HOME Intervention for Postpartum Health

(HOME Trial)

Overseen By Angelina Malenda

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Pennsylvania

Disqualifiers: Unable to consent, Non-English speakers

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this educational clinical trial is to identify Black 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 high-risk women. The main question\[s\] it aims to answer are: * How can the investigators help postpartum Black people who have poor outcomes by decreasing the number of ED visits/readmissions for postpartum people 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.

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 data supports the effectiveness of the HOME Discharge Planning Intervention treatment for postpartum health?

Research shows that patient-centered discharge planning, like the HOME Intervention, can improve health outcomes and reduce hospital readmissions by involving family caregivers and addressing both medical and social needs after leaving the hospital. ^{1 2 3 4 5}

Is the HOME Intervention for Postpartum Health safe for humans?

The available research on discharge planning interventions, including those similar to the HOME Intervention, focuses on improving patient care and reducing adverse events after hospital discharge. While specific safety data for the HOME Intervention in postpartum health is not provided, these types of interventions generally aim to enhance safety and care during the transition from hospital to home. ^{1 6 7 8 9}

How is the HOME Intervention for Postpartum Health different from other postpartum treatments?

The HOME Intervention for Postpartum Health is unique because it focuses on flexible, client-centered planning for postpartum care at home, which allows for personalized care that adapts to the diverse and changing needs of new mothers. This approach contrasts with traditional postpartum care that often involves standard procedures and less personalized attention. ^{10 11 12 13 14}

Eligibility Criteria

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

I am 18 years old or older.

Self-identify as Black (listed on chart)

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

Exclusion Criteria

Speaks a language other than English

I am unable to understand and give consent for treatment.

Trial Timeline

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

Treatment Details

Interventions

• HOME (Behavioral Intervention)

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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 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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Using Post-discharge Home Visitation to Improve Cultural Sensitivity and Patient-centered Discharge Planning by Internal Medicine Trainees. [2021]

2. Australia 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. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

What do discharge planners plan? Implications for older Medicare patients. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Discharge planning scale: community physicians' perspective. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

SAFER Care: Improving Caregiver Comprehension of Discharge Instructions. [2022]

8. United States 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Brief scale measuring patient preparedness for hospital discharge to home: Psychometric properties. [2015]

10. Scotland 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. [2021]

11. Iran pubmed.ncbi.nlm.nih.gov

Comparison of effects of home visits and routine postpartum care on the healthy behaviors of Iranian low-risk mothers. [2022]

12. India pubmed.ncbi.nlm.nih.gov

Postpartum home care and its effects on mothers' health: A clinical trial. [2020]

13. Scotland 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. [2021]

14. Greece pubmed.ncbi.nlm.nih.gov

Midwives' experiences of an organizational change in early postpartum care services in Norway: A qualitative study. [2022]