Clinical trial NCT02087956: Realizing Opportunities for Self Empowerment
Official title: Patient Priorities and Community Context: Navigation for Disadvantaged Women With Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Women
Depression
Socioeconomically Disadvantaged
Navigation
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-03-14
Enrollment: 223
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether priority-based patient navigation will improve patient satisfaction, quality of life (QOL), and depression when compared to screening-and-referral for socioeconomically disadvantaged women's health patients with depression. The investigators goal is to establish patient-driven, effective, generalizable, and disseminable interventions to reduce depression-related disparities and improve outcomes.

Detailed description: * In this comparative effectiveness study, 200 participants who are patients at the University of Rochester Women's Health Practice or Highland Woman's Health and report significant depressive symptoms will be randomized to either PSP (Personal Support for Progress) or ESR (Enhanced Screening and Referral). Participants assigned to PSP will work with a patient navigator to prioritize their concerns, develop a personalized care plan, and implement their plan. Participants assigned to ESR will receive a personalized report of community resources that may be helpful for their identified needs.
* The investigators will use a simple 1:1 randomized design with treatment assignment being conducted using a random number generator. All analyses will follow an intent-to-treat protocol, such that all participants randomized will be followed for data collection and analyzed according to her randomized condition
* Each participant will be assessed 4 times for outcome changes: at baseline, post treatment (4 months), and two follow up ( at 7 and 10 months).
* Assessments are self report on iPads and they are linked directly to a Red Cap database.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with depression (PHQ9 score 10 or higher)
* Patient of University of Rochester Women's Health Practice or Highland Women's Health
* Monroe County resident
* English speaking

Exclusion Criteria:

* Currently receiving case management services
* In need of acute psychiatric services
* Unable to commit to the duration of the project

Primary outcomes:
measure: Patient Quality of Life
timeFrame: Post treatment (4 months after enrollment)
measure: Depression Change Outcome Measure
timeFrame: baseline, post treatment (4 months after enrollment), 3 months and 6 months follow up (7 and 10 months after enrollment)
measure: Client Satisfaction Questionnaire- 8 Items
timeFrame: Post treatment- 4 months after enrollment, 3 and 6 months follow-up (7 and 10 months after the enrollment)
Secondary outcomes:
measure: Domestic Violence (Feldhaus)
timeFrame: baseline, post treatment (4 months after enrollment), 3 and 6 months follow-up (7 and 10 months after enrollment)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester, Women Health Practice
state: New York
Study officials:
affiliation: University of Rochester
name: Ellen Poleshuck, PhD
role: PRINCIPAL_INVESTIGATOR
References: