NCT07766811

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Aug 2026Apr 2027

First Submitted

Initial submission to the registry

August 5, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 17, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

August 26, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

8 months

First QC Date

August 5, 2026

Last Update Submit

August 26, 2026

Conditions

Implementation ScienceType 1 Diabetes in AdolescenceImplementation Strategies

Keywords

Implementation strategiesType 1 DiabetesAdolescenceImplementation outcomesPsychosocial intervention

Outcome Measures

Primary Outcomes (2)

  • 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.

    Post-completion of Sustainment implementation strategies; 10 months

  • 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.

    Post-completion of Sustainment implementation strategies (10 months)

Secondary Outcomes (3)

  • Adoption of Referral Practices

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

  • Reach of Diabetes Coaching

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

  • Fidelity of Delivering Diabetes Coaching

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

Study Arms (1)

Implementation Toolkit

EXPERIMENTAL

In this arm, all participants will receive BIT. If indicated, BIT-Enhanced will be deployed. All participants will receive BIT-Sustainment.

Behavioral: Base Implementation Toolkit (BIT)Behavioral: BIT-EnhancedBehavioral: BIT-Sustainment

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.

Also known as: BIT-Enhanced, BIT-Sustainment
Implementation Toolkit
BIT-EnhancedBEHAVIORAL

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.

Implementation Toolkit
BIT-SustainmentBEHAVIORAL

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.

Implementation Toolkit

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nemours Children's Hospital - Delaware

Wilmington, Delaware, 19803, United States

RECRUITING

Related Publications (5)

  • 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.

    BACKGROUND

  • 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.

    PMID: 31045228BACKGROUND

  • 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.

    PMID: 37583560BACKGROUND

  • 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.

    PMID: 39470899BACKGROUND

  • 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.

    PMID: 42163052BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Julia EW Price, PhD

CONTACT

302-287-9391julia.price@nemours.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: This single site pilot implementation trial employs a roll-out design to test three toolkits: Basic Implementation Toolkit (BIT), Enhanced Toolkit (BIT-Enhanced), and Sustainment Toolkit (BIT-Sustainment).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist/Associate Professor

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 17, 2026

Study Start

August 26, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

De-identified questionnaire responses will be shared. De-identified qualitative data from semi-structured interviews may be shared under a data use agreement. Recordings of qualitative interviews will not be shared publicly due to the potential of voice identification of participants. Original data will be maintained on a secure drive at Nemours Children's Hospital, Delaware. Metadata that will be made accessible to facilitate interpretation of scientific data include study protocols, consent forms, interview scripts, codebooks, questionnaires, data dictionaries, analysis codes, and other supporting documentation. The data dictionaries will define and describe all variables in the dataset.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 3 months after the publication of results with no end date.
Access Criteria
Investigators who have interest in the data for research purposes may access the IPD and supporting information. De-identified questionnaire responses will be shared. De-identified qualitative data from semi-structured interviews may be shared under a data use agreement. Recordings of qualitative interviews will not be shared publicly due to the potential of voice identification of participants. Original data will be maintained on a secure drive at Nemours Children's Hospital, Delaware. Metadata that will be made accessible to facilitate interpretation of scientific data include study protocols, consent forms, interview scripts, codebooks, questionnaires, data dictionaries, analysis codes, and other supporting documentation. The data dictionaries will define and describe all variables in the dataset. De-identified data will be available through openICPSR.

Locations

US(1)