Making Decisions About Depression Medications

Not Applicable

Completed

• Conditions: Depression
• Interventions: Other: Decision Aid

• Registration Number: NCT01502891
• Lead Sponsor: Victor Montori

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-23
• Study First Submitted QC: 2011-12-30
• Study First Posted: 2012-01-02
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-30
• Last Update Posted: 2015-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decision aid	Decision Aid	DEPRESSION CHOICE decision aid is provided to clinician to share with patient

Primary Outcome Measures

Name	Time	Method
Knowledge Transfer	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	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 Outcome Measures

Name	Time	Method
Medication Adherence to Antidepressants	Six months post-prescription	Investigators will obtain pharmacy records to determine anti-depressant use, adherence, and persistence based on prescription refills.
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.	Investigators will survey clinicians at the end of each index visit with a standardized clinician satisfaction questionnaire.
Reach and Fidelity of Use of Decision Aids	At end of study (approximately 2 years)	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.
Depression Control	At six months post index visit	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.

Trial Locations

Locations (4)

Entira Family Clinics (formerly known as Family Health Services Minnesota); 🇺🇸 St. Paul, Minnesota, United States

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Mayo Clinic Health System - Franciscan Healthcare; 🇺🇸 LaCrosse, Wisconsin, United States