Making Decisions About Depression Medications

Depression Clinical Trial

— iADAPT  

Official title:

Translation of Comparative Effectiveness of Depression Medications Into Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01502891
• Other study ID #: 11-003507
• Status: Completed
• Phase: N/A
• First received: December 23, 2011
• Last updated: December 30, 2015
• Start date: December 2011
• Est. completion date: October 2013

Study information

• Verified date: December 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic Health System - Franciscan Healthcare	LaCrosse	Wisconsin
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Mayo Clinic	Rochester	Minnesota
United States	Entira Family Clinics (formerly known as Family Health Services Minnesota)	St. Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Victor Montori	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Secondary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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.	No

External Links

•   Mayo Clinic Clinical Trials