Feasibility and Acceptability of an Agenda-Setting Kit in the Care of People With Type 2 Diabetes: The QBSAFE ASK Feasibility Study.

This article reports on a study to assess the feasibility of research procedures and acceptability of QBSAFE, a set of conversation cards focused on quality of life, treatment burden, safety, and avoidance of future events in people with type 2 diabetes. The study enrolled 84 patients and 7 clinicians. Of the 58 patients who completed questionnaires, 64% agreed that the QBSAFE agenda-setting kit (ASK) helped them discuss their situation, 78% agreed that others could benefit from it, and 38% said they would use it again. Most clinicians felt confident responding to issues (in 89% of encounters) and said they would use the kit again (78%) and recommend it to colleagues (82%). The QBSAFE ASK can be feasibly implemented and holds promise in facilitating discussion and collaborative problem-solving.

Development and Iterative Design of Peer-based Discussions about Heart Health for Women.

Objective: To support women in their health journeys around cardiovascular risk reduction, providing: access to information; space to discuss complex and personal issues that may factor into decision making; and skills to support conversations with healthcare providers. Methods: We used a participatory design approach to develop peer sessions led by a non-clinical facilitator and a cardiologist, for women to learn, think, and discuss information and decision-making around cardiovascular risk. These sessions took place in-person and over video. A host invited her friends, family or network to the events. Sessions were designed to bring information to women at all stages of cardiovascular risk, including women with no prior experiences with heart health and women with established cardiovascular disease. The sessions provided information about cardiovascular risk and facilitated discussion around risk factors and treatment. Sessions were recorded, transcribed and analyzed using a grounded theory approach to identify emerging themes. Results: We conducted 12 groups, with an average of 6 women per group. Women were of all ages and spectrums of cardiovascular risk. The three major themes that emerged were: Starting Place (attitudes, beliefs, and behaviors toward cardiovascular care are informed by a blend of one's family history, personal interactions with their health and the health system, and approach to managing uncertainty); Lack of Sense-Making (seemingly simple recommendations to support heart health were much more complicated when related to their own risk and experience), and Self-Judgement and Judgement by Others (without support or validation, women may feel judged by others for not doing enough). Conclusion: Peer sessions can illuminate the complicated issues women face when approaching decisions regarding cardiovascular health. These sessions may offer an alternative to the healthcare setting, for women to wrestle with complex issues that relate to their risk, and better prepare for visits with their healthcare providers.

Quality of life, burden of treatment, safety, and avoidance of future events (QBSAfe) protocol: a pilot study testing an intervention to shift the paradigm of diabetes care.

BACKGROUND: Diabetes care has been traditionally focused on targeting certain levels of glycemic control. This narrow emphasis may impose burdens on patients, including high treatment costs, illness-related work, or side effects from medications, while leaving other patient needs and goals under-addressed. The authors aim to shift the paradigm of care for people with diabetes, to focus on quality of life, burden of treatment, safety, and avoidance of future events: the QBSAfe domains. METHODS: We describe a single-arm pilot study to assess the feasibility and acceptability of using the QBSAfe agenda setting kit (ASK) during routine clinical visits. The set of 14 conversation aid cards was co-developed with patients, family caregivers, and clinicians. The ASK will be used in the context of a clinic visit, which will be recorded by members of the study team to identify patterns of clinician-patient conversations. Feasibility will be measured by the number of participants recruited, time to goal accrual, and completeness of data collection; acceptability will be assessed using post-visit surveys of patients and clinicians. A subgroup of patients will be invited to participate in post-visit qualitative semi-structured interviews for additional feedback. This study will be conducted across three medical centers in the Midwest and East Coast of the USA. DISCUSSION: Current healthcare infrastructure and associated demands and pressures on clinicians make changes in care difficult. However, this intervention has the potential to shift conversations during clinical encounters so they can address and directly respond to patient needs, symptoms, and capacity. As part of the QBSAfe ASK, the authors are also actively collaborating with a variety of stakeholders to create tools to help clinicians respond more effectively to patient concerns as they are raised during the clinical encounters. Additional insights about the use of the QBSAfe approach in the virtual space will be gathered during the process of our study due to restrictions imposed upon face to face visit during the COVID-19 pandemic. TRIAL REGISTRATION: ClinicalTrials.gov , NCT04514523 . Registered 17 August 2020-retrospectively registered.

