Encounter Decision Aid Research Articles

Combining Default Choices and an Encounter Decision Aid to Improve Tobacco Cessation in Primary Care Patients: A Pragmatic, Cluster-Randomized Trial.

Primary care providers (PCPs) prescribe less often treatments for smoking cessation than for other major risk factors. We assessed the effect of training PCPs to offer smoking cessation treatments to current smokers as the default choice using an encounter decision aid (DA) on smoking cessation. Pragmatic, cluster-randomized controlled trial with PCPs in private practice in Switzerland and France. The intervention was a half-day course teaching PCPs the default choice approach using a DA. Control PCPs received a 1-h refresher training on smoking cessation aids. PCPs recruited daily smokers seen for routine care. The primary outcome was self-reported, 7-day, point prevalence smoking abstinence at 6 months. Secondary outcomes were quit attempts and use of smoking cessation aids at 3 weeks, 3 months, and 6 months, and a patient-reported measure of shared decision-making (CollaboRATE scale 1-10, higher scores = more involvement). Forty-two PCPs completed the training (76% Swiss) and recruited 287 current smokers (105 intervention group, 182 control group), with 51% women, mean age 48 (SD, 2.6), 77% who smoked <20 cigarettes/day, and 221 who responded at 6 months follow-up (77%). The intervention did not affect self-reported smoking abstinence rate at 6 months (9.5% intervention and 10.4% control groups, respectively; OR 0.88 (95%CI 0.37-2.10). It did however increase the number of quit attempts at 3 weeks (OR 2.09, 95%CI 1.04-4.20) and the use of smoking cessation aids at the 3-week and 3-month follow-ups (OR 2.57, 95%CI 1.21-5.45 and OR 2.00, 95%CI 1.11-3.60, respectively). The mean CollaboRATE score was 8.05/10 in the intervention group and 7.28/10 in the control group (p=0.02), reflecting more patient involvement in decision-making. Training PCPs to use a decision aid did not improve smoking abstinence rate, despite short-term increases in quit attempts and use of smoking cessation aids. It improved patient involvement in decision-making. ClinicalTrials.gov identifier: NCT04868474.

Digital encounter decision aids linked to clinical practice guidelines: results from user testing SHARE-IT decision aids in primary care

BackgroundEncounter decision aids (EDAs) are tools that can support shared decision making (SDM), up to the clinical encounter. However, adoption of these tools has been limited, as they are hard to produce, to keep up-to-date, and are not available for many decisions. The MAGIC Evidence Ecosystem Foundation has created a new generation of decision aids that are generically produced along digitally structured guidelines and evidence summaries, in an electronic authoring and publication platform (MAGICapp). We explored general practitioners’ (GPs) and patients' experiences with five selected decision aids linked to BMJ Rapid Recommendations in primary care.MethodsWe applied a qualitative user testing design to evaluate user experiences for both GPs and patients. We translated five EDAs relevant to primary care, and observed the clinical encounters of 11 GPs when they used the EDA with their patients. We conducted a semi-structured interview with each patient after the consultation and a think-aloud interview with each GPs after multiple consultations. We used the Qualitative Analysis Guide (QUAGOL) for data analysis.ResultsDirect observations and user testing analysis of 31 clinical encounters showed an overall positive experience. The EDAs created better involvement in decision making and resulted in meaningful insights for patients and clinicians. The design and its interactive, multilayered structure made the tool enjoyable and well-organized. Difficult terminology, scales and numbers hindered understanding of certain information, which was sometimes perceived as too specialized or even intimidating. GPs thought the EDA was not suitable for every patient. They perceived a learning curve was required and the need for time investment was a concern. The EDAs were considered trustworthy as they were provided by a credible source.ConclusionsThis study showed that EDAs can be useful tools in primary care by supporting actual shared decision making and enhancing patient involvement. The graphical approach and clear representation help patients better understand their options. To overcome barriers such as health literacy and GPs attitudes, effort is still needed to make the EDAs as accessible, intuitive and inclusive as possible through use of plain language, uniform design, rapid access and training.Trial registrationThe study protocol was approved by the The Research Ethics Committee UZ/KU Leuven (Belgium) on 31–10-2019 with reference number MP011977.

Development of Complementary Encounter and Patient Decision Aids for Shared Decision Making about Stroke Prevention in Atrial Fibrillation.

