Study to Test Use of a Decision Aid in a Clinical Visit to Help Patients Choose a Diabetes Medication (TRICEP)
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|ClinicalTrials.gov Identifier: NCT01293578|
Recruitment Status : Completed
First Posted : February 10, 2011
Last Update Posted : September 28, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Other: Diabetes Medication Choice Cards||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||550 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Translating Information on Comparative Effectiveness Into Practice (TRICEP)|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
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.
- Patient Satisfaction and knowledge [ Time Frame: 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).
- Physician adoption and satisfaction with the decision aid. [ Time Frame: baseline to 12 months ]Brief post-visit surveys will be completed by the clinicians, directly following clinical visit.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Saint Louis Park, Minnesota, United States, 55416|
|United States, Wisconsin|
|Mayo Clinic Health System-Franciscan Healthcare|
|La Crosse, Wisconsin, United States, 54601|
|Principal Investigator:||Victor Montori, MD||Mayo Clinic|
Publications of Results:
|Responsible Party:||Victor Montori, Principal Investigator, Mayo Clinic|
|Other Study ID Numbers:||
|First Posted:||February 10, 2011 Key Record Dates|
|Last Update Posted:||September 28, 2022|
|Last Verified:||September 2022|
Shared Medical Decision Making
Endocrine System Diseases
Glucose Metabolism Disorders
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases