Assessing the Maternal Outcome Monitoring Systems (MOMS)

Single Arm Clinical Trial of a Novel Smartphone-based Somatic and Psychological Symptom Monitoring and Decision Support Tool for African American and Spanish Speaking Patients in the Near Postpartum Period

Pregnancy-related death is a growing public health issues, which are of particular concern to minority groups, including African-Americans and Spanish-speaking Latinas. Our proposal aims to improve a patient's ability to detect warning signs of pregnancy related death and seek medical care.

Study Overview

• Status: Not yet recruiting
• Conditions: Maternal Death; Maternal Complication of Pregnancy
• Intervention / Treatment: Other: Maternal Outcome Monitoring and Support system

Detailed Description

Pregnancy-related death (PRD) rates have risen 120-200% in the United States in the past two decades, and experts estimate that 40-60% of these cases are preventable. Improvement initiatives are predominantly hospital-based and rely on perinatal people recognizing their own symptoms and seeking care without ample support or education. We hypothesize that we can improve patients' self-efficacy and decision-making about when to seek care by helping them to self-monitor symptoms and by providing decision support. We propose to develop a mHealth-based, patient-reported outcome (PRO) and decision-support system to help mothers determine when to seek care for warning signs of PRD. Our project focuses on diverse populations facing postpartum disparities, particularly African- American and Spanish-speaking Latina women. This protocol involves a single-arm pilot trial assessing the feasibility and preliminary effectiveness of MOMS/MAMA for improving knowledge and patient activation among postpartum patients.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natalie Benda; Phone Number: 917-426-3069; Email: nb3115@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • NewYork-Presbyterian Columbia University Irving Medical Center
      • Contact: Natalie Benda; Email: nb3115@cumc.columbia.edu
      • Principal Investigator: Natalie Benda, PhD
    • New York, New York, United States, 10065
      • NewYork-Prebyterian/Weill Cornell Medical Center
      • Contact: Natalie Benda; Email: ncb4001@med.cornell.edu
      • Contact: Robin Kalish; Email: rbk9001@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Greater than 28 weeks pregnant
• Receiving healthcare in the United States
• Age 18 years or older
• [Identify as Black or African American race AND able to speak and read English, AND preferred language of English] OR [Identify as Hispanic/Latino Ethnicity AND Spanish able to speak and read Spanish AND preferred language of Spanish]
• Planned delivery at the following NewYork-Presbyterian hospitals: Children's Hospital of New York, Allen Hospital, Weill Cornell Medical Center, Lower Manhattan Hospital

Exclusion Criteria:

• Severe cognitive impairment
• Major psychiatric illness
• Concomitant terminal illness that would preclude participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MOMS intervention; Participants in this condition will receive the MOMS symptom monitoring and decision support intervention. This is a single arm trial.	Other: Maternal Outcome Monitoring and Support system; The Maternal Outcome Monitoring and Support system is a mobile health application that allows participants to choose symptoms they may be having that are warning signs of pregnancy related death. They then receive decision support about when they should seek medical care (call their provider or go to an emergency room).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient activation	Change in patient activation measured using the validated Patient Activation Measure (PAM)	Baseline to 6 weeks postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge of pregnancy related death warning signs	Change in knowledge of warning signs for pregnancy related death	Baseline to 6 weeks postpartum

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: May 13, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: mHealth; patient activation; patient reported outcomes; pregnancy related death
• Additional Relevant MeSH Terms: Pathologic Processes; Death; Parental Death; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Maternal Death
• Other Study ID Numbers: AAAU9647; 5R00MD015781-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be shared in the aggregate. There is no plan to make IDP available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No