ORIGINAL ARTICLE
Concepts for the Development of a Customizable Checklist for Use by Patients Rohesh J. Fernando, MD,* Fred E. Shapiro, DO,‡ Noah M. Rosenberg, MD,† Angela M. Bader, MD, MPH,§ and Richard D. Urman, MD, MBA|| Objectives: Checklists are tools that are developed to complete tasks by drawing on specific and relevant knowledge and supporting communication at critical times. If checklists were designed specifically for patient use, they could promote patient engagement, potentially leading to improved quality of care. Physicians of all specialties, nurses, patients, patient advocates, and administrators can take an active role in checklist development and dissemination. Methods: Our method to investigate concepts in developing a customizable patient checklist included a literature search concerning existing checklists and resources currently available to patients. Literature containing expert opinion regarding checklists, professional organization statements, and patients and providers were consulted. Results: A template for designing a patient checklist was developed incorporating methods from previous literature and resources regarding checklists. This template includes a development, drafting, and validation phase. Sample content for inclusion in potential checklists for patients with diabetes and patients undergoing anesthesia was devised. Conclusions: Developed by physicians with input from patients and other involved health-care providers such as nurses, this relatively novel concept of a patient’s checklist creates a role for the patient to ensure their own safety. With increasing attention to high-quality and cost-effective health care, patient satisfaction surveys will be assessed to rate overall health care. Further development of checklists will need to be guided by specific medical conditions and acceptance by patients and providers. Providers can use these checklists as a method to gauge a patient’s understanding of an intervention, solidify the patient-doctor relationship, and improve patient safety. Key Words: patient checklist, quality improvement, patient safety, patient satisfaction, patient centeredness, diabetes, anesthesia checklist, patient education (J Patient Saf 2015;00: 00–00)
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ncouraging patients to share decision making with medical providers is essential to enhancing the quality of health care. In medicine, there are often multiple treatments that can be administered for a given condition with no known superior course of action. In such instances, patients’ preferences should be paramount and must guide clinical decisions. As it stands, health
From the *Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston; †Department of Family Medicine & Community Health, University of Massachusetts Memorial Medical Center, Worcester; ‡Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center; §Department of Anesthesia, Critical Care, and Pain Medicine, and ||Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA. Correspondence: Richard D. Urman, MD, MBA, Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women’s Hospital, 75 Francis Street, Boston MA 02115 (email: [email protected]). The authors disclose no conflict of interest. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.
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care is full of opportunities to improve patient-centered medicine— defined as where the primary focus is on the patient’s needs and concerns.1 Physicians and other medical providers need to adopt a systematic approach consisting of patient decision aids such as checklists to empower patients to exercise their own selfdetermination. This would ensure that treatment goals align with the individual patient’s values and predilections, possibly conferring a safety and/or outcomes benefit. The scale of the problem can be illustrated by the dramatic variation in medical and surgical practice across the regions of the United States. For example, consider treatment for prostate cancer. In the Medicare population, there is almost sevenfold variation in the rate of radical prostatectomy for prostate cancer.2 These variations in surgery may exist because of medical evidence suggesting that other alternatives like external-beam radiation therapy and brachytherapy are clinically equivalent when it comes to overall survival rates among early stage cancers.3 In cases where options are clinically equivalent, it would seem reasonable to allow patient preference to dictate treatment. However, the discrepancy in diagnostic and treatment patterns does not seem to reflect patients’ preferences for care.4 Although another possible explanation is that each of these patients had different health comorbidities that made certain options more desirable, the preponderance of health services research indicates that these divergences in care utilization do not stem from differences in patients health status or demographics.3 Rather, this variation has been attributed to the willingness and ability of doctors to provide certain treatments.2 The presence of these unwarranted geographic variations and deficiencies in health-care patient-centeredness has precipitated calls for greater patient engagement, defined as patient involvement in the decision-making process in matters pertaining to health. This call was further substantiated by a study revealed that in more than 1000 office encounters in which more than 3500 health-care decisions were made, only 9% of decisions met the minimum standards of informed decision making.5,6 As a result, a variety of patient decision aids are being used to educate patients and their families about different treatment options for a given medical condition.6 A patient decision aid is a tool designed to make the decision explicit, describe options, and explain risks and benefits of each option.7 They may include written publications, videos, and electronic presentations. However, a checklist may be a better alternative. Although checklists can incorporate all of the knowledge-based components of a decision-aid, they also promote communication at the most crucial times. Because of their systematic approach, use of checklists can also help with detecting and preventing errors, also known as “error-trapping.8” Specifically, checklists ideally address errors of ineptitude—that is to say errors which are made not because those involved did not have the knowledge but rather they did not know how to properly use the knowledge.9 Although checklists have been used and integrated into a variety of medical settings, the use of a checklist with patients as the user has not been significantly explored. Perhaps one reason for this is provider resistance. Even with checklists designed for www.journalpatientsafety.com
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providers, clinicians often cite barriers such as lack of time, no mandate to use such tools, and no need for such tools.10 However, there are many potential benefits to using checklists. Checklists can facilitate shared decision making, defined as a shared process of making a selective intellectual judgment when presented with several complex alternatives consisting of several variables and usually defining a course of action or an idea. In addition, as informal caregivers such as family members and healthcare advocates become increasingly part of the decision-making milieu, treating an individual patient now rarely entails interacting with just one person. A patient’s checklist is uniquely positioned to help navigate this milieu as it promotes knowledge, communication, and preventing errors8,9 in a setting that may include multiple caregivers. Given that a patient’s checklist is a novel concept, a guide to develop such a checklist could prove useful to aid providers in educating their patients and helping them to play a more integral role in their health care. This paper provides a framework for developing a patient’s checklist.
