Navigating New Motherhood 2

Study Overview
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Brief Summary
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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
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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, receipt of desired contraception, postpartum depression screening/care, breastfeeding initiation/maintenance, and receipt of preventive care. Sub-Aims will include investigation of 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.

Official Title
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Navigating New Motherhood 2: Patient Navigation to Improve Outcomes Among Low-income Women in the Postpartum Period

Conditions
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Postpartum Health, Breastfeeding, Contraception, Preventive Care / Anticipatory Guidance, Retention in Care

Intervention / Treatment
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* Behavioral: Patient Navigation Program


Participation Criteria
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Eligibility Criteria
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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). 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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There will be two cohorts: One cohort 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 second cohort will receive usual care.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Navigation Group<br>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. | Behavioral: Patient Navigation Program<br>* A postpartum patient navigation program is designed to reduce barriers to care, enhance access, and improve multiple postpartum health outcomes, including retention in care, contraception uptake, vaccination, and depression screening.<br>|
| No Intervention: Non-navigation cohort<br>No navigation will be provided; women will receive usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum health at 4-12 weeks after delivery | 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 contraception, postpartum depression screening and care, breastfeeding initiation and maintenance, and receipt of preventive care. 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) | 4-12 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention in care (component of primary outcome) | Number of participants who return for comprehensive medical care at least once between 4 and 12 weeks postpartum. | 4-12 weeks postpartum | 
| Receipt of recommended counseling/anticipatory guidance (component of primary outcome) | Number of participants who have been counseled about indicated topics recommended for postpartum care/health | 4-12 weeks and 1 year postpartum | 
| Receipt of desired contraception (component of primary outcome) | Among participants who desire a contraceptive method, number of participants who received their chosen method | 4-12 weeks and 1 year postpartum | 
| Postpartum depression screening and care (component of primary outcome) | 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 further care | 4-12 weeks and 1 year postpartum | 
| Breastfeeding initiation and maintenance (component of primary outcome) | Among participants who desire to breastfeed, number of participants who have initiated and maintained exclusive or partial breastfeeding | 4-12 weeks postpartum | 
| Receipt of preventive care (component of primary outcome) | Number of participants who received indicated vaccines (e.g. influenza, TDaP, HPV, MMR; based on individual need) and screening tests (e.g. cervical cytology, pelvic/breast exams) by 12 weeks postpartum | 4-12 weeks postpartum | 
| Postpartum diabetes screening | Among women with gestational diabetes mellitus (GDM), number of women with completion of a 2-hour oral glucose tolerance test by 12 weeks postpartum | 4-12 weeks and 1 year postpartum | 
| Postpartum atherosclerotic cardiovascular disease screening | Among women with ASCVD-associated adverse pregnancy outcomes, number of women who undergo indicated clinical assessments for blood pressure, lipids, weight, nutrition, activity | 4-12 weeks and 1 year postpartum | 
| Gestational weight retention | Difference between weight at delivery and 1) weight at early postpartum (4-12 weeks) and 2) weight at 1 year postpartum | 4-12 weeks and 1 year postpartum | 
| Breastfeeding duration | Total duration of exclusive or partial breastfeeding among women who desired breastfeeding | 4-12 weeks and 1 year postpartum | 
| Postpartum transition to primary care | Number of women with appointment made and kept for primary care by 1 year postpartum | 1 year postpartum | 
| Patient-reported outcomes - self-efficacy, activation, engagement, quality of life, and other PROs | 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). | 4-12 weeks and 1 year postpartum | 
| Patient-reported outcomes - experiences with navigation (survey) | 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). | 4-12 weeks and 1 year postpartum | 
| Experiences with navigation (qualitative) | Qualitative perspectives on experiences with the navigation program, based on interviews with women who received navigation | 3-6 months postpartum and 1 year postpartum | 
| Pregnancy/postpartum experiences during 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 | At any point during the COVID-19 pandemic, up to 3 months after the end of the pandemic |