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.

Assessing collaborative efforts of making care fit for each patient: A systematic review.

INTRODUCTION: For too many people, their care plans are designed without fully accounting for who they are, the lives they live, what matters to them or what they aspire to achieve. We aimed to summarize instruments capable of measuring dimensions of patient-clinician collaboration to make care fit. METHODS: We systematically searched several databases (Medline, Embase, Cochrane, Scopus and Web of Science) from inception to September 2021 for studies using quantitative measures to assess, evaluate or rate the work of making care fit by any participant in real-life clinical encounters. Eligibility was assessed in duplicate. After extracting all items from relevant instruments, we coded them deductively on dimensions relevant to making care fit (as presented in a recent Making Care Fit Manifesto), and inductively on the main action described. RESULTS: We included 189 papers, mostly from North America (N = 83, 44%) and in the context of primary care (N = 54, 29%). Half of the papers (N = 88, 47%) were published in the last 5 years. We found 1243 relevant items to assess efforts of making care fit, included within 151 instruments. Most items related to the dimensions 'Patient-clinician collaboration: content' (N = 396, 32%) and 'Patient-clinician collaboration: manner' (N = 382, 31%) and the least related to 'Ongoing and iterative process' (N = 22, 2%) and in 'Minimally disruptive of patient lives' (N = 29, 2%). The items referred to 27 specific actions. Most items referred to 'Informing' (N = 308, 25%) and 'Exploring' (N = 93, 8%), the fewest items referred to 'Following up', 'Comforting' and 'Praising' (each N = 3, 0.2%). DISCUSSION: Measures of the work that patients and clinicians do together to make care fit focus heavily on the content of their collaborations, particularly on exchanging information. Other dimensions and actions previously identified as crucial to making care fit are assessed infrequently or not at all. The breadth of extant measures of making care fit and the lack of appropriate measures of this key construct limit both the assessment and the successful implementation of efforts to improve patient care. PATIENT CONTRIBUTION: Patients and caregivers from the 'Making care fit Collaborative' were involved in drafting the dimensions relevant to patient-clinician collaboration.

Comparing Methods for Identifying Post-Market Patient Preferences at the Point of Decision-Making: Insights from Patients with Chronic Pain Considering a Spinal Cord Stimulator Device.

Purpose: To compare three methods for identifying patient preferences (MIPPs) at the point of decision-making: analysis of video-recorded patient-clinician encounters, post-encounter interviews, and post-encounter surveys. Patients and Methods: For the decision of whether to use a spinal cord stimulator device (SCS), a video coding scheme, interview guide, and patient survey were iteratively developed with 30 SCS decision-making encounters in a tertiary academic medical center pain clinic. Burke's grammar of motives was used to classify the attributed source or justification for a potential preference for each preference block. To compare the MIPPs, 13 patients' encounters with their clinician were video recorded and subsequently analyzed by 4 coders using the final video coding scheme. Six of these patients were interviewed, and 7 surveyed, immediately following their encounters. Results: For videos, an average of 66 (range 33-106) sets of utterances potentially indicating a patient preference (a preference block), surveys 33 (range 32-34), and interviews 25 (range 18-30) were identified. Thirty-eight unique themes (75 subthemes), each a preference topic, were identified from videos, surveys 19 themes (12 subthemes), and interviews 39 themes (54 subthemes). The proportion of preference blocks that were judged as expressing a preference that was clearly important to the patient or affected their decision was highest for interviews (72.8%), surveys (68.0%), and videos (27.0%). Videos mostly attributed preferences to the patient's situation (scene) (65%); interviews, the act of receiving or living with SCS (43%); surveys, the purpose of SCS (40%). Conclusion: MIPPs vary in the type of preferences identified and the clarity of expressed preferences in their data sets. The choice of which MIPP to use depends on projects' goals and resources, recognizing that the choice of MIPP may affect which preferences are found.

Clinician feedback using a shared decision-making tool for the evaluation of patients with thyroid nodules-an observational study.

