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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Victor Montori, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01029288
First received: December 4, 2009
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  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 Midwestern US. 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 decision aids
Other: Cardiovascular decision aids

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:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

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: CV risk decision aid clinic
Decision Aid Intervention vs. Usual Care
 Other: Cardiovascular decision aids
Statin Choice
Active Comparator: Diabetes Decision Aid Clinic
Decision Aid Intervention vs. Usual Care
 Other: Diabetes decision aids
Diabetes Choice cards

  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
  • Have signed research authorization
  • Are an adult (≥ 18 years) with type 2 diabetes
  • 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:

  • Do not 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)
  Contacts and Locations
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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Victor Montori, M.D., M.Sc. Mayo Clinic
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

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: May 14, 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

ClinicalTrials.gov processed this record on May 21, 2013