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 : Not yet recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Health Breastfeeding Contraception Preventive Care / Anticipatory Guidance Retention in Care||Behavioral: Patient Navigation Program||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|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|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||January 2024|
|Estimated Study Completion Date :||December 2024|
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.
- 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.
- 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
- 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
- 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
- Breastfeeding [ Time Frame: 4-12 weeks and 1 year postpartum ]Total duration of exclusive or partial breastfeeding among women who desired breastfeeding
- 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
- 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.
- Experiences with navigation [ Time Frame: 1 year postpartum ]Qualitative perspectives on experiences with the navigation program, based on interviews with women who received navigation
- 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
- 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
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
|Contact: Lynn M Yee, MD, MPHfirstname.lastname@example.org|
|Contact: Jade Rayemail@example.com|
|Principal Investigator:||Lynn M Yee, MD, MPH||Northwestern University|