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. Author manuscript; available in PMC: 2019 Apr 1.
Published in final edited form as: Acad Emerg Med. 2018 Feb 20;25(4):425–433. doi: 10.1111/acem.13373

Development of a Patient Decision Aid for Syncope in the Emergency Department: the SynDA tool

Marc A Probst a, Erik P Hess b, Maggie Breslin c, Dominick L Frosch d, Benjamin C Sun e, Marie-Noelle Langan f, Lynne D Richardson a
PMCID: PMC5906162  NIHMSID: NIHMS932207  PMID: 29288554

Abstract

Objectives

To develop a patient decision aid to promote shared decision-making for stable, alert patients who present to the emergency department (ED) with syncope.

Methods

Using input from patients, clinicians, and experts in the field of syncope, health care design, and shared decision-making, we created a prototype of a paper-based decision aid to engage patients in the disposition decision (admission vs. discharge) after an unremarkable ED evaluation for syncope. In phase 1, we conducted 1-on-1 semi-structured exploratory interviews with 10 emergency physicians and 10 ED syncope patients. In phase 2, we conducted 1-on-1 directed interviews with 15 emergency care clinicians, 5 cardiologists, and 12 ED syncope patients to get detailed feedback on decision aid content and design. We iteratively modified the aid using feedback from each interviewee until clarity and usability had been optimized.

Results

The 11- × 17-inch, paper-based decision aid, titled SynDA, includes 4 sections: 1) Explanation of syncope, 2) Explanation of future risks, 3) Personalized 30-day risk estimate, and 4) Disposition options. The personalized risk estimate is calculated using a recently published syncope risk-stratification tool. This risk estimate is stated in natural frequency and graphically displayed using a 100-person color-coded pictogram. Patient-oriented questions are included to stimulate dialogue between patient and clinician. At the end of the development process, patient and physician participants expressed satisfaction with the clarity and usability of the decision aid.

Conclusions

We iteratively developed an evidence-based decision aid to facilitate shared decision-making for alert syncope patients after an unremarkable ED evaluation. Further testing is required to determine its effects on patient care. This decision aid has the potential to improve care for syncope patients and promote patient-centered care in emergency medicine.

Introduction

Syncope, defined as a transient loss of consciousness with inability to maintain postural tone followed by spontaneous recovery, is a common reason patients visit the Emergency Department (ED). Syncope accounts for over 1 million ED visits each year in the United States (US), with roughly one third of these visits resulting in admission to the hospital.(1) The hospital costs of syncope have been estimated to be over $2.4 billion per year.(2) More specifically, the average cost of hospital or observation admission for adult syncope patients who had no clear diagnosis found in the ED was $1,486.(3)

The etiology of syncope is often difficult to discern despite considerable testing in the ED. Potential causes include serious cardiovascular conditions such as cardiac arrhythmias or structural heart disease, as well as more benign causes such as vaso-vagal syncope or dehydration.(4) The standard ED diagnostic evaluation involves a history, physical examination, electrocardiogram, and laboratory testing, when indicated.(5) Over half the time, this testing does not reveal a specific diagnosis.(6, 7) Patients at very low risk for adverse events are generally discharged from the ED with outpatient follow-up. However, due to the potential seriousness of the underlying cause of syncope, moderate to high-risk patients who have a normal diagnostic evaluation in the ED are often admitted to the hospital for prolonged monitoring and further testing.(1) These admissions are largely low yield and are associated with certain iatrogenic harms, such as medication errors and in-hospital delirium.(8, 9) Over one third of patients admitted to the hospital after an ED visit for syncope have a hospital discharge diagnosis of “syncope and collapse”, suggesting that no additional diagnostic information was gained from the in-patient stay.(1) Decreasing these low-yield hospital admissions, or using observation unit syncope protocols, could result in substantial costs savings.(10)

Often the decision to admit to the hospital is made without meaningful input from the patient. Yet, the uncertainty and potential harms associated with the decision to admit the patient to the hospital creates a situation in which patients’ values and preferences should be taken into consideration.(11, 12) Thus, engaging patients in the decision to be admitted to the hospital or to follow-up closely as an outpatient should be incorporated in clinical pathways for low-to-moderate risk syncope patients. Patients who present after syncope fall into two broad categories: 1) those with a clear diagnosis found in the ED, and 2) those without a clear diagnosis. If a diagnosis is made, then the patient should receive standard care to treat the underlying cause. However, if no diagnosis is found, the patient should be risk-stratified into three broad categories: very low risk, low-to-moderate risk, and high risk. Those at very low risk for adverse events are not likely to benefit from admission and should generally be discharged home. Those at high risk for adverse events should generally be admitted for monitoring and further testing. For those who are at low-to-moderate risk, clinical equipoise exists with regard to the best disposition: expedited out-patient follow-up or admission for observation. Thus, these patients should be meaningfully engaged in the decision regarding disposition and future care (See Figure 1).

