Depression
Conditions
Keywords
Women, Depression, Socioeconomically Disadvantaged, Navigation
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.
Interventions
BEHAVIORALNavigation
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.
BEHAVIORALEnhanced 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.
Sponsors
Patient-Centered Outcomes Research Institute
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 111 |
| Enhanced Screening and Referral (ESR) (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. | 112 |
| Total | 223 |
Baseline characteristics
| Characteristic | Enhanced Screening and Referral (ESR) | Personalized Support for Progress (PSP) | Total |
|---|---|---|---|
| Age, Continuous | 30.5 years STANDARD_DEVIATION 10.1 | 29.7 years STANDARD_DEVIATION 8.8 | 30.1 years STANDARD_DEVIATION 9.5 |
| Race/Ethnicity, Customized AA/Black | 68 Participants | 69 Participants | 137 Participants |
| Race/Ethnicity, Customized Biracial/More than one race | 11 Participants | 7 Participants | 18 Participants |
| Race/Ethnicity, Customized Hispanic/Latina | 24 Participants | 19 Participants | 43 Participants |
| Race/Ethnicity, Customized Other (Native American, Asian, Hawaiian) | 8 Participants | 4 Participants | 12 Participants |
| Race/Ethnicity, Customized White/Caucasian | 27 Participants | 26 Participants | 53 Participants |
| Region of Enrollment United States | 112 participants | 111 participants | 223 participants |
| Sex: Female, Male Female | 112 Participants | 111 Participants | 223 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 111 | 0 / 112 |
| other Total, other adverse events | 0 / 111 | 0 / 112 |
| serious Total, serious adverse events | 0 / 111 | 0 / 112 |
Outcome results
Primary
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.
Time frame: Post treatment- 4 months after enrollment, 3 and 6 months follow-up (7 and 10 months after the enrollment)
Population: We had attrition of about 5% throughout the study, therefor number of analyzed at post treatment differs from initial number of participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Personalized Support for Progress (PSP) | Client Satisfaction Questionnaire- 8 Items | CSQ 1. post treatment | 1.57 units on a scale | Standard Deviation 0.65 |
| Personalized Support for Progress (PSP) | Client Satisfaction Questionnaire- 8 Items | CSQ 1. 3 months follow-up | 1.72 units on a scale | Standard Deviation 0.7 |
| Personalized Support for Progress (PSP) | Client Satisfaction Questionnaire- 8 Items | CSQ 1. 6 months follow-up | 1.63 units on a scale | Standard Deviation 0.75 |
| Enhanced Screening and Referral (ESR) | Client Satisfaction Questionnaire- 8 Items | CSQ 1. post treatment | 1.43 units on a scale | Standard Deviation 0.65 |
| Enhanced Screening and Referral (ESR) | Client Satisfaction Questionnaire- 8 Items | CSQ 1. 3 months follow-up | 1.50 units on a scale | Standard Deviation 0.64 |
| Enhanced Screening and Referral (ESR) | Client Satisfaction Questionnaire- 8 Items | CSQ 1. 6 months follow-up | 1.41 units on a scale | Standard Deviation 0.62 |
Primary
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.
Time frame: baseline, post treatment (4 months after enrollment), 3 months and 6 months follow up (7 and 10 months after enrollment)
Population: We had 5% attrition throughout the study, therefore number of subjects differ at each assessment point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Personalized Support for Progress (PSP) | Depression Change Outcome Measure | baseline | 13.92 units on a scale | Standard Deviation 3.78 |
| Personalized Support for Progress (PSP) | Depression Change Outcome Measure | post treatment | 10.61 units on a scale | Standard Deviation 6.43 |
| Personalized Support for Progress (PSP) | Depression Change Outcome Measure | 3 months follow-up | 10.14 units on a scale | Standard Deviation 6.19 |
| Personalized Support for Progress (PSP) | Depression Change Outcome Measure | 6 months follow-up | 10.21 units on a scale | Standard Deviation 6.27 |
| Enhanced Screening and Referral (ESR) | Depression Change Outcome Measure | 6 months follow-up | 10.36 units on a scale | Standard Deviation 6.4 |
| Enhanced Screening and Referral (ESR) | Depression Change Outcome Measure | baseline | 14.74 units on a scale | Standard Deviation 4.21 |
| Enhanced Screening and Referral (ESR) | Depression Change Outcome Measure | 3 months follow-up | 11.39 units on a scale | Standard Deviation 6.45 |
| Enhanced Screening and Referral (ESR) | Depression Change Outcome Measure | post treatment | 12.58 units on a scale | Standard Deviation 6.56 |
Primary
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.
Time frame: Post treatment (4 months after enrollment)
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Personalized Support for Progress (PSP) | Patient Quality of Life | baseline | 79.51 units on a scale | Standard Deviation 13.82 |
| Personalized Support for Progress (PSP) | Patient Quality of Life | post treatment | 82.70 units on a scale | Standard Deviation 14.14 |
| Enhanced Screening and Referral (ESR) | Patient Quality of Life | baseline | 76.91 units on a scale | Standard Deviation 13.7 |
| Enhanced Screening and Referral (ESR) | Patient Quality of Life | post treatment | 78.85 units on a scale | Standard Deviation 15.57 |
Secondary
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.
Time frame: baseline, post treatment (4 months after enrollment), 3 and 6 months follow-up (7 and 10 months after enrollment)
Population: We had attrition of 5% throughout the study; additionally we had some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Personalized Support for Progress (PSP) | Domestic Violence (Feldhaus) | DV_baseline | 0.29 units on a scale | Standard Deviation 0.45 |
| Personalized Support for Progress (PSP) | Domestic Violence (Feldhaus) | DV_post treatment | 0.17 units on a scale | Standard Deviation 0.38 |
| Personalized Support for Progress (PSP) | Domestic Violence (Feldhaus) | DV_3 months follow-up | 0.17 units on a scale | Standard Deviation 0.38 |
| Personalized Support for Progress (PSP) | Domestic Violence (Feldhaus) | DV_6 months follow-up | 0.11 units on a scale | Standard Deviation 0.31 |
| Enhanced Screening and Referral (ESR) | Domestic Violence (Feldhaus) | DV_6 months follow-up | 0.20 units on a scale | Standard Deviation 0.4 |
| Enhanced Screening and Referral (ESR) | Domestic Violence (Feldhaus) | DV_baseline | 0.23 units on a scale | Standard Deviation 0.42 |
| Enhanced Screening and Referral (ESR) | Domestic Violence (Feldhaus) | DV_3 months follow-up | 0.23 units on a scale | Standard Deviation 0.42 |
| Enhanced Screening and Referral (ESR) | Domestic Violence (Feldhaus) | DV_post treatment | 0.26 units on a scale | Standard Deviation 0.44 |