METHODS A Medline search was performed using Medical Subject Headings (MeSH) Terms patient, and decision aid with 604 hits. When checklist was added as a MeSH term, no studies were found regarding a checklist designed with patients as the end user. To develop a methodology to design a checklist, literature concerning existing checklists and resources currently available to patients regarding medical care was reviewed.11–15 Patients and providers were consulted regarding the creation of checklists. Literature containing expert opinion regarding checklists was also consulted, including statements from professional societies such as the American College of Obstetrics and Gynecology as well as the Institute of Medicine.8,16–18 A template specific for a patient-centered checklist was designed after examining the methodology in these resources and adapted based on a previously published “Checklist for Checklists.”19 Sample content for a checklist was then developed for patients with diabetes after researching evidence-based guidelines. An additional example was designed for use by patients based on common anesthetic questions and concerns.20
RESULTS Concepts in Designing a Patient’s Checklist A patient’s checklist should incorporate attributes that have made previous safety checklists extensively used and applicable to a variety of clinical situations. A “Checklist for Checklists”— designed by Dr. Atul Gawande, of The Brigham and Women’s Hospital Center for Surgery and Public Health Dissemination Team, and Dan Boorman of Boeing—is illustrative of how any checklist should be structured to ensure usability and clinical effectiveness.19 Table 1 summarizes the different phases and respective steps needed to generate checklists for patient use. These drafting guidelines use many of the same principles of “Checklists for Checklists.”
A Checklist for Patient Checklists: Development Phase The initial development phase of any checklist should entail the formation of a care redesign team. This team should consist of patients, clinicians, staff, and other stakeholders. During this period, care redesign teams will have to decide the scope of
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health-care services that a patient’s checklist should encompass. A patient’s checklist would not be suitable for medical emergencies in which imminent, life-altering decisions need to be made. In contrast, a patient’s checklist would be most optimal for patients who have medical conditions in which there are multiple treatment options and scientific evidence does not overwhelmingly support the use of one therapy over other alternatives. Furthermore, the available options should involve significant tradeoffs that would affect the patient’s quality and length of life. Medical conditions in which a patient’s checklist would be most appropriate include—but are not limited to—osteoarthritis of the hip and knee, lower back pain secondary to a herniated disc, stable angina, benign prostatic hypertrophy, and early-stage prostate and breast cancer.21 Health-care groups that are interested in adopting a patient’s checklist would also need to determine a suitable time in the clinical-decision pathway when use of the checklist is most appropriate. For example, many angioplasties are unplanned procedures performed during diagnostic coronary angiography. Consequently, there is limited time for an informed discussion about treatment alternatives.22 In such situations, a patient’s checklist would be most applicable before diagnostic intervention at a natural pause point in the care pathway. For situations in which considerable time elapses between the diagnosis and treatment, a patient’s checklist could be considered after relevant diagnostic tests have taken place. In the initial development period, care redesign teams should focus on ascertaining issues and steps that are frequently omitted from clinician-patient discussions regarding therapeutic options. Although convening such a team may seem onerous, a number of groups, including Dr. Gawande’s at the Brigham and Women’s Hospital, have successfully done so. In terms of operationally defining issues and steps that are frequently omitted, this entails identifying care critical information, without which a patient could not be said to be making an informed decision. Health-care institutions may need to convene focus groups consisting of patients, clinicians, and other health-care staff for people to verbalize expectations of care. It is crucially important to balance the specificity and generality of any decision making aid, including a checklist, such that a variety of distinct medical conditions could be discussed even if they are not the checklist’s main focus.
A Checklist for Patient Checklists: Drafting Phase The second phase in engineering a patient’s checklist is the drafting phase. This period should focus on making the checklist legible, uncluttered, and consistent with the workflow of the health-care institution. First, a pause point must be defined; this is an event whose occurrence should always trigger the use of the checklist. Each section of the patient’s checklist should correspond to a unique pause point along the continuum of a patient’s care. For the checklist to properly mesh with the workflow of the health-care institution, each checklist section should contain less than 10 items. This will prevent the checklist from becoming overly taxing to the patient. Each checklist item should be able to be easily read aloud by patients. This would serve as an explicit verbal cue for physicians to guarantee that the issue is not missed. Also, the patient’s checklist should be styled in a fashion that facilitates easy reading as suggested by the drafting steps listed in Table 1. For example, the patient’s checklist should be no more than one page long and should be typed in a simple, large font like sans serif. Because these checklists will be used by patients, care redesign teams should ensure that the checklist is brief and written at an eighth grade level.23 © 2015 Wolters Kluwer Health, Inc. All rights reserved.
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Customizable Checklist for Patient Use
TABLE 1. Designing a Patient’s Checklist Development
Drafting
Does the checklist: □ Has a care redesign team been established? □ Utilize natural breaks (“pause points”) in workflow? □ Is the team broadly representative of patients, □ Use simple sentence structure and providers, and other stakeholders? language (written at an 8th grade level)? □ Which clinical conditions will be covered □ Have a simple, uncluttered, by the patient’s checklist? logical format? □ When will the patient’s checklist be used? □ Fit on one page? □ Have participants verbalized missteps that arise during patient encounters? □ Does each checklist item address a critical step that is missed during patient encounters?
□ Minimize use of color? □ Have a title that reflects its objectives? Is the font: □ Easy to read? □ Upper and lower case text? □ Large enough?
Validation □ Are key processes and outcomes being measured? □ Has the checklist been trialed in simulated settings? □ How did the checklist affect quality measures during simulation trials? □ Was the checklist modified after it was tested in simulations? □ Has the checklist been tested in real clinical settings? □ How did the checklist affect quality measures in real clinical settings? □ Was feedback received from patients and providers? □ How did the checklist affect workflow? □ Was the checklist completed in a reasonable amount of time? □ Was the checklist revised after it was adopted into clinical practice?
□ Dark on a light background? □ Does each pause point contain less than 10 items? If the answer to any question is “No,” then please pause and address the question with your team before proceeding. Adopted from: Reference #19. Checklist for Checklists. Available at: http://www.projectcheck.org/checklist-for-checklists.html. Accessed January 13, 2014.
