Clinical trial NCT01144104: Activating Messages for Enhancing Primary Care Practice (AMEP2): Effectiveness Study
Official title: Targeted and Tailored Messages to Enhance Depression Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2010-06-15
Enrollment: 925
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Detailed description: This project is an investigator-initiated study involving two sequential phases and is funded by the National Institute of Mental Health. Phase I included the use of marketing research (i.e. focus groups, adaptive conjoint analysis, and other survey methods) to produce two clinic-based interventions: a public service announcement (PSA) and interactive multimedia computer program (IMCP). The two clinic-based interventions are intended to include messages that will activate patients to talk with their physicians about specific health concerns (depression) and/or any depressive symptoms they've been experiencing. In Phase II (as described in this registration protocol), those interventions will undergo assessment in a randomized controlled effectiveness trial (RCT) in primary care settings in Sacramento and San Francisco.

Eligibility criteria: Inclusion Criteria:

* Age 25-70
* Visual acuity and manual dexterity to operate a laptop computer

Exclusion Criteria:

* Currently being treated for depression with anti-depressant medications

Primary outcomes:
measure: Process of Care
timeFrame: Within 24 hours of intervention delivery (physician post-visit assessment)
measure: Patient Outcomes
timeFrame: Stigma: Within 24 hours of intervention delivery (patient post-visit assessment); depression symptoms: 12 weeks
measure: Toxicity
timeFrame: Within 24 hours of intervention delivery (patient and physician post-visit assessment, audio-recording of doctor-patient interaction at index visit)
Secondary outcomes:
measure: Direct or indirect patient requests for depression treatment
timeFrame: Within 24 hours of intervention delivery (physician post-visit assessment, audio-recording of doctor-patient interaction at index visit)
Other outcomes:
Locations:
city: Elk Grove
country: United States
facility: Sutter Health - Elk Grove Family Medicine
state: California
city: Mather
country: United States
facility: VA Northern California Healthcare System
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente - Point West
state: California
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, Davis
name: Richard L Kravitz, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Mitchell L Feldman, MD, MPhil
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Tancredi 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.