Decision aids (DAs) are helpful instruments used to support shared decision making (SDM). Patients with atrial fibrillation (AF) face complex decisions regarding stroke prevention strategies. While a few DAs have been made for AF stroke prevention, an encounter DA (EDA) and patient DA (PDA) have not been created to be used in conjunction with each other before. Using iterative user-centered design, we developed 2 DAs for anticoagulation choice and stroke prevention in AF. Prototypes were created, and we elicited feedback from patients and experts via observations of encounters, usability testing, and semistructured interviews. User testing was done with 33 experts (in AF and SDM) and 51 patients from 6 institutions. The EDA and PDA underwent 1 and 4 major iterations, respectively. Major differences between the DAs included AF pathophysiology and a preparation to meet with the clinician in the PDA as well as different language throughout. Content areas included personalized stroke risk, differences between anticoagulants, and risks of bleeding. Based on user feedback, developers 1) addressed feelings of isolation with AF, 2) improved navigation options, 3) modified content and flow for users new to AF and those experienced with AF, 4) updated stroke risk pictographs, and 5) added structure to the preparation for decision making in the PDA. These DAs focus only on anticoagulation for stroke prevention and are online, which may limit participation for those less comfortable with technology. Designing complementary DAs for use in tandem or separately is a new method to support SDM between patients and clinicians. Extensive user testing is essential to creating high-quality tools that best meet the needs of those using them. First-time complementary encounter and patient decision aids have been designed to work together or separately.User feedback led to greater structure and different experiences for patients naïve or experienced with anticoagulants in patient decision aids.Online tools allow for easier dissemination, use in telehealth visits, and updating as new evidence comes out.

Acceptability and perceived feasibility of adapted encounter decision aids on contraceptive methods: An interview study with healthcare providers and Chinese migrant women.

This study aimed to explore the perceived acceptability, usefulness, and feasibility of a suite of encounter decision aids (DAs) on contraceptive methods with Chinese migrant women living in Australia and healthcare providers. Semi-structured in-depth interviews with 22 Chinese migrant women and twenty healthcare providers were conducted. Transcribed data were analysed using the qualitative content analysis method. Women perceived the DAs to be informative and useful. They suggested making the DAs available outside the clinical settings. Healthcare providers perceived the DAs to be comprehensive and valuable in informing women about contraceptive methods. Some providers had concerns as to the information load and the length of the DAs. Such concerns were eased when provided with an explanation of how to use the DAs. Most women and healthcare providers preferred the numerical format for side-effect probability information presentation. Making the encounter DAs available in both the Chinese and English languages can be valuable in assisting Chinese migrant women in making informed decisions about contraceptive methods. This study is the first to evaluate the acceptability and perceived feasibility of patient decision aids with members of a migrant community in Australia. The findings highlight the need for disseminating the DAs both within and outside the clinical settings.

Combining default choices and an encounter decision aid to improve tobacco cessation in primary care patients: protocol for a cluster-randomized trial

BackgroundWhile quitting smoking dramatically decreases overall mortality, general practitioners (GPs) are less likely to prescribe medications for smoking cessation than other cardiovascular risk factors. Guidelines recommend providers first assess patients’ “readiness” to quit, an “opt-in” strategy, but only a minority of tobacco users are ready to quit on a given day. An “opt-out” strategy offering treatment as the default choice increased quit attempts in hospital and with pregnant women, but has not been tested in primary care. We will assess the efficacy of training GPs to offer treatment as the default choice using an encounter decision aid with current smokers seen in primary care.MethodsThis is a pragmatic cluster-randomized controlled superiority trial with block randomization at the GP level in private practice in French-speaking Switzerland. GPs will be blinded to the arm allocation. The intervention is a half-day training course teaching an ‘opt-out’ approach to smoking cessation using an encounter decision aid (paper or electronic). GPs in the enhanced usual care group receives a brief refresher training about smoking cessation without changing their behaviour. GPs in both arms will recruit 23 patients each prior to routine primary care visits. The primary outcome is the effect of consulting a GP who received the intervention on the 7-day, point prevalence, smoking abstinence 6 months after the baseline appointment. Secondary outcomes include continuous abstinence; number of quit attempts; use of smoking cessation aids; patient-perceived involvement in discussions; and changes in GP behaviour. Patient outcomes will be collected using paper and telephone questionnaires. Assuming 15% drop-out, recruiting 46 GPs with 23 patients each will give us 80% power to detect an increase in smoking cessation from 4% (control) to 10.5% (intervention), with an alpha < 0.05.DiscussionGP visits are an opportunity to administer proven smoking cessation treatments. We hypothesize GPs offering smoking cessation treatment as the default choice using an encounter decision aid will increase the number of patients who quit. This study could significantly change our approach to smoking cessation in primary care. Default choices and the electronic decision aid are low-cost, easily diffusible interventions.Trial registrationClinicalTrials.gov Identifier: NCT04868474, First Posted May 3, 2021, Last Update Posted October 6, 2021.