Figure 1. Emergency Department Syncope Clinical Pathway.

Figure 1

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Patients presenting after syncope may or may not have a diagnosis uncovered in the emergency department. If no cause is found, risk stratification and shared decision-making are indicated.

Shared decision making (SDM) has been defined as a “process by which patients and providers consider outcome probabilities and patient preferences and reach a health care decision based on mutual agreement.” (13) Charles et al. proposed four essential ingredients to SDM: 1) participation of two parties -- patient and clinician, 2) bidirectional sharing of information, 3) involvement of both parties in the consensus building process, and 4) agreement by both parties.(14) For low-to-moderate risk syncope patients with an unremarkable ED evaluation, SDM has the potential to increase patient engagement and safely promote patient-centered care.(15) Disposition for syncope patients was recently highlighted as a research priority for the emergency medicine community in the Academic Emergency Medicine (AEM) Consensus Conference in New Orleans, LA in May of 2016.(16)

Patient decision aids -- patient-centered tools that educate patients about the medical decision at hand and highlight the pros and cons of the available management options-- facilitate SDM and have been shown to have beneficial effects on patient knowledge, decisional quality(17) and, in some cases, clinical outcomes.(18, 19) Our objective was to develop a patient decision aid to engage low-to-moderate risk ED syncope patients in the decision to be admitted for observation or to be discharged with expedited follow-up for further evaluation.

Methods

Study Design

From January to November 2016, we developed a paper-based DA to facilitate SDM for hemodynamically stable, alert adult patients who present to the ED after a syncopal episode and have an unremarkable ED diagnostic evaluation. The decision in question is ED disposition: admit for observation versus discharge home with follow-up with a primary care physician/cardiologist for further evaluation. Our team consisted of emergency physician-researchers with expertise in SDM and syncope (MP, BS, EH), a cardiologist (ML), as well as a health psychologist (DF) and an interaction designer (MB) with previous experience developing SDM tools for acute care settings. We followed the systematic development process put forth by the International Patient Decision Aid Standards (IPDAS) Collaboration(20). These steps included assembly of the steering group, assessment of patient and clinician needs, review and synthesize of the evidence, drafting of a prototype, alpha-testing with iterative redrafting, and field testing. Development occurred in two broad phases: exploratory interviews to inform initial prototype development, and iterative modification of this prototype. The Institutional Review Board at our center reviewed and approved all study procedures. All patients and clinicians provided informed consent before participation.

Study Setting and Population

Development of the DA was conducted at a high-volume, urban, academic medical center in New York City. Our study population consisted of actual ED syncope patients, emergency clinicians (physician assistants, resident and attending physicians), ED nurses, and attending cardiologists.

Study Protocol

Phase 1: Exploratory Interviews with Emergency Department physicians and patients

In phase 1A, we conducted semi-structured interviews via telephone with a convenience sample of practicing attending emergency physicians at our medical center. Key “opinion leaders” (clinicians with seniority, in leadership positions, or who were held in high regard by their peers) were sought out and initially contacted via e-mail. All interviews were conducted by the lead author (MP), an emergency physician with training in qualitative research methods, and consisted of 11 open-ended questions regarding ED management of syncope, clinical decision-making, potential barriers and facilitators to SDM, and recommendations regarding DA content (See appendix A). Physicians were not compensated for their time.

In phase 1B, we conducted semi-structured interviews via telephone with syncope patients after ED discharge. Trained research assistants screened the electronic ED track-board for potential participants based on eligibility criteria, i.e. chief complaint of syncope, age over 40, English-speaking, without evidence of intoxication, and deemed clinically stable by the treating team. Patients were approached in the ED prior to discharge and contacted over the phone within 4–5 days. All interviews were conducted by the lead author (MP) and consisted of 9 open-ended questions regarding their experience as patients in the ED, their desire to be involved in medical decisions, and their preferred mode of information sharing (See appendix B). Patients were offered a $20 gift card for participating. All interviews in phase 1 were performed one-on-one, audio-recorded, and analyzed by the lead author to identify recurring themes.

