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

Tulane University2,000 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

2,000

Conditions

Maternal Health Care Hypertensive Disorder of Pregnancy

Interventions

Connected MOM +OTHER

Navigator support to encourage enrollment, consistent use, and postpartum follow-up in Connected MOM program

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Ochsner Health

New Orleans, Louisiana, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 6-9 months

Secondary Outcomes

Reach

Central Contacts

Emily W Harville, PhD

CONTACT

504-988-7327 harville@tulane.edu

Sherri M Longo, MD

CONTACT

504-842-4151 slongo@ochsner.org

Data from ClinicalTrials.gov

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