Gravholt, Derek

Abstract Background: Venous thromboembolism (VTE) in pregnancy is a major cause of maternal morbidity and mortality, and the use of preventive low-molecular-weight heparin (LMWH) can be challenging. Clinical guidelines recommend eliciting pregnant individuals’ preferences towards the use of daily injections of LMWH and discussing the best option through a shared decision-making (SDM) approach. Our aim was to identify individuals’ preferences concerning each of the main clinical outcomes, and categorize attributes influencing the use of LMWH during pregnancy. Methods: Design: Convergent mixed-methods. Participants: Pregnant women or those planning a pregnancy with VTE recurrence risk. Intervention: A SDM intervention about thromboprophylaxis with LMWH in pregnancy. Analysis: Quantitatively, we report preference scores assigned to each of the health states. Qualitatively, we categorized preference attributes using Burke’s pentad of motives framework: scene, agent, agency, act, and purpose. We use mixed-method convergent analysis to report findings using side-by-side comparison of concordance/discordance. Results: The least valued health state was to experience a pulmonary embolism (PE), followed by major obstetrical bleeding (MOB), deep vein thrombosis (DVT), and using daily injections of LMWH (valued as closest to a ‘healthy pregnancy’). Women's previous experiences, access to care (scene) and shared decision-making (agent) affected preferences. LMWH's benefits were noted, but substantial drawbacks described (agency). The main goal was avoiding the risk of VTE (purpose). Side-by-side comparisons revealed concordance between motives and DVT and PE health states. Discordance appeared between using daily injections of LMWH and agent- and agency motives and between MOB and the agency motive. Conclusions: Mixed-methods provide a nuanced understanding of women's LMWH preferences, by quantifying health states preferences and exploring attributes qualitatively. Incorporating both methods may improve patient-centered care around preference-sensitive decisions in thromboprophylaxis during pregnancy.

AbstractIntroductionFor 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.MethodsWe 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.ResultsWe 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%).DiscussionMeasures 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 ContributionPatients and caregivers from the ‘Making care fit Collaborative’ were involved in drafting the dimensions relevant to patient–clinician collaboration.

Abstract Background Venous thromboembolism (VTE) in pregnancy is a major cause of maternal morbidity and death. The use of low-molecular-weight heparin (LMWH), despite being the standard of care to prevent VTE, comes with some challenges. Shared decision-making (SDM) interventions are recommended to support patients and clinicians in making preference-sensitive decisions. The quality of the SDM process has been widely assessed with the decisional conflict scale (DCS). Our aim is to report participants’ perspectives of each of the components of an SDM intervention (DASH-TOP) in relation to the different subscales of the DCS. Methods Design: A convergent, parallel, mixed-methods design. Participants: The sample consisted of 22 health care professionals, students of an Applied Clinical Research in Health Sciences (ICACS) master program. Intervention: We randomly divided the participants in three groups: Group 1 received one component (evidence -based information), Group 2 received two components (first component and value elicitation exercises), and Group 3 received all three components (the first two and a decision analysis recommendation) of the SDM intervention. Analysis: For the quantitative strand, we used a non-parametric test to analyze the differences in the DCS subscales between the three groups. For the qualitative strand, we conducted a content analysis using the decisional conflict domains to deductively categorize the responses. Results Groups that received more intervention components experienced less conflict and better decision-making quality, although the differences between groups were not statistically significant. The decision analysis recommendation improved the efficacy with the decision-making process, however there are some challenges when implementing it in clinical practice. The uncertainty subscale showed a high decisional conflict for all three groups; contributing factors included low certainty of the evidence-based information provided and a perceived small effect of the drug to reduce the risk of a VTE event. Conclusions The DASH-TOP intervention reduced decisional conflict in the decision -making process, with decision analysis being the most effective component to improve the quality of the decision. There is a need for more implementation research to improve the delivery of SDM interventions in the clinical encounter.

Abstract Background: Trial recruitment of Black, indigenous, and people of color (BIPOC) is key for interventions that interact with socioeconomic factors and cultural norms, preferences, and values. We report on our experience enrolling BIPOC participants into a multicenter trial of a shared decision-making intervention about anticoagulation to prevent strokes, in patients with atrial fibrillation (AF). Methods: We enrolled patients with AF and their clinicians in 5 healthcare systems (three academic medical centers, an urban/suburban community medical center, and a safety-net inner-city medical center) located in three states (Minnesota, Alabama, and Mississippi) in the United States. Clinical encounters were randomized to usual care with or without a shared decision-making tool about anticoagulation. Analysis: We analyzed BIPOC patient enrollment by site, categorized reasons for non-enrollment, and examined how enrollment of BIPOC patients was promoted across sites.Results: Of 2247 patients assessed, 922 were enrolled of which 147 (16%) were BIPOC patients. In comparison to trial-eligible White participants, eligible Black participants more frequently did not enroll (102 (11%) vs. 185 (15%); p <.001). The rate of BIPOC patients enrollment varied substantially by site and was generally reflective of the population served at each participating site. Enrollment of BIPOC patients benefited most from including and prioritizing practices most likely to care for BIPOC patients, with lower yield from specific efforts to reach BIPOC clinic attendees and enrolling BIPOC patients first when possible. Conclusions: Enrollment from practices that have implemented policies that favor the care of BIPOC patients can contribute to generate trustworthy estimates of the effect of these interventions in clinical practice that are applicable to BIPOC populations. Best practices to optimize the enrollment of BIPOC participants into trials that examined complex and culturally sensitive interventions remain to be developed.Clinical trial registration: ClinicalTrials.gov (NCT02905032)