Navigating New Motherhood 2 (NNM2)

• ClinicalTrials.gov Identifier: NCT03922334
• Recruitment Status: Recruiting
• First Posted: April 19, 2019
• Last Update Posted: March 3, 2021
• Sponsor: Northwestern University
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): Lynn M Yee, Northwestern University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Postpartum Health; Breastfeeding; Contraception; Preventive Care / Anticipatory Guidance; Retention in Care	Behavioral: Patient Navigation Program	Not Applicable

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, 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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)
• Primary Purpose: Supportive Care
• Official Title: Navigating New Motherhood 2: Patient Navigation to Improve Outcomes Among Low-income Women in the Postpartum Period
• Actual Study Start Date: January 21, 2020
• Estimated Primary Completion Date: January 2024
• Estimated Study Completion Date: December 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Navigation Group; 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; 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.
No Intervention: Non-navigation cohort; No navigation will be provided; women will receive usual care.

Outcome Measures

Primary Outcome Measures :

1. Postpartum health at 4-12 weeks after delivery [ Time Frame: 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 contraception, postpartum depression screening and care, breastfeeding initiation and maintenance, and receipt of preventive care. (Outcome is modified to include receipt telemedicine for health care for women who require postpartum care during the pandemic)

Secondary Outcome Measures :

1. Postpartum diabetes screening [ Time Frame: 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
2. Postpartum atherosclerotic cardiovascular disease screening [ Time Frame: 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
3. Gestational weight retention [ Time Frame: 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
4. Breastfeeding [ Time Frame: 4-12 weeks and 1 year postpartum ]
   Total duration of exclusive or partial breastfeeding among women who desired breastfeeding
5. Postpartum transition to primary care [ Time Frame: 1 year postpartum ]
   Number of women with appointment made and kept for primary care by 1 year postpartum
6. Patient-reported outcomes - self-efficacy, activation, and engagement [ Time Frame: 4-12 weeks and 1 year postpartum ]
   Differences between self-efficacy, activation, and engagement between women who are randomized to navigation versus usual care, using the Department of Health and Human Services (DHHS) Patient-Reported Outcomes Measurement Information System.
7. Experiences with navigation [ Time Frame: 3-6 months postpartum and 1 year postpartum ]
   Qualitative perspectives on experiences with the navigation program, based on interviews with women who received navigation
8. Pregnancy/postpartum experiences during the pandemic [ Time Frame: 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

Other Outcome Measures:

1. Evaluate clinician perspectives on patient navigation [ Time Frame: Through completion of study, an average of 3 years ]
   Qualitative feedback on how NNM2 can meet the needs of the clinicians and optimize the transition to primary care, as assessed by feedback from obstetrician and primary care provider focus groups
2. Evaluate clinician experiences with NNM2 [ Time Frame: Through completion of study, an average of 5 years ]
   Number of clinicians who believed NNM2 met their needs and improved patient care, as determined by surveys feedback

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 50 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Contacts

Contact: Lynn M Yee, MD, MPH; 312-472-0119; lynn.yee@northwestern.edu

Contact: Brittney Williams, MPH; 312-503-3476; brittney.williams@northwestern.edu

Locations

United States, Illinois

Northwestern Memorial Hospital; Recruiting

Chicago, Illinois, United States, 60611

Contact: Brittney Williams 312-503-3476

Sponsors and Collaborators

Northwestern University

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

• Principal Investigator: Lynn M Yee, MD, MPH; Northwestern University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ruderman RS, Dahl EC, Williams BR, Davis K, Feinglass JM, Grobman WA, Kominiarek MA, Yee LM. Provider Perspectives on Barriers and Facilitators to Postpartum Care for Low-Income Individuals. Womens Health Rep (New Rochelle). 2021 Jul 16;2(1):254-262. doi: 10.1089/whr.2021.0009. eCollection 2021.

• Responsible Party: Lynn M Yee, Assistant Professor, Northwestern University
• ClinicalTrials.gov Identifier: NCT03922334
• Other Study ID Numbers: STU002096009; 1R01HD098178 ( U.S. NIH Grant/Contract )
• First Posted: April 19, 2019
• Last Update Posted: March 3, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No