BACKGROUND: We pilot-tested an encounter conversation aid to support shared decision making (SDM) between patients with thyroid nodules and their clinicians. OBJECTIVE: Characterize the clinician feedback after providing care to patients with thyroid nodules using a tool to promote SDM conversations during the clinical encounter, and evaluate how clinicians used the tool during the visit. METHODS: Mixed method study in two academic centers in the U.S., including adult patients presenting for evaluation of thyroid nodules and their clinicians. We thematically analyzed interviews with clinicians after they used the SDM tool in at least three visits to characterize their feedback. Additionally, investigators evaluated visits recordings to determine the extent to which clinicians engaged patients in the decision-making process (OPTION score, scale 0 to 100, higher levels indicating higher involvement), the tool's components used (fidelity), and encounter duration. Using a post-visit survey, we evaluated the extent to which clinicians felt the tool was easy to use, helpful, and supportive of the patient-clinician collaboration. RESULTS: Thirteen clinicians participated in the study and used the SDM tool in the care of 53 patients. Clinicians thought the tool was well-organized and beneficial to patients and clinicians. Clinicians noticed a change in their routine with the use of the conversation aid and suggested it needed to be more flexible to better support varying conversations. The median OPTION score was 34, the fidelity of use 75%, and the median visit duration 17 min. In most encounters, clinicians agreed or strongly agreed the tool was easy to use (86%), helpful (65%), and supported collaboration (62%). CONCLUSION: Clinicians were able to use a SDM tool in the care of patients with thyroid nodules. Although they wished it were more flexible, they found on the whole that its use in the clinical encounter was beneficial to patients and clinicians.

Patient feedback receiving care using a shared decision making tool for thyroid nodule evaluation-an observational study.

PURPOSE: To characterize the feedback of patients with thyroid nodules receiving care using a shared decision making (SDM) tool designed to improve conversations with their clinicians related to diagnostic options (e.g. thyroid biopsy, ultrasound surveillance). METHODS: Investigators qualitatively analyzed post-encounter interviews with patients to characterize their feedback of a SDM tool used during their clinical visits. Additionally, investigators counted instances of diagnostic choice awareness and of patients' expression of a diagnostic management preference in recordings of clinical encounters of adult patients presenting for evaluation of thyroid nodules in which the SDM tool was used. RESULTS: In total, 53 patients (42 (79%) women); median age 62 years were enrolled and had consultations supported by the SDM tool. Patients were favorable about the design of the SDM tool and its ability to convey information about options and support patient-clinician interactions. Patients identified opportunities to improve the tool through adding more content and improve its use in practice through training of clinicians in its use. There was evidence of diagnostic choice awareness in 52 (98%) of these visits and patients expressed a diagnostic management preference in 40 (76%). CONCLUSION: User centered design including feedback from patients and real life observation supports the use of the SDM tool to facilitate collaboration between patients and clinicians.

Remote shared decision making through telemedicine: A systematic review of the literature.

OBJECTIVES: To assess the extent to which shared decision making (SDM) can take place in telemedicine (remote SDM). METHODS: We searched Medline, Cochrane, and Scopus from 2010 until August 7th, 2020 for articles on remote SDM in the care of any patient using any technology. We also conducted a search for telemedicine articles citing key reports on SDM outcome measures. Two reviewers independently screened titles and abstracts, reviewed full text eligible studies, and synthesized their content using thematic analysis. RESULTS: Of the 12 eligible articles, most were European with patients with chronic disease or mental and behavioral health. 8 articles used synchronous remote SDM and 1 used asynchronous remote SDM. Themes related to interactional workability of both telemedicine technologies and SDM emerged, namely access to broadband, digital literacy, and satisfaction with the convenience of remote visits. CONCLUSIONS: Telemedicine technologies may foster virtual interactions that support remote SDM, which, in turn, may promote productive patient-clinician interactions and patient-centered care. PRACTICE IMPLICATIONS: Digitally-mediated consultations surged amidst the COVID-19 pandemic. The extent to which SDM frameworks developed for in-person use need any adaptation for remote SDM remains unclear. Investment in innovation, design, implementation, and effectiveness research to advance remote SDM are needed.

Shared decision making process measures and patient problems.

