Maternal Behavior, Postpartum Depression
Conditions
Keywords
Postpartum
Brief summary
The goal of this educational clinical trial is to identify high-need women most at risk for poor outcomes following delivery, the problems they experience, and to create a system to improve quality of postpartum care for these high-need patients. The main question\[s\] it aims to answer are: 1. How can the investigators help postpartum patients who have poor outcomes by decreasing the number of ED visits/readmissions for these patients within the first 30 days postpartum? 2. How can the investigators increase the ability of participants to "obtain needed services" and ability for patients to see their provider when they need to, in the 30-day post discharge period as one of the main pathways of unnecessary ED visits? Participants will be put into the study group or control group. The study group will receive a pamphlet postpartum with helpful information as well as a patient navigator who the participants will be able to reach out to their first 30 days postpartum.
Interventions
BEHAVIORALHOME
The study intervention consists of a patient education pamphlet and partner sheet (physically and virtually accessible) that will educate and prepare post-partum patients. The patient navigator will explain this pamphlet at postpartum discharge, then will follow-up with the patients up to 30 days in the postpartum period.
Sponsors
University of Pennsylvania
National Institutes of Health (NIH)
Columbia University
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Postpartum patients who have delivered a baby at the Hospital of University of Pennsylvania * Ages 18 or older * Self-identify as Black (listed on chart) * Speak English * Able to read * Other characteristics defined by our risk prediction model (algorithm)
Exclusion criteria
* Unable to provide informed consent * Speaks a language other than English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emergency Department (ED) Visits and Readmissions | 1-30 days postpartum | To obtain data for the primary outcome of postpartum morbidity and mortality as measured by Emergency Department (ED) visits and hospital readmissions in the 30-day post discharge period. Investigators will use chart reviews to obtain this ED/Readmission information. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ability to Obtain Needed Services | 1-30 days postpartum | To detect the ability of participants to "obtain needed services" in the 30-day post discharge period as one of the main pathways of unnecessary ED visits. Investigators ask patients three weeks postpartum: "Please rate your ability to do the following on a scale of never-sometimes-often-always: Your ability to get through to the doctor's or midwife's office by phone; Your ability to speak to your provider by phone; Your ability to see your provider if you felt you needed to." We score never as 1 and always as 4. If access score is greater than or equal to 11, they are considered having high provider access. Percentage of patients reflects those who had high provider access. |
| Depressive Symptoms | 1 day-6 months postpartum | A score of 11 or higher on the Edinburgh Postnatal Depression Scale (EPDS: a ten-item scale that measures minor or major depression and self-harm through 4-point Likert scale responses. Scores can range from 0-30. Higher scores indicate worse outcomes). The score was ascertained from a Redcap survey including EPDS. For more information see Cox et al. 1987 |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 220 Participants |
| Age, Continuous | 30.0 years STANDARD_DEVIATION 6.3 |
| Education Graduate | 10 Participants |
| Education HS/GED | 46 Participants |
| Education Less than HS | 8 Participants |
| Education Missing | 15 Participants |
| Education Other | 0 Participants |
| Education Some college- Bachelor | 35 Participants |
| Household Income <$15,000 | 32 Participants |
| Household Income $15,000-$45,000 | 24 Participants |
| Household Income $45,000-$75,000 | 36 Participants |
| Household Income $75,000+ | 16 Participants |
| Household Income Missing | 57 Participants |
| Martial Status Married | 34 Participants |
| Martial Status Missing | 8 Participants |
| Martial Status Other | 13 Participants |
| Martial Status Single | 109 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black | 192 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Missing | 13 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Native American | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 0 Participants |
| Sex: Female, Male Female | 110 Participants |
| Sex: Female, Male Male | 0 Participants |
| Type of Housing Missing | 14 Participants |
| Type of Housing No Housing | 20 Participants |
| Type of Housing Own | 59 Participants |
| Type of Housing Prefer Not to Say | 11 Participants |
| Type of Housing Rent | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 110 | 0 / 110 |
| other Total, other adverse events | 33 / 110 | 39 / 110 |
| serious Total, serious adverse events | 2 / 110 | 0 / 110 |
Outcome results
None listed