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
  Purpose

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.


Condition Intervention
Diabetes
Other: Diabetes Medication Choice Decision Aid
Other: Statin Choice Decision Aid
Other: Usual care for lipid therapy medication
Other: Usual care for antihyperglycemic medication

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Impact of Decision Aids to Enhance Shared Decision Making for Diabetes

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 110
Study Start Date: April 2010
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Statin Choice Decision Aid
Statin Choice Cards
Other: Usual care for antihyperglycemic medication
Clinicians will follow their clinic's usual care practice for antihyperglycemic medication discussions.
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.
Other: Diabetes Medication Choice Decision Aid
Diabetes Medication Choice cards
Other: Usual care for lipid therapy medication
Clinicians will follow their clinic's usual care practice for lipid therapy medication (statin) discussions.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029288

Locations
United States, Minnesota
MCHS-Albert Lea
Albert Lea, Minnesota, United States, 56007
MCHS-Austin
Austin, Minnesota, United States, 55912
Mayo Family Clinic
Kasson, Minnesota, United States, 55944
Olmsted Medical Center
Rochester, Minnesota, United States, 55904
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Victor Montori, M.D., M.Sc. Mayo Clinic
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Victor Montori, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01029288     History of Changes
Other Study ID Numbers: DK084009
Study First Received: December 4, 2009
Last Updated: August 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Diabetes
Decision aid
Cardiovascular risk
Patient education

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Physiological Effects of Drugs
Pharmacologic Actions
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014