Beyond hemoglobin A1c: a videographic analysis of conversations about quality of life and treatment burden during clinical encounters for diabetes care.

PURPOSE: Diabetes care has largely focused on reducing the risk of complications by achieving hemoglobin A1c (HbA1c) targets; yet, whole-person care may be more effective and desirable. We sought to determine the nature of discussions about quality of life, burden of treatment, hypoglycemia, sexual function, and social support during diabetes-focused clinical encounters. METHODS: We analyzed 41 previously recorded clinical encounters with patients with type 2 diabetes from the control arms of practice-based trials of shared decision-making. Two coders evaluated videos for discussions about aspects of life with diabetes: quality of life, burden of treatment, hypoglycemia, sexual function, and social supports. When an aspect was raised, coders evaluated the nature of the conversation, clinician responses, and time spent on discussing the aspect. RESULTS: Median length of the encounter was 15 min, 6 s (IQR: 11:16-20:23 min). Overall, 35 of 41 encounters (85.4%) included some discussion of quality of life (58.5%), burden of treatment (51.2%), social support (2.4%), or hypoglycemia (9.8%). Sexual function was not discussed. On average, 4.5% (1.4-5.5%) of the encounter time involved conversations about HbA1c, whereas 15.0% (0-25%) of the encounter time was spent on some aspect of quality of life, burden of treatment, social support, or hypoglycemia. If a topic related to quality of life was raised, clinicians most often responded by acknowledging patient's concern without providing a solution (45.8%). CONCLUSIONS: A significant part of the patient-clinician encounter involves discussion of quality of life and burden of treatment, but clinicians rarely address these issues by providing solutions.

Integrating shared decision making into trial consent: A nested, cluster-randomized trial.

OBJECTIVE: Using a nested, cluster-randomized trial, we tested the hypothesis that a shared decision-making intervention, as part of consent, would improve study-related knowledge. METHODS: We developed a shared decision-makingintervention then randomized sites in a clinical trial to intervention or control (standard consent). We collected participants' knowledge (primary outcome) and decisional support data. Other data came from a clinical registry and research coordinator surveys. We compared outcomes between study arms using generalized estimating equation models, accounting for clustering. We used qualitative description to understand variation in intervention use. RESULTS: 265 individuals, from 34 sites, enrolled in the parent trial during our study period. Of those, 241 participants completed our survey. There was no knowledge difference between arms (mean difference = 0.56 (95 %CI: -3.8, 4.9)). Both groups had a considerable number of participants with misunderstandings. We also found no difference for decisional support (mean difference = 1.5 (95 %CI: -1.8, 4.8)) or enrollment rate between arms. Clinician use of the intervention varied between sites. CONCLUSIONS: We found no differences in outcomes but demonstrated the feasibility and acceptability of incorporating a shared decision-making intervention into consent. PRACTICE IMPLICATIONS: Future work should consider adapting our intervention to other trials and more robust measurement strategies.

Shared Decision Making for Syncope in the Emergency Department: A Randomized Controlled Feasibility Trial.

OBJECTIVES: Significant practice variation is seen in the management of syncope in the emergency department (ED). We sought to evaluate the feasibility of performing a randomized controlled trial of a shared decision making (SDM) tool for low-to-intermediate-risk syncope patients presenting to the ED. METHODS: We performed a randomized controlled trial of adults (≥30 years) with unexplained syncope who presented to an academic ED in the United States. Patients with a serious diagnosis identified in the ED were excluded. Patients were randomized, 1:1, to receive either usual care or a personalized syncope decision aid (SynDA) meant to facilitate SDM. Our primary outcome was feasibility, i.e., ability to enroll 50 patients in 24 months. Secondary outcomes included patient knowledge, involvement (measured with OPTION-5), rating of care, and clinical outcomes at 30 days post-ED visit. RESULTS: After screening 351 patients, we enrolled 50 participants with unexplained syncope from January 2017 to January 2019. The most common reason for exclusion was lack of clinical equipoise to justify SDM (n = 124). Patients in the SynDA arm tended to have greater patient involvement, as shown by higher OPTION-5 scores: 52/100 versus 27/100 (between-group difference = -25.4, 95% confidence interval = -13.5 to -37.3). Both groups had similar levels of clinical knowledge, ratings of care, and serious clinical outcomes at 30 days. CONCLUSIONS: Among ED patients with unexplained syncope, a randomized controlled trial of a shared decision-making tool is feasible. Although this study was not powered to detect differences in clinical outcomes, it demonstrates feasibility, while providing key lessons and effect sizes that could inform the design of future SDM trials.

