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

Type 2 Diabetes Mellitus Clinical Trial

— TRICEP  

Official title:

Translating Information on Comparative Effectiveness Into Practice (TRICEP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293578
• Other study ID #: 10-006952
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: June 2015

Study information

• Verified date: September 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	Albert Lea Medical Center	Albert Lea	Minnesota
United States	Mayo Clinic Kasson	Kasson	Minnesota
United States	Mayo Clinic Health System-Franciscan Healthcare	La Crosse	Wisconsin
United States	Mayo Clinic Health System- Immanual St. Joseph's	Mankato	Minnesota
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Park Nicollet Institute	Saint Louis Park	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

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, Smi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Physician adoption and satisfaction with the decision aid.	Brief post-visit surveys will be completed by the clinicians, directly following clinical visit.	baseline to 12 months

External Links

•   Mayo Clinic Clinical Trials