Hypertensive Disorder of Pregnancy, Maternal Health Care
Conditions
Keywords
maternal and infant health, prenatal care, postpartum follow-up
Brief summary
Quality improvement (QI) initiative to improve uptake and utilization of Connected MOM, particularly among those with limited access to health care
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.
Interventions
OTHERConnected MOM +
Navigator support to encourage enrollment, consistent use, and postpartum follow-up in Connected MOM program
Sponsors
Tulane University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Ochsner Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Statistician
Intervention model description
Cluster-randomized
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful use of the intervention and control programs measured by enrollment aggregate | 6-9 months | 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. |
| Successful use of the intervention and control programs as determined by the systolic and diastolic blood pressure measurements | 6-9 months | This is determined by measuring the systolic and diastolic blood pressure in mmHg at least once per week during pregnancy. |
| Successful use of the intervention and control programs as determined by postpartum blood pressure measurement | 6-9 months | This is determined by measuring at least one postpartum blood pressure measurement (systolic and diastolic) in mmHg before a postpartum visit. |
| Adequacy of prenatal care | 6-9 months | 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. |
| Adverse composite maternal outcome | 6-9 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reach | 6-9 months | Number of patients enrolled by 25 weeks' gestation)/# of patients either eligible, order placed, onboarded, or contacted by navigator |
| Sustainability | 6-9 months | Number of Connected MOM enrolled pregnancies in a given year / # eligible pregnancies by geographic residence |
| Engagement | 6-9 months | Percent of eligible weeks with a remote BP measurement |
| Retention | 6-9 months | Percent of people who remain in the program to delivery and to 4-6 weeks postpartum |
| Attendance of a postpartum visit | 6-9 months | Attendance at at least 1 postpartum visit to compare compliance with physicians' recommendations for postpartum care between the 2 groups. |
Countries
United States
Contacts
CONTACTEmily W Harville, PhD
CONTACTSherri M Longo, MD
PRINCIPAL_INVESTIGATOREmily W Harville, PhD
Tulane University Weatherhead School of Public Health
Outcome results
None listed