Shared Decision Making in Patients With Suspected Uncomplicated Ureterolithiasis: A Decision Aid Development Study.

OBJECTIVE: The objective was to develop a decision aid (DA) to facilitate shared decision making (SDM) around whether to obtain computed tomography (CT) imaging in patients presenting to the emergency department (ED) with suspected uncomplicated ureterolithiasis. METHODS: We used evidence-based DA development methods, including qualitative methods and iterative stakeholder engagement, to develop and refine a DA. Guided by the Ottawa Decision Support Framework, International Patient Decision Aid Standards (IPDAS), and a steering committee made up of stakeholders, we conducted interviews and focus groups with a purposive sample of patients, community members, emergency clinicians, and other stakeholders. We used an iterative process to code the transcripts and identify themes. We beta-tested the DA with patient-clinician dyads facing the decision in real time. RESULTS: From August 2018 to August 2019, we engaged 102 participants in the design and iterative refinement of a DA focused on diagnostic options for patients with suspected ureterolithiasis. Forty-six were ED patients, community members, or patients with ureterolithiasis, and the remaining were emergency clinicians (doctors, residents, advanced practitioners), researchers, urologists, nurses, or other physicians. Patients and clinicians identified several key decisional needs including an understanding of accuracy, uncertainty, radiation exposure/cancer risk, and clear return precautions. Patients and community members identified facilitators to SDM, such as a checklist of signs and symptoms. Many stakeholders, including both patients and ED clinicians, expressed a strong pro-CT bias. A six-page DA was developed, iteratively refined, and beta-tested. CONCLUSIONS: Using stakeholder engagement and qualitative inquiry, we developed an evidence-based DA to facilitate SDM around the question of CT scan utilization in patients with suspected uncomplicated ureterolithiasis. Future research will test the efficacy of the DA in facilitating SDM.

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

OBJECTIVES: The objective was to develop a patient decision aid (DA) to promote shared decision making (SDM) 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 SDM, we created a prototype of a paper-based DA to engage patients in the disposition decision (admission vs. discharge) after an unremarkable ED evaluation for syncope. In phase 1, we conducted one-on-one semistructured exploratory interviews with 10 emergency physicians and 10 ED syncope patients. In phase 2, we conducted one-on-one directed interviews with 15 emergency care clinicians, five cardiologists, and 12 ED syncope patients to get detailed feedback on DA 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 DA, titled SynDA, includes four 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 DA. CONCLUSIONS: We iteratively developed an evidence-based DA to facilitate SDM for alert syncope patients after an unremarkable ED evaluation. Further testing is required to determine its effects on patient care. This DA has the potential to improve care for syncope patients and promote patient-centered care in emergency medicine.

Tablet-Based Patient-Centered Decision Support for Minor Head Injury in the Emergency Department: Pilot Study.

