Clinical trial NCT01293578: Study to Test Use of a Decision Aid in a Clinical Visit to Help Patients Choose a Diabetes Medication
Official title: Translating Information on Comparative Effectiveness Into Practice (TRICEP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Decision Aids
Shared Medical Decision Making
Patient Education
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-02-10
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Patient Satisfaction and knowledge
timeFrame: baseline to 12 months
Secondary outcomes:
measure: Physician adoption and satisfaction with the decision aid.
timeFrame: baseline to 12 months
Other outcomes:
Locations:
city: Albert Lea
country: United States
facility: Albert Lea Medical Center
state: Minnesota
city: Kasson
country: United States
facility: Mayo Clinic Kasson
state: Minnesota
city: Mankato
country: United States
facility: Mayo Clinic Health System- Immanual St. Joseph's
state: Minnesota
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet Institute
state: Minnesota
city: La Crosse
country: United States
facility: Mayo Clinic Health System-Franciscan Healthcare
state: Wisconsin
Study officials:
affiliation: Mayo Clinic
name: Victor Montori, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.