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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Nilay D. Shah, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01293578
First received: February 1, 2011
Last updated: September 13, 2012
Last verified: September 2012
History of Changes
  Purpose

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)

Resource links provided by NLM:

U.S. FDA Resources

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.


Estimated Enrollment: 620
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: March 2014 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293578

Locations
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
Investigators
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
ClinicalTrials.gov Identifier: NCT01293578     History of Changes
Other Study ID Numbers: 10-006952
Study First Received: February 1, 2011
Last Updated: September 13, 2012
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
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013