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.

A stakeholder engagement method navigator webtool for clinical and translational science.

Stakeholder engagement is increasingly expected by funders and valued by researchers in clinical and translational science, yet many researchers lack access to expert consultation or training in selecting appropriate stakeholder engagement methods. We describe the development of a novel Stakeholder Engagement Navigator webtool. We conducted an environmental scan and literature review, along with investigator interviews, surveys, and engagement expert facilitated group discussion. We formally reviewed and cataloged 29 distinct engagement methods. To develop the webtool, we used an iterative design process that followed Design Thinking phases: empathize, define, ideate, prototype, and test. As prioritized during user testing, the Stakeholder Engagement Navigator webtool both educates and guides investigators in selecting an engagement method based on key criteria. The V1.0 Navigator webtool filters methods first by purpose of engagement (noted by 62% of users as the highest priority criteria), then by budget, time per stakeholder interaction, and total interactions. The tool is available at DICEMethods.org. The Stakeholder Engagement Navigator webtool is a user-centered, interactive webtool suitable for use by researchers seeking guidance on appropriate stakeholder engagement methods for clinical and translational research projects.

Practice Characteristics Associated with Better Implementation of Patient Self-Management Support.

BACKGROUND: Advanced primary care models emphasize patient-centered care, including self-management support (SMS). This study aimed to promote the translation of SMS into primary care practices and reported on key baseline practice characteristics that may impact SMS implementation. METHODS: Thirty-six practices in Colorado and California participated in the study from December 2013 to March 2017. Practice administrators completed a Practice Information Form describing practice characteristics. Clinicians and staff (n = 716) completed the Practice Culture Assessment and the Patient-Centered Medical Home (PCMH) Monitor. Descriptive statistics were computed to determine practice characteristics related to culture, quality improvement, level of PCMH, and SMS implementation. Field notes and key informant interviews provided contextual details about practices. Iterative qualitative analyses identified important facilitators and barriers and change capabilities around SMS implementation. RESULTS: In bivariate analyses, rural locations, fewer uncontrolled patients with diabetes, higher Medicaid or uninsured populations, underserved designation, and higher level of "PCMHness" were associated with greater reported implementation of patient SMS (all P < .05) at baseline. In the final multilevel model, specialty (FM vs mixed, P = .0081), rural location (P = .0109), and higher percent Medicaid (P < .0001) were associated with greater SMS. Practices described key facilitators (alignment, motivation, a visible champion, supporting infrastructure, and functional quality improvement and care teams) and barriers (no shared vision, no visible champion, siloed infrastructure, competing programs, turnover, and time constraints) to improving SMS delivery. CONCLUSIONS: Careful attention-and action-on key practice characteristics and context may create more favorable initial conditions for practice change efforts to improve SMS in primary care practices.

Recruiting Primary Care Practices for Research: Reflections and Reminders.

BACKGROUND: Recruiting primary care practices for research projects has always required carefully tended relationships, a compelling message, and good timing. Recruiting practices to participate in practice transformation research trials may take more and different efforts. We reflect on practice recruitment for a recently-concluded trial of a diabetes self-management support system in 2 states and 36 practices. METHODS: Iterative qualitative analysis of field notes, semistructured clinician and staff interviews, and meeting notes from a 2-state, cluster-randomized trial that aimed to improve self-management support for patients with type 2 diabetes mellitus. RESULTS: Although all 36 enrolled practices finished the study, fully recruiting practices early on took considerable effort, yielding 2 primary lessons: 1) practice-based research networks (PBRNs) must recruit more stakeholders at more levels, at the clinic, in the system, and across roles; and 2) practice recruitment is a process and may take longer than expected with unplanned turnover of key contacts. Adjusting our recruitment strategies required: helping with communication efforts in practices; aligning our study message according to stakeholders' interests; allowing for minor adaptations at the practice-level to align with critical practice workflows, staffing, and resources; re-engaging with clinical leadership over time; and identifying a "backup" champion due to turnover. CONCLUSIONS: When undertaking a pragmatic clinical trial requiring substantial practice change in a PBRN setting across a large number of practices, it is important that PBRN leaders develop a comprehensive strategy to identify and engage a broad group of stakeholders within each practice, understand their needs and priorities around research, and design and implement a structured communications strategy to maintain engagement throughout every phase of the project.

Stakeholder engagement in diabetes self-management: patient preference for peer support and other insights.

