Comparative Effectiveness of Patient-Driven versus Standardized Diabetes Shared Medical Appointments: A Pragmatic Cluster Randomized Trial.

BACKGROUND: Diabetes self-management education and support can be effectively and efficiently delivered in primary care in the form of shared medical appointments (SMAs). Comparative effectiveness of SMA delivery features such as topic choice, multi-disciplinary care teams, and peer mentor involvement is not known. OBJECTIVE: To compare effects of standardized and patient-driven models of diabetes SMAs on patient-level diabetes outcomes. DESIGN: Pragmatic cluster randomized trial. PARTICIPANTS: A total of 1060 adults with type 2 diabetes in 22 primary care practices. INTERVENTIONS: Practice personnel delivered the 6-session Targeted Training in Illness Management (TTIM) curriculum using either standardized (set content delivered by a health educator) or patient-driven SMAs (patient-selected topic order delivered by health educators, behavioral health providers [BHPs], and peer mentors). MAIN MEASURES: Outcomes included self-reported diabetes distress and diabetes self-care behaviors from baseline and follow-up surveys (assessed at 1st and final SMA session), and HbA1c, BMI, and blood pressure from electronic health records. Analyses used descriptive statistics, linear regression, and linear mixed models. KEY RESULTS: Both standardized and patient-driven SMAs effectively improved diabetes distress, self-care behaviors, BMI (- 0.29 on average), and HbA1c (- 0.45% (mmol/mol) on average, 8.3 to 7.8%). Controlling for covariates, there was a small, significant effect of condition on overall diabetes distress in favor of standardized SMAs (F(1,841) = 4.3, p = .04), attributable to significant effects of condition on emotion and regimen distress subscales. There was a small, significant effect of condition on diastolic blood pressure in favor of standardized SMAs (F(1,5199) = 4.50, p = .03). There were no other differences between conditions. CONCLUSIONS: Both SMA models using the TTIM curriculum yielded significant improvement in diabetes distress, self-care, and HbA1c. Patient-driven diabetes SMAs involving BHPs and peer mentors and topic selection did not lead to better clinical or patient-reported outcomes than standardized diabetes SMAs facilitated by a health educator following a set topic order. NIH TRIAL REGISTRY NUMBER: NCT03590041.

What works in implementing shared medical appointments for patients with diabetes in primary care to enhance reach: a qualitative comparative analysis from the Invested in Diabetes study.

BACKGROUND: Diabetes is a serious public health problem affecting 37.3 million Americans. Diabetes shared medical appointments (SMAs) are an effective strategy for providing diabetes self-management support and education in primary care. However, practices delivering SMAs experience implementation challenges. This analysis examined conditions associated with successful practice implementation of diabetes SMAs in the context of participation in a pragmatic trial. METHODS: Mixed methods study using qualitative and quantitative data collected from interviews, observations, surveys, and practice-reported data, guided by the practical, robust implementation and sustainability model (PRISM). Data were analyzed using qualitative comparative analysis (QCA). Successful implementation was defined as meeting patient recruitment targets (Reach) during the study period. Participants were clinicians and staff members from 22 primary care practices in Colorado and Missouri, USA. RESULTS: The first necessary condition identified from the QCA was the presence of additional resources for patients with diabetes in the practice. Within practices that had these additional resources, we found that a sufficiency condition was the presence of an effective key person to make things happen with the SMAs. A second QCA was conducted to determine conditions underlying the presence of the effective key person (often performing functions of an implementation champion), which revealed factors including low or managed employee turnover, a strong baseline practice culture, and previous experience delivering SMAs. CONCLUSIONS: Identification of key factors necessary and sufficient for implementation of new care processes is important to enhance patient access to evidence-based interventions. This study suggests that practice features and resources have important implications for implementation of diabetes SMAs. There may be opportunities to support practices with SMA implementation by enabling the presence of skilled implementation champions. TRIAL REGISTRATION: Registered at clinicaltrials.gov under trial ID NCT03590041, registered on July 18, 2018.

Parkinson disease patients' and carepartners' perceptions of palliative care.

INTRODUCTION: Outpatient palliative care offers an opportunity to improve the quality of life of Parkinson's disease (PD) patients and families. While there are efforts to improve clinicians' palliative care knowledge and skills, there is limited knowledge on patients and carepartners' knowledge and perceptions of palliative care. As part of a larger study on implementing outpatient palliative care, this study aimed to understand patients' and carepartners' knowledge and perceptions of palliative care, and their palliative care needs and preferences prior to the implementation. METHODS: Using qualitative descriptive research design, we completed semi-structured interviews with 47 patients and carepartners prior to the project implementation. De-identified transcripts of interviews were coded and analyzed. RESULTS: Five themes were identified that describe patients' and carepartners' palliative care knowledge, perceptions, needs and preferences: (a) Patients and carepartners have varied knowledge and perceptions of palliative care (b) Non-motor symptoms are challenging for patients and carepartners, (c) Addressing patients' grief and emotional needs is important to patients and carepartners, (d) Carepartners want a place for emotional care, well-being, and strategizing and (e) Patients and carepartners desire anticipatory guidance and care planning. Study participants desired guidance to manage non-motor symptoms, support for patients' emotional needs and for carepartners, and for anticipatory guidance to guide future planning. CONCLUSIONS: Despite varied palliative care knowledge, PD patients and carepartners universally desire care that addresses their palliative care needs. Palliative care education and integration of palliative care approaches into standard care may facilitate increased acceptance of outpatient palliative care throughout the disease trajectory.

A virtual recruitment protocol promotes enrollment of underrepresented groups in a diabetes prevention trial.

Strategies are needed to ensure greater participation of underrepresented groups in diabetes research. We examined the impact of a remote study protocol on enrollment in diabetes research, specifically the Pre-NDPP clinical trial. Recruitment was conducted among 2807 diverse patients in a safety-net healthcare system. Results indicated three-fold greater odds of enrolling in remote versus in-person protocols (AOR 2.90; P < 0.001 [95% CI 2.29-3.67]). Priority populations with significantly higher enrollment included Latinx and Black individuals, Spanish speakers, and individuals who had Medicaid or were uninsured. A remote study design may promote overall recruitment into clinical trials, while effectively supporting enrollment of underrepresented groups.