Pilot Implementation Trial of Implementation Toolkits for Diabetes Coaching
Single Site Implementation Pilot Trial of Base, Enhanced, and Sustainment Implementation Toolkits for Diabetes Coaching for Families With an Adolescent With Type 1 Diabetes
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Type 1 diabetes (T1D), one of the most prevalent chronic pediatric diseases in the United States, requires a complex treatment regimen. Youth with T1D, particularly adolescents, more frequently have higher glycemic levels. Less than 30% of youth achieve the recommended level of glycemic control. Compared to adults, youth are more at-risk for related complications (diabetic ketoacidosis) that can lead to heart disease, diabetic coma, and death. These complications often result from challenges completing T1D care tasks. Evidence-based behavioral interventions can increase T1D care task completion and lower glycemic levels (i.e., A1c). Integrating these interventions into standard T1D care may lead to better overall health for this population. Implementation science offers theory and rigorous methods to accomplish this goal, but few studies have employed them.
Behavioral Family Systems Therapy-Diabetes (BFST-D) is efficacious for increasing T1D care task completion and lowering A1c, particularly among adolescents who have higher glycemic levels (A1c≥9.0%). A brief 4-session, adapted version of BFST-D (Diabetes Coaching) delivered as part of standard care was associated with lowered glycemic levels. Despite these efficacy and initial effectiveness data, few receive this evidence-based care. Although Diabetes Coaching has been offered at the PI's institution, less than 10% of patients received it. Evaluation of strategies to improve reach of Diabetes Coaching in standard care is needed.
In a large national qualitative study of key informants (adolescents with T1D-caregiver dyads, medical and psychosocial healthcare providers, healthcare leaders) drawn from 5 children's hospitals, the PI identified determinants of implementing Diabetes Coaching (K23 Aim 1). Factors influencing implementation ranged across all domains of the Consolidated Framework for Implementation Research (CFIR), including those related to family needs and opportunity to engage in this care (evening, telehealth delivery, expert providers who are empathic, patient, encouraging, referrals from trusted provider when A1c rising, evidence of improved A1c), provider knowledge and self-efficacy in referring to and delivering Diabetes Coaching, and clinic resources (lack of streamlined referral processes; leadership buy-in), as well as external factors (insurance coverage).
Using these rich data and an evidence-based quality improvement (EBQI) approach with iterative feedback from Family and Healthcare Professional Diabetes Care Advisory Boards (F-DCAB; P-DCAB) drawn from Nemours Children's Hospital Delaware (NCHD), the PI developed a toolkit of implementation strategies (K23 Aim 2). Implementation strategies are methods for integrating evidence-based practices into standard care.20 Critical strategies needed to integrate Diabetes Coaching into standard T1D care at NCHD emerged and comprise a Base Implementation Toolkit (BIT). Pre-implementation BIT strategies include provider and staff education meetings (e.g., referring and delivering Diabetes Coaching), identification of and training of Champions for implementation, 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 implementation strategies include feedback loop to clinical provider team regarding summary level data on uptake of referrals to and family engagement in Diabetes Coaching, as well as consultation to support problem-solving workflow and other implementation challenges with Champions. 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 and/or to increase reach if few families attend Diabetes Coaching. BIT-Enhanced requires additional time and resources (e.g., Champion and providers review individual data, collaborate on ways to increase referrals). Thus, examining if this additional strategy meaningfully improves outcomes offers critical data for maintaining only the strategies that are necessary and sufficient. Key to maintaining implementation of any evidence-based practice, including Diabetes Coaching, is considering sustainability early on. The primary sustainability strategy involves training the Champions early and planful progression of their role in the implementation efforts, from first attending the PI-led (implementation and content expert) brief consultation meetings and data tracking to then independently leading these meetings (BIT-Sustainment)
Guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) and the Reach, Efficacy, Adoption, Implementation, Maintenance (RE-AIM) frameworks, the goals of the current single site pilot implementation feasibility trial (K23 Aim 3) are to pilot study procedures and the implementation toolkits and track effectiveness of implementation toolkits in preparation for a fully powered trial. The overarching aim of this study is to gather preliminary data to support an R01 application to conduct a large, multi-site randomized hybrid implementation-effectiveness trial testing uptake of Diabetes Coaching and tracking patient health outcomes.
