HOME Intervention for Postpartum Health

(HOME Trial)

Overseen By Angelina Malenda

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Unable to consent, Non-English speakers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve postpartum care for women who may face challenges after giving birth, focusing on reducing unnecessary emergency department visits and ensuring access to needed services. Participants will be divided into two groups: one will receive a helpful pamphlet and support from a patient navigator as part of the HOME Discharge Planning Intervention, while the other will receive standard care. The trial seeks postpartum women who have delivered at the Hospital of the University of Pennsylvania, identify as Black, speak English, and meet other risk factors. This initiative supports new mothers in managing health conditions like hypertension, diabetes, and depression. As an unphased trial, it offers participants the opportunity to contribute to innovative postpartum care solutions that could benefit future mothers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this educational intervention is safe for postpartum women?

Research has shown that education programs can improve care for new mothers after childbirth. One study on postpartum nursing programs found that they ease the transition from hospital to home. These programs provide essential medical advice and emotional support, helping mothers feel safer and more prepared after leaving the hospital.

Another review emphasizes the importance of education at discharge. It covers crucial safety topics like preventing falls, reducing infections, and recognizing postpartum depression. These programs ensure new mothers know when and how to seek help, teaching them to notice warning signs and act quickly.

In this trial, the HOME intervention provides new mothers with a pamphlet and access to a patient navigator, similar to the programs in the studies mentioned. The goal is to help mothers manage their health and connect them with useful resources. No harm or safety issues have been reported with these types of programs. Participants generally find them well-received and helpful. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HOME intervention for postpartum health because it offers a comprehensive and proactive approach to managing postpartum conditions like hypertension, diabetes, and depression. Unlike standard postpartum care, which typically involves routine check-ups and addressing issues as they arise, the HOME intervention provides tailored education through pamphlets and partner sheets, empowering new mothers with self-management skills and enhanced social support. Moreover, the involvement of a patient navigator who maintains regular contact with participants ensures ongoing support and connection to resources, which can significantly improve postpartum outcomes. This personalized and continuous support system sets the HOME intervention apart from typical postpartum care practices.

What evidence suggests that the HOME intervention is effective for improving postpartum care?

Studies show that postpartum care should be ongoing and personalized for each woman. Research indicates that good planning and education upon hospital discharge can improve health by connecting new mothers with the right resources and support. One study found that postpartum clinics focusing on issues like high blood pressure and offering lifestyle advice proved helpful. Although some research suggests that a single educational session might not reduce depression, ongoing support and personalized care can address various postpartum challenges. In this trial, one group will receive a patient education pamphlet and partner sheet, along with support from a patient navigator to provide comprehensive resources and fill gaps in care. Another group will receive standard postpartum care. This approach aims to provide essential support during the important postpartum period. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for postpartum Black women aged 18 or older who have recently delivered at the Hospital of University of Pennsylvania. Participants must speak English, be able to read, and meet certain risk criteria as determined by a prediction model.

Inclusion Criteria

Self-identify as Black (listed on chart)

Postpartum patients who have delivered a baby at the Hospital of University of Pennsylvania

Other characteristics defined by our risk prediction model (algorithm)

Exclusion Criteria

Speaks a language other than English

I am unable to understand and give consent for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a patient education pamphlet and partner sheet, and are supported by a patient navigator for 30 days postpartum

4 weeks

4-20 contacts (phone/text)

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on ED visits and readmissions

6 months

What Are the Treatments Tested in This Trial?

Interventions

• HOME

Trial Overview

The study aims to reduce emergency department visits/readmissions within the first 30 days after childbirth. It tests whether providing a pamphlet and access to a patient navigator can improve postpartum care quality and service accessibility for high-risk individuals.

How Is the Trial Designed?

Group I: Patient Education Pamphlet and Partner Sheet Experimental Treatment 1 Intervention

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.

Group II: Standard Postpartum Care Active Control 1 Intervention

These patients will receive Standard postpartum care.

HOME is already approved in Canada for the following indications:

Approved in Canada as HOME for:

• Improving daily life activities for frail older adults
• Reducing hospital and emergency readmissions

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

A randomized controlled trial involving 200 low-risk Iranian mothers showed that home-based postpartum care provided by midwives significantly improved maternal healthy behaviors compared to routine care, with a notable increase in mean scores from 120.5 to 148.9 in the intervention group.

The study found that many mothers in the control group did not receive their postpartum care, highlighting the effectiveness of home visits in ensuring mothers receive necessary support and care after delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of effects of home visits and routine postpartum care on the healthy behaviors of Iranian low-risk mothers. Mirmolaei, ST., Valizadeh, MA., Mahmoodi, M., et al.[2022]

Midwives reported both positive and negative experiences with the shift from hospital to home-based postpartum care, highlighting the need for clearer leadership and better resource allocation during this transition.

The change was associated with increased continuity of care and professional growth for midwives, suggesting that while the transition has challenges, it also offers opportunities for improvement in care quality and job satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Midwives' experiences of an organizational change in early postpartum care services in Norway: A qualitative study. Levorstad, T., Saue, MS., Nilsen, ABV., et al.[2022]

The SAFER Care framework, which includes standardized written and verbal discharge counseling, significantly improved caregiver comprehension of discharge instructions from 37% to 62% after implementation, based on surveys from 433 caregivers.