BACKGROUND: The Concussion or Brain Bleed app is a clinician- and patient-facing electronic tool to guide decisions about head computed tomography (CT) use in patients presenting to the emergency department (ED) with minor head injury. This app integrates a patient decision aid and clinical decision support (using the Canadian CT Head Rule, CCHR) at the bedside on a tablet computer to promote conversations around individualized risk and patients' specific concerns within the ED context. OBJECTIVE: The objective of this study was to describe the use of the Concussion or Brain Bleed app in a high-volume ED and to establish preliminary efficacy estimates on patient experience, clinician experience, health care utilization, and patient safety. These data will guide the planning of a larger multicenter trial testing the effectiveness of the Concussion or Brain Bleed app. METHODS: We conducted a prospective pilot study of adult (age 18-65 years) patients presenting to the ED after minor head injury who were identified by participating clinicians as low risk by the CCHR. The primary outcome was patient knowledge regarding the injury, risks, and CT use. Secondary outcomes included patient satisfaction, decisional conflict, trust in physician, clinician acceptability, system usability, Net Promoter scores, head CT rate, and patient safety at 7 days. RESULTS: We enrolled 41 patients cared for by 29 different clinicians. Patient knowledge increased after the use of the app (questions correct out of 9: pre-encounter, 3.3 vs postencounter, 4.7; mean difference 1.4, 95% CI 0.8-2.0). Patients reported a mean of 11.7 (SD 13.5) on the Decisional Conflict Scale and 92.5 (SD 12.0) in the Trust in Physician Scale (both scales range from 0 to 100). Most patients were satisfied with the app's clarity of information (35, 85%), helpfulness of information (36, 88%), and amount of information (36, 88%). In the 41 encounters, most clinicians thought the information was somewhat or extremely helpful to the patient (35, 85%), would want to use something similar for other decisions (27, 66%), and would recommend the app to other providers (28, 68%). Clinicians reported a mean system usability score of 85.1 (SD 15; scale from 0 to 100 with 85 in the "excellent" acceptability range). The total Net Promoter Score was 36.6 (on a scale from -100 to 100). A total of 7 (17%) patients received a head CT in the ED. No patients had a missed clinically important brain injury at 7 days. CONCLUSIONS: An app to help patients assess the utility of CT imaging after head injury in the ED increased patient knowledge. Nearly all clinicians reported the app to be helpful to patients. The high degree of patient satisfaction, clinician acceptability, and system usability support rigorous testing of the app in a larger multicenter trial.

Shared Decisionmaking in the Emergency Department: A Guiding Framework for Clinicians.

Shared decisionmaking has been proposed as a method to promote active engagement of patients in emergency care decisions. Despite the recent attention shared decisionmaking has received in the emergency medicine community, including being the topic of the 2016 Academic Emergency Medicine Consensus Conference, misconceptions remain in regard to the precise meaning of the term, the process, and the conditions under which it is most likely to be valuable. With the help of a patient representative and an interaction designer, we developed a simple framework to illustrate how shared decisionmaking should be approached in clinical practice. We believe it should be the preferred or default approach to decisionmaking, except in clinical situations in which 3 factors interfere. These 3 factors are lack of clinical uncertainty or equipoise, patient decisionmaking ability, and time, all of which can render shared decisionmaking infeasible. Clinical equipoise refers to scenarios in which there are 2 or more medically reasonable management options. Patient decisionmaking ability refers to a patient's capacity and willingness to participate in his or her emergency care decisions. Time refers to the acuity of the clinical situation (which may require immediate action) and the time that the clinician has to devote to the shared decisionmaking conversation. In scenarios in which there is only one medically reasonable management option, informed consent is indicated, with compassionate persuasion used as appropriate. If time or patient capacity is lacking, physician-directed decisionmaking will occur. With this framework as the foundation, we discuss the process of shared decisionmaking and how it can be used in practice. Finally, we highlight 5 common misconceptions in regard to shared decisionmaking in the ED. With an improved understanding of shared decisionmaking, this approach should be used to facilitate the provision of high-quality, patient-centered emergency care.

Patient-Centered Decision Support: Formative Usability Evaluation of Integrated Clinical Decision Support With a Patient Decision Aid for Minor Head Injury in the Emergency Department.

BACKGROUND: The Canadian Computed Tomography (CT) Head Rule, a clinical decision rule designed to safely reduce imaging in minor head injury, has been rigorously validated and implemented, and yet expected decreases in CT were unsuccessful. Recent work has identified empathic care as a key component in decreasing CT overuse. Health information technology can hinder the clinician-patient relationship. Patient-centered decision tools to support the clinician-patient relationship are needed to promote evidence-based decisions. OBJECTIVE: Our objective is to formatively evaluate an electronic tool that not only helps clinicians at the bedside to determine the need for CT use based on the Canadian CT Head Rule but also promotes evidence-based conversations between patients and clinicians regarding patient-specific risk and patients' specific concerns. METHODS: User-centered design with practice-based and participatory decision aid development was used to design, develop, and evaluate patient-centered decision support regarding CT use in minor head injury in the emergency department. User experience and user interface (UX/UI) development involved successive iterations with incremental refinement in 4 phases: (1) initial prototype development, (2) usability assessment, (3) field testing, and (4) beta testing. This qualitative approach involved input from patients, emergency care clinicians, health services researchers, designers, and clinical informaticists at every stage. RESULTS: The Concussion or Brain Bleed app is the product of 16 successive iterative revisions in accordance with UX/UI industry design standards. This useful and usable final product integrates clinical decision support with a patient decision aid. It promotes shared use by emergency clinicians and patients at the point of care within the emergency department context. This tablet computer app facilitates evidence-based conversations regarding CT in minor head injury. It is adaptable to individual clinician practice styles. The resultant tool includes a patient injury evaluator based on the Canadian CT Head Rule and provides patient specific risks using pictographs with natural frequencies and cues for discussion about patient concerns. CONCLUSIONS: This tool was designed to align evidence-based practices about CT in minor head injury patients. It establishes trust, empowers active participation, and addresses patient concerns and uncertainty about their condition. We hypothesize that, when implemented, the Concussion or Brain Bleed app will support-not hinder-the clinician-patient relationship, safely reduce CT use, and improve the patient experience of care.

State of the Science: Tools and Measurement for Shared Decision Making.

Shared decision making (SDM) has been advocated as an approach to selecting medical tests and treatments for many situations. The goal of SDM is to ensure that patients are well informed, are meaningfully involved in decisions, and receive treatments that meet their goals and preferences. There is considerable evidence about the tools used to promote SDM, called patient decision aids, and many different measures have been developed to assess the impact of SDM. However, fairly little is known about the applicability of the tools and measures in the emergency department (ED) setting. This article builds on insights from two keynote lectures presented at the 2016 Academic Emergency Medicine Consensus Conference discussing the state of the science for measurement of SDM and the design of patient decision aids to promote SDM conversations and highlights some key areas for further research to advance SDM in the ED.

Development and Testing of Shared Decision Making Interventions for Use in Emergency Care: A Research Agenda.

Decision aids are evidenced-based tools designed to increase patient understanding of medical options and possible outcomes, facilitate conversation between patients and clinicians, and improve patient engagement. Decision aids have been used for shared decision making (SDM) interventions outside of the ED setting for more than a decade. Their use in the ED has only recently begun to be studied. This article provides background on this topic and the conclusions of the 2016 Academic Emergency Medicine consensus conference SDM in practice work group regarding "Shared Decision Making in the Emergency Department: Development of a Policy-Relevant, Patient-Centered Research Agenda." The goal was to determine a prioritized research agenda for the development and testing of SDM interventions for use in emergency care that was most important to patients, clinicians, caregivers, and other key stakeholders. Using the nominal group technique, the consensus working group proposed prioritized research questions in six key domains: 1) content (i.e., clinical scenario or decision area), 2) level of evidence available, 3) tool design strategies, 4) risk communication, 5) stakeholders, and 6) outcomes.

The design of a low literacy decision aid about rheumatoid arthritis medications developed in three languages for use during the clinical encounter.

BACKGROUND: Shared decision-making in rheumatoid arthritis (RA) care is a priority among policy makers, clinicians and patients both nationally and internationally. Demands on patients to have basic knowledge of RA, treatment options, and details of risk and benefit when making medication decisions with clinicians can be overwhelming, especially for those with limited literacy or limited English language proficiency. The objective of this study is to describe the development of a medication choice decision aid for patients with rheumatoid arthritis (RA) in three languages using low literacy principles. METHODS: Based on the development of a diabetes decision aid, the RA decision aid (RA Choice) was developed through a collaborative process involving patients, clinicians, designers, decision-aid and health literacy experts. A combination of evidence synthesis and direct observation of clinician-patient interactions generated content and guided an iterative process of prototype development. RESULTS: Three iterations of RA Choice were developed and field-tested before completion. The final tool organized data using icons and plain language for 12 RA medications across 5 issues: frequency of administration, time to onset, cost, side effects, and special considerations. The tool successfully created a conversation between clinician and patient, and garnered high acceptability from clinicians. CONCLUSIONS: The process of collaboratively developing an RA decision aid designed to promote shared decision making resulted in a graphically-enhanced, low literacy tool. The use of RA Choice in the clinical encounter has the potential to enhance communication for RA patients, including those with limited health literacy and limited English language proficiency.

The chest pain choice decision aid: a randomized trial.

