognitive impairment. As Shenkin and colleagues have written, “We argue for a change in attitude to identification of cognitive impairment in the general hospital from ‘screening’ to it being seen as part of normal systems examination.”44 The assessment tools used must achieve a difficult balance: providing an accurate and comprehensive assessment while ensuring that patients and clinicians are not unduly burdened. Loss of executive function, for instance, interferes with a patient’s ability to make decisions, follow instructions in post–acute care settings, and adjust to the ongoing demands of living with and managing an illness; patients with such deficits require targeted assistance to ensure optimal outcomes. The CLOX 1 instrument,34 which requires little time to complete, has been shown to be helpful in detecting loss of executive function—but it should not be used alone. We recommend that future standard-of-care cognitive assessments include assessment for delirium. Lesson 2: Overcome barriers to learning health systems. A strong partnership between health care organizations and study teams is essential to accomplishing the aims of the study. A recent Institute of Medicine (IOM) report described the need for “a continuously learning health care system,”45 one that, among other intentions, fosters innovation by facilitating clinical research. Incentives for clinicians might include career ladders or systems that facilitate evidence-based practice accompanying Magnet designation. Study teams must fully engage such partnerships. Optimally, nursing leaders, clinical staff, and researchers share a commitment to the goals of designing research to solve problems. We recommend involving clinical colleagues in study design and jointly planning how the study will be most efficiently implemented. We should have made a stronger case with administrators and clinicians that active participation in the study would provide tangible benefit. Including nursing and other leaders (such as coinvestigators or members of advisory committees) would have advanced our study’s goals. We offered a state-of-the-science educational program for staff nurses but fell short in convincing our clinical [email protected]
partners that changes in care processes could enhance patient outcomes. As the IOM report states, research and clinical practice cannot afford to be separate ventures: “To achieve strong provider participation in the learning enterprise, data capture must be seamlessly integrated into providers’ daily workflow and must not disrupt the clinical routine.”45 Lesson 3: Routinely involve family caregivers. One of the largest hurdles we confronted was in engaging family caregivers. The challenge involved identifying, finding, and establishing relationships with caregivers in order to involve them in the trial. Their time in the hospital is often brief, therefore limiting our ability to engage them quickly. Our experience with caregivers in this study taught us that many are balancing enormous burdens caring for a loved one while meeting other responsibilities such as a job or children. Hospitalization of a frail elder may provide a respite for caregivers, but the patient often returns home with greater, if temporary, functional deficits. All of this is complicated by our lack of societal emphasis on caregiving. Many of the patients in this study had inadequate caregiving support networks. Based on available evidence,46 we believe that the challenges we faced in engaging family caregivers relate primarily to health system barriers to including family caregivers, especially in complex transitions. In particular, a recent report emphasizes that clinicians must change how they relate to family caregivers in daily practice and that policymakers should take family caregivers into account when creating new models seeking to improve care quality.46 In conclusion, by describing the complexity of our study’s design and the facilitators and barriers we faced in implementing our study protocols, we hope to provide a roadmap for other researchers seeking to improve the care of vulnerable older adults. Strong partnerships between researchers and health system leaders, coupled with ongoing communication, from study inception to completion, are critical to both science and practice. While the divide between the health care we have and the care we could have is changing with the passage of the Affordable Care Act, the experience reported here provides insights for a new partnership between researchers and clinicians that can aid in continuing to bridge the gap. ▼ Kathleen McCauley is associate dean for academic programs, the Class of 1965 Reunion Term Professor of Cardiovascular Nursing, and a member of the NewCourtland Center for Tran sitions and Health at the University of Pennsylvania School of Nursing, Philadelphia, where Christine Bradway is a member of the Center for Integrative Science in Aging and an associate professor of gerontological nursing, Karen B. Hirschman is a research associate professor and member of the NewCourtland Center for Transitions and Health, and Mary D. Naylor is the Marian S. Ware Professor in Gerontology and the director of the NewCourtland Center for Transitions and Health. All au thors are members of the Department of Biobehavioral Health
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Sciences at the University of Pennsylvania School of Nursing. The authors received support from the National Institute of Aging (R01AG023116) and the Marian S. Ware Alzheimer Dis ease Program at the University of Pennsylvania. Contact au thor: Kathleen McCauley, [email protected]. The authors have disclosed no potential conflicts of interest, finan cial or otherwise.