Aim 1 (Feasibility & Acceptability): Conduct a pilot implementation feasibility study at the PIs institution (NCHD) to examine acceptability and feasibility of BIT for Diabetes Coaching and BIT-Enhanced for providers with lower adoption rates (<80%) and with low reach (<5 families per group), and BIT-Sustainment. In addition, study procedures will be piloted in preparation for a fully powered trial.
Aim 2 (Implementation Outcomes): Examine four exploratory implementation outcomes, (1) medical provider adoption of referring to Diabetes Coaching (i.e., number of providers vs. number of providers referring >80% eligible families), (2) psychologist fidelity in delivering Diabetes Coaching, and (3) reach of Diabetes Coaching to the target patient population (i.e., number families eligible vs. referred, number of sessions attended, completion rate). (4) Sustainability of adoption, reach, and fidelity will be examined following the removal of most research resources.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Julia EW Price, PhD
- Phone Number: 302-287-9391
- Email: julia.price@nemours.org
Study Locations
-
-
Delaware
-
Wilmington, Delaware, United States, 19803
- Recruiting
- Nemours Children's Hospital - Delaware
-
Contact:
- Julia Price, PhD
- Phone Number: 302-287-9391
- Email: julia.price@nemours.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
1. Not involved in the direct clinical care or administrative parts of care of families with an adolescent with T1D at Nemours Children's Hospital - Delaware
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Implementation Toolkit
In this arm, all participants will receive BIT.
If indicated, BIT-Enhanced will be deployed.
All participants will receive BIT-Sustainment.
|
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.
Other Names:
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of Implementation Strategies
Time Frame: Post-completion of Sustainment implementation strategies; 10 months
|
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.
|
Post-completion of Sustainment implementation strategies; 10 months
|
|
Acceptability of Implementation Strategies
Time Frame: Post-completion of Sustainment implementation strategies (10 months)
|
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.
|
Post-completion of Sustainment implementation strategies (10 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adoption of Referral Practices
Time Frame: Post-Active Implementation Phase (6 months); Post-Sustainment Phase (10 months)
|
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.
|
Post-Active Implementation Phase (6 months); Post-Sustainment Phase (10 months)
|
|
Reach of Diabetes Coaching
Time Frame: Post-Active Implementation Phase (6 months); Post-Sustainment Phase (10 months)
|
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).
|
Post-Active Implementation Phase (6 months); Post-Sustainment Phase (10 months)
|
|
Fidelity of Delivering Diabetes Coaching
Time Frame: Post-Active Implementation Phase (6 months); Post-Sustainment Phase (10 months)
|
Percent of completed items on self-report checklists for delivering Diabetes Coaching sessions, as reported by psychology provider.
|
Post-Active Implementation Phase (6 months); Post-Sustainment Phase (10 months)
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Carpenter J, Price JE, Cohen MJ, Shoe KM, Shroff Pendley J. Multifamily group problem-solving intervention for adherence challenges in pediatric insulin-dependent diabetes. Clinical Practice in Pediatric Psychology. 2014; 2(2):101-115. doi: http://dx.doi.org/10.1037/cpp0000059.
- Price J, Beidas RS, Wolk CB, Genuario K, Kazak AE. Implementation Science in Pediatric Psychology: The Example of Type 1 Diabetes. J Pediatr Psychol. 2019 Oct 1;44(9):1068-1073. doi: 10.1093/jpepsy/jsz030.
- Price J, Lewis AM, Pierce JS, Enlow PT, Okonak K, Kazak AE. Psychosocial Staffing and Implementation of the International Society for Pediatric and Adolescent Diabetes Psychological Care Guidelines in U.S. Pediatric Diabetes Clinics. Diabetes Spectr. 2023 Summer;36(3):219-227. doi: 10.2337/ds22-0047. Epub 2023 Jan 24.
- Price J, Hawkins J, Amante DJ, James R, Haire-Joshu D. Implementation Science and Pediatric Diabetes: A Scoping Review of the State of the Literature and Recommendations for Future Research. Curr Diab Rep. 2024 Oct 29;25(1):2. doi: 10.1007/s11892-024-01561-3.
- Price J, Deatrick JA, Curran G, Yang CL, Perez Ramirez A, Thomas C, Kazak AE. Implementing a behavioural intervention for paediatric type 1 diabetes: Key informant perspectives of multilevel barriers and facilitators. Diabet Med. 2026 May 20:e70366. doi: 10.1111/dme.70366. Online ahead of print.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- K23DK125666 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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