BACKGROUND: Cardiac stress testing in patients at low risk for acute coronary syndrome is associated with increased false-positive test results, unnecessary downstream procedures, and increased cost. We judged it unlikely that patient preferences were driving the decision to obtain stress testing. METHODS AND RESULTS: The Chest Pain Choice trial was a prospective randomized evaluation involving 204 patients who were randomized to a decision aid or usual care and were followed for 30 days. The decision aid included a 100-person pictograph depicting the pretest probability of acute coronary syndrome and available management options (observation unit admission and stress testing or 24-72 hours outpatient follow-up). The primary outcome was patient knowledge measured by an immediate postvisit survey. Additional outcomes included patient engagement in decision making and the proportion of patients who decided to undergo observation unit admission and cardiac stress testing. Compared with usual care patients (n=103), decision aid patients (n=101) had significantly greater knowledge (3.6 versus 3.0 questions correct; mean difference, 0.67; 95% CI, 0.34-1.0), were more engaged in decision making as indicated by higher OPTION (observing patient involvement) scores (26.6 versus 7.0; mean difference, 19.6; 95% CI, 1.6-21.6), and decided less frequently to be admitted to the observation unit for stress testing (58% versus 77%; absolute difference, 19%; 95% CI, 6%-31%). There were no major adverse cardiac events after discharge in either group. CONCLUSIONS: Use of a decision aid in patients with chest pain increased knowledge and engagement in decision making and decreased the rate of observation unit admission for stress testing.

The Chest Pain Choice trial: a pilot randomized trial of a decision aid for patients with chest pain in the emergency department.

BACKGROUND: Chest pain is a common presenting complaint in the emergency department (ED). Despite the frequency with which clinicians evaluate patients with chest pain, accurately determining the risk of acute coronary syndrome (ACS) and sharing risk information with patients is challenging. The aims of this study are (1) to develop a decision aid (CHEST PAIN CHOICE) that communicates the short-term risk of ACS and (2) to evaluate the impact of the decision aid on patient participation in decision-making and resource use. METHODS/DESIGN: This is a protocol for a parallel, 2-arm randomized trial to compare an intervention group receiving CHEST PAIN CHOICE to a control group receiving usual ED care. Adults presenting to the Saint Mary's Hospital ED in Rochester, MN USA with a primary complaint of chest pain who are being considered for admission for prolonged ED observation in a specialized unit and urgent cardiac stress testing will be eligible for enrollment. We will measure the effect of CHEST PAIN CHOICE on six outcomes: (1) patient knowledge regarding their short-term risk for ACS and the risks of radiation exposure; (2) quality of the decision making process; (3) patient and clinician acceptability and satisfaction with the decision aid; (4) the proportion of patients who decided to undergo observation unit admission and urgent cardiac stress testing; (5) economic costs and healthcare utilization; and (6) the rate of delayed or missed ACS. To capture these outcomes, we will administer patient and clinician surveys after each visit, obtain video recordings of the clinical encounters, and conduct 30-day phone follow-up. DISCUSSION: This pilot randomized trial will develop and evaluate a decision aid for use in ED chest pain patients at low risk for ACS and provide a preliminary estimate of its effect on patient participation in decision-making and resource use. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT01077037.

Translating comparative effectiveness into practice: the case of diabetes medications.

BACKGROUND: In recent years, there has been significant interest and investment in conducting comparative effectiveness research (CER) of medical treatments to improve the quality of care and reduce costs. The Agency for Healthcare Research and Quality (AHRQ) has been leading this effort and has invested a significant amount of resources to advance CER. However, little is known about translating the findings from CER into routine practice such that it provides value to the patients, clinicians, and the healthcare system. METHODS: We present the role of shared decision making for patient-centered CER translation and its application to diabetes medications. CER of oral diabetes medications suggests that all medications are similar in their effects on glycemic control, but there is variability in side-effects, which may affect medication adherence and treatment intensification. Shared decision making, facilitated by tools such as decision aids, may enhance the quality of diabetes care by activating patients, enhancing the patient-clinician communication, and improving uptake and adherence to the medication that is determined to be consistent with patients' goals, values, and preferences. We describe the iterative, multidisciplinary process for developing and testing a diabetes medication decision aid, and examine the implications for CER translation. RESULTS: In our pilot study we found the decision aid to be acceptable to patients and providers and effective for knowledge translation; however, it did not impact short-term outcomes. DISCUSSION: Our pilot trial found that decision aids enhanced the discussion about diabetes medications without any adverse effects on the outcomes. Further issues related to the use of decision aids to translate CER need to be addressed in larger trials to understand the effectiveness and efficiency of translating evidence into routine practice in unique contexts of patients, providers, and healthcare systems.

