Impact of Decision Aids to Enhance Shared Decision Making for Diabetes (DAD)
|ClinicalTrials.gov Identifier: NCT01029288|
Recruitment Status : Completed
First Posted : December 9, 2009
Last Update Posted : February 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Other: Diabetes Medication Choice Decision Aid Other: Statin Choice Decision Aid Other: Usual care for lipid therapy medication Other: Usual care for antihyperglycemic medication||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Impact of Decision Aids to Enhance Shared Decision Making for Diabetes|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||January 2013|
Active Comparator: Statin Choice Decision Aid
Subjects will receive an intervention of Statin Choice Decision Aid and usual care for antihyperglycemic medication discussion with their clinician.
Other: Statin Choice Decision Aid
Statin Choice CardsOther: Usual care for antihyperglycemic medication
Clinicians will follow their clinic's usual care practice for antihyperglycemic medication discussions.
Active Comparator: Diabetes Medication Choice Decision Aid
Subjects will receive an intervention of Diabetes Medication Choice Decision Aid and usual care for lipid therapy medication discussion with their clinician.
Other: Diabetes Medication Choice Decision Aid
Diabetes Medication Choice cardsOther: Usual care for lipid therapy medication
Clinicians will follow their clinic's usual care practice for lipid therapy medication (statin) discussions.
- Decisional quality (knowledge, decisional conflict, and satisfaction) [ Time Frame: Immediately (within 10 minutes) following clinical encounter, and 3- & 6-months post encounter ]
- Provider satisfaction [ Time Frame: Immediately following clinical encounter ]
- Patient medication adherence [ Time Frame: 6-months following clinical encounter ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029288
|United States, Minnesota|
|Albert Lea, Minnesota, United States, 56007|
|Austin, Minnesota, United States, 55912|
|Mayo Family Clinic|
|Kasson, Minnesota, United States, 55944|
|Olmsted Medical Center|
|Rochester, Minnesota, United States, 55904|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Victor Montori, M.D., M.Sc.||Mayo Clinic|