ArticleTrials2020
The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments.
Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03590041 (Invested in Diabetes), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Invested in Diabetes: Comparing Patient-Centered Outcomes of Standardized Versus Patient-Driven Diabetes Shared Medical Appointments (PCORI IHS-1609-36322)
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Collaborative care approaches for people with severe mental illness.The Cochrane database of systematic reviews · 2024Pooled it
- Comparative Effectiveness of Patient-Driven versus Standardized Diabetes Shared Medical Appointments: A Pragmatic Cluster Randomized Trial.Journal of general internal medicine · 2024Trial
- Sustaining Diabetes Shared Medical Appointments After a Pragmatic Trial.Journal of the American Board of Family Medicine : JABFMTrial
- Exploring Stakeholder Involvement in Intervention Implementation Studies: Systematic Evidence Synthesis With an Evidence Gap Map Approach.Evaluation & the health professions · 2026Review
- 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.Implementation science communications · 2024Article
- Delivering diabetes shared medical appointments in primary care: early and mid-program adaptations and implications for successful implementation.BMC primary care · 2023Article
- A Multi-Method Study of Patient Reach and Attendance in a Pragmatic Trial of Diabetes Shared Medical Appointments.Clinical diabetes : a publication of the American Diabetes Association · 2023Article
- Methodological approaches to study context in intervention implementation studies: an evidence gap map.BMC medical research methodology · 2022Article
- Methods for capturing and analyzing adaptations: implications for implementation research.Implementation science : IS · 2022Article
- Protocol refinement for a diabetes pragmatic trial using the PRECIS-2 framework.BMC health services research · 2021Article
- 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 Journal of pediatrics · 2021Article
- Article
Corrections and comments
- Erratum issued
Authors and funding
11 authors.
Funding
Abstract
backgroundShared 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.
methodsThis 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 practice-level 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.
trial registrationClinicalTrials.gov, NCT03590041. Registered on 5 July 2018.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.