Realizing Opportunities for Self Empowerment

NCT02087956 | Completed Results DMC

• 1 other identifier: AD-12-11-4261
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Women; Depression; Socioeconomically Disadvantaged; Navigation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Domestic Violence (Feldhaus)

  baseline, post treatment (4 months after enrollment), 3 and 6 months follow-up (7 and 10 months after enrollment)

Study Arms (2)

Personalized Support for Progress (PSP)

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.

Behavioral: Navigation

Enhanced Screening and Referral (ESR)

ACTIVE COMPARATOR

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

Behavioral: Enhanced Screening and Referral

Interventions

Navigation BEHAVIORAL

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.

Also known as: mentoring

Personalized Support for Progress (PSP)

Enhanced Screening and Referral BEHAVIORAL

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.

Also known as: Comprehensise health result screening

Enhanced Screening and Referral (ESR)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Rochester: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of Rochester, Women Health Practice

Rochester, New York, 14620, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Dr. Ellen Poleshuck
• Organization: University of Rochester

ellen_poleshuck@urmc.rochester.edu

585-275-3138

Study Officials

• Ellen Poleshuck, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Women's Behavioral Health Service; Associate Professor, Departments of Psychiatry and Obstetrics & Gynecology

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: March 14, 2014
• Study Start: January 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2017
• Last Updated: January 7, 2019
• Results First Posted: January 7, 2019

Record last verified: 2019-01

Locations

US (1)