Activating Messages for Enhancing Primary Care Practice (AMEP2): Effectiveness Study
AMEP2
Targeted and Tailored Messages to Enhance Depression Care
2 other identifiers
interventional
925
1 country
6
Brief Summary
This trial consists of two linked substudies. Substudy 1: Activating Messages for Enhancing Primary Care Practice (AMEP2): Effectiveness Study Substudy 2: Activating Messages for Enhancing Primary Care Practice (AMEP2): Toxicity Study The purpose of the Effectiveness Study is to assess the comparative effectiveness of three multimedia educational interventions (a targeted educational video, a tailored interactive multimedia computer program, and an "attention control") for increasing the likelihood that primary care patients with significant depressive symptoms will seek appropriate care (n = 510). The primary study outcomes are provision of minimally acceptable initial care, reductions in depression-related stigma, and improvement in depression symptoms. (See Process of Care and Patient Outcomes in Primary Outcome Measure section.) The purpose of the Toxicity Study is to assess the potential benefits (reduced stigma) and harms (inappropriate prescribing) associated with three multimedia depression educational interventions when administered to patients with few or no depressive symptoms (n = 308). The primary outcomes relating to this outcome are reducing depression-related stigma and reducing unnecessary prescribing. (See Toxicity in Primary Outcome Measure section.) Both studies will look at the secondary outcome measure of patient requests for depression treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Jun 2010
Longer than P75 for not_applicable depression
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedFirst Posted
Study publicly available on registry
June 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMay 30, 2017
May 1, 2017
1.4 years
May 14, 2010
May 25, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
Process of Care
Minimally acceptable initial care, meaning 1) antidepressant prescription, 2) referral to a mental health specialist, or 3) follow up within 14 days if PHQ \>= 15 or within 30 days otherwise
Within 24 hours of intervention delivery (physician post-visit assessment)
Patient Outcomes
1\) Stigma as measured by a scale adapted from Kanter JW, Rusch LC, Brondino MJ. Depression self-stigma: a new measure and preliminary findings. J Nervous Mental Dis 1008; 196(9):663-70, and 2) depression symptoms measured via PHQ-8 scores.
Stigma: Within 24 hours of intervention delivery (patient post-visit assessment); depression symptoms: 12 weeks
Toxicity
1\) Stigma as measured by a scale adapted from Kanter (see above) and 2) antidepressant prescribing by physician
Within 24 hours of intervention delivery (patient and physician post-visit assessment, audio-recording of doctor-patient interaction at index visit)
Secondary Outcomes (1)
Direct or indirect patient requests for depression treatment
Within 24 hours of intervention delivery (physician post-visit assessment, audio-recording of doctor-patient interaction at index visit)
Study Arms (3)
Public Service Announcements
EXPERIMENTALDemographically targeted public service announcement
Interactive Multi-Media Computer Program
EXPERIMENTALPersonally tailored information about seeking care for depression based on respondent characteristics
Attention Control Video
ACTIVE COMPARATORTwo-minute video focusing on common sleep disorders.
Interventions
Eligibility Criteria
You may qualify if:
- Age 25-70
- Visual acuity and manual dexterity to operate a laptop computer
You may not qualify if:
- Currently being treated for depression with anti-depressant medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Sutter Health - Elk Grove Family Medicine
Elk Grove, California, 95758, United States
VA Northern California Healthcare System
Mather, California, 95655, United States
Kaiser Permanente - Point West
Sacramento, California, 95815, United States
University of California, Davis
Sacramento, California, 95817, United States
San Francisco VA Medical Center
San Francisco, California, 94121, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Related Publications (2)
Kravitz RL, Franks P, Feldman MD, Tancredi DJ, Slee CA, Epstein RM, Duberstein PR, Bell RA, Jackson-Triche M, Paterniti DA, Cipri C, Iosif AM, Olson S, Kelly-Reif S, Hudnut A, Dvorak S, Turner C, Jerant A. Patient engagement programs for recognition and initial treatment of depression in primary care: a randomized trial. JAMA. 2013 Nov 6;310(17):1818-28. doi: 10.1001/jama.2013.280038.
PMID: 24193079DERIVEDTancredi DJ, Slee CK, Jerant A, Franks P, Nettiksimmons J, Cipri C, Gottfeld D, Huerta J, Feldman MD, Jackson-Triche M, Kelly-Reif S, Hudnut A, Olson S, Shelton J, Kravitz RL. Targeted versus tailored multimedia patient engagement to enhance depression recognition and treatment in primary care: randomized controlled trial protocol for the AMEP2 study. BMC Health Serv Res. 2013 Apr 17;13:141. doi: 10.1186/1472-6963-13-141.
PMID: 23594572DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard L Kravitz, MD, MSPH
University of California, Davis
- PRINCIPAL INVESTIGATOR
Mitchell L Feldman, MD, MPhil
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2010
First Posted
June 15, 2010
Study Start
June 1, 2010
Primary Completion
November 1, 2011
Study Completion
June 1, 2014
Last Updated
May 30, 2017
Record last verified: 2017-05