Patient (2014) 7:207–217 DOI 10.1007/s40271-014-0046-3

ORIGINAL RESEARCH ARTICLE

An Environmental Scan of Advance Care Planning Decision Aids for Patients Undergoing Major Surgery: A Study Protocol Rebecca A. Aslakson • Anne L. R. Schuster • Judith Miller Matthew Weiss • Angelo E. Volandes • John F. P. Bridges

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Published online: 28 January 2014  Springer International Publishing Switzerland 2014

Abstract Background Patients who undergo major surgery are at risk for perioperative morbidity and mortality. It would be appropriate to initiate advance care planning with patients prior to surgery, but surgeons may experience difficulty initiating such conversations. Rather than focus on changing clinician behavior, advance care planning decision aids can be an innovative vehicle to motivate advance care planning among surgical patients and their families. Objective The purpose of this paper is to describe a study protocol for conducting an environmental scan concerning

Registration of systematic review: The systematic review protocol has been registered with PROSPERO (Record #42013005399). R. A. Aslakson (&) Department of Anesthesiology and Critical Care Medicine, The Johns Hopkins School of Medicine, 600 North Wolfe Street, Meyer 297A, Baltimore, MD 21287-7295, USA e-mail: [email protected] A. L. R. Schuster
J. F. P. Bridges Department of Health Policy and Management, The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA J. Miller Ellicott City, MD, USA M. Weiss Department of Surgery, The Johns Hopkins School of Medicine, Baltimore, MD, USA A. E. Volandes General Medicine Unit, Massachusetts General Hospital, Boston, MA, USA

advance care planning decision aids that may be relevant to patients undergoing high-risk surgery. Methods/design This study will gather information from written or verbal data sources that incorporate professional and lay perspectives: a systematic review, a grey literature review, key informant interviews, and patient and family engagement. It is envisioned that this study will generate three outcomes: a synthesis of current evidence, a summary of gaps in knowledge, and a taxonomy of existing advance care planning decision aids. Discussion This environmental scan will demonstrate principles of patient-centered outcomes research, and it will exemplify a pioneering approach for reviewing complex interventions. Anticipated limitations are that information will be gathered from a small sample of patients and families, and that potentially relevant information could also be missing from the environmental scan due to the inclusion/exclusion criteria. Outcomes from the environmental scan will inform future patient-centered research to develop and evaluate a new decision aid.

Key Points for Decision Makers Patients preparing for high-risk surgery should initiate advance care planning preoperatively. Advance care planning decision aids may help highrisk surgery patients clarify and express their advance care wishes. Decision aids need to be designed for and evaluated in a surgical population.

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1 Background In 2010 there were approximately 51 million inpatient surgeries performed in the USA [1]. Although most surgeries will be performed successfully, significant patient morbidity and mortality persist, including a 1–4 % perioperative mortality for abdominal aortic aneurysm repair surgery [2], an 8 % perioperative morbidity and mortality for esophagectomy surgery [3], and an 8.6 % major morbidity or mortality for lung cancer resection surgery [4]. Moreover, a significant proportion of major surgeries require post-operative life-sustaining treatment in surgical intensive care units [4], and longer length of stay in a surgical intensive care unit is associated with increased morbidity and mortality [5]. Preparing for surgery, therefore, presents an opportunity for patients and families to initiate pre-operative advance care planning—preparations for perioperative medical decisions in the event that the patient becomes too sick to speak for him or herself. It is accepted that decision aids can be useful when there exist more than one effective treatment and when no treatment clearly outweighs another in terms of its benefits versus harms [6, 7]. Stacey et al. [6, 7], in their 2011 Cochrane review find that decision aids: (i) improve patients’ knowledge of available options; (ii) improve patients’ risk perception accuracy; (iii) help patients make choices that align with their values; and (iv) increase patients’ participation in decision making. However, these findings by Stacey et al. [7] focus on decision aids in general, and they do not include studies about advance care planning decision aids. Individual studies about previous advance care planning interventions increased discussions about end-of-life care between patients and surrogates, increased durable power of attorney completion rates, improved patient and surrogate decision maker congruence, and reduced patient decisional conflict [8–16]. At its core, advance care planning clarifies patient care goals, preferences, and beliefs. In their national guidelines, the National Consensus Project for Palliative Care recommends that an interdisciplinary team: (i) assess patient advance care planning concerns, preferences, and documentation; and (ii) educate patients and families about advance care planning documents so that patient preferences and values for care are known and understood [17]. Better palliative care, via advocacy for this type of planning, has already been associated with improving healthcare quality through decreasing the misuse and overuse of interventions and resources [18]. While it could be possible for surgeons to explore a patient’s advance care planning wishes during the surgical consent process, they may experience difficulty discussing such wishes [19–29]. In part, this may stem from feelings that

