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Impact of Decision Aids to Enhance Shared Decision Making for Diabetes (DAD)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Victor Montori, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01029288
First received: December 4, 2009
Last updated: August 29, 2013
Last verified: August 2013

December 4, 2009
August 29, 2013
April 2010
December 2012   (final data collection date for primary outcome measure)
Decisional quality (knowledge, decisional conflict, and satisfaction) [ Time Frame: Immediately (within 10 minutes) following clinical encounter, and 3- & 6-months post encounter ] [ Designated as safety issue: No ]
Decisional quality (knowledge, decisional conflict, and satisfaction) [ Time Frame: Immediately following clinical encounter, and 3- & 6-months post encounter ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01029288 on ClinicalTrials.gov Archive Site
  • Provider satisfaction [ Time Frame: Immediately following clinical encounter ] [ Designated as safety issue: No ]
  • Patient medication adherence [ Time Frame: 6-months following clinical encounter ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Impact of Decision Aids to Enhance Shared Decision Making for Diabetes
Impact of Decision Aids to Enhance Shared Decision Making for Diabetes

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Health Services Research
Diabetes
  • Other: Diabetes Medication Choice Decision Aid
    Diabetes Medication Choice cards
  • Other: Statin Choice Decision Aid
    Statin Choice Cards
  • Other: Usual care for lipid therapy medication
    Clinicians will follow their clinic's usual care practice for lipid therapy medication (statin) discussions.
  • Other: Usual care for antihyperglycemic medication
    Clinicians will follow their clinic's usual care practice for antihyperglycemic medication discussions.
  • Active Comparator: Statin Choice Decision Aid
    Subjects will receive an intervention of Statin Choice Decision Aid and usual care for antihyperglycemic medication discussion with their clinician.
    Interventions:
    • Other: Statin Choice Decision Aid
    • Other: Usual care for antihyperglycemic medication
  • Active Comparator: 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.
    Interventions:
    • Other: Diabetes Medication Choice Decision Aid
    • Other: Usual care for lipid therapy medication

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
January 2013
December 2012   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01029288
DK084009
Yes
Victor Montori, Mayo Clinic
Mayo Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Victor Montori, M.D., M.Sc. Mayo Clinic
Mayo Clinic
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP