Navigating New Motherhood 2

Not Applicable

Active, not recruiting

• Conditions: Preventive Care / Anticipatory Guidance; Postpartum Health; Breastfeeding; Contraception; Retention in Care
• Interventions: Behavioral: Patient Navigation Program

• Registration Number: NCT03922334
• Lead Sponsor: Northwestern University

Brief Summary

The primary aim of this study is to determine whether implementation of a postpartum patient navigation program improves health outcomes among low-income women. Patient navigation is a barrier focused, long-term patient-centered intervention that offers support for a defined set of health services. The intervention under investigation is a comprehensive postpartum patient navigator program. Women who are randomized to receive patient navigation will be compared to women who are randomized to receive usual care. Navigators will support women through one year postpartum. The NNM2 program will be grounded in understanding and addressing social determinants of health in order to promote self-efficacy, enhance access, and sustain long-term engagement. Participants will undergo surveys, interviews, and medical record review at 4-12 weeks and 11-13 months postpartum. The investigators will additionally conduct focus groups and surveys with clinical providers.

Detailed Description

The postpartum period - often called the "fourth trimester" - is a time of rapid and intense change in the life of a woman and her family, and uptake of health care during this transition is critical to optimizing women's long-term health and the health of their subsequent pregnancies. The importance of postpartum care has been reinforced by professional organizations, yet postpartum care in the United States remains inadequate. Substantial racial/ethnic and socioeconomic disparities in health care uptake, quality, and outcomes exist. Improving health for all women requires the development of new, more comprehensive approaches to postpartum and interconceptional care. One potential model may be patient navigation, which is a barrier-focused, longitudinal, patient-centered intervention that offers support for a defined set of health services.

This protocol is to evaluate whether implementation of a postpartum patient navigation program improves health outcomes among low-income women. The investigators previously developed a postpartum patient navigation program, called Navigating New Motherhood (NNM), which introduced a clinic-level intervention in which a patient navigator assumed postpartum supportive and logistical responsibilities for low-income women. Navigation was associated with improvements in outcomes (retention in care, contraception uptake, vaccination, and depression screening) compared to those of a historical cohort. The investigators now propose to test the efficacy of the updated NNM model - called "NNM2" - via a randomized trial. The study will randomize 400 pregnant or postpartum women (1:1) with publicly-funded prenatal care to NNM2 versus usual care. Women randomized to navigation will be provided intensive, individualized, one-on-one navigation services through 12 weeks postpartum and, based on individual needs, ongoing, tapered navigation through one year postpartum. The NNM2 program will be grounded in understanding and addressing social determinants of health in order to promote self-efficacy, enhance access, and sustain long-term engagement. Participants will undergo surveys, interviews, and medical record review at 4-12 weeks and 11-13 months postpartum.

Aim 1 will evaluate whether the navigation program improves clinical outcomes at 4-12 weeks postpartum as measured via a composite of health status that includes retention in care, receipt of recommended counseling ("anticipatory guidance"), receipt of desired family planning method, postpartum depression screening/care, breastfeeding initiation/maintenance, and receipt of indicated vaccinations. Sub-Aims will include investigation of relevant outcomes at 11-13 months postpartum. Aim 2 will evaluate whether NNM2 improves patient-reported outcomes. Aim 3 additionally involves examining obstetric and primary care provider perspectives on the navigation program and on optimizing the postpartum transition. Completion of this study will fill an evidence gap by demonstrating whether postpartum patient navigation is an effective mechanism to improve women's short- and long-term health, enhance health care utilization, and improve patient and provider satisfaction.

NNM2 suspended enrollment due to COVID-19 beginning March 16, 2020. For already enrolled individuals, study visits and patient navigation activities were converted to tele-research and tele-navigation. Recruitment was planned to resume when the COVID-19 pandemic resolves and normal outpatient care has resumed. For individuals already recruited and whose care occurred during the early phases of the pandemic, the outcomes definitions were appropriately modified for the conduct of telemedicine during the pandemic. Recruitment resumed on June 8, 2020, with continued use of telemedicine or tele-research when appropriate. Given the ongoing pandemic, the modified outcomes definitions for telemedicine provision of care were retained.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-04-18
• Study First Posted: 2019-04-19
• Study Start: 2020-01-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 405

Inclusion Criteria

• Pregnant (any plurality) delivering at or after 20 weeks of gestation OR postpartum (during hospitalization), regardless of perinatal outcome
• 16 years or older
• Low-income socioeconomic status (publicly funded prenatal care)
• Ability to speak and read English or Spanish
• Established patient at the Northwestern Medicine Prentice Ambulatory Care clinical site (at least one antenatal clinical visit).