A Checklist for Patient Checklists: Validation Phase The last step for devising a patient’s checklist is the validation phase. The checklist should be implemented in both real and simulated environments. One recent study demonstrated the value of checklists in simulated crises, indicating that critical processes of care were less likely to be missed if providers used a checklist rather than memory alone.24 Care redesign teams should identify key processes and outcomes of care—including measures of morbidity, mortality, and patient and provider satisfaction—to evaluate the effectiveness of the patient’s checklist.25 For example, before dissemination of the checklist into real settings, a health-care institution should consider first assessing the impact of the checklist on outcome and process metrics in simulations. After evaluating the efficacy of a patient’s checklist in more controlled settings, care redesign teams should modify the checklist accordingly before the intervention diffuses into clinical settings.
Example 1: Sample Content for Checklist for a Diabetic Patient One example of a patient’s checklist that would be most applicable to the outpatient office setting would be for patients diagnosed with diabetes. A patient can refer to it during visits with their provider. A diabetes checklist would be particularly useful not only because of its high prevalence in the general population but also because of the considerable practice variation related to diabetic care. This is especially true given recent guideline changes in cardiovascular and hypertension risk factor management.26,27 A simple, evidence-based checklist can help narrow provider-related differences in the optimal care that a diabetic patient receives within a physician group. Table 2 provides © 2015 Wolters Kluwer Health, Inc. All rights reserved.
sample content that may be used to develop a patient’s diabetes checklist, using the adapted template in Table 1. Table 2 outlines multifaceted aspects of complex medical care a diabetic patient should be educated about and can help position the patient to partake in shared decision making. Error trapping can also be incorporated by preventing unnecessary lapses in diabetic care. The intent is that once a checklist is created, the patient would refer to it during and between health-care visits or treatments.
TABLE 2. Sample Content for a Diabetes Patient’s Checklist: “Questions to Ask Your Doctor About Diabetes Care” □ Were you told which medications would help you improve blood sugar control? □ Were you told about how aspirin can reduce diabetic heart disease? □ Were you told about how cholesterol medications can reduce diabetic heart disease? □ Were you told about blood pressure goals for diabetics? □ Were you told about urine testing for diabetic kidney disease? □ Were you told about whether you would benefit from blood pressure medications called ACE inhibitors? □ Were you told about getting a routine diabetic eye exam? □ Were you told about diabetic foot care and hygiene? □ Were you told about the need for getting vaccinated for the flu and pneumonia? □ Were you told about the importance of losing weight and increasing exercise? If the answer to any question is “No,” then please pause and discuss the question with your provider before proceeding.
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TABLE 3. Sample Content for an Anesthesia Patient’s Checklist: “Questions to Ask your Doctor about Anesthesia Before Surgery” □ Were you told about the different types of anesthesia and the type that you would be getting (local vs regional vs sedation vs general)? □ Were you told about whether your current medical conditions affect the risk to undergo anesthesia? □ Were you told what medications you should or should not take before surgery? □ Were you told when you can last eat/drink before surgery and why this is important? □ Were you told how you will be monitored while the anesthesia is administered? □ Were you told who will be watching you both during and after surgery/anesthesia? □ Were you told what to expect in the recovery room and how long you may be there while recovering from anesthesia? □ Were you told about methods to deal with post-operative pain and nausea/vomiting after surgery? If the answer to any question is “No,” then please pause and discuss the question with your provider before proceeding.
Example 2: Sample Content for a Checklist for a Patient Requiring Anesthesia Table 3 illustrates sample content for another potential checklist concerning anesthesia designed for a patient about to undergo surgery. A patient may not be familiar with the different types of anesthesia in terms of what they mean and what to expect. Furthermore, they may not be aware that a procedure can often be done with different types of anesthesia. A future checklist that included this sample content could incorporate error trapping by ensuring patients are completely informed. Furthermore, it could encourage shared decision making by enabling patients to voice a preference where several types of anesthesia may be equally suitable.
DISCUSSION There is known evidence regarding the benefits of checklists when used by providers. For example, one such study investigated the reduction in morbidity and mortality in patients undergoing surgery.28 Although checklists have gained more acceptance after documented benefit in the surgical perioperative setting, their use should not be limited to that period. Many providers have expanded the role of the checklist to help in other medical arenas. A cardiology group, for instance, was able to decrease hospital readmission and improve adherence to the latest guidelines with heart failure patients.29 Another group used checklists to improve care in the ICU.30 Other uses include development of a checklist to help providers refer stroke patients at risk for long-term disability for further treatment based on a patient questionnaire14 and a checklist that was made to help providers doing inpatient rounds to ensure that a comprehensive review of each patient was performed.15 Although these tools have been developed to help providers become more engaged in health care, these checklists have not been significantly explored to further engage patients. Karen Curtiss, for example, has long been a patient safety advocate and is one of the few to consider this idea. She compiled several checklists to help patients and providers to be “on the same page.31” Although her checklists have similar goals to what is being proposed in this paper, they require the patient to seek out
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such tools and to take initiative. Furthermore, the patient’s provider may be unfamiliar with such a tool, and the full potential of the checklist may be impeded by lack of familiarity. For these reasons, it is imperative that clinicians adopt checklists as patient advocates and incorporate them into the health-care infrastructure. The framework provided in this paper also allows checklists to be designed systematically, so their effects can be measured and full potential reached. This concept paper argues that clinicians should take advantage of checklists and adapt them for use by patients. However, it should be noted that the intent is not to diminish the value of previously developed educational materials. Educating diabetics in their care, for example, has long been recognized as being of the utmost importance.32 As the patient is reading through the available materials about a complicated disease such as diabetes, a checklist can serve not only as a means to highlight important educational points, but it can also serve to further engage the patient as an active participant. Engaging the patient may also increase adherence to recommendations. A pilot study examining patient empowerment regarding a surgical safety checklist suggested that empowering patients to participate in their care may improve compliance with patient safety efforts and