Using input from the patient and physician interviews, an initial prototype of the Syncope DA, named SynDA, was created by our interaction designer (See figure 2). SynDA is a paper-based, 11- by 17-inch, patient decision aid with four main sections: 1) Explanation of syncope and its causes, 2) Explanation of potential future risks, 3) A personalized 30-day risk estimate for serious adverse events using the Canadian Syncope Risk Score (5), and 4) presentation of four options for further care. This prototype was then used as a basis for discussion for the interviews in phase 2.

Figure 2.

Figure 2

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The Syncope Decision Aid “SynDA” Prototype

Phase 2: Directed interviews with patients and clinicians with iterative modification

In phase 2A, we conducted in-person, semi-structured interviews with a convenience sample of 20 physicians, nurses, and physician assistants from emergency medicine and attending cardiologists from our academic medical center. Senior emergency medicine residents were also included since they are often responsible for having the disposition discussion with patients. All questions were centered on the content and design of the decision aid. Clinicians were initially contacted via e-mail to determine their willingness to participate and to schedule in-person interviews. Physicians were not compensated for their time. All interviews in phase 2A were performed one-on-one,

In phase 2B, the lead author and interaction designer pilot-tested a prototype of the SynDA tool in the ED with 12 individual syncope patients after the diagnostic evaluation was complete but prior to ED discharge. Our approach to decision aid development involves an iterative process of using the decision aid in clinical encounters, obtaining feedback from the patient and clinician regarding how well the decision aid facilitates an evidence-informed conversation that brings to light patient factors relevant to the decision at hand, refining the decision aid based on this feedback, using it again in the clinical setting, and obtaining additional feedback until no new themes emerge (thematic saturation is reached)(21, 22). In prior work this has been reached after approximately 15 iterations of the decision aid.(23) In this study, patients were identified by the lead author using the electronic track-board in the ED. Patients were presented the prototype under hypothetical conditions, i.e., “if your doctor were to show you this tool, how would you react?” Similar phrasing was used for all other phase 2b questioning. The tool was not used to guide clinical management in any way. Open-ended questions were posed regarding clarity, ease of use, and quantity of information. Brief cognitive interviews were then performed to assess comprehension and interpretation of the information provided in the tool. Patients were again offered a $20 gift card for participating. Interviews in phase 2B were performed two-on-one with the lead author and interaction designer eliciting feedback from the patient while in the ED.

Interviews in phase 2 were not recorded. Rather written notes were taken during the interviews and subsequently reviewed by the research team. The SynDA tool was iteratively modified after each set of interviews (2–4) after discussion with the research team. The process continued until the investigators were confident that the decision aid could successfully and consistently foster a dialogue between an individual patient and their treating clinician in the clinical scenario in question, i.e., a patient visit for syncope with a normal ED evaluation.

Data analysis

For the interviews in phase 1, the qualitative data analysis was performed by the first author, a clinician-researcher with previous training and experience in qualitative research.(24) Audio-recordings were listened to and notes were taken to identify key themes. Subsequent interviews were conducted until no new themes arose. For the interviews in phase 2, written notes were taken in real time during the interviews with patients and clinicians. These notes were then used to iteratively modify the decision aid after discussion with the rest of the research team. Subsequent interviews in phase 2 were performed until no new feedback was received from the interviewees.

Role of the Funding Source

The first author received funding from the National Institutes of Health (Grant number: K23HL132052) to develop this tool. The funding agency did not play any role in the planning, design, conduct, collection, analysis or data interpretation, in writing this report, or in the decision to submit this manuscript for publication.

Results

Phase 1A – Interviews with Emergency Physicians

The interview response rate was 77% (10/13). Each interview lasted 20–25 minutes. The emergency physicians in our sample (mean age 37.5 years, 20% female) generally agreed on the key clinical factors that would influence the ED evaluation and disposition of syncope patients: age, past medial history, and presence of new serious diagnosis in the ED related to the syncope. Most clinicians felt that SDM could be appropriate for syncope patients if they were in equipoise about admission versus discharge. A 37-year-old female emergency physician stated that for this scenario “I mean… it’s always shared decision-making….it’s never totally unilateral.” Equipoise was felt to exist in cases where patients were at moderate risk for a serious cause of syncope, without being too low risk or too high risk. Key factors felt to be important potential barriers were lack of time, low patient health literacy, language barriers, and alteration in mental status. Potential facilitators were felt to be higher patient health literacy and sufficient time for patient engagement. Participants stated that for the DA to be successful, it would need to be evidence-based, use simple language that patients could easily understand, and be brief enough to facilitate a conversation that was 5 minutes or less.

