Study to Test Use of a Decision Aid in a Clinical Visit to Help Patients Choose a Diabetes Medication (TRICEP)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Translating Information on Comparative Effectiveness Into Practice (TRICEP)|
- Patient Satisfaction and knowledge [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]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).
- Physician adoption and satisfaction with the decision aid. [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]Brief post-visit surveys will be completed by the clinicians, directly following clinical visit.
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
No Intervention: Usual Care
Clinicians will present diabetes medication options to patients, in their usual way.
Experimental: Diabetes Medication Decision Aid
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.
Other: Diabetes 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293578
|United States, Minnesota|
|Albert Lea Medical Center|
|Albert Lea, Minnesota, United States, 56007|
|Mayo Clinic Kasson|
|Kasson, Minnesota, United States, 55944|
|Mayo Clinic Health System- Immanual St. Joseph's|
|Mankato, Minnesota, United States, 56002|
|Hennepin County Medical Center|
|Minneapolis, Minnesota, United States, 55415|
|Park Nicollet Institute|
|St. Louis Park, Minnesota, United States, 55416|
|United States, Wisconsin|
|Mayo Clinic Health System-Franciscan Healthcare|
|La Crosse, Wisconsin, United States, 54601|
|Principal Investigator:||Nilay Shah, PhD||Mayo Clinic|