Formative Provider Testing of a New Encounter Decision Aid for Smoking Cessation: Questionnaire Study.

BackgroundSmoking cessation is an essential part of preventing and reducing the risk of smoking-associated morbidity and mortality. However, there is often little time to discuss smoking cessation in primary care. Decision aids (DAs) designed for clinic visits (encounter DAs) need to be clear, short, and concise to optimize therapeutic education, increase interaction, and improve the therapeutic alliance. Such a DA for smoking cessation could potentially improve counseling and increase the use of pharmacological treatments.ObjectiveWe aimed to collect feedback on an electronic encounter DA that facilitates physician-patient interaction and shared decision-making for smoking cessation in primary care.MethodsWe developed an electronic, encounter DA (howtoquit.ch) from a paper version created by our team in 2017 following user-centered design principles. The DA is a 1-page interactive website presenting and comparing medications for tobacco cessation and electronic cigarettes. Each smoking cessation medication has a drop down menu that presents additional information, a video demonstration, and prescribing information for physicians. To test the DA, we submitted a questionnaire to approximately 20 general practitioner residents of an academic general medicine department, 5 general practitioners, and 6 experts in the field of smoking cessation. The questionnaire consisted of 4 multiple-choice and 2 free-text questions assessing the usability or acceptability of the DA, the acquisition of new knowledge for practitioners, the perceived utility in supporting shared decision-making, perceived strengths and weaknesses, and whether the participants would recommend the tool to other clinicians.ResultsIn all, 6 residents, 3 general practitioners in private practice, and 2 tobacco cessation experts completed the questionnaire (N=11), with 4 additional experts providing open-text feedback. On the 11 questionnaires, the DA was rated as practical and intuitive (mean 4.6/5), and providers felt it supported shared decision-making (mean 4.4/5), as comparisons were readily possible. Inclusion of explanatory videos was seen as a bonus. Several changes were suggested, like grouping together similar medications and adding a landing page to briefly explain the site. Changes were implemented according to end-user comments.ConclusionsThe overall assessment of the encounter DA by a group of physicians and experts was positive. The ultimate objective is to have the tool deployed and easily accessible for all to use.

Randomized evaluation of decision support interventions for atrial fibrillation: Rationale and design of the RED-AF study

BackgroundShared decision making (SDM) improves the likelihood that patients will receive care in a manner consistent with their priorities. To facilitate SDM, decision aids (DA) are commonly used, both to prepare a patient before their clinician visit, as well as to facilitate discussion during the visit. However, the relative efficacy of patient-focused or encounter-based DAs on SDM and patient outcomes remains largely unknown. We aim to directly estimate the comparative effectiveness of two DA’s on SDM observed in encounters to discuss stroke prevention strategies in patients with atrial fibrillation (AF). MethodsThe study aims to recruit 1200 adult patients with non-valvular AF who qualify for anticoagulation therapy, and their clinicians who manage stroke prevention strategies, in a 2x2 cluster randomized multi-center trial at six sites. Two DA’s were developed as interactive, online, non-linear tools: a patient decision aid (PDA) to be used by patients before the encounter, and an encounter decision aid (EDA) to be used by clinicians with their patients during the encounter. Patients will be randomized to PDA or usual care; clinicians will be randomized to EDA or usual care. ResultsPrimary outcomes are quality of SDM, patient decision making, and patient knowledge. Secondary outcomes include anticoagulation choice, adherence, and clinical events. ConclusionThis trial is the first randomized, head-to-head comparison of the effects of an EDA versus a PDA on SDM. Our results will help to inform future SDM interventions to improve patients’ AF outcomes and experiences with stroke prevention strategies.

Antidepressant decision aid for major depressive disorder patients (ADAM): Development and pilot testing

ObjectivesThis study aimed to develop and assess the effectiveness of an encounter decision aid for Malaysian patients with MDD to support treatment decision-making during the consultation. MethodsThe decision aid prototype was developed following a literature review and six focus groups. Alpha testing assessed its comprehensibility, acceptability, usability and desirability through user-centered cognitive interviews. Beta-testing evaluated preliminary evidence on its efficacy using the SDM Scale and PDMS. Feasibility was assessed by timing the consultation. ResultsThe alpha testing demonstrated that the decision aid was patient-oriented, comprehensible, comprehensive, concise and objective with an appealing design. Beta-testing indicated that PtDA significantly increased patients satisfaction with SDM from patients' [83.32 (13.92) vs 85.76 (13.80); p < 0.05] and physicians' [81.07 (10.09) vs 86.36 (10.10); p < 0.05] perspectives and prepared the patients for decision making from the patients' [PDMS patients: 84.10 (12.69)] and physicians' [PDMS physicians: 83.78 (16.62)] perspectives as well. There was no change in the consultation time between the control and the intervention groups. ConclusionsWe developed an antidepressant PtDA for Malaysian patients with MDD that increases patients’ involvement in shared decision making and enhances their preparedness for decision making. Practice implicationsUsing the PtDA can support collaborative decision-making in routine clinical practice without extending the consultation time.

Decision aids linked to evidence summaries and clinical practice guidelines: results from user-testing in clinical encounters

BackgroundTools for shared decision-making (e.g. decision aids) are intended to support health care professionals and patients engaged in clinical encounters involving shared decision-making. However, decision aids are hard to produce, and onerous to update. Consequently, they often do not reflect best current evidence, and show limited uptake in practice. In response, we initiated the Sharing Evidence to Inform Treatment decisions (SHARE-IT) project. Our goal was to develop and refine a new generation of decision aids that are generically produced along digitally structured guidelines and evidence summaries.MethodsApplying principles of human-centred design and following the International Patient Decision Aid Standards (IPDAS) and GRADE methods for trustworthy evidence summaries we developed a decision aid prototype in collaboration with the Developing and Evaluating Communication strategies to support Informed Decisions and practice based on Evidence project (DECIDE). We iteratively user-tested the prototype in clinical consultations between clinicians and patients. Semi-structured interviews of participating clinicians and patients were conducted. Qualitative content analysis of both user-testing sessions and interviews was performed and results categorized according to a revised Morville’s framework of user-experience. We made it possible to produce, publish and use these decision aids in an electronic guideline authoring and publication platform (MAGICapp).ResultsDirect observations and analysis of user-testing of 28 clinical consultations between physicians and patients informed four major iterations that addressed readability, understandability, usability and ways to cope with information overload. Participants reported that the tool supported natural flow of the conversation and induced a positive shift in consultation habits towards shared decision-making. We integrated the functionality of SHARE-IT decision aids in MAGICapp, which has since generated numerous decision aids.ConclusionOur study provides a proof of concept that encounter decision aids can be generically produced from GRADE evidence summaries and clinical guidelines. Online authoring and publication platforms can help scale up production including continuous updating of electronic encounter decision aids, fully integrated with evidence summaries and clinical practice guidelines.

Encounter decision aids to facilitate shared decision-making with women experiencing heavy menstrual bleeding or symptomatic uterine fibroids: A before-after study

ObjectiveIs the level of shared decision-making (SDM) higher after introduction of a SDM package (including encounter decision aids on treatment options for heavy menstrual bleeding and training for clinicians) than before?. MethodsThis before-after study, performed in OB-GYN practice, compared consultations before and after introduction of a SDM package. The target sample size was 25 patients per group. Women seeking treatment for heavy menstrual bleeding were eligible. After their appointments, patients filled out a three-item patient-reported SDM measure. Treatment discussions were audio-recorded and rated for SDM using Observer OPTION5. Consultation transcripts in the ‘after’ group were checked for adherence to the steps required for intended use of decision aids. Results16 gynaecologists participated. 25 patients participated before introduction of the decision aids and 28 after. The proportion of women reporting optimal SDM was higher after introduction (75 %) than before (50 %;p < 0.001). The mean observer-rated level of SDM was also significantly higher after than before (MD = 12.50,95 % CI 5.53–19.47). ConclusionThe level of SDM was higher after the introduction of the package than before. Practice implicationsThis study was conducted in a real-life setting in three clinics, both large academic and small rural, offering opportunities for implementation in different type of organizations.

