Type 2 Diabetes Mellitus
Conditions
Keywords
Decision Aids, Shared Medical Decision Making, Patient Education, Endocrine System Diseases, Glucose Metabolism Disorders, Metabolic Diseases
Brief summary
The goal of this study is to test the relative merits of a decision aid for diabetes medications that we have developed - Diabetes Medication Choice Cards- versus usual care in translating comparative effectiveness research (CER) into real world clinics. This study will involve about 20 primary care practice sites affiliated with Mayo Health System, Park Nicollet, or Hennepin County Medical Center. There will be no recruiting done at the Mayo Clinic.
Detailed description
To conduct a cluster-randomized practical trial to evaluate the impact of our decision aid (Diabetes Medication Choice Cards) versus usual care as strategies to translate CER into practice among patients with poorly controlled diabetes in need of drug intensification (Hemoglobin Alc (HbA1c) \> 7.3%). Patient outcomes including reaching glycemic control target (HbA1c less than or equal to 7.3%), medication choice and adherence, satisfaction and knowledge. From the physician perspective, we will be measuring physician adoption and satisfaction with the decision aid. To identify, describe, and explain factors that promote or inhibit the uptake of complex interventions such as decision aids in practices participating in the trial. To conduct an exploratory analysis of the ability of patients to adhere to the medications chosen while exploring the factors that enable or hinder the patients' ability to incorporate these medications into their routine.
Interventions
OTHERDiabetes Medication Choice Cards
Clinician uses the Diabetes Medication Choice Cards to inform and engage patient in discussing the issues they find relevant in choosing a new diabetes medication.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age and older * Have a diagnosis of Type 2 diabetes mellitus and on diabetes medication * Have a diagnosis of Type 2 diabetes mellitus for 1 year or more if not currently on diabetes medication * Recognize their primary care provider as their main diabetes care provider * Use 0, 1, 2, or 3 oral hypoglycemic agents * Have a recent HbA1c measure (within 12 months) of greater than 7.3, with priority to patients with rising HbA1c levels.
Exclusion criteria
* Not available for follow-up for 12 months after study visit. * Unable to read and speak English. * Has major barriers to providing written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction and knowledge | baseline to 12 months | Primary outcome is to evaluate the impact of our decision aid (Diabetes Medication Choice Cards) versus usual care as strategies to translate CER into practice among patients with poorly controlled diabetes in need of drug intensification (Hemoglobin A1c (HbA1c) \> 7.3%). Patient outcomes include satisfaction with use of the decision aid and knowledge, compared to the control, usual care group (by written survey at point of care and follow-up). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician adoption and satisfaction with the decision aid. | baseline to 12 months | Brief post-visit surveys will be completed by the clinicians, directly following clinical visit. |
Countries
United States
Outcome results
None listed