REFERENCES 1. Thies W, et al. 2013 Alzheimer’s disease facts and figures. Alz heimers Dement 2013;9(2):208-45. 2. Heckman GA, et al. Heart failure and cognitive impairment: challenges and opportunities. Clin Interv Aging 2007;2(2): 209-18. 3. Inouye SK. Delirium in older persons. N Engl J Med 2006; 354(11):1157-65. 4. Wilson RS, et al. Cognitive decline after hospitalization in a community population of older persons. Neurology 2012; 78(13):950-6. 5. Boustani M, et al. Impact and recognition of cognitive impairment among hospitalized elders. J Hosp Med 2010;5(2): 69-75. 6. Boyd CM, et al. Recovery of activities of daily living in older adults after hospitalization for acute medical illness. J Am Geriatr Soc 2008;56(12):2171-9. 7. Bynum JP, et al. The relationship between a dementia diagnosis, chronic illness, medicare expenditures, and hospital use. J Am Geriatr Soc 2004;52(2):187-94. 8. Leslie DL, et al. One-year health care costs associated with delirium in the elderly population. Arch Intern Med 2008; 168(1):27-32. 9. Sands LP, et al. Cognitive screening predicts magnitude of functional recovery from admission to 3 months after discharge in hospitalized elders. J Gerontol A Biol Sci Med Sci 2003;58(1):37-45. 10. Arora VM, et al. Relationship between quality of care of hospitalized vulnerable elders and postdischarge mortality. J Am Geriatr Soc 2010;58(9):1642-8. 11. Naylor MD, et al. Cognitively impaired older adults: from hospital to home. Am J Nurs 2005;105(2):52-61. 12. Swigart SE, et al. Misdiagnosed delirium in patient referrals to a university-based hospital psychiatry department. Psy chosomatics 2008;49(2):104-8. 13. Hitcho EB, et al. Characteristics and circumstances of falls in a hospital setting: a prospective analysis. J Gen Intern Med 2004;19(7):732-9. 14. Krauss MJ, et al. A case-control study of patient, medication, and care-related risk factors for inpatient falls. J Gen Intern Med 2005;20(2):116-22. 15. Mecocci P, et al. Cognitive impairment is the major risk factor for development of geriatric syndromes during hospitalization: results from the GIFA study. Dement Geriatr Cogn Disord 2005;20(4):262-9. 16. Mitchell SL, et al. The clinical course of advanced dementia. N Engl J Med 2009;361(16):1529-38. 17. Pedone C, et al. Elderly patients with cognitive impairment have a high risk for functional decline during hospitalization: the GIFA Study. J Gerontol A Biol Sci Med Sci 2005; 60(12):1576-80. 18. Thornlow DK, et al. Cascade iatrogenesis: factors leading to the development of adverse events in hospitalized older adults. Int J Nurs Stud 2009;46(11):1528-35. 19. Fong TG, et al. Delirium in elderly adults: diagnosis, prevention and treatment. Nat Rev Neurol 2009;5(4):210-20. 20. Inouye SK, et al. A multicomponent intervention to prevent delirium in hospitalized older patients. N Engl J Med 1999; 340(9):669-76. 21. Inouye SK, et al. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med 1990;113(12):941-8. 22. Greer N, et al. Delirium: screening, prevention, and diagnosis— a systematic review of the evidence. Washington, DC: Department of Veterans Affairs; 2011. VA evidence-based synthesis program reports. https://www.ncbi.nlm.nih.gov/books/ NBK82554.
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23. Boustani MA, et al. Enhancing care for hospitalized older adults with cognitive impairment: a randomized controlled trial. J Gen Intern Med 2012;27(5):561-7. 24. Cole MG, et al. Systematic detection and multidisciplinary care of delirium in older medical inpatients: a randomized trial. CMAJ 2002;167(7):753-9. 25. Fulmer TT. Grow your own experts in hospital elder care. Geriatr Nurs 1991;12(2):64-6. 26. Wanich CK, et al. Functional status outcomes of a nursing intervention in hospitalized elderly. Image J Nurs Sch 1992; 24(3):201-7. 27. Naylor M, et al. Comprehensive discharge planning for the hospitalized elderly. A randomized clinical trial. Ann Intern Med 1994;120(12):999-1006. 28. Naylor MD, et al. Comprehensive discharge planning and home follow-up of hospitalized elders: a randomized clinical trial. JAMA 1999;281(7):613-20. 29. Naylor MD, et al. Transitional care of older adults hospitalized with heart failure: a randomized, controlled trial. J Am Geriatr Soc 2004;52(5):675-84. 30. Naylor MD, et al. The care span: the importance of transitional care in achieving health reform. Health Aff (Mill wood) 2011;30(4):746-54. 31. Rennke S, et al. Hospital-initiated transitional care interventions as a patient safety strategy: a systematic review. Ann Intern Med 2013;158(5 Pt 2):433-40. 32. Naylor MD, et al. Comparison of evidence-based interventions on outcomes of hospitalized, cognitively impaired older adults. J Comp Eff Res 2014;3(3):245-57. 33. Callahan CM, et al. Six-item screener to identify cognitive impairment among potential subjects for clinical research. Med Care 2002;40(9):771-81. 34. Royall DR, et al. CLOX: an executive clock drawing task. J Neurol Neurosurg Psychiatry 1998;64(5):588-94. 35. Hirschman KB, et al. Cognitive impairment among older adults in the emergency department. West J Emerg Med 2011;12(1):56-62. 36. Wilber ST, et al. The six-item screener to detect cognitive impairment in older emergency department patients. Acad Emerg Med 2008;15(7):613-6. 37. Batchelor-Aselage M, et al. Research with dementia patients in the nursing home setting: a protocol for informed consent and assent. IRB 2014;36(2):14-20. 38. Cole MG. Delirium in elderly patients. Am J Geriatr Psychi atry 2004;12(1):7-21. 39. Rapp CG, Iowa Veterans Affairs Consortium. Evidencebased protocol: acute confusion/delirium. Iowa City, IA: University of Iowa Gerontological Nursing Interventions Research Center, Research Dissemination Core; 1998. Series on evidence-based practice for older adults. 40. Sendelbach S, Guthrie PF. Acute confusion/delirium. Rockville, MD: Agency for Healthcare Research and Quality, National Guideline Clearinghouse; 2009 Mar. http://www. guideline.gov/content.aspx?id=14340%20. 41. Bradway C, et al. A qualitative analysis of an advanced practice nurse-directed transitional care model intervention. Gerontologist 2012;52(3):394-407. 42. Naylor MD, et al. Care coordination for cognitively impaired older adults and their caregivers. Home Health Care Serv Q 2007;26(4):57-78. 43. Bradway C, et al. Case study: Transitional care for a patient with benign prostatic hyperplasia and recurrent urinary tract infections. Urol Nurs 2013;33(4):177-9, 200. 44. Shenkin SD, et al. Screening for dementia and other causes of cognitive impairment in general hospital in-patients. Age Ageing 2014;43(2):166-8. 45. Smith M, et al., eds. Best care at lower cost: the path to con tinuously learning health care in America. Washington, DC: National Academies Press; 2013. http://www.nap.edu/catalog. php?record_id=13444. 46. Reinhard SC, et al. Home alone: family caregivers providing complex chronic care. Washington, DC: AARP Public Policy Institute; United Hospital Fund; 2012 Oct. http://www.aarp. org/content/dam/aarp/research/public_policy_institute/health/ home-alone-family-caregivers-providing-complex-chroniccare-rev-AARP-ppi-health.pdf. ajnonline.com
Studying Nursing Interventions in Acutely Ill, Cognitively Impaired Older Adults Lessons learned from conducting research in real-world settings on a vulnerable population.