ultimately improve the quality of care delivered.33 In a similar way, this patient’s checklist would help patients ask critical questions during encounters with providers about different therapeutic alternatives for their particular ailment as well as benefits, risks, and strength of medical evidence behind each option. This, in turn, would prompt clinicians to explain all treatment options in a comprehensive manner. Consequently, patients would have an ample knowledge base to share decision making with their physician.34 Further engaging the patient could potentially improve quality outcome measures. For example, shared decision making has been shown in some settings to improve patient satisfaction.35 A Cochrane review also suggested that providing patients with condition-specific educational materials improved patient-centered care, a crucial aspect of shared decision making.36 Thus, a patient checklist can potentially be the ideal tool for engaging a patient in their health care, further educating them on their condition, and possibly improving patient satisfaction. The template in Table 1 allows a patient’s checklist to be devised for multiple endpoints, including primary care and even in the perioperative setting.28,34 Once the checklist has been developed, there are more key steps to ensure success. First, the checklist should be implemented in a simulation setting. This can serve as a test to determine whether the checklist meets desired goals, and adjustments can be made as necessary within a more controlled environment. For example, one group designed crisis checklists for emergencies such as cardiac arrest, failed airway, and anaphylaxis. By simulating the checklist, they were able to establish a 6-fold reduction in failed adherence to critical steps.37 Simulating a checklist for patients may require a different approach compared with checklists for providers. One way to do this would be to get a focus group of patients or even standardized patients to go through the checklist in a simulated appointment with the provider. Validation in real situations should also be performed. Surveys can be sent to both patients and providers to measure the checklist’s effectiveness at conveying information and its impact on patient satisfaction.38 The timing of checklists is very important. Although using the checklist at a time that minimizes disruptions and allows efficient workflow is necessary, the chance to detect and prevent errors, sometimes called “error trapping,” is also critical.8 In addition, although the ability to catch errors is vital, perhaps even more important is the opportunity to take corrective action. The timing © 2015 Wolters Kluwer Health, Inc. All rights reserved.
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of checklist implementation needs to take all of these factors into account. Leaving room for feedback from both providers and patients is a critical step. With feedback, the checklist is more likely to become a tool for improving and facilitating patient care rather than creating an inconvenience whereby the end users are overburdened by completing the list.18 This also contributes to keeping the checklist relevant in a dynamic rather than static state. Other measures that can be taken to accomplish this include ensuring the checklist incorporates the latest evidence-based guidelines.18 Finally, the involvement of multiple parties and obtaining feedback helps to promote a team approach. It also serves to help fully integrate the checklist into the culture, which is critical to its success.8 If the groups that will be using the checklist have a role in designing it, then they may develop a vested interest in its successful implementation. A potential way to increase the usefulness of a checklist is to make it customizable. Electronic health records (EHRs) may be able to play a role in facilitating checklist customization and integration. Specifically, while the components of the checklist could be manually modified based on an individual patient’s specific conditions, it is important to acknowledge that some patients may be so medically complex as to make this approach overly burdensome. However, if prospective and outcome data for a patient’s checklist were collected and a regression analysis performed, the EHR could be used to identify patients that would benefit most from the checklist. In the example of a diabetic patient’s checklist, the EHR could be used to identify all diabetics with a given comorbidity or end-organ damage in a medical provider’s patient panel. Checklists could then be distributed specifically to these patients before visits. This could prove useful as there is a large range in disease severity and not all interventions may apply equally to an unstratified population of patients with diabetes. Future work includes formal development of a patient checklist because shared decision making is the future of health care. As new models, such as accountable care organizations emerge, providers will be continually challenged to ensure they are delivering patient-centered care.39 Checklists are tools that can be implemented to make the changes necessary to adapt and improve the way health care is delivered.25 Although transforming health care may mean applying checklists to new challenges, it may also mean addressing old and familiar illnesses, such as diabetes, with new methods—like a patient’s checklist—to transform adequate care into extraordinary, patient-centered care. There are potential challenges associated with the design and implementation of patient checklists. As mentioned earlier, provider resistance will likely continue to be an issue. Another challenge is to design checklists appropriate for an ethnically and culturally diverse patient population to ensure that it is sensitive to their varied needs. In addition, the checklist must take into consideration the variability in educational level of the end user and, therefore, use language that can be understood with relatively little formal education. Furthermore, the elderly population could pose a special challenge because of the prevalence of physical and cognitive impairments. Another challenge exists related to how the checklist should be distributed to the end user, the patient. Possible distribution channels include physician offices and hospitals, patient education Web sites, government and third-party agencies, and/or insurance companies, among others. The patients’ socioeconomic status will also likely play a role in how much exposure they have to these checklists. Finally, more research is needed to determine the most effective checklist design and validation and implementation strategies. In the future, we may be able to determine how much impact these checklists have on patient education, satisfaction, and health outcomes. © 2015 Wolters Kluwer Health, Inc. All rights reserved.
Customizable Checklist for Patient Use
CONCLUSIONS As the health-care system moves in a patient-centered direction, the practice of delegated decision making by physicians will be gradually supplanted by shared decision making with patients. The transition to informed patient choice—as opposed to informed consent—will require new strategies for activating patients. The concepts in this paper will allow providers to develop a customizable checklist for patient use. A patient’s checklist can be created for a variety of health-care settings and cover a diverse array of medical conditions and behaviors. The process of using the checklist has many steps, and designing it is only the first step. After the checklist is implemented and adopted into clinical practice, it has to be continually reevaluated, and revised if necessary, by care redesign teams. Although implementation will likely take time, it has the potential to enhance medical care by engaging the patient as an active participant, improving patient education, promoting shared decision making, improving patient safety, and increasing patient satisfaction.