Evaluating the feasibility of a decision aid to promote shared decision making among young adults with first-episode psychosis: protocol for a pilot study

BackgroundYoung adults ages 18 to 25 with first episode psychosis (FEP) have an increased risk of discontinuation antipsychotic medications and psychiatric service disengagement that lead to symptom exacerbation and deterioration. We seek to (1) examine the feasibility, usability, and potential impact of a Shared Decision Making (SDM) Antipsychotic Medication Decision Aid (DA) on decision-making, adherence to the decision made, and service engagement among young adults with FEP and (2) understand the role of additional patient-level factors on SDM.MethodsA randomized controlled trial is being conducted in a coordinated specialty care community program for FEP in an urban setting. Eligible patients are randomly assigned to receive an intervention, the Antipsychotic Medication Decision Aid, or treatment as usual. Patients receive their assigned intervention before their medication appointment with the psychiatrist and complete four interviews: before the appointment (T0), after the appointment (T1), and at 3- and 6-month follow-ups (T2 and T3). The study staff and participating psychiatrists are not blinded to the intervention. The data are de-identified to maintain blinding during the analysis process. The primary aims are feasibility of intervention delivery and research procedures and preliminary impact of the intervention on SDM-related outcomes, medication adherence, and service engagement. As a secondary aim, we will explore the contribution of personality and motivation variables, clinical relationships, cognitive functioning, and mental-health-related stigma to SDM. If the sample size permits, we plan to conduct parametric tests such as independent-samples t tests at T1 to compare differences in SDM, adherence, and engagement scales. In the case of a small sample size, we will use non-parametric tests and descriptive statistics.DiscussionThis protocol outlines the methodology for a feasibility pilot comparing the effect of a novel SDM Antipsychotic Medication encounter DA with treatment as usual on SDM, medication adherence, and service engagement in FEP care. SDM is endorsed as a framework for use in FEP and antipsychotic pharmacotherapy, but its impact on adherence and health outcomes is unclear. Understanding the potential contribution of an SDM Antipsychotic Medication DA compared with usual care in psychosis pharmacotherapy is critical. The study will help answer several key questions new to SDM research, including the contribution of personality and clinical relationships to SDM in mental health and psychosis in particular. The study will serve to gather feasibility data to inform future studies and scale-up.Trial registrationEthics approval was obtained through Temple University’s institutional review board (IRB) and the City of Philadelphia’s Department of Public Health IRB. The study has been retrospectively registered with ClinicalTrials.gov as NCT04373590 on 29 April 2020. https://clinicaltrials.gov/ct2/show/NCT04373590?term=NCT04373590&draw=2&rank=1

Pilot Study of an Encounter Decision Aid for Lung Cancer Screening.

The Centers for Medicare and Medicaid Services has mandated in-person shared decision-making (SDM) counseling with the use of one or more decision aids (DAs) prior to lung cancer screening. We developed a single-page, paper-based, encounter DA (EDA) to be used within a clinician-patient encounter for lung cancer screening and conducted a pre-post pilot intervention study to evaluate its feasibility and effects on patient decisional conflict. Patients referred to a pulmonary practice-based lung cancer screening program were surveyed before and after an SDM visit with a pulmonologist, who used the EDA to counsel the patient. Patient knowledge of the mortality benefit from screening and the frequency of abnormal screening test results was evaluated after the visit, while decisional conflict was measured before and after the visit using the Decisional Conflict Scale (DCS). Twenty-three patients participated (mean age = 65.8years; 43% female; mean smoking history = 57.8pack-years; 48% currently smoking). Following the visit, 28% of participants correctly understood the mortality benefit of lung cancer screening, while 82% understood the frequency of abnormal screening tests. The mean total DCS score decreased from 35.0 to 0.2 after the visit (p < 0.001). These data suggest that a single-page, paper-based EDA is feasible and potentially effective in reducing decision conflict when used within a SDM visit, although more research is needed to establish the independent effects of the EDA, and future efforts to promote SDM may need to devote greater attention to improving patient understanding of the mortality benefit of screening.

