Pilot Implementation Trial of Implementation Toolkits for Diabetes Coaching

Part of paid clinical trials in Wilmington, Delaware.

Sponsor
Nemours Children's Clinic
Study ID
NCT07766811
Status
Not Yet Recruiting

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Conditions

  • Implementation Science
  • Implementation Strategies
  • Type 1 Diabetes in Adolescence

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Base Implementation Toolkit (BIT) — BEHAVIORAL
    The Base Implementation Toolkit (BIT) includes strategies across pre-implementation, active implementation, and sustainment phases. Pre-implementation BIT strategies include provider and staff education meetings (e.g., meetings introducing processes for referring and delivering Diabetes Coaching), identification of and training the psychology providers and one medical provider as Champions for implementation and deliverer of Diabetes Coaching (psychology providers only), materials to increase demand for Diabetes Coaching among families (e.g., family-facing educational materials), and development of a workflow blueprint and of tools to monitor implementation. Active implementation BIT strategies include reporting summary level data on uptake of referrals to and family engagement in Diabetes Coaching to clinical type 1 diabetes providers, as well as facilitation (i.e., consultation) to support problem-solving workflow and other implementation challenges.
  • BIT-Enhanced — BEHAVIORAL
    During active implementation, two strategies (audit and feedback, adapting delivery format and timing of Diabetes Coaching) may be added to BIT (BIT-Enhanced) to improve adoption among medical providers with lower referral rates (adoption rate \<80%) and/or to increase reach if few families schedule and attend Diabetes Coaching (\<6 families scheduled per group and/or \<4 families attend group). BIT-Enhanced requires additional time and resources (e.g., Champions and providers review individual data, collaborate on ways to increase referrals). Thus, examining if these additional strategies meaningfully improve outcomes offers critical data for maintaining only the strategies that are necessary and sufficient for adoption, reach, and fidelity outcomes.
  • BIT-Sustainment — BEHAVIORAL
    Key to maintaining implementation of any evidence-based practice, including Diabetes Coaching, is considering sustainability early on. The primary sustainability strategy (BIT-Sustainment) involves training multiple Champions early and planful progression of their role in the implementation efforts, from first participating in PI-led (implementation and content expert) consultation huddles and shadowing data tracking to then independently leading these huddles, reporting adoption data, and, for those requiring BIT-Enhanced, employing audit and feedback and reach data as needed. The BIT-Sustainment will be deployed for all providers (BIT and BITE) during the sustainment phase of implementation.

Study Details

The goal of this study is to learn if toolkits of implementation strategies (e.g., provider and staff education, clear plan for how to refer and bill) help pediatric type 1 diabetes medical and psychology providers deliver a behavioral intervention (Diabetes Coaching) to more families. The main questions this study aims to answer are: * Is it possible to put these toolkits of implementation strategies into place in one pediatric hospital? * Do providers and staff find these toolkits of implementation strategies acceptable? Participants will be type 1 diabetes professionals (endocrinologists, nurse practitioners, psychologists, scheduling and billing staff) at Nemours Children's Hospital Delaware. Participants will: * Attend educational and/or planning meetings * Receive email updates on referral data * Complete surveys * Complete an interview

Key Dates

First listed
Aug 17, 2026
Start date
Aug 26, 2026
Status verified
Aug 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Implementation Toolkit
    In this arm, all participants will receive BIT. If indicated, BIT-Enhanced will be deployed. All participants will receive BIT-Sustainment.

Primary Outcome Measure

Feasibility of Implementation Strategies [ Time Frame: Post-completion of Sustainment implementation strategies; 10 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nemours Children's Hospital - DelawareWilmingtonDelaware19803-

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