Protocol for the Osteoporosis Choice trial. A pilot randomized trial of a decision aid in primary care practice.

BACKGROUND: Bisphosphonates can reduce fracture risk in patients with osteoporosis, but many at-risk patients do not start or adhere to these medications. The aims of this study are to: (1) preliminarily evaluate the effect of an individualized 10-year osteoporotic fracture risk calculator and decision aid (OSTEOPOROSIS CHOICE) for postmenopausal women at risk for osteoporotic fractures; and (2) assess the feasibility and validity (i.e., absence of contamination) of patient-level randomization (vs. cluster randomization) in pilot trials of decision aid efficacy. METHODS/DESIGN: This is a protocol for a parallel, 2-arm, randomized trial to compare an intervention group receiving OSTEOPOROSIS CHOICE to a control group receiving usual primary care. Postmenopausal women with bone mineral density T-scores of <-1.0, not receiving bisphosphonate therapy, and receiving care at participating primary care practices in and around Rochester, Minnesota, USA will be eligible to participate in the trial. We will measure the effect of OSTEOPOROSIS CHOICE on five outcomes: (a) patient knowledge regarding osteoporosis risk factors and treatment; (b) quality of the decision-making process for both the patient and clinician; (c) patient and clinician acceptability and satisfaction with the decision aid; (d) rate of bisphosphonate use and adherence, and (e) trial processes (e.g., ability to recruit participants, collect patient outcomes). To capture these outcomes, we will use patient and clinician surveys following each visit and video recordings of the clinical encounters. These video recordings will also allow us to determine the extent to which clinicians previously exposed to the decision aid were able to recreate elements of the decision aid with control patients (i.e., contamination). Pharmacy prescription profiles and follow-up phone interviews will assess medication start and adherence at 6 months. DISCUSSION: This pilot trial will provide evidence of feasibility, validity of patient randomization, and preliminary efficacy of a novel approach--decision aids--to improving medication adherence for postmenopausal women at risk of osteoporotic fractures. The results will inform the design of a larger trial that could provide more precise estimates of the efficacy of the decision aid. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT00578981.

The diabetes mellitus medication choice decision aid: a randomized trial.

BACKGROUND: Patient involvement in the choice of antihyperglycemic agents could improve adherence and optimize glycemic control in patients with type 2 diabetes mellitus. METHODS: We conducted a pilot, cluster randomized trial of Diabetes Medication Choice, a decision aid that describes 5 antihyperglycemic drugs, their treatment burden (adverse effects, administration, and self-monitoring demands), and impact on hemoglobin A(1c) (HbA(1c)) levels. Twenty-one clinicians were randomized to use the decision aid during the clinical encounter and 19 to dispense usual care and an educational pamphlet. We used surveys and video analysis to assess postvisit decisional outcomes, and medical and pharmacy records to assess 6-month medication adherence and HbA(1c) levels. RESULTS: Compared with usual care patients (n = 37), patients receiving the decision aid (n = 48) found the tool more helpful (clustered-adjusted mean difference [AMD] in a 7-point scale, 0.38; 95% confidence interval [CI], 0.04-0.72); had improved knowledge (AMD, 1.10 of 10 questions; 95% CI, 0.11-2.09); and had more involvement in making decisions about diabetes medications (AMD, 21.8 of 100; 95% CI, 13.0-30.5). At 6-month follow-up, both groups had nearly perfect medication use (median, 100% of days covered), with better adherence (AMD, 9% more days covered; 95% CI, 4%-14%) and persistence (AMD, 12 more days covered; 95% CI, 3-21 days) in the usual care group, and no significant impact on HbA(1c) levels (AMD, 0.01; 95% CI, -0.49 to 0.50). CONCLUSION: An innovative decision aid effectively involved patients with type 2 diabetes mellitus in decisions about their medications but did not improve adherence or HbA(1c) levels. Trial Registration clinicaltrials.gov Identifier: NCT00388050.