OVERVIEW: Although it increases the risk of poor outcomes and raises the costs of care, cognitive impairment in hospitalized older adults is often neither accurately identified nor well managed. In conducting a two-phase, comparative-effectiveness clinical trial of the effects of three nursing interventions—augmented standard care, resource nurse care, and the transitional care model—on hospitalized older adults with cognitive deficits, a team of researchers encountered several challenges. For example, in assessing potential subjects for the study, they found that nearly half of those assessed had cognitive impairment, yet many family caregivers could not be identified or had no interest in participating in the study. One lesson the researchers learned was that research involving cognitively impaired older adults must actively engage clinicians, patients, and family caregivers, as well as address the complex process of managing postdischarge care. Keywords: cognitive impairment, evidence-based intervention, family caregivers, older adults, research participation, transitional care
S
eventy-eight-year-old Mattie Gilpin has not been taking her medications as prescribed and is consequently hospitalized with worsening symptoms of heart failure. (This is the case of a patient involved in our research; we have changed her name and other identifying details.) After admission she is stabilized quickly and found to have intact orientation and recall but significant limitations in executive function—a form of cognitive impairment that affects the ability to undertake complex tasks such as medication management. A widow, Ms. Gilpin has four sons who care for her but who appear to be unaware of her difficulties in handling her health problems and treatment. During the hospitalization, Ms. Gilpin and her sons are approached and agree to participate in a study of the effects of various nursing interventions on rates of rehospitalization in older adults with cognitive impairment. She is assigned to an advanced practice nurse (APN) who visits Ms. Gilpin in the hospital within 24 hours of enrollment. 44
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During the meeting with Ms. Gilpin and her sons, the APN learns that the sons are sports fans and uses baseball analogies to get them involved. The APN has frank conversations with the Gilpin sons about their need to “step up to the plate” and “take their turn at bat.” But will they be able to ensure that their mother adheres to her medication regimen, attends her medical appointments, and has access to foods that fit her dietary restrictions? The APN explains that to “hit the ball out of the park,” they will need to work together to help their mother meet her goal of continuing to live independently in her apartment. The need for research in this vulnerable population is great. Cognitive deficits in older adults can result from neurodegenerative conditions such as Alzheimer’s disease,1 as well as from progressive chronic diseases such as heart failure2 or acute multifactorial syndromes such as delirium.3 And hospitalization itself can impair cognition in the elderly. A 2012 study, in which older adults were interviewed at three-year intervals for up to 12 years, found that in this population cognition ajnonline.com
By Kathleen McCauley, PhD, RN, FAAN, FAHA, Christine Bradway, PhD, CRNP, FAAN, Karen B. Hirschman, PhD, MSW, and Mary D. Naylor, PhD, RN, FAAN
declines considerably after hospitalization, “even after controlling for illness severity and prehospital cognitive decline.”4 Regardless of their cause, cognitive deficits affect an estimated 8% to 43% of hospitalized older adults and can affect health and quality of life and increase total annual health care costs.3-9 Notably, many hospitalized older patients who have cognitive deficits have no documented history of dementia.5 However, these patients are especially vulnerable to health care systems that ignore or inadequately address their needs.5, 10-12 Too often, cognitive deficits in older adults go unrecognized or, even if identified, are poorly managed. This can set off a cascade of A patient performs the CLOX 1, a clock-drawing task used to assess patients for cognitive impaircostly and often preventable adverse ment. Photo by Ed Eckstein. events during and after hospitalization, including falls, malnutrition, incontinence, functional decline, prolonged or repeated hospitalization, nursing home admission, a 2013 systematic review by Rennke and colleagues and death.3, 5-7, 9, 13-18 found that cognitive impairment or dementia was the Improving the care of such patients may involve most common exclusion criteria in studies on transithe early detection and management of cognitive imtional care.31 19-21 pairment during hospitalization, but the nature Therefore, since current literature suggests that simand intensity of the interventions needed are not ply detecting problems is insufficient to ensure that known. Nor is it certain that universal screening for patients receive the care they need, in 2006 we and delirium in hospitals is the answer; disadvantages can our multidisciplinary colleagues set out to study include “misclassification, subsequent treatment of which of several nursing interventions might improve non-delirious patients or misdiagnosis of those with outcomes in hospitalized older adults suffering from delirium,” according to a 2011 systematic review.22 cognitive impairment, building on our experience in Strategies have been proposed to improve hospital managing transitions in cognitively intact, high-risk and postdischarge outcomes, including systematic asolder patients. Our objective was to compare the efsessment and reporting of patients’ cognitive status to fects of three evidence-based interventions on several health team members, although such interventions primary outcomes involving patients, caregivers, and have not been shown to improve outcomes.23, 24 The costs. We also wanted to test whether well-educated use of hospital resource nurses with special training staff nurses (in an in-hospital intervention) could be in the clinical management of this high-risk patient as effective as transitional care (in a hospital-to-home group has been found to improve nursing staff’s unintervention). derstanding of the older patient’s needs,25 decrease Here, we summarize our methods for testing the delirium (the number and length of episodes),20 and three interventions in our two-phase, comparativeimprove patient function during hospitalization.26 effectiveness clinical trial (a report on the first phase Approaches that focus on episodes of acute illness of this study was published in May 201432) and defrom hospital to home, such as the transitional care scribe the facilitators and barriers found in conducting model (TCM),27-29 have demonstrated benefits among this research. We conclude with our recommendahigh-risk older adults, but until recently these care tions based on lessons learned in implementing this management models have not been tested in those with complex study in real-world clinical settings. cognitive deficits. In fact, Naylor and colleagues’ 2011 systematic review of transitional care interventions on OVERVIEW OF STUDY METHODS rates of hospital readmission found that studies exWe designed a multisite randomized clinical trial to cluded cognitively impaired older adults.30 Similarly, compare three interventions of varying intensities, [email protected]
