Realizing Opportunities for Self Empowerment
This trial is active, not recruiting.
|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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
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.
Change in Successful Health Care Engagement
time frame: 1 year before baseline, to 1 year post treatment
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
|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.|
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