This study highlights the effectiveness of structured discharge counseling in a pediatric inpatient setting, suggesting that similar approaches could benefit other patient populations, especially those with limited English proficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SAFER Care: Improving Caregiver Comprehension of Discharge Instructions. Uong, A., Philips, K., Hametz, P., et al.[2022]

In a study of 300 elderly patients, it was found that 48.7% experienced high-risk adverse health events within 12 months after discharge, highlighting the vulnerability of this population post-hospitalization.

The study developed a predictive model that outperformed existing screening tools (Pra and LACE index) in identifying high-risk patients, suggesting that improved discharge planning and continuity of care are essential for reducing readmissions and enhancing patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploration of risk factors for high-risk adverse events in elderly patients after discharge and comparison of discharge planning screening tools. Yen, HY., Lin, SC., Chi, MJ.[2022]

The study surveyed 16 discharge planners from both rural and metropolitan hospitals to evaluate the effectiveness of discharge-planning processes in acute-care settings.

While most discharge planners focused on client-centered activities, they often failed to fully assess clients' resources and care deficits upon admission, which could impact the quality of discharge planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do discharge planners plan? Implications for older Medicare patients. Wacker, RR., Kundrat, MA., Keith, PM.[2017]

A postpartum home care program significantly improved mothers' health outcomes, including reduced postpartum depression, breastfeeding issues, and fatigue, based on a clinical trial involving 276 women.

The study showed that mothers receiving home care were more likely to use supplements and birth control methods compared to those who did not receive the service, indicating enhanced health management during the postpartum period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum home care and its effects on mothers' health: A clinical trial. Milani, HS., Amiri, P., Mohseny, M., et al.[2020]

The Hospital to Home Program effectively improves transitional care for patients discharged from the hospital by addressing both medical and social needs, which helps prevent unnecessary readmissions.

This program not only enhances patient satisfaction but also promotes better perceptions of physical and mental health during the critical days following discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evidence-based strategy for transitioning patients from the hospital to the community. Watkins, L.[2012]

Mothers appreciated the flexibility in postpartum care planning, allowing them to tailor care to their personal needs, which can enhance client-centered care.

However, challenges arose in effectively communicating their needs and discomfort in delegating tasks to care workers, highlighting the importance of emotional support and clear communication in the care process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mothers' experiences of client-centred flexible planning in home-based postpartum care: A promising tool to meet their diverse and dynamic needs. Lambermon, FJ., van Duijnhoven, NTL., Kremer, JAM., et al.[2021]

The HOME Initiative, involving 52 internal medicine residents, demonstrated that structured home visits to recently discharged patients significantly improved residents' patient-centered discharge planning skills and culturally sensitive care delivery.

Residents who participated in the intervention showed enhanced communication skills, allowing them to better understand patients' illness narratives and assess their safety, functional status, and health literacy, indicating the effectiveness of this educational approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Post-discharge Home Visitation to Improve Cultural Sensitivity and Patient-centered Discharge Planning by Internal Medicine Trainees. Wilson, JD., Shaw, KC., Feldman, LS.[2021]

Involving caregivers in discharge education for elderly patients with community-acquired pneumonia can significantly reduce unplanned hospital readmissions within 30 days, as shown by a systematic review of five studies.

While the evidence suggests that structured caregiver education interventions can lead to a small reduction in readmissions, the variability in caregiver learning needs and the lack of uniform effectiveness highlight the need for more targeted research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of patient-caregiver dyad discharge interventions on hospital readmissions of elderly patients with community acquired pneumonia: a systematic review. McLeod-Sordjan, R., Krajewski, B., Jean-Baptiste, P., et al.[2020]

The study revealed that a flexible planning approach for postpartum care, allowing care to be spread over 14 days instead of the usual 8-10 days, led to unintended consequences for care workers, including a shift in their tasks and concerns about meeting contracted hours.

Care workers ended up performing more domiciliary activities than expected, indicating that the new planning structure may prioritize organizational needs over the individualized care that clients require.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The unintended consequences of client-centred flexible planning in home-based postpartum care: a shift in care workers' tasks and responsibilities. Lambermon, FJ., van Duijnhoven, NTL., Braat, DDM., et al.[2021]

The Modified Physician-PREPARED scale was validated as a reliable tool to measure outpatient physicians' perceptions of hospital discharge quality, based on a survey of 403 patients and a 76% response rate.

Higher scores on the scale were associated with better discharge planning and communication, particularly when outpatient physicians were involved in the discharge process and aware of community support services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discharge planning scale: community physicians' perspective. Graumlich, JF., Grimmer-Somers, K., Aldag, JC.[2015]

Parents taking care of high-risk infants after hospital discharge face challenges, but a collaborative discharge process where they are actively involved can improve their ability to manage their child's care at home.

The Transitional Care Center provides a supportive environment that helps parents learn and master caregiving skills, leading to better clinical outcomes, shorter hospital stays, and lower readmission rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New practices in the transitional care center improve outcomes for babies and their families. Forsythe, P.[2019]

The Brief PREPARED (B-PREPARED) instrument, tested in a study of 460 patients, effectively measures how prepared patients feel for discharge from the hospital, showing good internal consistency and predictive validity.

Higher scores on the B-PREPARED scale correlate with better satisfaction regarding medication information and predict fewer emergency department visits after discharge, indicating its potential usefulness in improving discharge processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief scale measuring patient preparedness for hospital discharge to home: Psychometric properties. Graumlich, JF., Novotny, NL., Aldag, JC.[2015]

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