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each designed to capitalize on nursing’s central role in the care and outcomes of hospitalized cognitively impaired older adults and their family caregivers. Since each of the interventions required changes in care processes that might affect more than the enrolled patients, we were unable to randomly assign patients at each given site. Thus, we elected to test the interventions at three different hospitals, all part of one system that shares standards of care. Also, to minimize threats to the internal validity, we conducted the study in two phases. In phase 1, we tested the three interventions at three different hospitals; interventions were randomly assigned to each site. In phase 2, we implemented the TCM at each site. This design enabled us to provide both cross-site (phase 132) and within-site (phase 1 versus phase 2) comparisons. Eligibility. Inclusion criteria were hospitalized older adults, 65 years of age or older, living in the community within 30 miles of the admitting hospital, who spoke English, had family caregivers willing to participate, and had a preexisting diagnosis of dementia or had been found to have cognitive impairment during hospitalization through our in-person assessments. Exclusion criteria were patients enrolled in Medicare’s hospice or end-stage renal disease programs, patients undergoing treatment for cancer, or those with unmanaged psychiatric conditions or a primary diagnosis of stroke. Cognitive assessments. Prior to cognitive assessment, research assistants—nurses or social workers with bachelor’s degrees—completed an orientation on the standardized instruments as well as the chartabstraction and documentation protocols. Also, each assistant completed online training in research ethics and in the Health Insurance Portability and Accountability Act (HIPAA) (the mean orientation time per research assistant was 40 hours). At weekly meetings, the research assistants and the project manager reviewed data and discussed quality improvement. Daily, the research assistants and the project manager received an electronic list of patients ages 65 and older who had been admitted to each hospital in the prior 24 hours. Data were stored in password- protected files on HIPAA-compliant computer servers. The University of Pennsylvania institutional review board (IRB) approved the screening of patients without requiring their enrollment; we made the case that such cognitive assessment should be but was not the standard of care. Initial patient screenings (that is, chart abstractions for documentation of preexisting diagnoses or assessments for cognitive deficits) were conducted by research assistants within 24 hours of hospitalization, and information from the screening was used to determine eligibility for study participation. For patients without a preexisting diagnosis of dementia, research assistants used the Six-Item Screener (SIS),33 and the CLOX 1, a clock-drawing task,34 to assess for cognitive deficits. In earlier studies, the SIS 46
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(consisting of three orientation and three recall questions) was effective in screening similar patients for cognitive impairment.35, 36 Patients with two errors were considered impaired (a score of 4 or lower in a range of 0 to 6).33 Patients with fewer than two errors were further assessed using the CLOX 1, a subscale of a two-part clock-drawing assessment. This clock-drawing task is strongly associated with executive function, defined as cognitive processes (decision making, memory, attention, focus) that enable planning, problem solving, and completion of daily tasks; it is used for basic assessment but not diagnosis of cognitive impairment. Patients with five or more errors on the CLOX 1 (a score of 10 or lower in a range of 0 to 15) were considered to have cognitive deficits.34 Cognitive findings were verbally communicated to patients’ assigned nurses and physicians (and discharge planners for the higher-dose TCM group) and, within four hours, were documented in patients’ records (and discharge planning system). Documentation for all patients with positive findings from the assessment consisted of a 4" × 4" blue-andwhite sticker containing information about the research and specific findings from chart review and assessment. (The screening protocol can be found at http://bit.ly/1vtb2L1; click the hyperlink for “Documentation and communication of assessment.”) (Editor’s note: For more on assessing cognitive dysfunction, see AJN’s How to Try This series, at http:// bit.ly/HTTT_AJN.) Approximately half the patients identified from chart review were further evaluated for eligibility (N = 5,398) (see Figure 1). Among this group, 1,062 patients (20%) were unable to be approached because of poor health (such as coma or intubation); an additional 553 (11%) refused or were unable to be assessed because of physical impairments (such as hearing or vision deficits). Of the remaining 3,783 patients, 1,884 (50%) had either a diagnosis of dementia (12%) or deficits in orientation or recall based on the SIS or deficits in executive function based on the CLOX 1 (88%). Among those with signs of cognitive deficits, 638 (34%) did not meet other eligibility criteria. Of the final eligible 1,246 patients, 536 (43%) were enrolled, along with 536 family caregivers. Primary reasons for refusals were patients’ or caregivers’ insufficient interest in research. Enrollment. Patients with a prior diagnosis of dementia or whose cognitive impairment was detected by assessment were given information about the study that was reviewed with them and with a family member (usually, the legally authorized representative). Since all patients had some cognitive impairment, the IRB approved that patients could provide assent (indicate willingness) to participate and family caregivers could provide informed consent that would cover both themselves and the patient. These procedures were similar to those recently published in an article ajnonline.com
Figure 1. Enrollment for Study Phases 1 and 2
9374 Patient charts reviewed 3976 Did not meet inclusion criteria 5398 Eligible for further evaluation
3783 Assessed for presence of cognitive deficits
1062 Unable to screen (comatose, intubated, unconscious) 553 Refused or unable to complete screening (injured hand, vision problems)
1899 No cognitive impairment 1884 Met cognitive impairment eligibility criteria 1650 Had deficits in orientation, recall, or executive function 234 Had diagnosis of dementia
638 Did not meet other eligibility criteria 266 Unable to reach a caregiver 127 Unable to identify a caregiver 122 Patient discharged 123 Change in diagnosis, prognosis, or discharge plan
1246 Met all eligibility criteria
536 Enrolled at hospital and provided site-specific dose intervention
[email protected]
710 Not enrolled 271 Patient not interested in research 217 Caregiver not interested in research 63 Patient/caregiver felt they did not need the services 38 Patient refused to give permission to contact caregiver 6 Patient stated “too ill” to participate 115 No reason given for refusal
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on recruitment of dementia patients into research.37 Enrolled patients’ health status, quality of life, and resource use (such as rehospitalization) and family caregivers’ care burden were assessed at two-, six-, 12-, and 26-week intervals after discharge.
