Impact of Decision Aids to Enhance Shared Decision Making for Diabetes

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Other: Diabetes Medication Choice Decision Aid; Other: Statin Choice Decision Aid; Other: Usual care for lipid therapy medication; Other: Usual care for antihyperglycemic medication

• Registration Number: NCT01029288
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Type 2 diabetes causes loss of quality and diminished duration of life for over 24 million Americans with great costs and heavy burden of treatment for both society and for affected families. Decision aids are tools that help clinicians involve patients in making deliberate choices by providing accessible information about the options available and their outcomes. We propose to conduct a cluster randomized trial to obtain an estimate of 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.

Participating clinicians will be trained to use decision aid tools to discuss starting either new diabetes medications or new statins with their enrolled patients. Surveys completed by clinicians and patients will assess satisfaction with decision making and knowledge gained by patients. 3- and 6-month follow-up surveys completed by patients will assess adherence to chosen medications and sustained knowledge. Primary analysis will be conducted utilizing generalized linear models. Some visits will be video and/or audio recorded with permission, and a small subset of patients, clinicians, and support staff will be interviewed by an experienced qualitative researcher using a semi-structured interview guide.

Primary care practices were enrolled then matched by size (less than or equal to 2 clinicians or greater than 2 clinicians) and randomly allocated by a statistician to 1) the use of the Diabetes Medication Choice decision aid and usual care for lipid therapy medication (statin) discussion during the encounter with subjects or to 2) the use of the Statin Choice decision aid and usual care for antihyperglycemic mediations discussion during the encounter with subjects.

Study Timeline

• Study First Submitted: 2009-12-04
• Study First Submitted QC: 2009-12-07
• Study First Posted: 2009-12-09
• Study Start: 2010-04
• Primary Completion: 2012-12
• Study Completion: 2013-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-01
• Last Update Posted: 2016-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• 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

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetes Medication Choice Decision Aid	Diabetes Medication Choice Decision Aid	Subjects will receive an intervention of Diabetes Medication Choice Decision Aid and usual care for lipid therapy medication discussion with their clinician.
Statin Choice Decision Aid	Statin Choice Decision Aid	Subjects will receive an intervention of Statin Choice Decision Aid and usual care for antihyperglycemic medication discussion with their clinician.
Diabetes Medication Choice Decision Aid	Usual care for lipid therapy medication	Subjects will receive an intervention of Diabetes Medication Choice Decision Aid and usual care for lipid therapy medication discussion with their clinician.
Statin Choice Decision Aid	Usual care for antihyperglycemic medication	Subjects will receive an intervention of Statin Choice Decision Aid and usual care for antihyperglycemic medication discussion with their clinician.

Primary Outcome Measures

Name	Time	Method
Decisional quality (knowledge, decisional conflict, and satisfaction)	Immediately (within 10 minutes) following clinical encounter, and 3- & 6-months post encounter

Secondary Outcome Measures

Name	Time	Method
Patient medication adherence	6-months following clinical encounter
Provider satisfaction	Immediately following clinical encounter

Trial Locations

Locations (5)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Olmsted Medical Center; 🇺🇸 Rochester, Minnesota, United States

MCHS-Austin; 🇺🇸 Austin, Minnesota, United States

MCHS-Albert Lea; 🇺🇸 Albert Lea, Minnesota, United States

Mayo Family Clinic; 🇺🇸 Kasson, Minnesota, United States