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Concepts for the Development of a Customizable Checklist for Use by Patients Rohesh J. Fernando, MD,* Fred E. Shapiro, DO,‡ Noah M. Rosenberg, MD,† Angela M. Bader, MD, MPH,§ and Richard D. Urman, MD, MBA|| Objectives: Checklists are tools that are developed to complete tasks by drawing on specific and relevant knowledge and supporting communication at critical times. If checklists were designed specifically for patient use, they could promote patient engagement, potentially leading to improved quality of care. Physicians of all specialties, nurses, patients, patient advocates, and administrators can take an active role in checklist development and dissemination. Methods: Our method to investigate concepts in developing a customizable patient checklist included a literature search concerning existing checklists and resources currently available to patients. Literature containing expert opinion regarding checklists, professional organization statements, and patients and providers were consulted. Results: A template for designing a patient checklist was developed incorporating methods from previous literature and resources regarding checklists. This template includes a development, drafting, and validation phase. Sample content for inclusion in potential checklists for patients with diabetes and patients undergoing anesthesia was devised. Conclusions: Developed by physicians with input from patients and other involved health-care providers such as nurses, this relatively novel concept of a patient’s checklist creates a role for the patient to ensure their own safety. With increasing attention to high-quality and cost-effective health care, patient satisfaction surveys will be assessed to rate overall health care. Further development of checklists will need to be guided by specific medical conditions and acceptance by patients and providers. Providers can use these checklists as a method to gauge a patient’s understanding of an intervention, solidify the patient-doctor relationship, and improve patient safety. Key Words: patient checklist, quality improvement, patient safety, patient satisfaction, patient centeredness, diabetes, anesthesia checklist, patient education (J Patient Saf 2015;00: 00–00)
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ncouraging patients to share decision making with medical providers is essential to enhancing the quality of health care. In medicine, there are often multiple treatments that can be administered for a given condition with no known superior course of action. In such instances, patients’ preferences should be paramount and must guide clinical decisions. As it stands, health
From the *Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston; †Department of Family Medicine & Community Health, University of Massachusetts Memorial Medical Center, Worcester; ‡Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center; §Department of Anesthesia, Critical Care, and Pain Medicine, and ||Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA. Correspondence: Richard D. Urman, MD, MBA, Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women’s Hospital, 75 Francis Street, Boston MA 02115 (email: [email protected]). The authors disclose no conflict of interest. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.
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care is full of opportunities to improve patient-centered medicine— defined as where the primary focus is on the patient’s needs and concerns.1 Physicians and other medical providers need to adopt a systematic approach consisting of patient decision aids such as checklists to empower patients to exercise their own selfdetermination. This would ensure that treatment goals align with the individual patient’s values and predilections, possibly conferring a safety and/or outcomes benefit. The scale of the problem can be illustrated by the dramatic variation in medical and surgical practice across the regions of the United States. For example, consider treatment for prostate cancer. In the Medicare population, there is almost sevenfold variation in the rate of radical prostatectomy for prostate cancer.2 These variations in surgery may exist because of medical evidence suggesting that other alternatives like external-beam radiation therapy and brachytherapy are clinically equivalent when it comes to overall survival rates among early stage cancers.3 In cases where options are clinically equivalent, it would seem reasonable to allow patient preference to dictate treatment. However, the discrepancy in diagnostic and treatment patterns does not seem to reflect patients’ preferences for care.4 Although another possible explanation is that each of these patients had different health comorbidities that made certain options more desirable, the preponderance of health services research indicates that these divergences in care utilization do not stem from differences in patients health status or demographics.3 Rather, this variation has been attributed to the willingness and ability of doctors to provide certain treatments.2 The presence of these unwarranted geographic variations and deficiencies in health-care patient-centeredness has precipitated calls for greater patient engagement, defined as patient involvement in the decision-making process in matters pertaining to health. This call was further substantiated by a study revealed that in more than 1000 office encounters in which more than 3500 health-care decisions were made, only 9% of decisions met the minimum standards of informed decision making.5,6 As a result, a variety of patient decision aids are being used to educate patients and their families about different treatment options for a given medical condition.6 A patient decision aid is a tool designed to make the decision explicit, describe options, and explain risks and benefits of each option.7 They may include written publications, videos, and electronic presentations. However, a checklist may be a better alternative. Although checklists can incorporate all of the knowledge-based components of a decision-aid, they also promote communication at the most crucial times. Because of their systematic approach, use of checklists can also help with detecting and preventing errors, also known as “error-trapping.8” Specifically, checklists ideally address errors of ineptitude—that is to say errors which are made not because those involved did not have the knowledge but rather they did not know how to properly use the knowledge.9 Although checklists have been used and integrated into a variety of medical settings, the use of a checklist with patients as the user has not been significantly explored. Perhaps one reason for this is provider resistance. Even with checklists designed for www.journalpatientsafety.com
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providers, clinicians often cite barriers such as lack of time, no mandate to use such tools, and no need for such tools.10 However, there are many potential benefits to using checklists. Checklists can facilitate shared decision making, defined as a shared process of making a selective intellectual judgment when presented with several complex alternatives consisting of several variables and usually defining a course of action or an idea. In addition, as informal caregivers such as family members and healthcare advocates become increasingly part of the decision-making milieu, treating an individual patient now rarely entails interacting with just one person. A patient’s checklist is uniquely positioned to help navigate this milieu as it promotes knowledge, communication, and preventing errors8,9 in a setting that may include multiple caregivers. Given that a patient’s checklist is a novel concept, a guide to develop such a checklist could prove useful to aid providers in educating their patients and helping them to play a more integral role in their health care. This paper provides a framework for developing a patient’s checklist.