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Exclusion Criteria

• Intent to transfer care to an outside institution
• HIV (as these patients already receive intensive social support and navigation-like services at this institution)
• Prior pregnancy in which individual declined participation
• Prior enrollment in NNM2
• Enrollment in a concurrent research study that poses a potential conflict to the aims of either NNM2 or the other study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Navigation Group	Patient Navigation Program	Women who are randomized into NNM2 will be assigned to a patient navigator. The patient navigator will meet with the patient after delivery occurs for introductions and education. The patient navigator will offer support and resources (transportation, community referrals, support for your mental health, connection to your doctors, etc.). The navigator will also help to schedule postpartum medical appointments, and will remind the patients of these appointments via text, email, or phone calls. The navigator will continue to provide psychosocial support and continued linkage to resources through one-year postpartum.

Primary Outcome Measures

Name	Time	Method
Postpartum health at 4-12 weeks after delivery	4-12 weeks postpartum	Number of women who achieve a composite measure of health status that includes retention in care, receipt of recommended counseling (anticipatory guidance), receipt of desired family planning method, postpartum depression screening and linkage, breastfeeding initiation and maintenance, and receipt of indicated vaccination. Components of the primary outcome composite will also be examined as a score and individually as secondary outcomes (see below). (Outcome is modified to include receipt telemedicine when appropriate for health care for women who require postpartum care during the pandemic)

Secondary Outcome Measures

Name	Time	Method
Receipt of desired family planning method (component of primary outcome)	4-12 weeks and 1 year postpartum	Number of participants who received their desired family planning method
Postpartum depression screening and care (component of primary outcome)	4-12 weeks and 1 year postpartum	Number of participants who undergo appropriate screening for postpartum depression with either 1) screening that indicates no depressive symptoms, or 2) if depressive symptoms are identified, patient receives linkage to further care
Breastfeeding initiation and maintenance (component of primary outcome)	4-12 weeks postpartum	Number of participants who have initiated and maintained exclusive or partial breastfeeding
Retention in care (component of primary outcome)	4-12 weeks postpartum	Number of participants who return for comprehensive medical care at least once between 4 and 12 weeks postpartum.
Receipt of recommended counseling/anticipatory guidance (component of primary outcome)	4-12 weeks and 1 year postpartum	Number of participants who have been counseled about indicated topics recommended for postpartum care/health
Receipt of indicated vaccinations (component of primary outcome)	4-12 weeks postpartum	Number of participants who received indicated vaccines (e.g. influenza, TDaP, HPV, MMR; based on individual need)
Postpartum diabetes screening	4-12 weeks and 1 year postpartum	Among women with gestational diabetes mellitus (GDM), number of women with completion of a 2-hour oral glucose tolerance test by 12 weeks postpartum and any other diabetes screening tests by 1 year postpartum
Postpartum atherosclerotic cardiovascular disease screening	4-12 weeks and 1 year postpartum	Among women with ASCVD-associated adverse pregnancy outcomes, number of women who undergo indicated clinical assessments for blood pressure, lipids, weight, nutrition, activity
Gestational weight retention	4-12 weeks and 1 year postpartum	Difference between weight at delivery and 1) weight at early postpartum (4-12 weeks) and 2) weight at 1 year postpartum
Breastfeeding duration	4-12 weeks and 1 year postpartum	Total duration of exclusive or partial breastfeeding among women who initated breastfeeding
Postpartum transition to primary care	1 year postpartum	Number of women with appointment made and kept for primary care by 1 year postpartum
Patient-reported outcomes - self-efficacy, activation, engagement, quality of life, and other PROs	4-12 weeks and 1 year postpartum	Differences in self-efficacy, activation, quality of life, engagement, and other PROs between women who are randomized to navigation versus usual care, using the DHHS PROMIS and other validated measures of PROs.; PROs to be measured include global health status (PROMIS Global Health), health literacy (Newest Vital Sign), depressive symptoms (Patient Health Questionnaire-9), pregnancy experience and pregnancy-related stress (Pregnancy Experience Scale - Brief, at 4-12 weeks only), patient activation (Patient Activation Measure), health-related self-efficacy (PROMIS Self-Efficacy - general), informational support (PROMIS Informational Support), perceived stress (Perceived Stress Scale), breastfeeding self-efficacy (Breastfeeding Self-Efficacy Scale), postpartum preparedness (Postpartum Preparedness Checklist), and satisfaction with prenatal and postpartum care (original and adaptation of Prenatal Care Satisfaction Scale).
Experiences with navigation (qualitative)	3-6 months postpartum and 1 year postpartum	Qualitative perspectives on experiences with the navigation program, based on interviews with women who received navigation
Pregnancy/postpartum experiences during the pandemic	At any point during the COVID-19 pandemic, up to 3 months after the end of the pandemic	Qualitative perspective of participants' experiences during the COVID-19 pandemic, utilizing a semi-structured interview guide developed by the research team, as it relates to their receipt of health care, experiences as a pregnant person and new parent, and the role of patient navigation in this time period
Patient-reported outcomes - experiences with navigation (survey)	4-12 weeks and 1 year postpartum	Navigated participants' experiences with navigation as assessed through PRO surveys (Patient Satisfaction with Interpersonal Relationship with Navigator Scale and Patient Satisfaction with Logistical Aspects of Navigation Scale).

Trial Locations

Locations (1)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States