Pilot Implementation Trial of Implementation Toolkits for Diabetes Coaching

Summary

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

Conditions

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

Interventions

BEHAVIORAL

Base Implementation Toolkit (BIT)

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.

BEHAVIORAL

BIT-Enhanced

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.

BEHAVIORAL

BIT-Sustainment

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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Nemours Children's Clinic

  lead OTHER

Study Design

Allocation

NA

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-08-26

Primary Completion

2027-04-30

Completion

2027-04-30

Countries

• United States

Study Locations