Shared Medical Decision Making in Pediatric Diabetes

Sponsor

Nemours Children's Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT02496156

Collaborator

Patient-Centered Outcomes Research Institute (Other)

153

Enrollment

Location

Arms

24.2

Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Mellitus	Behavioral: Usual Clinical Practice Behavioral: Shared Medical Decision Making	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

153 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Shared Medical Decision Making in Pediatric Diabetes

Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Feb 7, 2017

Actual Study Completion Date :

Feb 7, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Behavioral: Usual Clinical Practice Diabetes management and education related to insulin pump or continuous glucose monitor as currently practiced at the enrolling site.
Experimental: 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.	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.

Arm

Intervention/Treatment

Active Comparator: 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.

Behavioral: Usual Clinical Practice

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

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

Device utilization [1 year]
Downloaded data from insulin pump or continuous glucose monitor

Secondary Outcome Measures

Glycated hemoglobin (Hemoglobin A1C) [Quarterly for 1 year]
Glycated hemoglobin (Hemoglobin A1C)
Hypoglycemia Diary [Continuous for one year]
Frequency of severe and symptomatic hypoglycemic episodes
Decision quality [Quarterly for 1 year]
Questionnaires measuring decision making satisfaction and regret.
Knowledge of insulin pump or continuous glucose monitor [Baseline and 3 months later]
Brief test of parent and adolescent knowledge about the pertinent device and its use.
Diabetes Self Management Profile Self Report Form [Baseline and each 3 months throughout the study]
Measure of diabetes treatment adherence completed by parents and adolescents.

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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