Realizing Opportunities for Self Empowerment (ROSE)

Patient Priorities and Community Context: Navigation for Disadvantaged Women With Depression

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Navigation; Behavioral: Enhanced Screening and Referral

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.

• Study Type: Interventional
• Enrollment (Actual): 223
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14620
      • University of Rochester, Women Health Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Personalized Support for Progress (PSP); 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.	Behavioral: Navigation; 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.; Other Names: mentoring
Active Comparator: Enhanced Screening and Referral (ESR); (ESR)- participant will receive personal report of their current needs and list of resources available in the community.	Behavioral: Enhanced Screening and Referral; 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.; Other Names: Comprehensise health result screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Quality of Life	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.	Post treatment (4 months after enrollment)
Depression Change Outcome Measure	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.	baseline, post treatment (4 months after enrollment), 3 months and 6 months follow up (7 and 10 months after enrollment)
Client Satisfaction Questionnaire- 8 Items	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.	Post treatment- 4 months after enrollment, 3 and 6 months follow-up (7 and 10 months after the enrollment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Domestic Violence (Feldhaus)	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.	baseline, post treatment (4 months after enrollment), 3 and 6 months follow-up (7 and 10 months after enrollment)

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: Patient-Centered Outcomes Research Institute

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: March 12, 2014
• First Submitted That Met QC Criteria: March 13, 2014
• First Posted (Estimate): March 14, 2014

Study Record Updates

• Last Update Posted (Actual): January 7, 2019
• Last Update Submitted That Met QC Criteria: January 3, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Depression; Women; Navigation; Socioeconomically Disadvantaged
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: AD-12-11-4261