Impact of Decision Aids to Enhance Shared Decision Making for Diabetes

Completed · Not applicable

Conditions studied: Diabetes

In brief

The proposed trial seeks to determine the impact of patient decision aids versus usual care on measures of patient involvement in decision-making, diabetes care processes, medication adherence, glycemic and cardiovascular risk factor control, and resource utilization in nonurban practices in the Midwestern United States. Upon completion of this trial, the investigators will have new knowledge about both the effectiveness of diabetes decision aids in nonacademic nonurban practices and about the processes that promote or inhibit the successful implementation of patient decision aids in such practices.

Key facts

Study ID

NCT01029288

Run by

Mayo Clinic

People needed

110

Starts

2010-04-01

Expected to finish

2013-01-01

Last updated by the study team

2016-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Primary care provider is participating in trial
• Are an adult (≥ 18 years) with type 2 diabetes
• English speaking
• Recognize their primary care provider as their main diabetes care provider
• Declare being available for follow-up for six months after treatment decision

You may not qualify if…

• Have major barriers to provide written informed consent and to participate in shared decision making (i.e., severe vision or hearing impairment, cognitive impairment, non-English speaking)
• Additional Inclusion Criteria for Diabetes Medication:
• Have a clinical diagnosis of type 2 diabetes for one year or more (c-peptide test is not required)
• Use 0, 1, or 2 oral hypoglycemic agents at maximum doses
• Have stable but inadequate glycemic control or worsening glycemic control as identified by their most recent HbA1c measure (within 12 months of the time of eligibility over 7.3%
• Be identified by provider as a medically-appropriate candidate for diabetes medications, (i.e., have not contraindications to taking the medications, e.g., allergy).
• Additional Exclusion Criteria for Diabetes Medication:
• Use insulin therapy.
• Additional Inclusion Criteria for Cardiovascular Medication:
• Have a clinical diagnosis of type 2 diabetes for any duration (c-peptide test is not required).
• Be identified by provider as a medically-appropriate candidate for statins, (i.e., have not contraindications to taking the medications, e.g., allergy).
• Additional Exclusion Criteria for Cardiovascular Medication:
• Use a statin currently.

Where it is running

• MCHS-Albert Lea — Albert Lea, Minnesota, United States
• MCHS-Austin — Austin, Minnesota, United States
• Mayo Family Clinic — Kasson, Minnesota, United States
• Olmsted Medical Center — Rochester, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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