Phase 1B – Interviews with Syncope Patients

The response rate was 72% (10/14). Each interview lasted 10–20 minutes. The syncope patients in our sample (mean age 71.6 years, 33% female) were generally pleased with their experience in the ED. Commonly noted areas for improvement were waiting too long to be seen and waiting too long for test results. Other sources of dissatisfaction were insufficient explanation of test results and the reason(s) for fainting. When asked about decision-making in the ED, roughly one third of the patients were not aware that any decisions had been made. When asked whether any medical decisions had been made in the ED, one 74-year-old patient responded, “If there were, I was not made aware of any.” Almost all patients expressed a clear desire to be involved in their medical decisions. Patients expressed a preference for a verbal explanation from their clinician as a means of obtaining information but were amenable to paper-based graphs or diagrams as well.

Phase 2 – Interviews with patients and clinicians

The response rate for clinicians was 77% (20/26). Our sample (mean age 45.2 years, 30% female) was comprised of 10 attending emergency physicians, 5 attending cardiologists, 2 registered nurses, 2 emergency medicine senior residents, and 1 physician assistant. Interviews lasted 20–35 minutes each. Iterative modifications were made after each interview, including changes to language, lay-out, and content.

The response rate for ED syncope patients was 92% (12/13). Our participants (mean age 65.3 years, 33% female) were generally very satisfied with the clarity and quantity of information and the format of the DA. Modifications included simplifying certain phrases for ease of understanding. More color was added to emphasize the contrast between those who did and did not have a serious medical event within 30 days. The most significant change to the decision aid that emerged from patient feedback was the addition of patient-oriented “questions to stimulate discussion with your doctor.” These questions (‘Why do you think you passed out?’, ‘Are you worried that passing out is a sign of something else?’, ‘What is your reaction to this risk?’) are designed to empower patients to discuss issues or concerns they may have. These concerns were often more situational (e.g. anxiety about being home alone) rather than clinical.

The final SynDA tool is shown in figure 3. Every effort was made to use simple language without medical jargon. We evaluated the readability using an online tool (https://readable.io). The text from the SynDA tool received an A-rating (considered very easy to read for the general public) and a Flesch-Kincaid Grade Level of 6.1. The tool contains four main sections. The first section provides a basic explanation of syncope and its causes. The second provides an explanation of potential future risks, including arrhythmias, structural heart disease, and “circulatory problems.” These were intentionally phrased very generally to allow clinicians to personalize this explanation based on the specifics of a case. The third section offers a personalized 30-day risk estimate of serious medical events using the Canadian Syncope Risk Score.(5) This information is presented both as a natural frequency and in a color-coded 100-person pictogram. This risk score represents the best, available evidence published in the field of syncope risk-stratification. The fourth section is a presentation of four disposition options for further care: 1) outpatient follow-up with the patient’s primary care physician, 2) outpatient follow-up with a cardiologist, 3) observation in the hospital, or 4) deferral to the emergency physician to make the decision. The tool is meant to stimulate a SDM discussion between the patient and the clinician after the diagnostic evaluation.

Figure 3.

Figure 3

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The Final Syncope Decision Aid “SynDA”

Discussion

We developed an evidence-based paper-based, patient DA to be used in the ED after an unremarkable ED diagnostic evaluation for syncope. This tool aims to stimulate a SDM conversation between patient and clinician to facilitate patient-centered decisions regarding future options for care. Specifically, it presents three different dispositions options that may be of varying suitability for individual patients. It also offers a fourth option, deferral to the emergency physician, to respect the wishes of certain patients who may not be willing to engage in SDM for social, cognitive, or cultural reasons.

We selected the Canadian Syncope Risk Score to provide a 30-day risk estimate. Although not externally validated, it is the largest, prospectively-derived, risk-stratification tool which offers a gradient of risk categories.(5) It uses a combination of five clinical variables, three ECG parameters and results of a troponin assay to generate a score from −3 to +10. Each score corresponds to a 30-day risk of serious adverse events which ranges from 0.4% to 74%. Recently, the same investigators published a similar risk-stratification tool, the Canadian Syncope Arrhythmia Risk Score, which predicts the rate of 30-day arrhythmia or death after ED disposition.(25) Although this tool has potential utility in guiding the use of ambulatory cardiac monitoring, it would not be suitable for use in our patient-centered decision aid since it would theoretically fail to predict other clinically important outcomes such as pulmonary embolism or aortic dissection. Thus, we used the original and more inclusive tool. We did not use the widely cited San Francisco Syncope Rule(26) since it provides only a binary risk category and has failed external validation.(27, 28) Other syncope risk-stratification tools have suffered from poor study design, methodological weaknesses, or lack of external validation.(29)

