Shared Medical Decision Making in Pediatric Diabetes

NCT02496156 | Completed Results

• 1 other identifier: PCORI 805
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

This work is testing a shared medical decision making intervention for adolescents with type 1 diabetes and their parents who are candidates for adding either an insulin pump or continuous glucose monitor to their treatment plan. The first half of the work consisted of the stakeholder driven design, construction and refinement of web-delivered multimedia decision aids for each of these decisions. The randomized controlled trial of that intervention began enroling participants in February 2015. A sample of 166 eligible adolescents who receive care at an operating entity of the Nemours Children's Health System will be enrolled and randomized to either Usual Clinical Practice alone or augmented by the Shared Medical Decision Making intervention. Primary outcomes include measures of engagement with the pertinent technology if it is chosen and measures of decision quality; Secondary outcomes include indices of metabolic control, quality of life and parent-adolescent relationships around diabetes management.

Conditions

Type 1 Diabetes Mellitus

Keywords

type 1 diabetes mellitus; adolescence; adherence; insulin pump; continuous subcutaneous insulin infusion; continuous glucose monitor; shared medical decision making

Outcome Measures

Primary Outcomes (1)

• Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile

  Adolescent and Parent report regarding degree to which use of the device of interest has become an integral part of the adolescent's daily diabetes self management. Scores may range from 10 to 50, with higher scores reflecting more frequent and meticulous use of the diabetes device of interest.

  Measure was collected at each study visit after the participant actually obtained a CGM or Insulin Pump

Secondary Outcomes (5)

• Glycated Hemoglobin (Hemoglobin A1C)

  Every 3 months for for 1 year

• Decision Regret Scale

  Obtained at Visits 3 and 5 only

• Knowledge of Insulin Pump or Continuous Glucose Monitor

  Baseline and 3 months later

• Diabetes Self Management Profile Self Report Form

  Visits 1, 3 and 5

• SURE Test

  Measured at Follow-up Visits 3 and 5 only

Study Arms (2)

Usual Clinical Practice (UCP)

ACTIVE COMPARATOR

UCP participants will receive the same clinical and educational management for candidates for insulin pump or continuous glucose monitoring that is received by similar patients who are not enrolled in this study. The respective endocrinology practices at the enrolling sites all strive to meet or exceed the current American Diabetes Association Standards for Clinical Practice in the management of type 1 diabetes in this population. Thorough patient education is the cornerstone of that care, especially regarding the incorporation of insulin pumps and continuous glucose monitors into the treatment regimen for a given patient.

Behavioral: Usual Clinical Practice

Shared Medical Decision Making (SMDM)

EXPERIMENTAL

Participants randomized to SMDM receive all components of UCP supplemented with access to the decision aid website pertinent to the medical decision of interest (pump or CGM). Adolescents and parents will receive password-protected, secure access to the decision for their use until a decision is reached. The platform will then generate a summary report that the adolescent and parent will discuss with a diabetes nurse and then a visit with the treating endocrinologist will be scheduled to conclude the SMDM intervention for that adolescent and parent.

Behavioral: Shared Medical Decision Making

Interventions

Usual Clinical Practice BEHAVIORAL

Diabetes management and education related to insulin pump or continuous glucose monitor as currently practiced at the enrolling site.

Usual Clinical Practice (UCP)

Shared Medical Decision Making BEHAVIORAL

Access to and use of multimedia decision aid websites to facilitate adolescent and parent decision making about incorporating these devices into the diabetes management regimen.

Shared Medical Decision Making (SMDM)

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Type 1 diabetes for 1 year or more
• At least 2 diabetes clinic visits at the enrolling site in the prior year
• Considered by treating endocrinologist to be a candidate for insulin pump or continuous glucose monitor
• Intent to continue care at Nemours for 1 year
• Internet access at home, school, work or relative's home

You may not qualify if:

• Open case with child protection agency
• Unable to read and speak English

Sponsors & Collaborators

• Nemours Children's Clinic: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Related Publications (1)

• Wysocki T, Hirschfeld F, Miller L, Izenberg N, Dowshen SA, Taylor A, Milkes A, Shinseki MT, Bejarano C, Kozikowski C, Kowal K, Starr-Ashton P, Ross JL, Kummer M, Carakushansky M, Lyness D, Brinkman W, Pierce J, Fiks A, Christofferson J, Rafalko J, Lawson ML. Consideration of Insulin Pumps or Continuous Glucose Monitors by Adolescents With Type 1 Diabetes and Their Parents: Stakeholder Engagement in the Design of Web-Based Decision Aids. Diabetes Educ. 2016 Aug;42(4):395-407. doi: 10.1177/0145721716647492. Epub 2016 May 4.

  PMID: 27150606 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

A small percentage of all adolescents entering the study actually proceeded to acquire an insulin pump or continuous glucose monitor during the study period, impeding analyses of the effects of the SDM intervention on scores on the CGM Use Profile

Results Point of Contact

• Title: Vicky Funanage, PhD, Operational Vice President for Research
• Organization: Nemours Children's Health System

vfunanag@nemours.org

302-651-6819

Study Officials

• Tim Wysocki, PhD

  Nemours Biomedical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 group (Usual Clinical Practice or Shared Medical Decision Making X 5 time points (0, 3, 6, 9 and 12 months) repeated measures randomized treatments design.

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: July 14, 2015
• Study Start: February 1, 2015
• Primary Completion: February 7, 2017
• Study Completion: February 7, 2017
• Last Updated: February 1, 2024
• Results First Posted: February 1, 2024

Record last verified: 2023-05

Locations

US (1)