THE THREE PROTOCOLS AND FINDINGS
In phase 1 (2006–2008), enrolled patients received care at one of three sites: patients at site 1 received augmented standard care (ASC; the low-dose intervention); at site 2, ASC plus resource nurse care (RNC; medium dose); and at site 3, ASC plus the TCM (high dose). Interventions were randomly assigned to the three participating hospitals. In phase 2 (2008–2010), the same clinical sites were used, but all patients received the TCM protocol (phase 1 enrollees were not eligible for participation in phase 2). Site 1: The ASC protocol sought to determine whether notifying team members of patients’ cognitive deficits would influence care plans and outcomes.38 Once patient assent and caregiver informed consent were obtained, the 4" × 4" sticker was updated to indicate the patient’s enrollment. By design, no additional contact was made between the study team and enrolled patients’ primary nurses, physicians, or discharge planners. Assessment of fidelity to this protocol was maintained by the project manager via quarterly review of patients’ medical records and monthly calculation of time to assessment and enrollment of patients. The ASC protocol was completed in a mean time of 22 minutes per patient. Site 2: The RNC protocol sought to determine what effect preparing hospital RNs to care for or to coach others to care for cognitively impaired older adults would have on patients’ care plans and outcomes.25, 39, 40 The RNC protocol extended from each patient’s enrollment through the index hospital discharge. First, a research assistant implemented the ASC protocol as described above. Next, the assistant notified the unit’s nurse manager of the patient’s enrollment. The nurse manager was asked to assign a resource nurse to the enrolled patient throughout the index hospitalization (if not already assigned). In preparation for their role, resource nurses completed an online education program developed by APNs with expertise in working with cognitively impaired older adults and knowledgeable in the TCM. The content was independently reviewed by two external clinical experts in the care of cognitively impaired older adults (see Table 1 for program topics). This learning experience was designed using written case narratives to improve nurses’ knowledge and decision-making skills in managing hospitalization and discharge of cognitively impaired older adults. (Go to http://bit.ly/1mGSC49 for the RNC training modules.) Nurse managers invited 69 RNs, 57 with bachelor’s or master’s degrees in nursing, to complete the online program; 86% (59 of 69) did so and earned a test 48
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score of 80% or higher—required to be designated a “resource nurse”—in a mean of six hours. Throughout the study, resource nurses were invited to monthly seminars led by study team members on issues relevant to the RNC protocol, but few attended those sessions. Fidelity to the ASC component of this protocol was assessed as described earlier. Similarly, timely assignment of enrolled patients to resource nurses was monitored, but nurses’ contributions to patients’ care plans were not documented consistently, nor was the time devoted to direct care or coaching measured. Site 3: The TCM protocol extended from the index hospitalization through an average of two months after discharge, complementing care delivered in the hospital and substituting for post–acute skilled care provided by nurses in patients’ homes. Adapted from prior studies,27-29 the protocol sought to address the particular needs of this patient group and their family caregivers. APNs with master’s degrees in nursing and at least one year of clinical experience in the team-based care of older adults completed the RNC modules, as well as TCM-specific modules and individualized learning experiences guided by clinical experts. Over a one-month period, each APN spent a mean of 100 hours in orientation. Within 24 hours of patient enrollment, including application of the ASC protocol, an APN assigned by the project manager completed in-person assessment of the patient’s and family caregiver’s needs and goals; the APN visited the patient daily while hospitalized and collaborated with team members to implement care plans aimed at improving management of acute conditions complicated by cognitive impairment and preventing adverse events. The same APN visited the patient’s home within 24 hours of discharge, at least weekly during the first month, and at least every other week through completion of the intervention. APNs accompanied patients and family caregivers to their first postdischarge primary care visits to promote continuity of care. APNs also conducted telephone outreach and were available by phone seven days per week, working collaboratively with primary care clinicians to ensure smooth transitions following completion of this protocol.41 APNs documented assessments, patient and caregiver high-priority problems, and interventions and wrote case narratives.41 APNs met bimonthly with two clinical experts to review cases. The mean number of visits per patient was 11 and calls was 10. Fidelity to the TCM intervention protocol was also assessed. Results of phase 1 were published earlier this year.32 Of the 202 patients and family caregivers (a subset of the final 536 patients and caregivers) enrolled at the three sites, 65 received ASC, 71 RNC, and 66 the TCM. We found that 25% of patients were rehospitalized or died by day 33 in the ASC group, by day 58 in the RNC group, and by day 83 in the TCM group. The TCM protocol also showed lower ajnonline.com
Table 1. Training for Resource Nurse Certification Module Section
Content
Introduction
•• Enhancing care coordination in the presence of memory and thinking problems
Understanding cognitive impairment
•• What is dementia? •• What is delirium? •• Complicating factors
Assessing your patient with cognitive impairment (memory and thinking problems)
•• Neuropsychological screening and assessment •• Nursing assessment in the presence of cognitive impairment •• Physical assessment in the presence of cognitive impairment
Providing education and support from hospital to home
•• Discharge planning •• Understanding and managing common behaviors associated with cognitive impairment in the elderly •• From hospital to home: educating families on day-to-day issues •• Advance care planning and assessing capacity
Enhancing care coordination
•• Interactive case study
Building on the foundation
•• Managing memory impairment
Source: Transitional Care Model. Expanding TCM for cognitively impaired older adults and their family caregivers. University of Pennsylvania School of Nursing; 2013.
er-patient 30-day rehospitalization rates than either p the RNC or ASC protocols. We found no significant differences in functional status between groups. These are the first findings to suggest that the TCM may decrease costs and improve postdischarge outcomes in cognitively impaired older adults and their caregivers. Also, rather than comparing the TCM to a similar group receiving standard care, this study examined the performance of the TCM relative to other evidence-based interventions of varying intensities. Evidence suggests that ASC should be the standard of care.38 RNC capitalized on the critical role of hospital nurses in anticipating and responding to the clinical challenges posed by high-risk patient groups with complex physical and cognitive needs. This study’s phase 1 findings may have a role in determining how systems may better engage complex patients and their family caregivers. Along the way we encountered several challenges in testing new care models in a health care system where the primary commitment is not research but rather the care of patients—and where these can be seen as competing priorities. How might research be better aligned to real-world practice?
