Translation of Comparative Effectiveness of Depression Medications Into Practice
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- Victor Montori
- Enrollment
- 301
- Locations
- 4
- Primary Endpoint
- Knowledge Transfer
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to determine whether the Depression Medication Choice decision aid is effective in involving patients with depression in making deliberate choices when considering medication treatment.
Detailed Description
To determine the ability of decision aids to effectively translate a depression comparative effectiveness research (CER) review into practice, the investigators have developed a literacy-sensitive depression treatment decision aid, DEPRESSION MEDICATION CHOICE, which adapts the Agency for Healthcare Research and Quality (AHRQ)'s Effective Healthcare comparative effectiveness review and associated patient guide about antidepressant medicines to satisfy the needs of clinicians, patients, and other major stakeholders. The investigators will conduct a randomized study to estimate the effect of the decision aid on patient knowledge, patient involvement in decision making and decision-making quality, and on three and six-month measures of medication adherence and mental health, when compared with usual care.
Investigators
Victor Montori
Professor of Medicine, Endocrinology
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Presumed diagnosis of depression (PHQ-9 of 10 or greater)
- •As judged by clinician, need to initiate drug treatment for depression
- •Identify primary care clinician as main depression provider
- •Agree to be available for follow-up survey 6 months after treatment decision
Exclusion Criteria
- •Has prior diagnosis of bipolar disorder
- •Has major communication barrier (severe hearing/vision impairment, dementia, cannot communicate with clinician in same language)
Outcomes
Primary Outcomes
Knowledge Transfer
Time Frame: Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.
Questions have been crafted to assess knowledge about depression treatment contained in the decision aid. These questions use a response format "true/false/unsure," and are to be answered with full access to the decision aids since they are not a test of recall, but of 'use of information.'
Quality of Decision Making
Time Frame: Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.
A modified Decisional Conflict Scale will be used to ascertain decisional quality and satisfaction with decision making. The OPTION scale will be used to assess patient involvement in decision-making by reviewing video recordings of primary care visits with inter-rater reliability. Satisfaction with decision making will be assessed also by using two specific questions that require patients to assess the extent to which they would want for themselves and recommend to others similar decision support like what they received during the visit.
Secondary Outcomes
- Medication Adherence to Antidepressants(Six months post-prescription)
- Clinician Satisfaction with Decision Aids(Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.)
- Reach and Fidelity of Use of Decision Aids(At end of study (approximately 2 years))
- Depression Control(At six months post index visit)