ROSE: Realizing Opportunities for Self Empowerment

• Sponsor: University of Rochester (Other)
• Overall Status: Completed
• CT.gov ID: NCT02087956
• Collaborator: Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 223
• Location: 1
• Arms: 2
• Duration (Months): 43
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Behavioral: Navigation; Behavioral: Enhanced Screening and Referral	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 223 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Patient Priorities and Community Context: Navigation for Disadvantaged Women With Depression
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester, Women Health Practice	Rochester	New York	United States	14620

Sponsors and Collaborators

• University of Rochester
• Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Ellen Poleshuck, PhD, University of Rochester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ellen Poleshuck, Director, Women's Behavioral Health Service; Associate Professor, Departments of Psychiatry and Obstetrics & Gynecology, University of Rochester
• ClinicalTrials.gov Identifier: NCT02087956
• Other Study ID Numbers: AD-12-11-4261
• First Posted: Mar 14, 2014
• Last Update Posted: Jan 7, 2019
• Last Verified: Jan 1, 2019

• Keywords provided by Ellen Poleshuck, Director, Women's Behavioral Health Service; Associate Professor, Departments of Psychiatry and Obstetrics & Gynecology, University of Rochester: Women; Depression; Socioeconomically Disadvantaged; Navigation
• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

Participant Flow

Arm/Group Title	Personalized Support for Progress (PSP)	Enhanced Screening and Referral (ESR)
Arm/Group Description	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: 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.	(ESR)- participant will receive personal report of their current needs and list of resources available in the community. 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.
Period Title: Overall Study
STARTED	111	112
COMPLETED	105	107
NOT COMPLETED	6	5

Baseline Characteristics

Arm/Group Title	Personalized Support for Progress (PSP)	Enhanced Screening and Referral (ESR)	Total
Arm/Group Description	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: 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.	(ESR)- participant will receive personal report of their current needs and list of resources available in the community. 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.	Total of all reporting groups
Overall Participants	111	112	223
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.7 (8.8)	30.5 (10.1)	30.1 (9.5)
Sex: Female, Male (Count of Participants)
Female	111 100%	112 100%	223 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
AA/Black	69 62.2%	68 60.7%	137 61.4%
White/Caucasian	26 23.4%	27 24.1%	53 23.8%
Hispanic/Latina	19 17.1%	24 21.4%	43 19.3%
Other (Native American, Asian, Hawaiian)	4 3.6%	8 7.1%	12 5.4%
Biracial/More than one race	7 6.3%	11 9.8%	18 8.1%
Region of Enrollment (participants) [Number]
United States	111 100%	112 100%	223 100%

Outcome Measures

1. Primary Outcome

Title	Patient Quality of Life
Description	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.
Time Frame	Post treatment (4 months after enrollment)

Outcome Measure Data

Analysis Population Description

Results are presented for WHO-QOL total score. We had attrition of about 5% throughout the study, therefore number of analyzed at post treatment differs from initial number of participants.

Arm/Group Title	Personalized Support for Progress (PSP)	Enhanced Screening and Referral (ESR)
Arm/Group Description	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: 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.	(ESR)- participant will receive personal report of their current needs and list of resources available in the community. 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.
Measure Participants	111	112
baseline	79.51 (13.82)	76.91 (13.70)
post treatment	82.70 (14.14)	78.85 (15.57)

2. Primary Outcome

Title	Depression Change Outcome Measure
Description	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.
Time Frame	baseline, post treatment (4 months after enrollment), 3 months and 6 months follow up (7 and 10 months after enrollment)

Outcome Measure Data

Analysis Population Description

We had 5% attrition throughout the study, therefore number of subjects differ at each assessment point.

Arm/Group Title	Personalized Support for Progress (PSP)	Enhanced Screening and Referral (ESR)
Arm/Group Description	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: 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.	(ESR)- participant will receive personal report of their current needs and list of resources available in the community. 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.
Measure Participants	111	112
baseline	13.92 (3.78)	14.74 (4.21)
post treatment	10.61 (6.43)	12.58 (6.56)
3 months follow-up	10.14 (6.19)	11.39 (6.45)
6 months follow-up	10.21 (6.27)	10.36 (6.40)

3. Primary Outcome

Title	Client Satisfaction Questionnaire- 8 Items
Description	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.
Time Frame	Post treatment- 4 months after enrollment, 3 and 6 months follow-up (7 and 10 months after the enrollment)

Outcome Measure Data

Analysis Population Description

We had attrition of about 5% throughout the study, therefor number of analyzed at post treatment differs from initial number of participants

Arm/Group Title	Enhanced Screening and Referral (ESR)	Personalized Support for Progress (PSP)
Arm/Group Description	(ESR)- participant will receive personal report of their current needs and list of resources available in the community. 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.	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: 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.
Measure Participants	106	105
CSQ 1. post treatment	1.57 (0.65)	1.43 (0.65)
CSQ 1. 3 months follow-up	1.72 (0.70)	1.50 (0.64)
CSQ 1. 6 months follow-up	1.63 (0.75)	1.41 (0.62)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

We had attrition of 5% throughout the study; additionally we had some missing data.

Arm/Group Title	Personalized Support for Progress (PSP)	Enhanced Screening and Referral (ESR)
Arm/Group Description	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: 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.	(ESR)- participant will receive personal report of their current needs and list of resources available in the community. 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.
Measure Participants	108	109
DV_baseline	0.29 (0.45)	0.23 (0.42)
DV_post treatment	0.17 (0.38)	0.26 (0.44)
DV_3 months follow-up	0.17 (0.38)	0.23 (0.42)
DV_6 months follow-up	0.11 (0.31)	0.20 (0.40)

Adverse Events

Arm/Group Title	Personalized Support for Progress (PSP)		Enhanced Screening and Referral (ESR)
Arm/Group Description	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: 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.		Enhanced Screen and Referral (ESR)- participant will receive personal report of their current needs and list of resources available in the community. 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.
All Cause Mortality
	Personalized Support for Progress (PSP)		Enhanced Screening and Referral (ESR)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/111 (0%)		0/112 (0%)
Serious Adverse Events
	Personalized Support for Progress (PSP)		Enhanced Screening and Referral (ESR)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/111 (0%)		0/112 (0%)
Other (Not Including Serious) Adverse Events
	Personalized Support for Progress (PSP)		Enhanced Screening and Referral (ESR)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/111 (0%)		0/112 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.