Background: Self-management support (SMS) for patients with diabetes can improve adherence to treatment, mitigate disease-related distress, and improve health outcomes. Translating this evidence into real-world practice is needed, as it is not clear which SMS models are acceptable to patients, and feasible and sustainable for primary care practices. Objective: To use the Boot Camp Translation (BCT) method to engage patient, practice, community resource and research stakeholders in translation of evidence about SMS and diabetes distress into mutually acceptable care models and to inform patient-centred outcomes research (PCOR). Participants: Twenty-seven diabetes care stakeholders, including patients and providers from a local network of federally qualified health centres participated. Methods: Stakeholders met in-person and by conference call over the course of 8 months. Subject matter experts provided education on the diabetes SMS evidence. Facilitators engaged the group in discussions about barriers to self-management and opportunities for improving delivery of SMS. Key Results: BCT participants identified lack of social support, personal resources, trust, knowledge and confidence as barriers to diabetes self-management. Intervention opportunities emphasized peer support, use of multidisciplinary care teams and centralized systems for sharing information about community and practice resources. BCT informed new services and a PCOR study proposal. Conclusions: Patients and family engaged in diabetes care research value peer support, group visits, and multidisciplinary care teams as key features of SMS models. SMS should be tailored to an individual patient's health literacy. BCT can be used to engage multiple stakeholders in translation of evidence into practice and to inform PCOR.

Supporting primary care practices in building capacity to use health information data.

INTRODUCTION: Our objective was to describe essential support resources and strategies in order to advance the pace and scope of the use of health information technology (HIT) data. BACKGROUND AND CONTEXT: Primary data were collected between January 2011 and October 2012. The primary study population comprised 51 primary care practices enrolled in the Colorado Beacon Consortium in western Colorado. METHODS: We used qualitative methods embedded in a mixed-method evaluation: monthly narrative reports from practices; interviews with providers and staff; and focused, group discussions with quality improvement (QI) advisors and staff from the Health Information Technology Regional Extension Center. FINDINGS: Practices valued effective support strategies to assist with using HIT, including the following: translating rules and regulations into individual practice settings; facilitating peer-to-peer connections; providing processes and tools for practice improvement; maintaining accountability and momentum; and providing local electronic health record (EHR) technical expertise. Benefits of support included improved quality measures, operational improvements, increased provider and staff engagement, and deeper understanding of EHR data. DISCUSSION: The findings affirm the utility of practice facilitation for HIT-focused aims with personalized attention and cross-fertilization among practices for improvements. Facilitation to sustain ongoing improvements and prepare for future HIT-intensive improvement activities was highly valued. In addition to the general practice facilitator, an EHR technical expert was critical to improving practice capacity to use electronic clinical data. Collaborative learning expands the pool of mentors and teachers, who can further translate their own lessons into practical advice for their peers, yielding the emergence of a stronger sense of community among the practices. CONCLUSIONS: Using HIT more effectively in primary care will require sustained, focused efforts by practices as regulations, incentives and HIT evolve. Ongoing support for community-based practice facilitators; collaborative learning; and local, personalized EHR advisors will help practices care for patients while more effectively deploying HIT to improve care.

The journey of primary care practices to meaningful use: a Colorado Beacon Consortium study.

BACKGROUND: The Health Information Technology for Economic and Clinical Health Act of 2009 provides for incentive payments through Medicare and Medicaid for clinicians who implement electronic health records (EHRs) and use this technology meaningfully to improve patient care. There are few comprehensive descriptions of how primary care practices achieve the meaningful use of clinical data, including the formal stage 1 meaningful use requirements. METHODS: Evaluation of the Colorado Beacon Consortium project included iterative qualitative analysis of practice narratives, provider and staff interviews, and separate focus groups with quality improvement (QI) advisors and staff from the regional health information exchange (HIE). RESULTS: Most practices described significant realignment of practice priorities and aims, which often required substantial education and training of physicians and staff. Re-engineering office processes, data collection protocols, EHRs, staff roles, and practice culture comprised the primary effort and commitment to attest to stage 1 meaningful use and subsequent meaningful use of clinical data. While realizing important benefits, practices bore a significant burden in learning the true capabilities of their EHRs with little effective support from vendors. Attestation was an important initial milestone in the process, but practices faced substantial ongoing work to use their data meaningfully for patient care and QI. Key resources were instrumental to these practices: local technical EHR expertise; collaborative learning mechanisms; and regular contact and support from QI advisors. CONCLUSIONS: Meeting the stage 1 requirements for incentives under Medicare and Medicaid meaningful use criteria is the first waypoint in a longer journey by primary care practices to the meaningful use of electronic data to continuously improve the care and health of their patients. The intensive re-engineering effort for stage 1 yielded practice changes consistent with larger practice aims and goals. While many of these practices are now poised to use data meaningfully, faster progress will likely come with continued local QI and technical support and planned community-wide learning.