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

This study has been completed.
Information provided by (Responsible Party):
Nilay D. Shah, Mayo Clinic Identifier:
First received: February 1, 2011
Last updated: June 10, 2015
Last verified: June 2015

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 Intervention
Type 2 Diabetes Mellitus
Other: Diabetes Medication Choice Cards

Study Type: Interventional
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)

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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).

Secondary Outcome Measures:
  • 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.

Enrollment: 550
Study Start Date: January 2011
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its 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
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Nilay Shah, PhD Mayo Clinic
  More Information

No publications provided

Responsible Party: Nilay D. Shah, Assistant Professor of Health Services Research, Mayo Clinic Identifier: NCT01293578     History of Changes
Other Study ID Numbers: 10-006952
Study First Received: February 1, 2011
Last Updated: June 10, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Decision Aids
Shared Medical Decision Making
Patient Education
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases processed this record on October 06, 2015