Shared Medical Decision Making in Pediatric Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 11 - 17 |
| Updated: | 2/10/2017 |
| Start Date: | February 2015 |
| End Date: | February 7, 2017 |
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.
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.
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.
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.
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
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