Diabetes Clinical Trial
Official title:
Impact of Decision Aids to Enhance Shared Decision Making for Diabetes
The proposed trial seeks to determine the impact of patient decision aids versus usual care on measures of patient involvement in decision-making, diabetes care processes, medication adherence, glycemic and cardiovascular risk factor control, and resource utilization in nonurban practices in the Midwestern United States. Upon completion of this trial, the investigators will have new knowledge about both the effectiveness of diabetes decision aids in nonacademic nonurban practices and about the processes that promote or inhibit the successful implementation of patient decision aids in such practices.
Type 2 diabetes causes loss of quality and diminished duration of life for over 24 million
Americans with great costs and heavy burden of treatment for both society and for affected
families. Decision aids are tools that help clinicians involve patients in making deliberate
choices by providing accessible information about the options available and their outcomes.
We propose to conduct a cluster randomized trial to obtain an estimate of the impact of
patient decision aids versus usual care on measures of patient involvement in decision
making, diabetes care processes, medication adherence, glycemic and cardiovascular risk
factor control, and resource utilization.
Participating clinicians will be trained to use decision aid tools to discuss starting
either new diabetes medications or new statins with their enrolled patients. Surveys
completed by clinicians and patients will assess satisfaction with decision making and
knowledge gained by patients. 3- and 6-month follow-up surveys completed by patients will
assess adherence to chosen medications and sustained knowledge. Primary analysis will be
conducted utilizing generalized linear models. Some visits will be video and/or audio
recorded with permission, and a small subset of patients, clinicians, and support staff will
be interviewed by an experienced qualitative researcher using a semi-structured interview
guide.
Primary care practices were enrolled then matched by size (less than or equal to 2
clinicians or greater than 2 clinicians) and randomly allocated by a statistician to 1) the
use of the Diabetes Medication Choice decision aid and usual care for lipid therapy
medication (statin) discussion during the encounter with subjects or to 2) the use of the
Statin Choice decision aid and usual care for antihyperglycemic mediations discussion during
the encounter with subjects.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Health Services Research
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