Diabetes
Conditions
Keywords
Diabetes, Decision aid, Cardiovascular risk, Patient education
Brief summary
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.
Detailed description
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.
Interventions
Diabetes Medication Choice cards
Statin Choice Cards
OTHERUsual care for lipid therapy medication
Clinicians will follow their clinic's usual care practice for lipid therapy medication (statin) discussions.
OTHERUsual care for antihyperglycemic medication
Clinicians will follow their clinic's usual care practice for antihyperglycemic medication discussions.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decisional quality (knowledge, decisional conflict, and satisfaction) | Immediately (within 10 minutes) following clinical encounter, and 3- & 6-months post encounter |
Secondary
| Measure | Time frame |
|---|---|
| Provider satisfaction | Immediately following clinical encounter |
| Patient medication adherence | 6-months following clinical encounter |
Countries
United States
Outcome results
None listed