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wishes to limit postoperative life-sustaining care contradict the goals of surgery [20]. Consequently, interventions to standardize the number or content of clinician-driven preoperative discussions are likely to only minimally penetrate the community and to be frequently rejected by surgical clinicians. Evidence already suggests significant variation in practice between surgeons and other surgical clinicians about when, where, and how to discuss advance care wishes with patients [21–23, 25, 27, 28, 30, 31]. Consequently, rather than focusing on changing clinician behaviors or beliefs, we hypothesize that the use of patient/family decision aids may better allow patients to express their wishes and to better advocate for care based on those beliefs. Few existing advance care planning tools have been evaluated in surgical patient populations [13, 14], with no widely used tool developed specifically for, or routinely used in, patient populations undergoing major surgical interventions. Consequently, there is a need for advance care planning decision aids specific to a surgery setting. The purpose of this paper is to describe the protocol for conducting an environmental scan concerning surgeryspecific, advance care planning decision aids. In the absence of established recommendations on how to conduct environmental scans, environmental scans published in the peer-reviewed literature and in the grey literature have adopted a range of methodologies. These can range from systematic reviews [32] to scoping reviews [33], and may include consultations with key stakeholders as well as reviews of unpublished literature and publicly available information [34–37]. This proposed environmental scan incorporates methodologies adopted in the peer-reviewed literature and grey literature. Moreover, advance care planning decision aids meet all five of the Medical Research Council’s identified sources of complexity. In accordance with Anderson et al. [38], this study will aim to disaggregate the above complexities of advance care planning decision aids in order to make the evidence about them more meaningful. The environmental scan is the first component of a three-year study funded by the Patient-Centered Outcomes Research Institute (PCORI) and informs the next stages of research to develop an advance care planning decision aid for surgery patients and their families. The study team is a partnership between researchers, clinicians, and patientfamily advocates. The project itself originated through conversations between a patient-family advocate (JM) and the study principal investigator (RAA). As project details developed, additional patient and family advocates who had experiences with pancreatic cancer were recruited to the team and have been involved with all aspects of study development. One patient and two family advocates are study co-investigators.

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Table 1 Guiding questions for conducting the environmental scan Current evidence on advance care planning aids

Gaps in knowledge about advance care planning aids

Details on existing advance care planning aids

What exactly is an advance care planning decision aid?

What are the key uncertainties regarding advance care planning and advance care planning aids?

What aids exist?

What advance care planning interventions have shown previous benefit?

What are the on-going studies on advance care planning aids?

What are the previous benefits or drawbacks of advance care planning aids?

What populations are currently receiving optimal, or sub-optimal, advance care planning?

In what populations have advance care planning interventions been studied?

What aspects of advance care planning decision aids matter to different stakeholders?

What advance care planning aids were used by the intervention?

What are the benefits and drawbacks to each aid? What aspects of an aid are likely to make it more or less effective? For what, or in what, population was an aid developed? What are the key differences between existing aids?

When in a patient’s illness was the advance care planning undertaken?

Environmental scan – data sources and perspectives

Written data sources

Verbal data sources

Professional perspective

(i) Systematic review

(iii) Key informant interviews

Lay perspective

(ii) Grey literature review

(iv) Patient & family engagement

Fig. 1 Study overview

This protocol outlines three categories of pertinent questions to guide the conduct of the environmental scan. As seen in Table 1, the questions are categorized into three key areas of information: (i) current evidence on advance care planning decision aids, (ii) gaps in knowledge about advance care planning decision aids, and (iii) details about existing advance care planning decision aids.

