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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

Tracking Information
First Submitted Date  ICMJE February 1, 2011
First Posted Date  ICMJE February 10, 2011
Last Update Posted Date September 28, 2022
Study Start Date  ICMJE January 2011
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2012)		 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).
Original Primary Outcome Measures  ICMJE
 (submitted: February 9, 2011)		 Patient Satisfaction and knowledge [ Time Frame: up 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 and 2 months, 6 months and 12 months).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2012)		 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2011)		 Physician adoption and satisfaction with the decision aid. [ Time Frame: up to 12 months ]
Brief post-visit surveys will be completed by the clinicians, directly following clinical visit.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Test Use of a Decision Aid in a Clinical Visit to Help Patients Choose a Diabetes Medication
Official Title  ICMJE Translating Information on Comparative Effectiveness Into Practice (TRICEP)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Diabetes Medication Choice Cards
Publications * Kunneman M, Branda ME, Ridgeway JL, Tiedje K, May CR, Linzer M, Inselman J, Buffington ALH, Coffey J, Boehm D, Deming J, Dick S, van Houten H, LeBlanc A, Liesinger J, Lima J, Nordeen J, Pencille L, Poplau S, Reed S, Vannelli A, Yost KJ, Ziegenfuss JY, Smith SA, Montori VM, Shah ND. Making sense of diabetes medication decisions: a mixed methods cluster randomized trial using a conversation aid intervention. Endocrine. 2022 Feb;75(2):377-391. doi: 10.1007/s12020-021-02861-4. Epub 2021 Sep 9. Erratum In: Endocrine. 2023 Jan;79(1):221-222.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2015)		 550
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2011)		 620
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01293578
Other Study ID Numbers  ICMJE 10-006952
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Victor Montori, Mayo Clinic
Original Responsible Party Nilay Shah, PhD, Mayo Clinic
Current Study Sponsor  ICMJE Mayo Clinic
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Victor Montori, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP