Study to Test Use of a Decision Aid in a Clinical Visit to Help Patients Choose a Diabetes Medication (TRICEP)

Mayo Clinic

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Other: Diabetes Medication Choice Cards

Study type: Interventional

Funder types: Other

Identifiers

NCT01293578

10-006952

Details and patient eligibility

About

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.

Full 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.

Enrollment: 550 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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550 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Clinicians will present diabetes medication options to patients, in their usual way.

Diabetes Medication Decision Aid

Experimental group

Description:

In the decision aid arm, clinicians will use the diabetes medication decision aid cards (if they choose) when discussing diabetes medication options with their patients.

Treatment:

Other: Diabetes Medication Choice Cards