A Study of the Impact of Decision Aids to Enhance Shared Decision Making for Diabetes

Overview

About this study

The purpose of this study is to determine the impact of patient decision aids compared to usual care on measures of patient involvement in decision-making, diabetes care processes, medication adherence, glycemic and cardiovascular risk factor control, and use of resources in nonurban practices in the Midwestern United States.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Primary care provider is participating in trial
  • Adult, ≥ 18 years
  • Has type 2 diabetes
  • English speaking
  • Recognize primary care provider as main diabetes care provider
  • Can state is available for follow-up for six months after treatment decision
  • Specific for diabetes medication
    • 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
    • Stable but inadequate glycemic control or worsening glycemic control as identified by most recent HbA1c measure over 7.3% within 12 months of the time of eligibility 
    • Identified by provider as a medically-appropriate candidate for diabetes medications, (i.e. no contraindications to taking the medications, e.g., allergy)
  • Specific for cardiovascular medication
    • Clinical diagnosis of type 2 diabetes for any duration (c-peptide test is not required)
    • Identified by provider as a medically-appropriate candidate for statins, (i.e. no contraindications to taking the medications, e.g., allergy)

Exclusion Criteria

  • Major barriers to providing written informed consent and  participating in shared decision making (i.e. severe vision or hearing impairment, cognitive impairment, non-English speaking)
  • Specific for diabetes medication
    • Use insulin therapy
  • Specific for cardiovascular medication
  • Use a statin currently

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Victor Montori, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20314153

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