Implementation Models for Blood Pressure Monitoring in Pregnancy and Postpartum: Connected MOM Plus

Quality improvement (QI) initiative to improve uptake and utilization of Connected MOM, particularly among those with limited access to health care

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertensive Disorder of Pregnancy; Maternal Health Care
• Intervention / Treatment: Other: Connected MOM +

Detailed Description

Study outcomes include: 1) To determine whether providing enhanced support and coaching to support Connected MOM use increases use among those who stand to benefit; 2) To determine whether Connected MOM and healthcare resources are more appropriately used with provision of additional support; and 3) To determine whether the enhancement of support for the Connected MOM program improves maternal and infant health outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily W Harville, PhD; Phone Number: 504-988-7327; Email: harville@tulane.edu
• Study Contact Backup: Name: Sherri M Longo, MD; Phone Number: 504-842-4151; Email: slongo@ochsner.org

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Health
      • Principal Investigator: Sherri Longo, MD
      • Contact: Sherri Longo, MD; Phone Number: 504-842-4151; Email: slongo@ochsner.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Access to a smartphone
• Understanding of English or Spanish in oral and written discourses
• Have a participating Ochsner-employed provider
• Plan to deliver at a participating Ochsner hospital
• Reside in a zip code served by the participating clinics

Exclusion Criteria:

• Provider feels that study participation is not in patient's best interest
• Does not understand English or Spanish well enough to follow recommendations
• Plans to move from the study area served by the participating clinics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention - CM+; Navigator support to enroll and use Connected MOM	Other: Connected MOM +; Navigator support to encourage enrollment, consistent use, and postpartum follow-up in Connected MOM program
No Intervention: Control - CM; Standard protocol for offering Connected MOM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful use of the intervention and control programs measured by enrollment aggregate	Aggregate enrollment in the intervention or control arms by 25 weeks of gestation relative to the total number of eligible participants. This will be measured by the total number of women participating in the Connected MOM or Connected MOM+ divided by the total number of eligible pregnant women presenting to the hospital.	6-9 months
Successful use of the intervention and control programs as determined by the systolic and diastolic blood pressure measurements	This is determined by measuring the systolic and diastolic blood pressure in mmHg at least once per week during pregnancy.	6-9 months
Successful use of the intervention and control programs as determined by postpartum blood pressure measurement	This is determined by measuring at least one postpartum blood pressure measurement (systolic and diastolic) in mmHg before a postpartum visit.	6-9 months
Adequacy of prenatal care	Adequacy of prenatal care will be measured using the Kotelchuck index, a score that assesses the adequacy of maternal health care. The score ranges from 0% to above, with higher scores indicating better maternal health care.	6-9 months
Adverse composite maternal outcome	pre-eclampsia without severe features (~5%), pre-eclampsia with severe features (1-2%), HELLP syndrome; eclampsia (rare), preterm delivery < 37 weeks (spontaneous or indicated) (12-15%), SMM without transfusion included (around 2-3%), maternal mortality	6-9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach	Number of patients enrolled by 25 weeks' gestation)/# of patients either eligible, order placed, onboarded, or contacted by navigator	6-9 months
Sustainability	Number of Connected MOM enrolled pregnancies in a given year / # eligible pregnancies by geographic residence	6-9 months
Engagement	Percent of eligible weeks with a remote BP measurement	6-9 months
Retention	Percent of people who remain in the program to delivery and to 4-6 weeks postpartum	6-9 months
Attendance of a postpartum visit	Attendance at at least 1 postpartum visit to compare compliance with physicians' recommendations for postpartum care between the 2 groups.	6-9 months

Collaborators and Investigators

• Sponsor: Tulane University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Ochsner Health System
• Investigators: Principal Investigator: Emily W Harville, PhD, Tulane University Weatherhead School of Public Health

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: July 2, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: prenatal care; maternal and infant health; postpartum follow-up
• Additional Relevant MeSH Terms: Infections; Toxemia
• Other Study ID Numbers: U54HD113159 (RP2); U54HD113159 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data are covered by HIPAA

Drug and device information, study documents

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