METHODS A Medline search was performed using Medical Subject Headings (MeSH) Terms patient, and decision aid with 604 hits. When checklist was added as a MeSH term, no studies were found regarding a checklist designed with patients as the end user. To develop a methodology to design a checklist, literature concerning existing checklists and resources currently available to patients regarding medical care was reviewed.11–15 Patients and providers were consulted regarding the creation of checklists. Literature containing expert opinion regarding checklists was also consulted, including statements from professional societies such as the American College of Obstetrics and Gynecology as well as the Institute of Medicine.8,16–18 A template specific for a patient-centered checklist was designed after examining the methodology in these resources and adapted based on a previously published “Checklist for Checklists.”19 Sample content for a checklist was then developed for patients with diabetes after researching evidence-based guidelines. An additional example was designed for use by patients based on common anesthetic questions and concerns.20
RESULTS Concepts in Designing a Patient’s Checklist A patient’s checklist should incorporate attributes that have made previous safety checklists extensively used and applicable to a variety of clinical situations. A “Checklist for Checklists”— designed by Dr. Atul Gawande, of The Brigham and Women’s Hospital Center for Surgery and Public Health Dissemination Team, and Dan Boorman of Boeing—is illustrative of how any checklist should be structured to ensure usability and clinical effectiveness.19 Table 1 summarizes the different phases and respective steps needed to generate checklists for patient use. These drafting guidelines use many of the same principles of “Checklists for Checklists.”
A Checklist for Patient Checklists: Development Phase The initial development phase of any checklist should entail the formation of a care redesign team. This team should consist of patients, clinicians, staff, and other stakeholders. During this period, care redesign teams will have to decide the scope of
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health-care services that a patient’s checklist should encompass. A patient’s checklist would not be suitable for medical emergencies in which imminent, life-altering decisions need to be made. In contrast, a patient’s checklist would be most optimal for patients who have medical conditions in which there are multiple treatment options and scientific evidence does not overwhelmingly support the use of one therapy over other alternatives. Furthermore, the available options should involve significant tradeoffs that would affect the patient’s quality and length of life. Medical conditions in which a patient’s checklist would be most appropriate include—but are not limited to—osteoarthritis of the hip and knee, lower back pain secondary to a herniated disc, stable angina, benign prostatic hypertrophy, and early-stage prostate and breast cancer.21 Health-care groups that are interested in adopting a patient’s checklist would also need to determine a suitable time in the clinical-decision pathway when use of the checklist is most appropriate. For example, many angioplasties are unplanned procedures performed during diagnostic coronary angiography. Consequently, there is limited time for an informed discussion about treatment alternatives.22 In such situations, a patient’s checklist would be most applicable before diagnostic intervention at a natural pause point in the care pathway. For situations in which considerable time elapses between the diagnosis and treatment, a patient’s checklist could be considered after relevant diagnostic tests have taken place. In the initial development period, care redesign teams should focus on ascertaining issues and steps that are frequently omitted from clinician-patient discussions regarding therapeutic options. Although convening such a team may seem onerous, a number of groups, including Dr. Gawande’s at the Brigham and Women’s Hospital, have successfully done so. In terms of operationally defining issues and steps that are frequently omitted, this entails identifying care critical information, without which a patient could not be said to be making an informed decision. Health-care institutions may need to convene focus groups consisting of patients, clinicians, and other health-care staff for people to verbalize expectations of care. It is crucially important to balance the specificity and generality of any decision making aid, including a checklist, such that a variety of distinct medical conditions could be discussed even if they are not the checklist’s main focus.
A Checklist for Patient Checklists: Drafting Phase The second phase in engineering a patient’s checklist is the drafting phase. This period should focus on making the checklist legible, uncluttered, and consistent with the workflow of the health-care institution. First, a pause point must be defined; this is an event whose occurrence should always trigger the use of the checklist. Each section of the patient’s checklist should correspond to a unique pause point along the continuum of a patient’s care. For the checklist to properly mesh with the workflow of the health-care institution, each checklist section should contain less than 10 items. This will prevent the checklist from becoming overly taxing to the patient. Each checklist item should be able to be easily read aloud by patients. This would serve as an explicit verbal cue for physicians to guarantee that the issue is not missed. Also, the patient’s checklist should be styled in a fashion that facilitates easy reading as suggested by the drafting steps listed in Table 1. For example, the patient’s checklist should be no more than one page long and should be typed in a simple, large font like sans serif. Because these checklists will be used by patients, care redesign teams should ensure that the checklist is brief and written at an eighth grade level.23 © 2015 Wolters Kluwer Health, Inc. All rights reserved.
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Customizable Checklist for Patient Use
TABLE 1. Designing a Patient’s Checklist Development
Drafting
Does the checklist: □ Has a care redesign team been established? □ Utilize natural breaks (“pause points”) in workflow? □ Is the team broadly representative of patients, □ Use simple sentence structure and providers, and other stakeholders? language (written at an 8th grade level)? □ Which clinical conditions will be covered □ Have a simple, uncluttered, by the patient’s checklist? logical format? □ When will the patient’s checklist be used? □ Fit on one page? □ Have participants verbalized missteps that arise during patient encounters? □ Does each checklist item address a critical step that is missed during patient encounters?
□ Minimize use of color? □ Have a title that reflects its objectives? Is the font: □ Easy to read? □ Upper and lower case text? □ Large enough?
Validation □ Are key processes and outcomes being measured? □ Has the checklist been trialed in simulated settings? □ How did the checklist affect quality measures during simulation trials? □ Was the checklist modified after it was tested in simulations? □ Has the checklist been tested in real clinical settings? □ How did the checklist affect quality measures in real clinical settings? □ Was feedback received from patients and providers? □ How did the checklist affect workflow? □ Was the checklist completed in a reasonable amount of time? □ Was the checklist revised after it was adopted into clinical practice?
□ Dark on a light background? □ Does each pause point contain less than 10 items? If the answer to any question is “No,” then please pause and address the question with your team before proceeding. Adopted from: Reference #19. Checklist for Checklists. Available at: http://www.projectcheck.org/checklist-for-checklists.html. Accessed January 13, 2014.
