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| ID | Type | Description | Link |
|---|---|---|---|
| U54HD113159 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Ochsner Health System | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention - CM+ | Active Comparator | Navigator support to enroll and use Connected MOM |
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| Control - CM | No Intervention | Standard protocol for offering Connected MOM |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Connected MOM + | Other | Navigator support to encourage enrollment, consistent use, and postpartum follow-up in Connected MOM program |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emily W Harville, PhD | Contact | 504-988-7327 | harville@tulane.edu | |
| Sherri M Longo, MD | Contact | 504-842-4151 | slongo@ochsner.org |
| Name | Affiliation | Role |
|---|---|---|
| Emily W Harville, PhD | Tulane University Weatherhead School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ochsner Health | New Orleans | Louisiana | 70121 | United States |
Data are covered by HIPAA
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| ID | Term |
|---|---|
| D014115 | Toxemia |
| ID | Term |
|---|---|
| D007239 | Infections |
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Cluster-randomized
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Statistician
| 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 |