FACILITATORS AND BARRIERS TO EMPLOYING THE PROTOCOLS
We assessed multiple data sources in determining the facilitators and barriers we encountered in implementing the three interventions, including minutes from study-team meetings; notes from APN meetings [email protected]
with clinical experts; and recollections from investigators, research assistants, and APNs. An analysis of the specifics of the TCM intervention based on the use of APNs’ written case narratives is published elsewhere.41 Overall facilitators. Several factors influenced our ability to achieve the study’s aims. The health care system involved has long been dedicated to interdisciplinary, innovative care of older adults. At each hospital, nurse champions helped in establishing the relationships needed to launch the study and deploy team members (such as the research assistants). When the study began, hospital leaders expressed their commitment to enhancing patient safety and preventing adverse events such as avoidable rehospitalizations. Indeed, enhancing care transitions became a systemwide priority during the study period. The tools used to assess cognitive status were easy to administer, posing limited burden on patients or nurses. Also easing communication among clinicians at all sites were interprofessional patient rounds, documentation in integrated progress notes, and an online discharge-planning system. Overall barriers. We encountered some problems with recruitment. This study required the participation of family caregivers because the risk of poor outcomes increases if cognitively impaired patients have inadequate social support.42 Nearly half (1,884 of 3,783) of patients assessed in both phases of our study were found to have cognitive deficits, but despite the use of multiple strategies, some caregivers (393 of 1,884, or 21%) could not be identified or reached during the hospital stay, while others (217 of AJN ▼ October 2014
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1,246, or 17%) were unwilling to participate. Cognitive assessments across all three sites revealed previously unidentified deficits in 46% (1,650 of 3,549) of the hospitalized older adults assessed in our study. Understandably, some patients and caregivers found this upsetting. Research assistants had been prepared for a range of responses and assured the patients, the family members, and the health care team that the assessment findings signaled a deficit at one moment in time but was not diagnostic. Even after research assistants made many efforts (often over multiple visits) to explain the meaning of these assessment results and their potential implications for plans of care, some patients and family caregivers could not acknowledge deficits, presenting challenges to the research team in enrolling dyads. In addition, 20% of patients were not screened owing to poor health. Thus, patients with a possibly higher risk of poor outcomes did not receive the potential benefits of the protocols.
Partnerships result in better research and better practice. RNC facilitators. Based on prior testing of the RNC model, we knew that a voluntary process would engage more nurses. Nurse champions at Site 2 initially promoted the study and assisted in identifying potential nurses to participate. Designation as a resource nurse was acknowledged through a variety of modest mechanisms (such as a certificate). We focused on two units, where nurses were given time during the workday at a computer lab to complete the training, and many were excited to further their education. The evidence-based modules encouraged nurses to learn at their own pace. Nurses had various levels of expertise in caring for cognitively impaired older adults, and we asked for intermittent self-assessment of their progress during the modules. RNC barriers included inadequate resources. In retrospect, we realize that our use of a voluntary model did not account for the day-to-day pressures on the nursing leadership team and the bedside nurses. Specifically, the study design and funding did not adequately support, recognize, or reward resource nurses. Early on, we realized it was not possible to recruit enough nurses to cover all shifts on all units that might admit eligible patients. In response, and in collaboration with the nursing leaders, the team focused on recruitment of resource nurses from two highvolume units and invested study funds to reimburse the hospital for the time required for nurses to complete the modules. Nurses’ initial enthusiasm waned over time, but we persevered and, with the support of the nurse champions, achieved the modest engagement of staff nurses. 50
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Also, in order to approximate a real-world model of influencing nursing practice, we did not monitor the ongoing implementation of the RNC intervention. While we assessed that nurses acquired the knowledge needed to be resource nurses, we made no further effort to influence their care or coaching practices. Consequently, we acquired little data on how this training affected the care delivered to enrolled patients receiving the RNC protocol. TCM facilitators. Acceptance of the importance of the APN role in the TCM facilitated implementation of this protocol. Our history of multidisciplinary collaboration with the health system led to positive working relationships. The involvement of APNs with the same older adults and family caregivers from hospital to home fostered the subsequent collaborations between patients, caregivers, and clinicians.41, 43 APNs also encouraged relationships with community organizations that fostered sustainable plans of care. During biweekly one-hour case conferences, two of us (KM and CB) conducted root-cause analyses of positive and negative outcomes. This mentoring of the APNs facilitated problem solving. Consultation with other experts (gerontology–psychiatric nurse specialists, nutritionists, and a pharmacologist) also addressed knowledge gaps. As highly skilled providers, the APNs promoted care coordination and interprofessional collaboration, assisting care in the hospital and in the community. For example, collaboration with home care and palliative care programs eased the transition of patients to these services. TCM barriers. Study personnel needed to negotiate their roles within established inpatient and outpatient teams. This required that APNs and investigators teach clinical colleagues about the APNs’ potential contributions, including facilitating team effectiveness in managing the patient. Distrust emerged when other clinicians on the team perceived the APN as interfering with or usurping their role. The TCM APNs routinely participated in patient care rounds and discussed the enrolled patients with the nurses and physicians responsible for their care. It was part of the APNs’ research role to ensure that the care provided was evidence based and consistent with recognized strategies to decrease delirium and manage each patient’s health concerns. While the APNs were credentialed as APNs in the health system, they were not employees of these hospitals and had to negotiate their role on the health care team. Conflicts sometimes arose when APNs sought a balance between a patient’s readiness for discharge and the caregiver’s readiness to manage care at home. In most such cases, the APN supported families through this transition. On a few occasions, however, the APN identified safety issues and negotiated an additional day or two of hospitalization to ensure that needed community resources were in place. Most of the time, such dilemmas were amicably resolved, but they ajnonline.com
r equired of the APN a high level of communication skill and clinical acumen, as well as established trust among team members.