2 Methods/Design Figure 1 describes the data sources and perspectives that will make up this environmental scan. As shown, drawing from professional and lay perspectives in written or verbal formats, the environmental scan will use four key data sources: (i) a systematic review, (ii) a grey literature review, (iii) key informant interviews, and (iv) patient and family engagement. The methods for gathering information

from each of these data sources are described in the following sections. 2.1 Systematic Review Adhering to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methodology [39], a systematic literature review will be used to identify currently existing studies about advance care planning decision aids and to synthesize evidence about their effectiveness from the published literature. The following five sections describe the systematic review protocol and provide details on how the research team will systematically search, review, abstract from, summarize and assess the collected information; the systematic review protocol has also been registered with PROSPERO (Record #42013005399). 2.1.1 Literature Search Literature searches will be conducted in the following electronic bibliographic databases to identify articles for the systematic review: PubMed, EMBASE, Cochrane, SCOPUS, Web of Science, CINAHL, PsycINFO, and Sociological Abstracts. An experienced research librarian will assist in the development and execution of database search strategies that will include a predefined list of medical subject headings (MeSH), when applicable, and search terms such as ‘advance care planning’ [MESH Terms] OR ‘advance care planning’ [All Fields] OR ‘advance care plan’ [All Fields]. Table 2 lists the search terms and limits for each database. To identify additional studies that should be considered for inclusion, the reference lists of pertinent systematic reviews will be reviewed. The citation list of any included studies will also be reviewed to further identify potentially relevant studies.

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Table 2 Search strategies for electronic bibliographic database searches Database

Search Terms

PubMed

‘‘advance care planning’’[MeSH Terms] OR ‘‘advance care planning’’[All Fields] OR ‘‘advance care plan’’[All Fields] OR ‘‘advance care plans’’[All Fields] OR ‘‘Advance Health Care Planning’’[All Fields] OR ‘‘Advance Medical Planning’’[All Fields] OR ‘‘advanced care planning’’[All Fields] OR ‘‘advanced care plan’’[All Fields] OR ‘‘advanced care plans’’[All Fields] OR (advance[tw] AND care[tw] AND planning[tw]) OR (advance[tw] AND care[tw] AND plan[tw]) OR (advance[tw] AND care[tw] AND plans[tw]) AND (‘‘adult’’[MeSH Terms] OR ‘‘adult’’[All Fields] OR ‘‘adults’’[All Fields] OR ‘‘aged’’[MeSH Terms] OR ‘‘aged’’[All Fields] OR ‘‘elderly’’[All Fields] OR older[All Fields] OR senior[All Fields] OR seniors[All Fields])

EMBASE

‘advance care planning’ OR ‘advance care plan’ OR ‘advance care plans’ OR ‘advance health care planning’ OR ‘advance medical planning’ OR ‘advanced care planning’ OR ‘advanced care plan’ OR ‘advanced care plans’ AND (‘adult’/de OR ‘adult’ OR ‘adults’ OR ‘aged’/de OR ‘aged’ OR ‘elderly’ OR ‘older’ OR ‘senior’ OR ‘seniors’)

Cochrane

MeSH: ‘‘advance care planning’’[MeSH Terms]OR ‘‘advance care planning’’ or ‘‘advance care plan’’ or ‘‘advance care plans’’ or ‘‘advance health care planning’’ or ‘‘advance medical planning’’ or ‘‘advanced care planning’’ or ‘‘advanced care plan’’ or ‘‘advanced care plans’’ AND MeSH: ‘‘Adult’’[Mesh] OR ‘‘Aged’’[Mesh] OR adult OR adults OR elderly OR older OR senior OR seniors

SCOPUS

TITLE-ABS-KEY({advance care planning} OR {advance care plan} OR {advance care plans} OR {advance health care planning} OR {advance medical planning} OR {advanced care planning} OR {advanced care plan} OR {advanced care plans} OR ({advance} AND {care} AND {planning}) OR ({advance} AND {care} AND {plan}) OR ({advance} AND {care} AND {plans})) AND TITLE-ABS-KEY({adult} OR {adults} OR {aged} OR {elderly} OR {older} OR {senior} OR {seniors})

