Making Decisions About Depression Medications

NCT01502891 | Completed DMC

• 1 other identifier: 11-003507
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 4

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.

Conditions

Depression

Keywords

Comparative Effectiveness Research; Decision Support Techniques; Decision Making

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Reach and Fidelity of Use of Decision Aids

  At end of study (approximately 2 years)

• Medication Adherence to Antidepressants

  Six months post-prescription

• Depression Control

  At six months post index visit

• 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.

Study Arms (2)

Decision aid

ACTIVE COMPARATOR

DEPRESSION CHOICE decision aid is provided to clinician to share with patient

Other: Decision Aid

Normal care

NO INTERVENTION

Interventions

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.

Decision aid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Has prior diagnosis of bipolar disorder
• Has major communication barrier (severe hearing/vision impairment, dementia, cannot communicate with clinician in same language)

Sponsors & Collaborators

• Victor Montori: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (4)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Entira Family Clinics (formerly known as Family Health Services Minnesota)

Saint Paul, Minnesota, 55117, United States

Location

Mayo Clinic Health System - Franciscan Healthcare

La Crosse, Wisconsin, 54601, United States

Location

Related Publications (3)

• Kunneman M, Branda ME, Ridgeway JL, Tiedje K, May CR, Linzer M, Inselman J, Buffington ALH, Coffey J, Boehm D, Deming J, Dick S, van Houten H, LeBlanc A, Liesinger J, Lima J, Nordeen J, Pencille L, Poplau S, Reed S, Vannelli A, Yost KJ, Ziegenfuss JY, Smith SA, Montori VM, Shah ND. Making sense of diabetes medication decisions: a mixed methods cluster randomized trial using a conversation aid intervention. Endocrine. 2022 Feb;75(2):377-391. doi: 10.1007/s12020-021-02861-4. Epub 2021 Sep 9.

  PMID: 34499328 DERIVED

• LeBlanc A, Herrin J, Williams MD, Inselman JW, Branda ME, Shah ND, Heim EM, Dick SR, Linzer M, Boehm DH, Dall-Winther KM, Matthews MR, Yost KJ, Shepel KK, Montori VM. Shared Decision Making for Antidepressants in Primary Care: A Cluster Randomized Trial. JAMA Intern Med. 2015 Nov;175(11):1761-70. doi: 10.1001/jamainternmed.2015.5214.

  PMID: 26414670 DERIVED

• LeBlanc A, Bodde AE, Branda ME, Yost KJ, Herrin J, Williams MD, Shah ND, Houten HV, Ruud KL, Pencille LJ, Montori VM. Translating comparative effectiveness of depression medications into practice by comparing the depression medication choice decision aid to usual care: study protocol for a randomized controlled trial. Trials. 2013 May 7;14:127. doi: 10.1186/1745-6215-14-127.

  PMID: 23782672 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Victor Montori, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine, Endocrinology

Study Record Dates

• First Submitted: December 23, 2011
• First Posted: January 2, 2012
• Study Start: December 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 31, 2015

Record last verified: 2015-12

Locations

US (4)