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Navigating New Motherhood 2 (NNM2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03922334
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : April 14, 2022
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Lynn M Yee, Northwestern University

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, 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.

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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

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.



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. 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)


Secondary Outcome Measures :
  1. Retention in care (component of primary outcome) [ Time Frame: 4-12 weeks postpartum ]
    Number of participants who return for comprehensive medical care at least once between 4 and 12 weeks postpartum.

  2. Receipt of recommended counseling/anticipatory guidance (component of primary outcome) [ Time Frame: 4-12 weeks and 1 year postpartum ]
    Number of participants who have been counseled about indicated topics recommended for postpartum care/health

  3. Receipt of desired contraception (component of primary outcome) [ Time Frame: 4-12 weeks and 1 year postpartum ]
    Among participants who desire a contraceptive method, number of participants who received their chosen method

  4. Postpartum depression screening and care (component of primary outcome) [ Time Frame: 4-12 weeks and 1 year postpartum ]
    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

  5. Breastfeeding initiation and maintenance (component of primary outcome) [ Time Frame: 4-12 weeks postpartum ]
    Among participants who desire to breastfeed, number of participants who have initiated and maintained exclusive or partial breastfeeding

  6. Receipt of preventive care (component of primary outcome) [ Time Frame: 4-12 weeks postpartum ]
    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

  7. 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

  8. 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

  9. 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

  10. Breastfeeding duration [ Time Frame: 4-12 weeks and 1 year postpartum ]
    Total duration of exclusive or partial breastfeeding among women who desired breastfeeding

  11. 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

  12. Patient-reported outcomes - self-efficacy, activation, engagement, quality of life, and other PROs [ Time Frame: 4-12 weeks and 1 year postpartum ]

    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).


  13. Patient-reported outcomes - experiences with navigation (survey) [ Time Frame: 4-12 weeks and 1 year postpartum ]
    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).

  14. Experiences with navigation (qualitative) [ 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

  15. 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. 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 postpartum care and the transition to primary care, as assessed by feedback from obstetrician and primary care provider focus groups

  2. 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 survey feedback obtained at the time of participants' postpartum visits

  3. Navigation intensity and activities [ Time Frame: Through completion of study, an average of 5 years ]
    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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922334


Contacts
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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
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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
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Principal Investigator: Lynn M Yee, MD, MPH Northwestern University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: April 14, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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