Study to Test Use of a Decision Aid in a Clinical Visit to Help Patients Choose a Diabetes Medication
TRICEP
Translating Information on Comparative Effectiveness Into Practice (TRICEP)
1 other identifier
interventional
550
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes-mellitus
Started Jan 2011
Longer than P75 for not_applicable type-2-diabetes-mellitus
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 1, 2011
CompletedFirst Posted
Study publicly available on registry
February 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedSeptember 28, 2022
September 1, 2022
4.4 years
February 1, 2011
September 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Satisfaction and knowledge
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).
baseline to 12 months
Secondary Outcomes (1)
Physician adoption and satisfaction with the decision aid.
baseline to 12 months
Study Arms (2)
Usual Care
NO INTERVENTIONClinicians will present diabetes medication options to patients, in their usual way.
Diabetes Medication Decision Aid
EXPERIMENTALIn the decision aid arm, clinicians will use the diabetes medication decision aid cards (if they choose) when discussing diabetes medication options with their patients.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (6)
Albert Lea Medical Center
Albert Lea, Minnesota, 56007, United States
Mayo Clinic Kasson
Kasson, Minnesota, 55944, United States
Mayo Clinic Health System- Immanual St. Joseph's
Mankato, Minnesota, 56002, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Park Nicollet Institute
Saint Louis Park, Minnesota, 55416, United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601, United States
Related Publications (2)
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.
PMID: 34499328RESULTMontori VM, Ruissen MM, Branda ME, Hargraves IG, Kunneman M. Problem-based shared decision making: The role of canonical SDM steps. Health Expect. 2023 Feb;26(1):282-289. doi: 10.1111/hex.13654. Epub 2022 Nov 29.
PMID: 36448245DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Victor Montori, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 1, 2011
First Posted
February 10, 2011
Study Start
January 1, 2011
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
September 28, 2022
Record last verified: 2022-09