Making Decisions About Depression Medications (iADAPT)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
|Official Title:||Translation of Comparative Effectiveness of Depression Medications Into Practice|
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.'
- Reach and Fidelity of Use of Decision Aids [ Time Frame: At end of study (approximately 2 years) ] [ Designated as safety issue: No ]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.
- Medication Adherence to Antidepressants [ Time Frame: Six months post-prescription ] [ Designated as safety issue: No ]Investigators will obtain pharmacy records to determine anti-depressant use, adherence, and persistence based on prescription refills.
- Depression Control [ Time Frame: At six months post index visit ] [ Designated as safety issue: No ]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.
- Clinician Satisfaction with Decision Aids [ 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. ] [ Designated as safety issue: No ]Investigators will survey clinicians at the end of each index visit with a standardized clinician satisfaction questionnaire.
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||November 2014|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Decision aid
DEPRESSION CHOICE decision aid is provided to clinician to share with patient
Other: Decision Aid
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.
|No Intervention: Normal care|
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.
|United States, Minnesota|
|Hennepin County Medical Center|
|Minneapolis, Minnesota, United States, 55415|
|Rochester, Minnesota, United States, 55905|
|Entira Family Clinics (formerly known as Family Health Services Minnesota)|
|St. Paul, Minnesota, United States, 55117|
|United States, Wisconsin|
|Mayo Clinic Health System - Franciscan Healthcare|
|LaCrosse, Wisconsin, United States, 54601|
|Principal Investigator:||Victor Montori, MD||Mayo Clinic|