Quality and effectiveness of osteoporosis treatment decision aids: a systematic review and environmental scan.

Decision aids (DAs) are evidence-based tools that support shared decision-making (SDM) implementation in practice; this study aimed to identify existing osteoporosis DAs and assess their quality and efficacy; and to gain feedback from a patient advisory group on findings and implications for further research. We searched multiple bibliographic databases to identify research studies from 2000 to 2019 and undertook an environmental scan (search conducted February 2019, repeated in March 2020). A pair of reviewers, working independently selected studies for inclusion, extracted data, evaluated each trial's risk of bias, and conducted DA quality assessment using the International Patient Decision Aid Standards (IPDAS). Public contributors (patients and caregivers with experience of osteoporosis and fragility fractures) participated in discussion groups to review a sample of DAs, express preferences for a new DA, and discuss plans for development of a new DA. We identified 6 studies, with high or unclear risk of bias. Across included studies, use of an osteoporosis DA was reported to result in reduced decisional conflict compared with baseline, increased SDM, and increased accuracy of patients' perceived fracture risk compared with controls. Eleven DAs were identified, of which none met the full set of IPDAS criteria for certification for minimization of bias. Public contributors expressed preferences for encounter DAs that are individualized to patients' own needs and risk. Using a systematic review and environmental scan, we identified 11 decision aids to inform patient decisions about osteoporosis treatment and 6 studies evaluating their effectiveness. Use of decision aids increased accuracy of risk perception and shared decision-making but the decision aids themselves fail to comprehensively meet international quality standards and patient needs, underpinning the need for new DA development.

Development and Pilot Testing of Decision Aid for Shared Decision Making in Barrett's Esophagus With Low-Grade Dysplasia.

To develop an encounter decision aid [Barrett's esophagus Choice (BE-Choice)] for patients and clinicians to engage in shared decision making (SDM) for management of BE with low-grade dysplasia (BE-LGD) and assess its impact on patient-important outcomes. Currently, there are 2 strategies for management of BE-LGD-endoscopic surveillance and ablation. SDM can help patients decide on their preferred management option. Phase-I: Patients and clinicians were engaged in a user-centered design approach to develop BE-Choice. Phase-I included review of evidence on BE-LGD management, observation of usual care (UC), creation, field-testing, and iterative development of BE-Choice in clinical settings. Phase-II: Impact of BE-Choice on patient-important outcomes (patient knowledge, decisional conflict, and patient involvement in decision making) was assessed using a controlled before-after study design (UC vs. BE-Choice). Phase-I: Initial prototype was designed with observation of 8 clinical encounters. With field-testing, 3 successive iterations were made before finalizing BE-Choice. BE-Choice was paper based and fulfilled the qualifying criteria of International patient decision aid standards. Phase II: 29 patients were enrolled, 8 to UC and 21 to BE-Choice. Compared with UC, use of BE-Choice improved patient knowledge (90.4% vs. 70.5%; P=0.03), decisional comfort (89.6 vs. 71.9; P=0.01), and patient involvement (OPTION score: 27.1 vs. 19.2; P=0.01). BE-Choice is a feasible and effective decision aid to promote SDM in the management of BE-LGD. On pilot testing, BE-Choice had promising impact on patient-important outcomes. A larger multicenter trial is needed to confirm our results and promote widespread use of BE-Choice.

Encounter Decision Aids Can Prompt Breast Cancer Surgery Cost Discussions: Analysis of Recorded Consultations.

Background. Patients frequently worry about care costs, but clinicians seldom address the topic. Cost information is not typically included in patient decision aids (DAs). We examined whether including cost information in an encounter DA, with clinician training, influenced cost conversations. Method. As part of a larger trial, 14 surgeons from 4 cancer centers were randomized to 1 of 3 interventions: (1) Picture Option Grid DA that included a prompt to discuss relative treatment costs, hereafter called "cost prompt group"; (2) a text-only Option Grid DA that did not include cost information; (3) usual care. Groups 2 and 3 hereafter are referred to as "non-cost prompt groups." Adult (18+) female patients, with stages I-IIIA breast cancer, eligible for both breast-conserving surgery and mastectomy were included. We gave surgeons feedback about adherence to the study protocol at 3, 6, and 12-months. We adapted a checklist to code the content of the audio-recorded clinical encounters. Results. 424/622 (68%) patients consented; 311 (73%) were eligible and successfully recorded (143 in the cost prompt group, 168 in the non-cost prompt groups). Costs were discussed in 132/311 (42.4%) encounters, and occurred more often in the cost prompt versus non-cost prompt groups (66.7% versus 33.3%; p<.001). Surgeons initiated the cost discussion in 86.4% of encounters in the cost prompt group vs. 34.1% in the non-cost prompt groups (p<0.001). In the non-cost prompt groups, insurance or employment questions led patients to ask about costs. Cost discussions lasted about 34 seconds when present and had sparse comparative details. Conclusions. Encounter DAs containing cost information trigger cost discussions. Additional support should help clinicians improve the quality of cost discussions and address financial distress.