A Checklist for Patient Checklists: Validation Phase The last step for devising a patient’s checklist is the validation phase. The checklist should be implemented in both real and simulated environments. One recent study demonstrated the value of checklists in simulated crises, indicating that critical processes of care were less likely to be missed if providers used a checklist rather than memory alone.24 Care redesign teams should identify key processes and outcomes of care—including measures of morbidity, mortality, and patient and provider satisfaction—to evaluate the effectiveness of the patient’s checklist.25 For example, before dissemination of the checklist into real settings, a health-care institution should consider first assessing the impact of the checklist on outcome and process metrics in simulations. After evaluating the efficacy of a patient’s checklist in more controlled settings, care redesign teams should modify the checklist accordingly before the intervention diffuses into clinical settings.
Example 1: Sample Content for Checklist for a Diabetic Patient One example of a patient’s checklist that would be most applicable to the outpatient office setting would be for patients diagnosed with diabetes. A patient can refer to it during visits with their provider. A diabetes checklist would be particularly useful not only because of its high prevalence in the general population but also because of the considerable practice variation related to diabetic care. This is especially true given recent guideline changes in cardiovascular and hypertension risk factor management.26,27 A simple, evidence-based checklist can help narrow provider-related differences in the optimal care that a diabetic patient receives within a physician group. Table 2 provides © 2015 Wolters Kluwer Health, Inc. All rights reserved.
sample content that may be used to develop a patient’s diabetes checklist, using the adapted template in Table 1. Table 2 outlines multifaceted aspects of complex medical care a diabetic patient should be educated about and can help position the patient to partake in shared decision making. Error trapping can also be incorporated by preventing unnecessary lapses in diabetic care. The intent is that once a checklist is created, the patient would refer to it during and between health-care visits or treatments.
TABLE 2. Sample Content for a Diabetes Patient’s Checklist: “Questions to Ask Your Doctor About Diabetes Care” □ Were you told which medications would help you improve blood sugar control? □ Were you told about how aspirin can reduce diabetic heart disease? □ Were you told about how cholesterol medications can reduce diabetic heart disease? □ Were you told about blood pressure goals for diabetics? □ Were you told about urine testing for diabetic kidney disease? □ Were you told about whether you would benefit from blood pressure medications called ACE inhibitors? □ Were you told about getting a routine diabetic eye exam? □ Were you told about diabetic foot care and hygiene? □ Were you told about the need for getting vaccinated for the flu and pneumonia? □ Were you told about the importance of losing weight and increasing exercise? If the answer to any question is “No,” then please pause and discuss the question with your provider before proceeding.
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TABLE 3. Sample Content for an Anesthesia Patient’s Checklist: “Questions to Ask your Doctor about Anesthesia Before Surgery” □ Were you told about the different types of anesthesia and the type that you would be getting (local vs regional vs sedation vs general)? □ Were you told about whether your current medical conditions affect the risk to undergo anesthesia? □ Were you told what medications you should or should not take before surgery? □ Were you told when you can last eat/drink before surgery and why this is important? □ Were you told how you will be monitored while the anesthesia is administered? □ Were you told who will be watching you both during and after surgery/anesthesia? □ Were you told what to expect in the recovery room and how long you may be there while recovering from anesthesia? □ Were you told about methods to deal with post-operative pain and nausea/vomiting after surgery? If the answer to any question is “No,” then please pause and discuss the question with your provider before proceeding.
Example 2: Sample Content for a Checklist for a Patient Requiring Anesthesia Table 3 illustrates sample content for another potential checklist concerning anesthesia designed for a patient about to undergo surgery. A patient may not be familiar with the different types of anesthesia in terms of what they mean and what to expect. Furthermore, they may not be aware that a procedure can often be done with different types of anesthesia. A future checklist that included this sample content could incorporate error trapping by ensuring patients are completely informed. Furthermore, it could encourage shared decision making by enabling patients to voice a preference where several types of anesthesia may be equally suitable.
DISCUSSION There is known evidence regarding the benefits of checklists when used by providers. For example, one such study investigated the reduction in morbidity and mortality in patients undergoing surgery.28 Although checklists have gained more acceptance after documented benefit in the surgical perioperative setting, their use should not be limited to that period. Many providers have expanded the role of the checklist to help in other medical arenas. A cardiology group, for instance, was able to decrease hospital readmission and improve adherence to the latest guidelines with heart failure patients.29 Another group used checklists to improve care in the ICU.30 Other uses include development of a checklist to help providers refer stroke patients at risk for long-term disability for further treatment based on a patient questionnaire14 and a checklist that was made to help providers doing inpatient rounds to ensure that a comprehensive review of each patient was performed.15 Although these tools have been developed to help providers become more engaged in health care, these checklists have not been significantly explored to further engage patients. Karen Curtiss, for example, has long been a patient safety advocate and is one of the few to consider this idea. She compiled several checklists to help patients and providers to be “on the same page.31” Although her checklists have similar goals to what is being proposed in this paper, they require the patient to seek out
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such tools and to take initiative. Furthermore, the patient’s provider may be unfamiliar with such a tool, and the full potential of the checklist may be impeded by lack of familiarity. For these reasons, it is imperative that clinicians adopt checklists as patient advocates and incorporate them into the health-care infrastructure. The framework provided in this paper also allows checklists to be designed systematically, so their effects can be measured and full potential reached. This concept paper argues that clinicians should take advantage of checklists and adapt them for use by patients. However, it should be noted that the intent is not to diminish the value of previously developed educational materials. Educating diabetics in their care, for example, has long been recognized as being of the utmost importance.32 As the patient is reading through the available materials about a complicated disease such as diabetes, a checklist can serve not only as a means to highlight important educational points, but it can also serve to further engage the patient as an active participant. Engaging the patient may also increase adherence to recommendations. A pilot study examining patient empowerment regarding a surgical safety checklist suggested that empowering patients to participate in their care may improve compliance with patient safety efforts and ultimately improve the quality