This trial is active, not recruiting.

Condition depression
Treatments navigation, enhanced screening and referral
Sponsor University of Rochester
Collaborator Patient-Centered Outcomes Research Institute
Start date January 2014
End date August 2016
Trial size 223 participants
Trial identifier NCT02087956, AD-12-11-4261


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
(Active Comparator)
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.
navigation mentoring
The navigator provides up to 4 months outreach and support to implement the personal care plan. Patients determine the preferred frequency and type of contact with the navigator. . At the end of the four months, the patient and navigator will review the personal care plan, and the navigator will work with the patient as to how she can continue progress through accessing other supports and resources as needed.
(Active Comparator)
(ESR)- participant will receive personal report of their current needs and list of resources available in the community.
enhanced screening and referral Comprehensise health result screening
Patients assigned to ESR will be provided with a print-out of their Promote-W comprehensive health screening results. More specifically, they will receive a list of concerns they endorsed plus a resource list of locations where they can obtain assistance with those issues, which are largely free.

Primary Outcomes

Patient Quality of Life
time frame: Post treatment (4 months after enrollment)
Depression Change Outcome Measure
time frame: Change in depression score (PHQ 9) from baseline to 4, 7 and 10 months follow up.
Change in Patient Satisfaction
time frame: Change in QOL from baseline to 4, 7, 10 months follow up.

Secondary Outcomes

Change in Successful Health Care Engagement
time frame: 1 year before baseline, to 1 year post treatment

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Patient Priorities and Community Context: Navigation for Disadvantaged Women With Depression
Principal investigator Ellen Poleshuck, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Rochester.