Maternal BehaviorHOMENCT06276647
Improving Health Outcomes and Equity by Targeting Postpartum Mothers at Highest Risk
A study testing HOME in people with Maternal Behavior and Postpartum Depression, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Maternal Behavior, Postpartum Depression
- What is being tested?
- HOME
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2024to 5 Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- Unable to provide informed consent
- Speaks a language other than English
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Improving Health Outcomes and Equity by Targeting Postpartum Mothers at Highest Risk: a Pilot Randomized Control Trial
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:
Read more
- 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?
- 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.
- Conditions
- Maternal Behavior, Postpartum Depression
- Being tested
- HOME
- Keywords
- Postpartum
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOMEBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient Education Pamphlet and Partner Sheet | Experimental | The study intervention consists of a patient education pamphlet and partner sheet (physically and virtually accessible) that will educate and prepare post-partum participants about health conditions (hypertension, diabetes, and depression), important health behaviors , physical and emotional postpartum symptoms, teach self-management skills, enhance social support, and connect post-partum participants with community resources. The education materials will provide simple actions that participants can utilize to address symptoms, realistic time frames for healing, danger signs to look out for and contact their physicians, and a list of resources for specific issues. The patient navigator will spend approximately 20 minutes with participants after enrollment, in the hospital. Following discharge, the patient navigator will contact each patient between 4 and 20 times, by phone and/or text with a research phone, to address questions and link participants to medical and community resources. Receives: Behavioral: HOME |
| Standard Postpartum Care | No intervention | These patients will receive Standard postpartum care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency Department (ED) Visits and Readmissions
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.
Measured: 1-30 days postpartum
Secondary outcomes (2)
Ability to Obtain Needed Services
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.
Measured: 1-30 days postpartum
Depressive Symptoms
The number of participants in the trial who scored an 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
Measured: 1 day-6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start20 Feb 2024
- Primary completion6 Jun 2025
- Study completion5 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Maternal BehaviorStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Columbia University, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Elizabeth Howell, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276647
- Sponsor's protocol ID
- 850584
- Other IDs
- R01MD016029
- Acronym
- HOME
- Status last verified
- Jan 2026
- First submitted
- 7 Feb 2024
- Last updated
- 7 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Health Outcomes and Equity by Targeting Postpartum Mothers at Highest Risk: a Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06276647
- Acronym / sponsor ID
- HOME / 850584
- Conditions
- Maternal Behavior, Postpartum Depression
- Keywords
- Postpartum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Columbia University, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 5 Dec 2025 (actual)
- First posted
- 26 Feb 2024 (actual)
- Results
- Posted 10 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Education Pamphlet and Partner Sheet | Experimental | Behavioral: HOMEThe study intervention consists of a patient education pamphlet and partner sheet (physically and virtually accessible) that will educate and prepare post-partum participants about health conditions (hypertension, diabetes, and depression), important health behaviors , physical and emotional postpartum symptoms, teach self-management skills, enhance social support, and connect post-partum participants with community resources. The education materials will provide simple actions that participants can utilize to address symptoms, realistic time frames for healing, danger signs to look out for and contact their physicians, and a list of resources for specific issues. The patient navigator will spend approximately 20 minutes with participants after enrollment, in the hospital. Following discharge, the patient navigator will contact each patient between 4 and 20 times, by phone and/or text with a research phone, to address questions and link participants to medical and community resources. |
| Standard Postpartum Care | No intervention | –These patients will receive Standard postpartum care. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to provide informed consent
- Speaks a language other than English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HOMEThe 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. | Behavioural | Patient Education Pamphlet and Partner Sheet |
Primary outcome
Emergency Department (ED) Visits and Readmissions
Time frame: 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.
2 secondary outcomes
Ability to Obtain Needed Services
Time frame: 1-30 days postpartum
Depressive Symptoms
Time frame: 1 day-6 months postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Maternal Behavior
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding
Recruiting
Maximising Maternal Milk for Preterm Infant
Breastfeeding, Prematurity
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOME in people with Maternal Behavior and Postpartum Depression, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergency Department (ED) Visits and Readmissions (time frame: 1-30 days postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.