Making Decisions About Depression Medications

Study Overview
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Brief Summary
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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
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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.

Official Title
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Translation of Comparative Effectiveness of Depression Medications Into Practice

Conditions
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Depression

Intervention / Treatment
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* Other: Decision Aid


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Decision aid<br>DEPRESSION CHOICE decision aid is provided to clinician to share with patient | Other: Decision Aid<br>* The decision aid, Depression Medication Choice, uses plain language and is designed to enhance patient understanding and satisfy the International Patient Decision Aid Standards (IPDAS) requirements for a safe and unbiased decision aid.<br>|
| No Intervention: Normal care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Decision Making | 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. | 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. | 
| Knowledge Transfer | 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.' | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reach and Fidelity of Use of Decision Aids | Reach will be estimated by the proportion of the eligible patients who received the intervention of the entire eligible population allocated to its use. Fidelity will be determined using a checklist for each encounter to determine the proportion of visits in which more than >80% of decision aid items were delivered. | At end of study (approximately 2 years) | 
| Medication Adherence to Antidepressants | Investigators will obtain pharmacy records to determine anti-depressant use, adherence, and persistence based on prescription refills. | Six months post-prescription | 
| Depression Control | Investigators will assess patients at baseline, 3 and 6 months using the Patient Health Questionnaire 9 (PHQ-9) to measure the extent to which their depressed symptoms changed over time. | At six months post index visit | 
| Clinician Satisfaction with Decision Aids | Investigators will survey clinicians at the end of each index visit with a standardized clinician satisfaction questionnaire. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Comparative Effectiveness Research, Decision Support Techniques, Decision Making