The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments

Abstract

Background: Shared medical appointments (SMAs) have been shown to be an efficient and effective strategy for providing diabetes self-management education and self-management support. SMA features vary and it is not known which features are most effective for different patients and practice settings. The Invested in Diabetes study tests the comparative effectiveness of SMAs with and without multidisciplinary care teams and patient topic choice for improving patient-centered and clinical outcomes related to diabetes. Methods: This study compares the effectiveness of two SMA approaches using the Targeted Training for Illness Management (TTIM) curriculum. Standardized SMAs are led by a health educator with a set order of TTIM topics. Patient-driven SMAs are delivered collaboratively by a multidisciplinary care team (health educator, medical provider, behavioral health provider, and a peer mentor); patients select the order and emphasis on TTIM topics. Invested in Diabetes is a cluster randomized pragmatic trial involving approximately 1440 adult patients with type 2 diabetes. Twenty primary care practices will be randomly assigned to either standardized or patient-driven SMAs. A mixed-methods evaluation will include quantitative (practice-and patient-level data) and qualitative (practice and patient interviews, observation) components. The primary patient-centered outcome is diabetes distress. Secondary outcomes include autonomy support, self-management behaviors, clinical outcomes, patient reach, and practicelevel value and sustainability. Discussion: Practice and patient stakeholder input guided protocol development for this pragmatic trial comparing SMA approaches. Implementation strategies from the enhanced Replicating Effective Programs framework will help ensure practices maintain fidelity to intervention protocols while tailoring workflows to their settings. Invested in Diabetes will contribute to the literature on chronic illness management and implementation science using the RE-AIM model.

Adapting Diabetes Shared Medical Appointments to Fit Context for Practice-Based Research (PBR)

“…Invested in Diabetes is a cluster randomized pragmatic trial testing the comparative effectiveness of patient-driven versus standardized models of diabetes SMAs. 9 We used quantitative and qualitative methods to assess practice contextual factors relevant to intervention adaptation and implementation. We used the enhanced REP framework to adapt interventions for fit within this context, while retaining core elements needed to address research questions.…”

“…Invested in Diabetes is testing the comparative effectiveness of 2 models of diabetes shared medical appointments (SMAs) in primary care. 9 The study compares "patient-driven" to "standardized" diabetes SMAs. Both behavioral intervention models include diabetes self-management education and support (DSME/S) using the evidence-based Targeted Training in Illness Management (TTIM) curriculum.…”

Implementation of a Rapid Evidence Assessment Infrastructure during the Coronavirus Disease 2019 (COVID-19) Pandemic to Develop Policies, Clinical Pathways, Stimulate Academic Research, and Create Educational Opportunities

“…The SAC team initially assembled by the ICT was a multidisciplinary translational team, characterized by diversity in: ( 1 ) clinical setting—inpatient, critical care, emergency department, outpatient; ( 2 ) subspecialty—infectious disease, rheumatology, surgery, etc. ; ( 3 ) research expertise across the entire translational spectrum, from basic science to clinical science to public health; ( 4 ) training—including medical and surgical subspecialties, microbiology, epidemiology, respiratory therapy, pharmacology, health psychology, nursing, public health, communications, and CE; and ( 5 ) career stage—including senior and mid-career researchers as well as junior faculty, trainees and students. All who volunteered to be on the SAC were included.…”

“…The REP framework is an implementation science framework commonly used in quality improvement and health services research to guide selection, adaptation, and implementation of evidence-based interventions in real-world care settings. [6][7][8] The REP has 4 phases: the preconditions phase involves identification of the need and determining most effective strategies; preimplementation incorporates the development, orientation, and logistics of the program; the implementation phase encompasses the roll out and dissemination of the various components; and the maintenance and evolution phase involves organizational steps to sustain the intervention in the short and long term. Figure 1 (available at www.jpeds.com) summarizes application of each phase for development and implementation of CCREADS.…”

Correction to: The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments

“…After publication of our article [1] the authors have notified us that the title for Figure 1 was incorrectly captioned in addition it was noticed that the Interventions section contained two errors.…”