Web of Science

TS = (‘‘advance care planning’’ OR ‘‘advance care plan’’ OR ‘‘advance care plans’’ OR ‘‘advance health care planning’’ OR ‘‘advance medical planning’’ OR ‘‘advanced care planning’’ OR ‘‘advanced care plan’’ OR ‘‘advanced care plans’’ OR (advance AND care AND planning) OR (advance AND care AND plan) OR (advance AND care AND plans)) AND TS = (adult OR adults OR aged OR elderly OR older OR senior OR seniors)

CINAHL

((MH ‘‘Advance Care Planning’’) OR ‘‘advance care planning’’ OR ‘‘advance care plan’’ OR ‘‘advance care plans’’ OR ‘‘advance health care planning’’ OR ‘‘advance medical planning’’ OR ‘‘advanced care planning’’ OR ‘‘advanced care plan’’ OR ‘‘advanced care plans’’ OR (advance AND care AND planning) OR (advance AND care AND plan) OR (advance AND care AND plans)) AND ((MH ‘‘Adult ? ’’) OR adult OR adults OR (MH ‘‘Aged ? ’’) OR aged OR elderly OR older OR senior OR seniors)

PsycInfo

(‘‘advance care planning’’ OR ‘‘advance care plan’’ OR ‘‘advance care plans’’ OR ‘‘advance health care planning’’ OR ‘‘advance medical planning’’ OR ‘‘advanced care planning’’ OR ‘‘advanced care plan’’ OR ‘‘advanced care plans’’ OR (advance AND care AND planning) OR (advance AND care AND plan) OR (advance AND care AND plans)) AND (adult OR adults OR aged OR elderly OR older OR senior OR seniors)

Sociological Abstracts

(‘‘advance care planning’’ OR ‘‘advance care plan’’ OR ‘‘advance care plans’’ OR ‘‘advance health care planning’’ OR ‘‘advance medical planning’’ OR ‘‘advanced care planning’’ OR ‘‘advanced care plan’’ OR ‘‘advanced care plans’’ OR (advance AND care AND planning) OR (advance AND care AND plan) OR (advance AND care AND plans)) AND (adult OR adults OR aged OR elderly OR older OR senior OR seniors)

2.1.2 Article Screen All titles and abstracts will be independently reviewed by two trained research team members and screened against inclusion and exclusion criteria. As can be seen from the inclusion and exclusion criteria described in Table 3, studies will be included if they (i) include individuals aged 19 and older; (ii) use or describe the development of an instrument-based advanced care planning decision aid; (iii) compare a group that did receive an advance care planning decision aid to a group that did not receive one or compare two different types of advance care planning decision aids; (iv) consider any quantitative or qualitative outcome related to the development or use of an advance care planning decision aid; (v) are in English; and (vi) are a systematic review, randomized controlled trial, nonrandomized controlled trial, prospective cohort study, case control study, or psychometric analysis of a decision aid in development.

Studies marked for inclusion by either reviewer will be included for full article review. For studies without adequate title and abstract screening information, the full text will be retrieved to then make a decision. All results will be tracked in a RefWorks (2.0, ProQuest, Ann Arbor, MI, USA) database. Spreadsheets will be developed and used for the inclusion and exclusion process at the title/abstract and full-text review stages. Full-text copies of papers will be retrieved for studies identified for full article review and two trained research team members will independently screen articles. If both reviewers agree that a study does not meet inclusion criteria, then it will be excluded. If the two reviewers disagree about including an article, a third research team member will assess the article to resolve the conflict. Results from the full article review will also be tracked in the RefWorks database, and the rationale for excluding studies will be recorded.

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Table 3 Eligibility criteria for advance care planning decision aid studies and information Criterion

Inclusion

Exclusion

Population

Age 19 and above

Age 18 and younger

Intervention

Use of advance care planning aid

No use of an advance care planning aid

Study describing development of a decision aid Comparator

Comparison with a group that did not receive an advance care planning aid

None

Comparison between different types of advance care planning aids Outcomes

Any quantitative or qualitative outcomes related to development of, or use of an advance care planning aid

None

Timing Setting

Any timing Any setting

None None

Study design

Systematic reviews

Case reports

Randomized controlled trials

Case series

Nonrandomized controlled trials

Opinions

Prospective cohort studies

Commentaries

Case control studies

Retrospective or descriptive studies

Psychometric study describing development of a decision aid

Non-systematic reviews* Letters to the editor with no primary data

Other

English language

Non-English language

* Non-systematic reviews may be used to inform responses to the guiding questions