LESSONS LEARNED
Our experience provides important lessons that we hope can inform the conduct of complex studies, especially in vulnerable populations. Lesson 1: Make cognitive assessment of hospitalized older adults a standard of care. Because 46% of the older adults assessed in our study showed signs of previously undetected cognitive impairment, we recommend that all older adults hospitalized for an acute condition be assessed for signs of cognitive impairment. We do not advocate the use of any single screening tool in hospitals but rather encourage detection of cognitive impairment. As Shenkin and colleagues have written, “We argue for a change in attitude to identification of cognitive impairment in the general hospital from ‘screening’ to it being seen as part of normal systems examination.”44 The assessment tools used must achieve a difficult balance: providing an accurate and comprehensive assessment while ensuring that patients and clinicians are not unduly burdened. Loss of executive function, for instance, interferes with a patient’s ability to make decisions, follow instructions in post–acute care settings, and adjust to the ongoing demands of living with and managing an illness; patients with such deficits require targeted assistance to ensure optimal outcomes. The CLOX 1 instrument,34 which requires little time to complete, has been shown to be helpful in detecting loss of executive function—but it should not be used alone. We recommend that future standard-of-care cognitive assessments include assessment for delirium. Lesson 2: Overcome barriers to learning health systems. A strong partnership between health care organizations and study teams is essential to accomplishing the aims of the study. A recent Institute of Medicine (IOM) report described the need for “a continuously learning health care system,”45 one that, among other intentions, fosters innovation by facilitating clinical research. Incentives for clinicians might include career ladders or systems that facilitate evidence-based practice accompanying Magnet designation. Study teams must fully engage such partnerships. Optimally, nursing leaders, clinical staff, and researchers share a commitment to the goals of designing research to solve problems. We recommend involving clinical colleagues in study design and jointly planning how the study will be most efficiently implemented. We should have made a stronger case with administrators and clinicians that active participation in the study would provide tangible benefit. Including nursing and other leaders (such as coinvestigators or members of advisory committees) would have advanced our study’s goals. We offered a state-of-the-science educational program for staff nurses but fell short in convincing our clinical [email protected]
partners that changes in care processes could enhance patient outcomes. As the IOM report states, research and clinical practice cannot afford to be separate ventures: “To achieve strong provider participation in the learning enterprise, data capture must be seamlessly integrated into providers’ daily workflow and must not disrupt the clinical routine.”45 Lesson 3: Routinely involve family caregivers. One of the largest hurdles we confronted was in engaging family caregivers. The challenge involved identifying, finding, and establishing relationships with caregivers in order to involve them in the trial. Their time in the hospital is often brief, therefore limiting our ability to engage them quickly. Our experience with caregivers in this study taught us that many are balancing enormous burdens caring for a loved one while meeting other responsibilities such as a job or children. Hospitalization of a frail elder may provide a respite for caregivers, but the patient often returns home with greater, if temporary, functional deficits. All of this is complicated by our lack of societal emphasis on caregiving. Many of the patients in this study had inadequate caregiving support networks. Based on available evidence,46 we believe that the challenges we faced in engaging family caregivers relate primarily to health system barriers to including family caregivers, especially in complex transitions. In particular, a recent report emphasizes that clinicians must change how they relate to family caregivers in daily practice and that policymakers should take family caregivers into account when creating new models seeking to improve care quality.46 In conclusion, by describing the complexity of our study’s design and the facilitators and barriers we faced in implementing our study protocols, we hope to provide a roadmap for other researchers seeking to improve the care of vulnerable older adults. Strong partnerships between researchers and health system leaders, coupled with ongoing communication, from study inception to completion, are critical to both science and practice. While the divide between the health care we have and the care we could have is changing with the passage of the Affordable Care Act, the experience reported here provides insights for a new partnership between researchers and clinicians that can aid in continuing to bridge the gap. ▼ Kathleen McCauley is associate dean for academic programs, the Class of 1965 Reunion Term Professor of Cardiovascular Nursing, and a member of the NewCourtland Center for Tran sitions and Health at the University of Pennsylvania School of Nursing, Philadelphia, where Christine Bradway is a member of the Center for Integrative Science in Aging and an associate professor of gerontological nursing, Karen B. Hirschman is a research associate professor and member of the NewCourtland Center for Transitions and Health, and Mary D. Naylor is the Marian S. Ware Professor in Gerontology and the director of the NewCourtland Center for Transitions and Health. All au thors are members of the Department of Biobehavioral Health
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Sciences at the University of Pennsylvania School of Nursing. The authors received support from the National Institute of Aging (R01AG023116) and the Marian S. Ware Alzheimer Dis ease Program at the University of Pennsylvania. Contact au thor: Kathleen McCauley, [email protected]. The authors have disclosed no potential conflicts of interest, finan cial or otherwise.
