Shared Medical Decision Making in Pediatric Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

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.
    

Intervention name(s): Usual Clinical Practice; Shared Medical Decision Making
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Diabetes management and education related to insulin pump or continuous glucose monitor as currently practiced at the enrolling site.; 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.
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.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: type 1 diabetes mellitus; adolescence; adherence; insulin pump; continuous subcutaneous insulin infusion; continuous glucose monitor; shared medical decision making