Strengths of this study including the multidisciplinary research team, the board stakeholder input including patients, emergency physicians, cardiologists, emergency nurses, and physician assistants. Our systematic, iterative, multi-step approach is consistent with that put forth by the IPDAS collaboration, as mentioned above.(20) As well, the SynDA tool provides a personalized risk estimate that varies from one patient to the other depending on his/her Canadian Syncope Risk Score, i.e. some patients will receive a version of the tool with one red icon, illustrating a 1% risk of serious adverse events at 30 days, while other patients will receive a version with nine red icons, illustrating a 9% risk. This risk is displayed both as natural frequency and depicted as a 100-person pictogram, which serves to maximize patient understanding.(30) This approach to risk communication is consistent with that put forth by Melnick et al. in the proceedings of the AEM Consensus Conference.(11) We choose not to present confidence intervals since these have been shown to be generally poorly understood by patients, harm credibility, and increase patient anxiety.(30)

The four sections of the DA were designed to address the desires expressed by patients in phase 1B, i.e. patients wanted to know the cause of their fainting spell, the results of their testing, and wanted to be involved in any decisions about their care. Patients were especially concerned about the possibility of a stroke or a heart attack. This tool is not meant to be independently read by the patient without the input of the clinician and intentionally relies on the expertise of the clinician caring for that particular patient. Syncope presentations to the ED vary with respect to context, signs, and symptoms. Thus the discussion of the nature of future risks must be tailored to each specific patient. This brief 1-page DA was designed to be used in the ED setting where clinicians often only have a few minutes to engage patients in care decisions. Based on input from clinicians in phase 1A, it became clear that a more detailed, multipage DA would not be acceptable to ED clinicians and would not promote an authentic conversational dynamic to facilitate SDM. Based on input from syncope patients in phase 1b and on expert opinion from within the research team, we felt that a paper-based DA would be more effective than a digital, tablet-based DA, since digital tools often distract from the direct interpersonal communication between patient and clinician. This DA is currently being evaluated in a randomized controlled trial to determine its effects on patient knowledge, involvement, and satisfaction. Similar ED-based DAs have been successfully studied for other clinical scenarios, i.e., low-risk chest pain after a negative diagnostic evaluation.(18, 19) SynDA is the first syncope DA of its kind.

Limitations

Our developmental process included patients and clinicians from a single academic center. Although we made every effort to keep the generalizability of the intervention in mind during the development process, the DA may need to be adapted prior to use in other clinical settings. At the time of writing, the Canadian Syncope Risk Score has not yet been validated, although such efforts are currently underway. This may affect the acceptability of the DA for certain clinicians. Since a convenience sample of patients and clinicians were enrolled, selection bias may have affected the responses. The qualitative analysis was performed by the lead author alone, which increases the risk of interpretation bias. The tool in its current form only exists in English and cannot be used with patients who lack English proficiency.

Conclusion

Using qualitative techniques and broad stakeholder input, we developed an evidence-based, patient DA to facilitate SDM for syncope patients with an unremarkable ED evaluation. This tool, if shown to be effective, could increase patient engagement and help promote a more patient-centered approach to decision-making for emergency syncope care. By facilitating the SDM conversation for this clinical scenario, the SynDA tool has the potential to improve the experience of care for syncope patients and could help improve resource utilization. Further research is necessary to evaluate the effect of the tool on these outcomes. A randomized controlled trial is underway to evaluate the effects of SynDA on patient-centered outcomes and resource utilization. Meanwhile, other SDM researchers should consider utilizing these methods when developing DAs for other ED clinical scenarios.

Acknowledgments

Grant Funding: The research was supported by a grant from the NIH / National Heart, Lung and Blood Institute.

The authors would like to thank the research coordinators of the Department of Emergency Medicine (Daniela Garcia, Diana Gregoriou, Aria Matias, Kavey Vidal).

Funding:

This work was supported by the National Institutes of Health, National Heart Lung and Blood Institute (grant number 1K23HL032052).

Footnotes

Prior presentation: This research was previously presented as an oral abstract at the Society for Medical Decision Making conference in October of 2016 in Vancouver, BC.

Conflict of Interest Disclosure: MP, EH, MB, DF, BC, ML, LR report no conflicts of interest.

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