2.1.3 Data Abstraction Pertinent information will be abstracted from the included studies. A trained research team member will extract the information in a pre-determined abstraction tool; a second trained study team member will check the abstraction for completeness and accuracy. Abstracted information will include the following: study characteristics (i.e., sample size, study design); population characteristics (i.e., age, disease, race/ethnicity); intervention characteristics (i.e., goals of intervention, components of intervention, context of where decision aid distributed); and outcome measures (i.e., patient-centered outcomes, treatment preferences, advance directive completion). 2.1.4 Risk of Bias Assessment A trained research team member will also assess each study’s risk of bias using an abstraction tool based on the Cochrane Collaboration Tool for Assessing Risk of Bias [40], and studies will be evaluated based on sequence generation (for randomized controlled trials); allocation concealment (for randomized controlled trials); intervention independent of other changes (for observational studies); shape of intervention effect pre-specified (for observational studies); intervention unlikely to affect data collection (for observational studies); blinding of personnel and outcome assessors; completeness of outcome data; selective outcome reporting; and other sources of bias. A second trained study team member will check study quality

abstraction, with disagreements resolved by discussion between the team members and input from a third reviewer, if necessary. After evaluating each study and resolving any disagreements, study team members will assign each study an overall risk of bias rating. For both RCTs and observational studies, their overall risk of bias will be rated as low, medium, or high risk of bias. 2.1.5 Strength of Evidence Grading The GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group criteria adopted by the Agency for Healthcare Research and Quality [41, 42] will be used to assess the quality of the body of evidence. The research team will determine specific outcomes for which to assess the quality of the evidence. Studies that address these outcomes will be identified. An overall strength of evidence grade will be determined for each outcome and will include high, moderate, low, or insufficient evidence. The overall grade will be derived from conclusions regarding four quality of evidence domains. These four domains are risk of bias, consistency, directness, and precision of the evidence [43]. Two trained research team members will independently assess the quality of evidence according to these four domains and will then assign a strength of evidence grade. Disagreements about the final grade will be resolved through discussion and input from a third team member, if necessary.

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2.1.6 Data Synthesis and Presentation Data will be collected and synthesized using summary tables. Findings will be summarized in study-specific tables with cross-cutting tables to highlight the current state of evidence regarding outcomes as well as study and intervention characteristics. The research team will review the data summary tables to determine optimal use and presentation of information from these tables in a manuscript suitable for publication. 2.2 Grey Literature Review A grey literature review will be conducted to gather information from unpublished or in-progress research and also to learn what advance care planning information is publicly available to patients. This information will be used to detail existing advance care planning decision aids and, in concert with data from other sources, to identify gaps in the evidence about advance care planning aids. The information sources that will be used to obtain the grey literature and the methods to analyze it are described below. 2.2.1 Search Strategy Unpublished or in-progress research will be identified by searching the following relevant databases. The LexisNexis Academic database will provide access to general, regional, and international news, as well as company news, financial information, and some legal information. Unpublished dissertations and theses will be sought using ProQuest database for Dissertation and Theses. ProQuest indexes dissertations submitted from 1861 up to the last semester at more than 1,000 institutions in the USA, Canada, Great Britain, and some European institutions. The dissertation content will be obtained either through ProQuest, which offers the full text of most theses published since 2008, or via inter-library loan. Information about in-progress research projects will be gathered from Health Services Research Projects in Progress (HSRProj). HSRProj indexes summaries of research projects in progress that are funded by Federal and private grants and contracts for use by policymakers, managers, clinicians, and other stakeholders. In doing so, it provides insight into findings from these ongoing projects prior to the availability of published results. Unpublished or ongoing research studies that match the inclusion criteria previously described for the systematic review (Table 3) will be included in the grey literature review. In order to understand what advance care planning decision aids are publicly available, a web search of relevant organizations will be conducted. Organizations will be selected on the basis of being focused on medical decision

