Skip to main content
OpenTrials
Completed

NCT Number: NCT01502891

Making Decisions About Depression Medications

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hennepin County Medical Center, Minneapolis, Minnesota, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Decision Aid

Other

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.

Primary outcomes

  1. 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.

  2. 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.'

Secondary outcomes

  1. Reach and Fidelity of Use of Decision Aids

    Time frame: 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.

  2. Medication Adherence to Antidepressants

    Time frame: Six months post-prescription

    Investigators will obtain pharmacy records to determine anti-depressant use, adherence, and persistence based on prescription refills.

  3. Depression Control

    Time frame: 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.

  4. 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.

    Investigators will survey clinicians at the end of each index visit with a standardized clinician satisfaction questionnaire.

Sponsors and collaborators

Lead sponsor

Victor Montori

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Translation of Comparative Effectiveness of Depression Medications Into Practice

Acronym: iADAPT

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 2, 2012
Registry last updated
Dec 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.