OBJECTIVES: Purposeful SDM posits four modes of shared decision making (SDM). The use of each mode depends on the type of problem of care that is being addressed. We sought to identify how current observer-based SDM measures apply to each mode of Purposeful SDM. METHODS: Four coders, working independently, evaluated 192 items pertaining to 12 observer-based SDM process measures. They classified the items into 6 themes that vary across Purposeful SDM modes and then into one of the four modes (weighing, negotiating, problem-solving, developing insight). Disagreements were resolved by consensus. RESULTS: The items were classified as pertaining to the following themes: problem (28), roles/participation (84), options (62), preferences (21), decision (15), and evaluation (6). They were then classified as pertaining particularly to the SDM modes of weighing (54), negotiating (5), problem-solving (0), and developing insight (0) modes, with 191 items applying broadly to all modes of Purposeful SDM. CONCLUSIONS: Observer-based SDM measures describe behaviors pertinent to all modes but lack items sensitive to behaviors particular to some modes of SDM. PRACTICE IMPLICATIONS: New or revised observer-based measures of the SDM process could help estimate the extent to which the appropriate SDM mode is being used to address the patient's problem.

The design and development of an encounter tool to support shared decision making about preventing cardiovascular events.

Patients at high risk for cardiovascular disease (CVD) tend to receive less intensive preventive care. Clinical practice guidelines recommend shared decision making (SDM) to improve the quality of primary CVD prevention. There are tools for use during the clinical encounter that promote SDM, but, to our knowledge, there are no SDM encounter tools that support conversations about available lifestyle and pharmacological options that can lead to preventive care that is congruent with patient goals and CVD risk. Using the best available evidence and human-centered design (iterative design in the context of ultimate use with users), our team developed a SDM encounter tool, CV Prevention Choice. Each subsequent version during the iterative development process was evaluated in terms of content, usefulness, and usability by testing it in real preventive encounters. The final version of the tool includes a calculator that estimates the patient's risk of a major atherosclerotic CVD event in the next 10 years. Lifestyle and medication options are presented, alongside their pros, cons, costs, and other burdens. The risk reduction achieved by the selected prevention program is then displayed to support collaborative deliberation and decision making. A U.S. multicenter trial is estimating the effectiveness of CV Prevention Choice in achieving risk-concordant CV prevention while identifying the best strategies for increasing the adoption of the SDM encounter tool and its routine use in practice.

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.

Increasing risk-concordant cardiovascular care in diverse health systems: a mixed methods pragmatic stepped wedge cluster randomized implementation trial of shared decision making (SDM4IP).

BACKGROUND: The primary prevention of cardiovascular (CV) events is often less intense in persons at higher CV risk and vice versa. Clinical practice guidelines recommend that clinicians and patients use shared decision making (SDM) to arrive at an effective and feasible prevention plan that is congruent with each person's CV risk and informed preferences. However, SDM does not routinely happen in practice. This study aims to integrate into routine care an SDM decision tool (CV PREVENTION CHOICE) at three diverse healthcare systems in the USA and study strategies that foster its adoption and routine use. METHODS: This is a mixed method, hybrid type III stepped wedge cluster randomized study to estimate (a) the effectiveness of implementation strategies on SDM uptake and utilization and (b) the extent to which SDM results in prevention plans that are risk-congruent. Formative evaluation methods, including clinician and stakeholder interviews and surveys, will identify factors likely to impact feasibility, acceptability, and adoption of CV PREVENTION CHOICE as well as normalization of CV PREVENTION CHOICE in routine care. Implementation facilitation will be used to tailor implementation strategies to local needs, and implementation strategies will be systematically adjusted and tracked for assessment and refinement. Electronic health record data will be used to assess implementation and effectiveness outcomes, including CV PREVENTION CHOICE reach, adoption, implementation, maintenance, and effectiveness (measured as risk-concordant care plans). A sample of video-recorded clinical encounters and patient surveys will be used to assess fidelity. The study employs three theoretical approaches: a determinant framework that calls attention to categories of factors that may foster or inhibit implementation outcomes (the Consolidated Framework for Implementation Research), an implementation theory that guides explanation or understanding of causal influences on implementation outcomes (Normalization Process Theory), and an evaluation framework (RE-AIM). DISCUSSION: By the project's end, we expect to have (a) identified the most effective implementation strategies to embed SDM in routine practice and (b) estimated the effectiveness of SDM to achieve feasible and risk-concordant CV prevention in primary care. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04450914 . Posted June 30, 2020 TRIAL STATUS: This study received ethics approval on April 17, 2020. The current trial protocol is version 2 (approved February 17, 2021). The first subject had not yet been enrolled at the time of submission.