Clinical trial NCT03922334: Navigating New Motherhood 2
Official title: Navigating New Motherhood 2: Patient Navigation to Improve Outcomes Among Low-income Women in the Postpartum Period
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Postpartum Health
Breastfeeding
Contraception
Preventive Care / Anticipatory Guidance
Retention in Care
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-04-19
Enrollment: 405
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 (11-13 months) postpartum. The second cohort will receive usual care.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Postpartum health at 4-12 weeks after delivery
timeFrame: 4-12 weeks postpartum
Secondary outcomes:
measure: Retention in care (component of primary outcome)
timeFrame: 4-12 weeks postpartum
measure: Receipt of recommended counseling/anticipatory guidance (component of primary outcome)
timeFrame: 4-12 weeks and 1 year postpartum
measure: Receipt of desired family planning method (component of primary outcome)
timeFrame: 4-12 weeks and 1 year postpartum
measure: Postpartum depression screening and care (component of primary outcome)
timeFrame: 4-12 weeks and 1 year postpartum
measure: Breastfeeding initiation and maintenance (component of primary outcome)
timeFrame: 4-12 weeks postpartum
measure: Receipt of indicated vaccinations (component of primary outcome)
timeFrame: 4-12 weeks postpartum
measure: Postpartum diabetes screening
timeFrame: 4-12 weeks and 1 year postpartum
measure: Postpartum atherosclerotic cardiovascular disease screening
timeFrame: 4-12 weeks and 1 year postpartum
measure: Gestational weight retention
timeFrame: 4-12 weeks and 1 year postpartum
measure: Breastfeeding duration
timeFrame: 4-12 weeks and 1 year postpartum
measure: Postpartum transition to primary care
timeFrame: 1 year postpartum
measure: Patient-reported outcomes - self-efficacy, activation, engagement, quality of life, and other PROs
timeFrame: 4-12 weeks and 1 year postpartum
measure: Patient-reported outcomes - experiences with navigation (survey)
timeFrame: 4-12 weeks and 1 year postpartum
measure: Experiences with navigation (qualitative)
timeFrame: 3-6 months postpartum and 1 year postpartum
measure: Pregnancy/postpartum experiences during the pandemic
timeFrame: At any point during the COVID-19 pandemic, up to 3 months after the end of the pandemic
Other outcomes:
measure: Clinician perspectives on patient navigation
timeFrame: Through completion of study, an average of 3 years
measure: Clinician experiences with NNM2
timeFrame: Through completion of study, an average of 5 years
measure: Navigation intensity and activities
timeFrame: Through completion of study, an average of 5 years
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Lynn M Yee, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.