Investigation of factors influencing the implementation of two shared decision-making interventions in contraceptive care: a qualitative interview study among clinical and administrative staff

BackgroundThere is limited evidence on how to implement shared decision-making (SDM) interventions in routine practice. We conducted a qualitative study, embedded within a 2 × 2 factorial cluster randomized controlled trial, to assess the acceptability and feasibility of two interventions for facilitating SDM about contraceptive methods in primary care and family planning clinics. The two SDM interventions comprised a patient-targeted intervention (video and prompt card) and a provider-targeted intervention (encounter decision aids and training).MethodsParticipants were clinical and administrative staff aged 18 years or older who worked in one of the 12 clinics in the intervention arm, had email access, and consented to being audio-recorded. Semi-structured telephone interviews were conducted upon completion of the trial. Audio recordings were transcribed verbatim. Data collection and thematic analysis were informed by the 14 domains of the Theoretical Domains Framework, which are relevant to the successful implementation of provider behaviour change interventions.ResultsInterviews (n = 29) indicated that the interventions were not systematically implemented in the majority of clinics. Participants felt the interventions were aligned with their role and they had confidence in their skills to use the decision aids. However, the novelty of the interventions, especially a need to modify workflows and change behavior to use them with patients, were implementation challenges. The interventions were not deeply embedded in clinic routines and their use was threatened by lack of understanding of their purpose and effect, and staff absence or turnover. Participants from clinics that had an enthusiastic study champion or team-based organizational culture found these social supports had a positive role in implementing the interventions.ConclusionsVariation in capabilities and motivation among clinical and administrative staff, coupled with inconsistent use of the interventions in routine workflow contributed to suboptimal implementation of the interventions. Future trials may benefit by using implementation strategies that embed SDM in the organizational culture of clinical settings.

Adaptation and qualitative evaluation of encounter decision aids in breast cancer care

PurposeShared decision-making is currently not widely implemented in breast cancer care. Encounter decision aids support shared decision-making by helping patients and physicians compare treatment options. So far, little was known about adaptation needs for translated encounter decision aids, and encounter decision aids for breast cancer treatments were not available in Germany. This study aimed to adapt and evaluate the implementation of two encounter decision aids on breast cancer treatments in routine care.MethodsWe conducted a multi-phase qualitative study: (1) translation of two breast cancer Option Grid™ decision aids; comparison to national clinical standards; cognitive interviews to test patients’ understanding; (2) focus groups to assess acceptability; (3) testing in routine care using participant observation. Data were analysed using qualitative content analysis.ResultsPhysicians and patients reacted positively to the idea of encounter decision aids, and reported being interested in using them; patients were most receptive. Several adaptation cycles were necessary. Uncertainty about feasibility of using encounter decision aids in clinical settings was the main physician-reported barrier. During real-world testing (N = 77 encounters), physicians used encounter decision aids in one-third of potentially relevant encounters. However, they did not use the encounter decision aids to stimulate dialogue, which is contrary to their original scope and purpose.ConclusionsThe idea of using encounter decision aids was welcomed, but more by patients than by physicians. Adaptation was a complex process and required resources. Clinicians did not follow suggested strategies for using encounter decision aids. Our study indicates that production of encounter decision aids alone will not lead to successful implementation, and has to be accompanied by training of health care providers.