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making, aging populations, palliative care, and/or end-of-life issues from the perspectives of research, policy, patient advocacy, and/or patient clinical care. We will search organizations in the USA in order to obtain specific guidance on the construction and use of decision aids in a US context. We will also search for videos about advance care planning via YouTube, which offers an approach to identify decision aids that provide an international perspective. Appendix A contains a complete list of organization websites to be searched, but some examples include the American Cancer Society, The American Academy of Hospice and Palliative Medicine, National Institute of Health-National Institute for Aging, AARP, the Informed Medical Decisions Foundation, and Family Caregiver Alliance. 2.2.2 Inclusion Criteria The decision to include a research study on an advance care planning decision aid will follow the same criteria described above for the systematic review (Table 3). The following criteria will be used to determine the eligibility of a website-identified advance care planning decision aid: (i) it is designed for people aged 19 and older; (ii) it is an instrument-based advanced care planning decision aid; and (iii) it is in English. 2.2.3 Data Abstraction For research studies identified in the grey literature review, information will be abstracted using a pre-determined, standardized template that includes the following information: date accessed, source, web address, study design, eligibility criteria, study characteristics, population characteristics, intervention characteristics, significant and nonsignificant outcomes, and comments. Data on the included advance care planning decision aids will also be extracted. The abstracted information on the decision aids will detail date accessed, source, web address, the target population (i.e., patient, family, or both), format (paper, video, webbased tool), and the length of the decision aid. Additionally, data will be abstracted about the decision aids content (i.e., exercises to clarify values and risk perceptions or to identify, evaluate, and name a surrogate decision maker) and style (i.e., narrative style, point-of-view). Findings about the included articles, unpublished studies, and advance care planning decision aids will be qualitatively summarized and presented. 2.3 Key Informant Interviews In this section, we discuss the recruitment of key informants as well as methods to conduct and analyze data from the interviews.

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2.3.1 Participants

2.3.3 Data Analysis

In order to gather a full range of perspectives, key informants will be selected using purposive and snowball sampling on the basis of being involved in surgical clinical care as well as palliative and end-of-life clinical care, research, policy, and/or advocacy. Potential informants will be identified using the following criteria: (i) actively working in palliative and/or surgical clinical practice, (ii) actively involved in palliative care research or policy, and/ or (iii) actively involved in the development and evaluation of decision aids. Approval to conduct the interviews will be sought from the Johns Hopkins School of Medicine Institutional Review Board. Upon receiving this designation, we will begin recruiting key informants. Individuals who are identified as key informants will be informed about the study via email and will receive a follow-up email if they do not respond within 2 weeks. Upon agreement to participate, an interview will be scheduled and a summary of the interview protocol will be sent. The interview protocol outlines the purpose of the study, describes the structure of the interview, informs participants of potential for harms, outlines the consent to participate, and provides some example questions to discuss during the interview.

After each interview, the two researchers will conduct preliminary data analysis to identify key points to highlight from the interview as well as to identify issues that require further elaboration in future interviews. One team member will compare and merge the field notes taken during each interview to create one comprehensive document; it will include the raw text as well as a summary of the key points and their supporting quotes, when applicable. This document will be shared with the respective key informant for final approval using a password-protected electronic system. Interpretive phenomenological analysis (IPA) [44] will be used to analyze the collected data. This will include looking for and connecting themes as well as noting where themes are discordant. When presenting information gathered from the interviews, key informant names will not be disclosed in any published materials.

2.3.2 Interviews The primary endpoint will be theoretical saturation [43] and interviews will, therefore, be conducted until no new insights emerge from them. We anticipate inviting up to 25 people to participate. These interviews will follow a semistructured interview approach [44], whereby researchers and participants engage in a dialogue guided by customized questions. Some prototypical questions are as follows: • • •

What does the term ‘advance care planning decision aid’ mean to you? What advance care planning aids are available and in use in clinical settings? How would you define the goals of advance care planning decision aids?

Furthermore, and in accordance with semi-structured interview methods, researchers will ask follow-up, clarifying, and specifying questions about important comments that surface in the conversation. Similarly, participants will be able to add comments they deem to be relevant to the conversation and to contribute their own perceptions of advance care planning decision aids. Two trained research team members will conduct the interviews. While the interviews will not be recorded, the researchers will take de-identified field notes. Field notes will be stored on password-protected computers.

