Navigating New Motherhood 2

Contraception Clinical Trial

— NNM2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03922334
• Other study ID #: STU002096009
• Secondary ID: 1R01HD098178
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 21, 2020
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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, 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 405
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinician perspectives on patient navigation	Qualitative feedback on how NNM2 can meet the needs of the clinicians and optimize postpartum care and the transition to primary care, as assessed by feedback from obstetrician and primary care provider focus groups	Through completion of study, an average of 3 years
Other	Clinician experiences with NNM2	Number of clinicians who believed NNM2 met their needs and improved patient care, as determined by survey feedback obtained at the time of participants' postpartum visits	Through completion of study, an average of 5 years
Other	Navigation intensity and activities	Mixed methods data on navigation intensity (number of interactions over the postpartum year), types of activities completed for/with participants, types of communication modes used, and numbers/types of other health care team members involved in navigation activities. Data will be integrated from navigator weekly logs of navigation activities and quarterly in-depth qualitative interviews with the navigators.	Through completion of study, an average of 5 years
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Breastfeeding duration	Total duration of exclusive or partial breastfeeding among women who desired breastfeeding	4-12 weeks and 1 year postpartum
Secondary	Postpartum transition to primary care	Number of women with appointment made and kept for primary care by 1 year postpartum	1 year postpartum
Secondary	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
Secondary	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
Secondary	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
Secondary	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