End-user views of an electronic encounter decision aid linked to routine depression screening

ObjectiveOur aim was to gather community stakeholder input to inform the development of a digital system linking depression screening to decision support. MethodsViews and feature requirements were identified through (1) focus groups with patients and consumers with depression, and interviews with primary care clinicians and (2) usability sessions where patients and consumers used the current version of encounter decision aid (eDA) in a primary care waiting room. Qualitative data were analyzed using the framework method. ResultsWe conducted six focus groups with 15 participants, seven clinician interviews and 10 usability sessions. Patients were comfortable completing the Patient Health Questionnaire (PHQ-9) and receiving the electronic eDA in clinic. They felt this would allow patients to prepare for their visit and instill a sense of agency. Participants were comfortable receiving the PHQ-9 results and a subsequent eDA on a tablet in the waiting room. ConclusionPatients with and without depression, as well as clinicians, viewed linking the PHQ-9, results, and eDA positively. Patients were comfortable doing this in the clinic waiting room. Practice implicationsLinking depression decision support to screening was viewed positively by patients and clinicians, and could help overcome barriers to shared decision-making implementation in this population.

Continue, adjust, or stop antipsychotic medication: developing and user testing an encounter decision aid for people with first-episode and long-term psychosis

BackgroundPeople with psychosis struggle with decisions about their use of antipsychotics. They often want to reduce the dose or stop, while facing uncertainty regarding the effects these decisions will have on their treatment and recovery. They may also fear raising this issue with clinicians. The purpose of this study was to develop and test a shared decision making (SDM) tool to support patients and clinicians in making decisions about antipsychotics.MethodsA diverse editorial research team developed an Encounter Decision Aid (EDA) for patients and clinicians to use as part of the psychiatric consultation. The EDA was tested using 24 semistructured interviews with participants representing six stakeholder groups: patients with first-episode psychosis, patients with long-term psychosis, family members, psychiatrists, mental health counselors, and administrators. We used inductive and deductive coding of interview transcripts to identify points to revise within three domains: general impression and purpose of the EDA; suggested changes to the content, wording, and appearance; and usability and potential contribution to the psychiatric consultation.ResultsAn EDA was developed in an iterative process that yielded evidence-based answers to five frequently asked questions about antipsychotic medications. Patients with long-term psychosis and mental health counselors suggested more changes and revisions than patients with first-episode psychosis and psychiatrists. Family members suggested more revisions to the answers about potential risks of stopping or adjusting antipsychotics than other respondents.ConclusionsThe EDA was perceived as potentially useful and feasible in psychiatric routine care, especially if presented during the consultation.

What matters most: protocol for a randomized controlled trial of breast cancer surgery encounter decision aids across socioeconomic strata

BackgroundBreast cancer is the most commonly diagnosed malignancy in women. Mastectomy and breast-conserving surgery (BCS) have equivalent survival for early stage breast cancer. However, each surgery has different benefits and harms that women may value differently. Women of lower socioeconomic status (SES) diagnosed with early stage breast cancer are more likely to experience poorer doctor-patient communication, lower satisfaction with surgery and decision-making, and higher decision regret compared to women of higher SES. They often play a more passive role in decision-making and are less likely to undergo BCS. Our aim is to understand how best to support women of lower SES in making decisions about early stage breast cancer treatments and to reduce disparities in decision quality across socioeconomic strata.MethodsWe will conduct a three-arm, multi-site randomized controlled superiority trial with stratification by SES and clinician-level randomization. At four large cancer centers in the United States, 1100 patients (half higher SES and half lower SES) will be randomized to: (1) Option Grid, (2) Picture Option Grid, or (3) usual care. Interviews, field-notes, and observations will be used to explore strategies that promote the interventions’ sustained use and dissemination. Community-Based Participatory Research will be used throughout. We will include women aged at least 18 years of age with a confirmed diagnosis of early stage breast cancer (I to IIIA) from both higher and lower SES, provided they speak English, Spanish, or Mandarin Chinese. Our primary outcome measure is the 16-item validated Decision Quality Instrument. We will use a regression framework, mediation analyses, and multiple informants analysis. Heterogeneity of treatment effects analyses for SES, age, ethnicity, race, literacy, language, and study site will be performed.DiscussionCurrently, women of lower SES are more likely to make treatment decisions based on incomplete or uninformed preferences, potentially leading to poorer decision quality, quality of life, and decision regret. This study hopes to identify solutions that effectively improve patient-centered care across socioeconomic strata and reduce disparities in decision and care quality.Trial registrationNCT03136367 at ClinicalTrials.govProtocol version: Manuscript based on study protocol version 2.2, 7 November 2017.