2.4 Patient and Family Engagement Adhering to PCORI Methodology Standards [45], patients and families were engaged in the development of the contract protocol and will be engaged further to help detail existing advance care planning decision aids as they represent the population of interest. They will help us begin to identify factors that matter to a high-risk surgery population. This section identifies the patients and family advocates we will engage and articulates the methods we will use to engage them. 2.4.1 Participants Key advance care planning decision aids identified through the systematic review, grey literature review, and the key informant interviews will be reviewed by the three patientfamily study co-investigators. The study team will also convene a 1-day research meeting to review and discuss content and stylistic aspects of existing decision aids. Participants at the summit will include study team members as well as other invited patient-family advocates, key stakeholders, and decision aid and advance care planning experts. Other patient-family advocates could include members of hospital Patient-Family Advisory Council as well as patient-family advocates involved in other research projects. 2.4.2 Data Collection and Synthesis Patients and family advocates will be asked to comment on decision aid content, style, and relevancy as well as to provide their own experiences and perceptions concerning decision aids. We will gather input using multiple

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modalities but will primarily include in-person and phone conversations. Patient and family comments about the content and style of advance care planning decision aids will be documented in notes by research team members. Additionally, throughout the 1-day research meeting, research team members will document stakeholders’ perceptions and discussions of existing advance care planning decision aids. The research team will synthesize the notes taken independent of and during the meeting.

3 Anticipated Outcomes We anticipate this environmental scan will generate three outcomes: a synthesis of current evidence; a summary of gaps in knowledge; and a taxonomy of the decision aids. The synthesis of current evidence will draw its information from one data source, while the summary of gaps in knowledge and taxonomy of the decision aids will synthesize information gathered from more than one data source. The anticipated outcomes and respective results are described in more detail below. The first outcome will be a synthesis of current evidence on existing advance care planning decision aids. It will present and discuss the decision aids that have been evaluated in previous studies along with results from those studies. Some results that we anticipate to find in the literature and to report on include evidence on patients’ preferences for medical therapies such as cardiopulmonary resuscitation (CPR) or mechanical ventilation (MV), evidence on changes in healthcare utilization outcomes, evidence on changes in patient and surrogate quality of life, and evidence about whether or not advanced care wishes get documented more frequently than they would otherwise without the use of advance care planning decision aids. We also expect that this outcome will distinguish approaches that better support advance care planning. This outcome is expected to provide an additional overview on the types of past studies conducted on advance care planning decision aids. The overview will make it possible to assess the overall quality of evidence. The second outcome will be a summary of gaps in knowledge about advance care planning decision aids. It will synthesize information from all four data sources: the systematic review, the grey literature review, key informant interviews, and patient and family engagement. By incorporating information from peer-reviewed literature and grey literature as well as professional and patientfamily perspectives, we expect this outcome to identify gaps in knowledge on the use and application of advance care planning decision aids. It will provide evidence as to what degree advance care planning decision aids are available to the public and specific sub-populations as well

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as the degree to which clinicians implement various advance care planning decision aids. We also expect this outcome to illuminate situations where it would be beneficial to initiate advance care planning. Furthermore, it will begin to identify what outcomes matter to clinicians and patients and where their priorities converge or diverge. The third outcome is the creation of a taxonomy of advance care planning decision aids that will offer a muchneeded description of the content of different decision aids identified through the systematic review, grey literature review, and key informant interviews. We anticipate the taxonomy will delineate the types of advance care planning decision aid delivery systems (i.e., written, video, computer, or audio formats). The taxonomy’s intent is also to provide details on decision aid content and how that content is conveyed via characteristics such as tone, pacing, length, narrative style, and point of view. Furthermore, the taxonomy is expected to render information on different intended purposes of existing advance care planning decision aids (i.e., satisfy legal requirements).

