Impact of Decision Aids to Enhance Shared Decision Making for Diabetes

Diabetes Clinical Trial

— DAD  

Official title:

Impact of Decision Aids to Enhance Shared Decision Making for Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01029288
• Other study ID #: DK084009
• Status: Completed
• Phase: N/A
• First received: December 4, 2009
• Last updated: February 1, 2016
• Start date: April 2010
• Est. completion date: January 2013

Study information

• Verified date: February 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes

Intervention

Other:
• Diabetes Medication Choice Decision Aid
Diabetes Medication Choice cards
• Statin Choice Decision Aid
Statin Choice Cards
• Usual care for lipid therapy medication
Clinicians will follow their clinic's usual care practice for lipid therapy medication (statin) discussions.
• Usual care for antihyperglycemic medication
Clinicians will follow their clinic's usual care practice for antihyperglycemic medication discussions.

Locations

Country	Name	City	State
United States	MCHS-Albert Lea	Albert Lea	Minnesota
United States	MCHS-Austin	Austin	Minnesota
United States	Mayo Family Clinic	Kasson	Minnesota
United States	Mayo Clinic	Rochester	Minnesota
United States	Olmsted Medical Center	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Branda ME, LeBlanc A, Shah ND, Tiedje K, Ruud K, Van Houten H, Pencille L, Kurland M, Yawn B, Montori VM. Shared decision making for patients with type 2 diabetes: a randomized trial in primary care. BMC Health Serv Res. 2013 Aug 8;13:301. doi: 10.1186/14 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decisional quality (knowledge, decisional conflict, and satisfaction)		Immediately (within 10 minutes) following clinical encounter, and 3- & 6-months post encounter	No
Secondary	Provider satisfaction		Immediately following clinical encounter	No
Secondary	Patient medication adherence		6-months following clinical encounter	No

External Links

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