of care delivered.33 In a similar way, this patient’s checklist would help patients ask critical questions during encounters with providers about different therapeutic alternatives for their particular ailment as well as benefits, risks, and strength of medical evidence behind each option. This, in turn, would prompt clinicians to explain all treatment options in a comprehensive manner. Consequently, patients would have an ample knowledge base to share decision making with their physician.34 Further engaging the patient could potentially improve quality outcome measures. For example, shared decision making has been shown in some settings to improve patient satisfaction.35 A Cochrane review also suggested that providing patients with condition-specific educational materials improved patient-centered care, a crucial aspect of shared decision making.36 Thus, a patient checklist can potentially be the ideal tool for engaging a patient in their health care, further educating them on their condition, and possibly improving patient satisfaction. The template in Table 1 allows a patient’s checklist to be devised for multiple endpoints, including primary care and even in the perioperative setting.28,34 Once the checklist has been developed, there are more key steps to ensure success. First, the checklist should be implemented in a simulation setting. This can serve as a test to determine whether the checklist meets desired goals, and adjustments can be made as necessary within a more controlled environment. For example, one group designed crisis checklists for emergencies such as cardiac arrest, failed airway, and anaphylaxis. By simulating the checklist, they were able to establish a 6-fold reduction in failed adherence to critical steps.37 Simulating a checklist for patients may require a different approach compared with checklists for providers. One way to do this would be to get a focus group of patients or even standardized patients to go through the checklist in a simulated appointment with the provider. Validation in real situations should also be performed. Surveys can be sent to both patients and providers to measure the checklist’s effectiveness at conveying information and its impact on patient satisfaction.38 The timing of checklists is very important. Although using the checklist at a time that minimizes disruptions and allows efficient workflow is necessary, the chance to detect and prevent errors, sometimes called “error trapping,” is also critical.8 In addition, although the ability to catch errors is vital, perhaps even more important is the opportunity to take corrective action. The timing © 2015 Wolters Kluwer Health, Inc. All rights reserved.
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of checklist implementation needs to take all of these factors into account. Leaving room for feedback from both providers and patients is a critical step. With feedback, the checklist is more likely to become a tool for improving and facilitating patient care rather than creating an inconvenience whereby the end users are overburdened by completing the list.18 This also contributes to keeping the checklist relevant in a dynamic rather than static state. Other measures that can be taken to accomplish this include ensuring the checklist incorporates the latest evidence-based guidelines.18 Finally, the involvement of multiple parties and obtaining feedback helps to promote a team approach. It also serves to help fully integrate the checklist into the culture, which is critical to its success.8 If the groups that will be using the checklist have a role in designing it, then they may develop a vested interest in its successful implementation. A potential way to increase the usefulness of a checklist is to make it customizable. Electronic health records (EHRs) may be able to play a role in facilitating checklist customization and integration. Specifically, while the components of the checklist could be manually modified based on an individual patient’s specific conditions, it is important to acknowledge that some patients may be so medically complex as to make this approach overly burdensome. However, if prospective and outcome data for a patient’s checklist were collected and a regression analysis performed, the EHR could be used to identify patients that would benefit most from the checklist. In the example of a diabetic patient’s checklist, the EHR could be used to identify all diabetics with a given comorbidity or end-organ damage in a medical provider’s patient panel. Checklists could then be distributed specifically to these patients before visits. This could prove useful as there is a large range in disease severity and not all interventions may apply equally to an unstratified population of patients with diabetes. Future work includes formal development of a patient checklist because shared decision making is the future of health care. As new models, such as accountable care organizations emerge, providers will be continually challenged to ensure they are delivering patient-centered care.39 Checklists are tools that can be implemented to make the changes necessary to adapt and improve the way health care is delivered.25 Although transforming health care may mean applying checklists to new challenges, it may also mean addressing old and familiar illnesses, such as diabetes, with new methods—like a patient’s checklist—to transform adequate care into extraordinary, patient-centered care. There are potential challenges associated with the design and implementation of patient checklists. As mentioned earlier, provider resistance will likely continue to be an issue. Another challenge is to design checklists appropriate for an ethnically and culturally diverse patient population to ensure that it is sensitive to their varied needs. In addition, the checklist must take into consideration the variability in educational level of the end user and, therefore, use language that can be understood with relatively little formal education. Furthermore, the elderly population could pose a special challenge because of the prevalence of physical and cognitive impairments. Another challenge exists related to how the checklist should be distributed to the end user, the patient. Possible distribution channels include physician offices and hospitals, patient education Web sites, government and third-party agencies, and/or insurance companies, among others. The patients’ socioeconomic status will also likely play a role in how much exposure they have to these checklists. Finally, more research is needed to determine the most effective checklist design and validation and implementation strategies. In the future, we may be able to determine how much impact these checklists have on patient education, satisfaction, and health outcomes. © 2015 Wolters Kluwer Health, Inc. All rights reserved.
Customizable Checklist for Patient Use
CONCLUSIONS As the health-care system moves in a patient-centered direction, the practice of delegated decision making by physicians will be gradually supplanted by shared decision making with patients. The transition to informed patient choice—as opposed to informed consent—will require new strategies for activating patients. The concepts in this paper will allow providers to develop a customizable checklist for patient use. A patient’s checklist can be created for a variety of health-care settings and cover a diverse array of medical conditions and behaviors. The process of using the checklist has many steps, and designing it is only the first step. After the checklist is implemented and adopted into clinical practice, it has to be continually reevaluated, and revised if necessary, by care redesign teams. Although implementation will likely take time, it has the potential to enhance medical care by engaging the patient as an active participant, improving patient education, promoting shared decision making, improving patient safety, and increasing patient satisfaction.
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