Skip to main content
OpenTrials
Completed

NCT Number: NCT01293578

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Albert Lea Medical Center, Albert Lea, Minnesota, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diabetes Medication Choice Cards

Other

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Translating Information on Comparative Effectiveness Into Practice (TRICEP)

Acronym: TRICEP

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Feb 10, 2011
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.