Diabetes Clinical Trial
— DADOfficial title:
Impact of Decision Aids to Enhance Shared Decision Making for Diabetes
Verified date | February 2016 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 110 |
Est. completion date | January 2013 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Primary care provider is participating in trial - Are an adult (= 18 years) with type 2 diabetes - English speaking - Recognize their primary care provider as their main diabetes care provider - Declare being available for follow-up for six months after treatment decision Exclusion Criteria: - Have major barriers to provide written informed consent and to participate in shared decision making (i.e., severe vision or hearing impairment, cognitive impairment, non-English speaking) Additional Inclusion Criteria for Diabetes Medication: - Have a clinical diagnosis of type 2 diabetes for one year or more (c-peptide test is not required) - Use 0, 1, or 2 oral hypoglycemic agents at maximum doses - Have stable but inadequate glycemic control or worsening glycemic control as identified by their most recent HbA1c measure (within 12 months of the time of eligibility over 7.3% - Be identified by provider as a medically-appropriate candidate for diabetes medications, (i.e., have not contraindications to taking the medications, e.g., allergy). Additional Exclusion Criteria for Diabetes Medication: - Use insulin therapy. Additional Inclusion Criteria for Cardiovascular Medication: - Have a clinical diagnosis of type 2 diabetes for any duration (c-peptide test is not required). - Be identified by provider as a medically-appropriate candidate for statins, (i.e., have not contraindications to taking the medications, e.g., allergy). Additional Exclusion Criteria for Cardiovascular Medication: - Use a statin currently. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United States | MCHS-Albert Lea | Albert Lea | Minnesota |
United States | MCHS-Austin | Austin | Minnesota |
United States | Mayo Family Clinic | Kasson | Minnesota |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Olmsted Medical Center | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Branda ME, LeBlanc A, Shah ND, Tiedje K, Ruud K, Van Houten H, Pencille L, Kurland M, Yawn B, Montori VM. Shared decision making for patients with type 2 diabetes: a randomized trial in primary care. BMC Health Serv Res. 2013 Aug 8;13:301. doi: 10.1186/14 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decisional quality (knowledge, decisional conflict, and satisfaction) | Immediately (within 10 minutes) following clinical encounter, and 3- & 6-months post encounter | No | |
Secondary | Provider satisfaction | Immediately following clinical encounter | No | |
Secondary | Patient medication adherence | 6-months following clinical encounter | No |
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