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Pilot Implementation Trial of Implementation Toolkits for Diabetes Coaching

ConditionsImplementation ScienceType 1 Diabetes in AdolescenceImplementation Strategies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorNemours Children's Clinic

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Involved in the direct clinical medical care of adolescents with T1D at Nemours Children's Hospital - Delaware OR

Involved in the direct clinical psychological care of adolescents with T1D at Nemours Children's Hospital - Delaware OR

Involved in the scheduling and/or insurance coverage verification in the clinical psychological care of adolescents with T1D at Nemours Children's Hospital - Delaware OR

Holds a leadership role in Endocrinology and/or Behavioral Health at Nemours Children's Hospital - Delaware

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Implementation ToolkitExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Feasibility of Implementation Strategies

Total score on the Feasibility of Intervention Measure (FIM) for each implementation strategy. The FIM is a validated, brief, 4-item, survey on the feasibility of implementation strategies. Each item is rated on a 5-point Likert scale, from completely disagree (1) to completely agree (5), with higher scores indicating greater feasibility.

Time frame
Post-completion of Sustainment implementation strategies; 10 months
2

Acceptability of Implementation Strategies

Total score on the Acceptability of Intervention Measure (FIM) for each implementation strategy. The AIM is a validated, brief, 4-item, survey on the feasibility of implementation strategies. Each item is rated on a 5-point Likert scale, from completely disagree (1) to completely agree (5), with higher scores indicating greater acceptability.

Time frame
Post-completion of Sustainment implementation strategies (10 months)

Secondary outcomes

1

Adoption of Referral Practices

Percentage of providers who reach adoption (total number of medical providers vs. number of medical providers referring \>80% of eligible families per week) measured via electronic health record data.

Time frame
Post-Active Implementation Phase (6 months); Post-Sustainment Phase (10 months)
2

Reach of Diabetes Coaching

Percent of eligible families completing at least 3 of 4 Diabetes Coaching sessions versus total number of eligible families (based on electronic health record data).

Time frame
Post-Active Implementation Phase (6 months); Post-Sustainment Phase (10 months)
3

Fidelity of Delivering Diabetes Coaching

Percent of completed items on self-report checklists for delivering Diabetes Coaching sessions, as reported by psychology provider.

Time frame
Post-Active Implementation Phase (6 months); Post-Sustainment Phase (10 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nemours Children's Clinic

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
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