Realizing Opportunities for Self Empowerment

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: Enhanced Screening and Referral; Behavioral: Navigation

• Registration Number: NCT02087956
• Lead Sponsor: University of Rochester

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-03-12
• Study First Submitted QC: 2014-03-13
• Study First Posted: 2014-03-14
• Primary Completion: 2016-08
• Results First Submitted: 2017-06-12
• Study Completion: 2017-08
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-03
• Last Update Submitted: 2019-01-03
• Results First Posted: 2019-01-07
• Last Update Posted: 2019-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 223

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Screening and Referral (ESR)	Enhanced Screening and Referral	(ESR)- participant will receive personal report of their current needs and list of resources available in the community.
Personalized Support for Progress (PSP)	Navigation	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.

Primary Outcome Measures

Name	Time	Method
Patient Quality of Life	Post treatment (4 months after enrollment)	We will use the WHOQOL-BREF measure. The WHOQOL-bref contains 26 items; the first two questions evaluate self-perceived quality of life and satisfaction with health.The remaining 24 questions represent four domains: physical, psychological, social relationships and environment.; The WHOQOL-bref contains five Likert style response scales: "very poor to very good" (evaluation scale), "very dissatisfied to very satisfied" (evaluation scale), "none to extremely" (intensity scale), "none to complete" (capacity scale) and "never to always" (frequency scale).The mean score in each domain indicates the individual's perception of their satisfaction with each aspect of their life, relating it with quality of life. The higher the score, the better this is perceived to be. Total score was computed by summing all 26 items. The possible range is from 26 to 130.
Depression Change Outcome Measure	baseline, post treatment (4 months after enrollment), 3 months and 6 months follow up (7 and 10 months after enrollment)	Depression was measured by PHQ-9, a screen for major depressive disorder with good discriminant validity and sensitivity to change validated in Ob/Gyn settings, and with pregnant and postpartum women, and with women of color. Scale ranges 0-27. Higher the score, higher severity of depression and cutpoints of 5, 10, 15 and 20 representing mild, moderate, moderately severe and severe levels of depressive symptoms.
Client Satisfaction Questionnaire- 8 Items	Post treatment- 4 months after enrollment, 3 and 6 months follow-up (7 and 10 months after the enrollment)	The Client Satisfaction Questionnaire (CSQ-8) is an 8-item self-report instrument to assess subjective satisfaction with treatment which was administered to all participants post-treatment We analyzed 4 items: CSQ1: "How would you rate the quality of service you have received?", CSQ 3: "To what extent has our program met your needs?", CSQ 6: "Have the services you received helped you to deal more effectively with your problems?" and CSQ 7: "In an overall, general sense, how satisfied are you with the service you have received?" (1 = Excellent, 2 = Good, 3 = Fair, 4 = Poor). We are reporting on CSQ 1 outcome.

Secondary Outcome Measures

Name	Time	Method
Domestic Violence (Feldhaus)	baseline, post treatment (4 months after enrollment), 3 and 6 months follow-up (7 and 10 months after enrollment)	Feldhaus Partner Violence Screen is 3 items measure assessing physical abuse by partner in the past year. Scale range: 0-3; higher the score higher frequency of physical abuse.

Trial Locations

Locations (1)

University of Rochester, Women Health Practice; 🇺🇸 Rochester, New York, United States