Clinical trial NCT01502891: Making Decisions About Depression Medications
Official title: Translation of Comparative Effectiveness of Depression Medications Into Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Comparative Effectiveness Research
Decision Support Techniques
Decision Making
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2012-01-02
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Quality of Decision Making
timeFrame: 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.
measure: Knowledge Transfer
timeFrame: 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:
measure: Reach and Fidelity of Use of Decision Aids
timeFrame: At end of study (approximately 2 years)
measure: Medication Adherence to Antidepressants
timeFrame: Six months post-prescription
measure: Depression Control
timeFrame: At six months post index visit
measure: Clinician Satisfaction with Decision Aids
timeFrame: 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.
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: St. Paul
country: United States
facility: Entira Family Clinics (formerly known as Family Health Services Minnesota)
state: Minnesota
city: LaCrosse
country: United States
facility: Mayo Clinic Health System - Franciscan Healthcare
state: Wisconsin
Study officials:
affiliation: Mayo Clinic
name: Victor Montori, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.