4 Discussion The environmental scan will serve a number of purposes; it will (i) identify and synthesize current evidence about existing advance care planning decision aids, (ii) identify gaps in the current evidence, and (iii) provide details about existing advance care planning decision aids. Collectively, its outcomes will represent an accumulated understanding of advance care planning decision aids. These findings will be crucial to initiating the first phase of designing an advance care planning decision aid specifically for a surgical population. The research team is committed to designing an advance care planning decision aid that is not only supported by data gathered from the environmental scan, but one that will meet the expressed needs and preferences of patients and families preparing for surgery. While we expect the findings in this study to endorse developing a video-based advance care planning decision aid for a high-risk surgical population, the findings will be used to illuminate the questions we need to ask to build an effective decision aid. Conducting an environmental scan like the one we have proposed provides advantages to researchers and patients alike. A notable strength of this study is that it will gather both expert and patient-family perspectives. Not only will this approach offer the research team a way to understand the overlap between experts’ and patients’ perspectives, but also it can provide insight into how to address discrepancies that exist between them. Incorporating the patient-family perspective is an innovative addition to environmental scans published in the peer-reviewed and grey literature,

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which typically focus on gathering expert opinions only. Further, drawing data from four discrete sources will allow researchers to synthesize information from different sectors of the healthcare system. The approach of this study, therefore, offers a more complex, systems’ perspective to the field of advance care planning. The proposed study has limitations that should be considered. One limitation will be engaging patients and family members who are deeply committed to the project and who consequently may not provide a representative range of patient-family perspectives. However, their insights will be vital to identifying key aspects of patient/family-centered decision aids and they will directly inform the next stage of our research—cognitive interviews with patients and their families about advance care planning aids. The findings will potentially be limited by excluding studies that are not in English and do not include individuals who are under the age of 19 years. Another limitation concerns the wide variation in advance care planning decision aid strategies. Similarly, the results may not include all relevant information because we will only include studies that evaluate instrument-based advance care planning decision aids and will not evaluate studies concerning conversation-based advance care planning interventions. However, we believe that confining the definition of advance care planning decision aids will appropriately narrow the scope and application of our findings to the study at hand; future research should focus on these equally important approaches to advance care planning. As mentioned above, this environmental scan will inform future interviews with patients and their families. The purposeful involvement of patients and their families is inherent to conducting patient-centered research and will be a vital aspect of the next step in our research. With their involvement, we expect to further identify components of decision aids that confer ‘real–world’ meaning and utility to patients and their families. Subsequently, the team will use another patient-centered research technique, conjoint analysis [46–48], to understand patient preferences and further delineate content for a new decision aid. The aid will then be developed and evaluated in a randomized controlled trial.

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information from these data sources. Moreover, it demonstrates principles of patient-centered outcomes research by incorporating patient and family engagement. This environmental scan can generate a spectrum of analyses to better understand complex interventions. It establishes a comprehensive framework for other environmental scans conducted in the future. While there is more ground to cover in understanding the relationship between advance care planning decision aids and the advance care planning process, this study will be a significant step in that direction. Acknowledgments This work was (partially) supported through a Patient-Centered Outcomes Research Institute (PCORI) Communication and Dissemination Research Award (CD-12-11-4362). RAA is the guarantor for the overall content of this paper. RAA, JM, MW, and JFPB made substantial contributions to the study design and generation of content. AEV and RAA generated the key informants contact list and contributed to content generation. RAA, ALRS, and JFPB have drafted the manuscript. All authors have reviewed it critically, edited content, and have given approval of the final version to be submitted. AEV’s spouse is the Executive Director of a non-profit foundation 501(c)3, Nous Foundation Inc. The mission of the non-profit is to educate patients about advance care planning. The authors have no further potential conflicts of interest to report.

Appendix A: List of organizations’ websites to be searched for advance care planning decision aids The American Cancer Society, the American Geriatrics Society, The American Academy of Hospice and Palliative Medicine, the Center to Advance Palliative Care, the National Palliative Care Research Center, National Institute of Health-National Institute for Aging, the Coalition to Transform Advanced Care, AARP, the Informed Medical Decisions Foundation, the Center for Shared Decision Making, the International Patient Decision Aids Standards, National Quality Forum, Family Caregiver Alliance, Gerontological Society of America, Medline Plus (NIH), National Cancer Institute, National Hospice and Palliative Care Organization, Heart Failure Society of America, Agency for Healthcare Research and Quality, Mayo Clinic, the National Coalition of Cancer Survivors, and the American Society of Clinical Oncology.

5 Conclusion The environmental scan described in this paper rises to the challenge of conceptualizing a research methodology that can accommodate the review of complex interventions. It brings together various approaches—a systematic review, grey literature review, and interviews with key informants—seen previously in the published and grey literature. It is unique for the very reason that it synthesizes

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