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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01293578
Recruitment Status : Completed
First Posted : February 10, 2011
Last Update Posted : September 28, 2022
Sponsor:
Information provided by (Responsible Party):
Victor Montori, Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Other: Diabetes Medication Choice Cards Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 550 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Victor Montori, MD Mayo Clinic
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Victor Montori, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01293578    
Other Study ID Numbers: 10-006952
First Posted: February 10, 2011    Key Record Dates
Last Update Posted: September 28, 2022
Last Verified: September 2022
Keywords provided by Victor Montori, Mayo Clinic:
Decision Aids
Shared Medical Decision Making
Patient Education
 Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases