Shared Medical Decision Making in Pediatric Diabetes

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Shared Medical Decision Making in Pediatric Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02496156
• Other study ID #: PCORI 805
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: February 7, 2017

Study information

• Verified date: May 2023
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: February 7, 2017
• Est. primary completion date: February 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Behavioral:
• Usual Clinical Practice
Diabetes management and education related to insulin pump or continuous glucose monitor as currently practiced at the enrolling site.
• 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.

Locations

Country	Name	City	State
United States	Nemours Children's Clinic	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Nemours Children's Clinic	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Glycated Hemoglobin (Hemoglobin A1C)	Glycated hemoglobin (Hemoglobin A1C) expressed as the percentage of hemoglobin molecules that are bound to glucose. Normal range is approximately 4.5% to 6.5%, Higher values indicate a higher blood glucose concentration over the preceding 2-3 months.	Every 3 months for for 1 year
Secondary	Decision Regret Scale	Questionnaire measuring decision making regret. Reflecting on a specific decision (accept or decline opportunity to use CGM or insulin pump), higher score reflect a greater degree of regret regarding the decision that was made. Scores may range from 5 to 20.	Obtained at Visits 3 and 5 only
Secondary	Knowledge of Insulin Pump or Continuous Glucose Monitor	Brief test of parent and adolescent knowledge about the pertinent device and its use. Higher scores reflect more precise knowledge about the diabetes device of interest. Scores may range from 1 to 5.	Baseline and 3 months later
Secondary	Diabetes Self Management Profile Self Report Form	Composite measure of diabetes treatment adherence consisting of combined scores based on reports of parents and adolescents. Higher scores reflect more meticulous adherence to recommended diabetes self management behaviors. Scores may range from 0 to 86.	Visits 1, 3 and 5
Secondary	SURE Test	4-item questionnaire that measures patients' confidence in a health care decision that has been made. Scores may range from 0-4 with higher scores reflecting greater confidence in the decision made regarding insulin pump or CGM.	Measured at Follow-up Visits 3 and 5 only