Navigating New Motherhood 2

NCT03922334 | Completed

• 2 other identifiers: STU0020960091R01HD098178
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding; Contraception; Retention in Care; Postpartum Health; Preventive Care / Anticipatory Guidance

Outcome Measures

Primary Outcomes (1)

• 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 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)

  4-12 weeks postpartum

Secondary Outcomes (15)

• Retention in care (component of primary outcome)

  4-12 weeks postpartum

• Receipt of recommended counseling/anticipatory guidance (component of primary outcome)

  4-12 weeks and 1 year postpartum

• Receipt of desired family planning method (component of primary outcome)

  4-12 weeks and 1 year postpartum

• Postpartum depression screening and care (component of primary outcome)

  4-12 weeks and 1 year postpartum

• Breastfeeding initiation and maintenance (component of primary outcome)

  4-12 weeks postpartum

Other Outcomes (3)

• Clinician perspectives on patient navigation

  Through completion of study, an average of 3 years

• Clinician experiences with NNM2

  Through completion of study, an average of 5 years

• Navigation intensity and activities

  Through completion of study, an average of 5 years

Study Arms (2)

Navigation Group

EXPERIMENTAL

Women who are randomized into NNM2 will be assigned to a patient navigator. The patient navigator will meet with the patient during pregnancy and 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, social needs support, and continued linkage to resources through one-year postpartum.

Behavioral: Patient Navigation Program

Non-navigation cohort

NO INTERVENTION

No navigation will be provided; women will receive usual care.

Interventions

Patient Navigation Program BEHAVIORAL

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.

Navigation Group

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant (any plurality) delivering at or after 20 weeks of gestation OR postpartum (during hospitalization), regardless of perinatal outcome
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (8)

• Yee LM, Williams B, Green HM, Carmona-Barrera V, Diaz L, Davis K, Kominiarek MA, Feinglass J, Zera CA, Grobman WA. Bridging the postpartum gap: best practices for training of obstetrical patient navigators. Am J Obstet Gynecol. 2021 Aug;225(2):138-152. doi: 10.1016/j.ajog.2021.03.038. Epub 2021 Apr 1.

  PMID: 33812809 BACKGROUND

• 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.

  PMID: 34318295 RESULT

• Filicko A, Huennekens K, Davis K, Dolan BM, Williams BR, Feinglass J, Grobman WA, Kominiarek MA, Yee LM. Primary Care Clinician Perspectives on Patient Navigation to Improve Postpartum Care for Patients with Low Income. Womens Health Rep (New Rochelle). 2022 Dec 15;3(1):1006-1015. doi: 10.1089/whr.2022.0064. eCollection 2022.

  PMID: 36636317 RESULT

• Green HM, Diaz L, Carmona-Barrera V, Grobman WA, Yeh C, Williams B, Davis K, Kominiarek MA, Feinglass J, Zera C, Yee LM. Mapping the Postpartum Experience Through Obstetric Patient Navigation for Low-Income Individuals. J Womens Health (Larchmt). 2024 Jul;33(7):975-985. doi: 10.1089/jwh.2023.0459. Epub 2024 Jan 23.

  PMID: 38265478 RESULT

• Green HM, Carmona-Barrera V, Diaz L, Yeh C, Williams B, Davis K, Kominiarek MA, Feinglass J, Grobman WA, Zera C, Yee LM. Implementation of postpartum navigation for low-income individuals at an urban academic medical center. PLoS One. 2023 Feb 23;18(2):e0282048. doi: 10.1371/journal.pone.0282048. eCollection 2023.

  PMID: 36821597 RESULT

• Ruderman RS, Dahl EC, Williams BR, Feinglass JM, Kominiarek MA, Grobman WA, Yee LM. Obstetric Provider Perspectives on Postpartum Patient Navigation for Low-Income Patients. Health Educ Behav. 2023 Apr;50(2):260-267. doi: 10.1177/10901981211043117. Epub 2021 Oct 12.

  PMID: 34636273 RESULT

• Green HM, Williams B, Diaz L, Carmona-Barrera V, Davis K, Feinglass J, Kominiarek MA, Dolan BM, Grobman WA, Yee LM. Evaluating feedback from an implementation advisory board to assess the rollout of a postpartum patient navigation program. Implement Sci Commun. 2024 May 3;5(1):50. doi: 10.1186/s43058-024-00589-6.

  PMID: 38702751 DERIVED

• Davis KM, Lu L, Williams B, Roas-Gomez MV, Leziak K, Jackson J, Feinglass J, Yee LM. The Stress of Parenting in the Postpartum Period During the COVID-19 Pandemic. Womens Health Rep (New Rochelle). 2022 Nov 9;3(1):895-903. doi: 10.1089/whr.2022.0029. eCollection 2022.

  PMID: 36479375 DERIVED

MeSH Terms

Conditions

Breast Feeding

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Lynn M Yee, MD, MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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 (11-13 months) postpartum. The second cohort will receive usual care.

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 19, 2019
• Study Start: January 21, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)