Shared Medical Decision Making in Pediatric Diabetes

NCT ID: NCT02496156

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-02-07

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.

Detailed Description

Abstract (modified after achievement of Aims 1 and 2):

Treatment adherence in type 1 diabetes (T1D) tends to decline among adolescents, increasing risks of acute and chronic complications, excess health care use, poorer quality of life, and T1D-related family conflict. Poor adherence is associated with psychiatric and family dysfunction and often persists into early adulthood. Therapeutic advances such as continuous subcutaneous insulin infusion (CSII or "insulin pump") and continuous glucose monitoring (CGM) could improve metabolic control and quality of life.

But, teens often do not benefit fully from such advances. Many studies of adults show that patient-centered communication styles predict more favorable clinical outcomes. Shared medical decision making (SMDM) interventions have improved outcomes among adults with diabetes and other conditions. Research in pediatrics has also shown that patient-centered and family-centered communication styles predict favorable outcomes, but most of this research is in primary care and has not studied youth with chronic conditions. Since there have been no controlled trials of SMDM with chronically ill youths, we propose a randomized controlled trial of an SMDM intervention compared with Usual Clinical Practice (UCP). Qualitative interviews of youths and parents who have previously faced these decisions and reliance on expert consultants, pediatric endocrinologists and diabetes educators have preceded this trial and provided valued input for refining the planned intervention and adapting the structured SMDM format for pediatrics. Now, we will recruit and randomize 166 11-<17 year old youth with T1D who are candidates for CSII or CGM (and a parent/caregiver) at all Nemours sites. The SMDM intervention will be delivered via a web-based platform, facilitated by Diabetes Educators (DEs) at each site in a standardized, yet individually tailored format. SMDM will employ multimedia "decision aids" prepared with the award-winning Nemours Center for Children's Health Media and the "e-city interactive" web design firm in Philadelphia in accord with pertinent international standards. SMDM will also include individualized assistance from the DE in assuring that each youth's and parent's preferences, values and cultural beliefs are carefully addressed and communicated to the attending endocrinologist. After a baseline evaluation and randomization to SMDM or UCP, effects on the primary outcome (treatment adherence; device utilization) and secondary outcomes (glycemic control, treatment alliance, decision conflict and regret, treatment satisfaction, diabetes-related distress and self-efficacy) will be measured over 1 year. Mixed effects modeling will be the primary analytic technique for evaluating effects on primary/secondary outcomes, examining selected variables as moderators and mediators of treatment effects, and assessing whether such effects are comparable for the two medical decisions of interest. The results will verify whether SMDM in this context enhances treatment adherence, device use and parent/patient-reported outcomes in youth with T1D.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual Clinical Practice (UCP)

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.

Group Type: ACTIVE_COMPARATOR

Usual Clinical Practice

Intervention Type: BEHAVIORAL

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

Shared Medical Decision Making (SMDM)

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.

Group Type: EXPERIMENTAL

Shared Medical Decision Making

Intervention Type: 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.

Interventions

Usual Clinical Practice

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

Intervention Type: BEHAVIORAL

Shared Medical Decision Making

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Nemours Children's Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tim Wysocki, PhD

Role: PRINCIPAL_INVESTIGATOR

Nemours Biomedical Research

Locations

Nemours Children's Clinic

Jacksonville, Florida, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 27150606 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

PCORI 805

Identifier Type: -

Identifier Source: org_study_id