REFERENCES 1. Thies W, et al. 2013 Alzheimer’s disease facts and figures. Alz heimers Dement 2013;9(2):208-45. 2. Heckman GA, et al. Heart failure and cognitive impairment: challenges and opportunities. Clin Interv Aging 2007;2(2): 209-18. 3. Inouye SK. Delirium in older persons. N Engl J Med 2006; 354(11):1157-65. 4. Wilson RS, et al. Cognitive decline after hospitalization in a community population of older persons. Neurology 2012; 78(13):950-6. 5. Boustani M, et al. Impact and recognition of cognitive impairment among hospitalized elders. J Hosp Med 2010;5(2): 69-75. 6. Boyd CM, et al. Recovery of activities of daily living in older adults after hospitalization for acute medical illness. J Am Geriatr Soc 2008;56(12):2171-9. 7. Bynum JP, et al. The relationship between a dementia diagnosis, chronic illness, medicare expenditures, and hospital use. J Am Geriatr Soc 2004;52(2):187-94. 8. Leslie DL, et al. One-year health care costs associated with delirium in the elderly population. Arch Intern Med 2008; 168(1):27-32. 9. Sands LP, et al. Cognitive screening predicts magnitude of functional recovery from admission to 3 months after discharge in hospitalized elders. J Gerontol A Biol Sci Med Sci 2003;58(1):37-45. 10. Arora VM, et al. Relationship between quality of care of hospitalized vulnerable elders and postdischarge mortality. J Am Geriatr Soc 2010;58(9):1642-8. 11. Naylor MD, et al. Cognitively impaired older adults: from hospital to home. Am J Nurs 2005;105(2):52-61. 12. Swigart SE, et al. Misdiagnosed delirium in patient referrals to a university-based hospital psychiatry department. Psy chosomatics 2008;49(2):104-8. 13. Hitcho EB, et al. Characteristics and circumstances of falls in a hospital setting: a prospective analysis. J Gen Intern Med 2004;19(7):732-9. 14. Krauss MJ, et al. A case-control study of patient, medication, and care-related risk factors for inpatient falls. J Gen Intern Med 2005;20(2):116-22. 15. Mecocci P, et al. Cognitive impairment is the major risk factor for development of geriatric syndromes during hospitalization: results from the GIFA study. Dement Geriatr Cogn Disord 2005;20(4):262-9. 16. Mitchell SL, et al. The clinical course of advanced dementia. N Engl J Med 2009;361(16):1529-38. 17. Pedone C, et al. Elderly patients with cognitive impairment have a high risk for functional decline during hospitalization: the GIFA Study. J Gerontol A Biol Sci Med Sci 2005; 60(12):1576-80. 18. Thornlow DK, et al. Cascade iatrogenesis: factors leading to the development of adverse events in hospitalized older adults. Int J Nurs Stud 2009;46(11):1528-35. 19. Fong TG, et al. Delirium in elderly adults: diagnosis, prevention and treatment. Nat Rev Neurol 2009;5(4):210-20. 20. Inouye SK, et al. A multicomponent intervention to prevent delirium in hospitalized older patients. N Engl J Med 1999; 340(9):669-76. 21. Inouye SK, et al. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med 1990;113(12):941-8. 22. Greer N, et al. Delirium: screening, prevention, and diagnosis— a systematic review of the evidence. Washington, DC: Department of Veterans Affairs; 2011. VA evidence-based synthesis program reports. https://www.ncbi.nlm.nih.gov/books/ NBK82554.
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23. Boustani MA, et al. Enhancing care for hospitalized older adults with cognitive impairment: a randomized controlled trial. J Gen Intern Med 2012;27(5):561-7. 24. Cole MG, et al. Systematic detection and multidisciplinary care of delirium in older medical inpatients: a randomized trial. CMAJ 2002;167(7):753-9. 25. Fulmer TT. Grow your own experts in hospital elder care. Geriatr Nurs 1991;12(2):64-6. 26. Wanich CK, et al. Functional status outcomes of a nursing intervention in hospitalized elderly. Image J Nurs Sch 1992; 24(3):201-7. 27. Naylor M, et al. Comprehensive discharge planning for the hospitalized elderly. A randomized clinical trial. Ann Intern Med 1994;120(12):999-1006. 28. Naylor MD, et al. Comprehensive discharge planning and home follow-up of hospitalized elders: a randomized clinical trial. JAMA 1999;281(7):613-20. 29. Naylor MD, et al. Transitional care of older adults hospitalized with heart failure: a randomized, controlled trial. J Am Geriatr Soc 2004;52(5):675-84. 30. Naylor MD, et al. The care span: the importance of transitional care in achieving health reform. Health Aff (Mill wood) 2011;30(4):746-54. 31. Rennke S, et al. Hospital-initiated transitional care interventions as a patient safety strategy: a systematic review. Ann Intern Med 2013;158(5 Pt 2):433-40. 32. Naylor MD, et al. Comparison of evidence-based interventions on outcomes of hospitalized, cognitively impaired older adults. J Comp Eff Res 2014;3(3):245-57. 33. Callahan CM, et al. Six-item screener to identify cognitive impairment among potential subjects for clinical research. Med Care 2002;40(9):771-81. 34. Royall DR, et al. CLOX: an executive clock drawing task. J Neurol Neurosurg Psychiatry 1998;64(5):588-94. 35. Hirschman KB, et al. Cognitive impairment among older adults in the emergency department. West J Emerg Med 2011;12(1):56-62. 36. Wilber ST, et al. The six-item screener to detect cognitive impairment in older emergency department patients. Acad Emerg Med 2008;15(7):613-6. 37. Batchelor-Aselage M, et al. Research with dementia patients in the nursing home setting: a protocol for informed consent and assent. IRB 2014;36(2):14-20. 38. Cole MG. Delirium in elderly patients. Am J Geriatr Psychi atry 2004;12(1):7-21. 39. Rapp CG, Iowa Veterans Affairs Consortium. Evidencebased protocol: acute confusion/delirium. Iowa City, IA: University of Iowa Gerontological Nursing Interventions Research Center, Research Dissemination Core; 1998. Series on evidence-based practice for older adults. 40. Sendelbach S, Guthrie PF. Acute confusion/delirium. Rockville, MD: Agency for Healthcare Research and Quality, National Guideline Clearinghouse; 2009 Mar. http://www. guideline.gov/content.aspx?id=14340%20. 41. Bradway C, et al. A qualitative analysis of an advanced practice nurse-directed transitional care model intervention. Gerontologist 2012;52(3):394-407. 42. Naylor MD, et al. Care coordination for cognitively impaired older adults and their caregivers. Home Health Care Serv Q 2007;26(4):57-78. 43. Bradway C, et al. Case study: Transitional care for a patient with benign prostatic hyperplasia and recurrent urinary tract infections. Urol Nurs 2013;33(4):177-9, 200. 44. Shenkin SD, et al. Screening for dementia and other causes of cognitive impairment in general hospital in-patients. Age Ageing 2014;43(2):166-8. 45. Smith M, et al., eds. Best care at lower cost: the path to con tinuously learning health care in America. Washington, DC: National Academies Press; 2013. http://www.nap.edu/catalog. php?record_id=13444. 46. Reinhard SC, et al. Home alone: family caregivers providing complex chronic care. Washington, DC: AARP Public Policy Institute; United Hospital Fund; 2012 Oct. http://www.aarp. org/content/dam/aarp/research/public_policy_institute/health/ home-alone-family-caregivers-providing-complex-chroniccare-rev-AARP-ppi-health.pdf. ajnonline.com
