Realizing Opportunities for Self Empowerment (ROSE)

University of Rochester

Status: Completed

Conditions: Depression

Treatments: Behavioral: Enhanced Screening and Referral; Behavioral: Navigation

Study type: Interventional

Funder types: Other

Identifiers

NCT02087956

AD-12-11-4261

Details and patient eligibility

About

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.

Full 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.

Enrollment: 223 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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223 participants in 2 patient groups

Personalized Support for Progress (PSP)

Active Comparator group

Description:

In Personalized Support for Progress (PSP), patients meet with a navigator to prioritize their concerns using a decision aid, develop a plan based on their identified priorities, and execute the plan.

Treatment:

Behavioral: Navigation

Enhanced Screening and Referral (ESR)

Active Comparator group

Description:

(ESR)- participant will receive personal report of their current needs and list of resources available in the community.

Treatment:

Behavioral: Enhanced Screening and Referral