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Making Decisions About Depression Medications

NCT ID: NCT01502891

Last Updated: 2015-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

301 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-10-31

Brief Summary

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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

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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.

Conditions

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Depression

Keywords

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Comparative Effectiveness Research Decision Support Techniques Decision Making

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Decision aid

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

Group Type ACTIVE_COMPARATOR

Decision Aid

Intervention Type 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.

Normal care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

Victor Montori

OTHER

Sponsor Role lead

Responsible Party

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Victor Montori

Professor of Medicine, Endocrinology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Victor Montori, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

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

Saint Paul, Minnesota, United States

Site Status

Mayo Clinic Health System - Franciscan Healthcare

La Crosse, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34499328 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26414670 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23782672 (View on PubMed)

Other Identifiers

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11-003507

Identifier Type: -

Identifier Source: org_study_id