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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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This is a pragmatic randomized control trial to evaluate the BETTER intervention compared to standard obstetrical care (control) to determine whether it helps to reduce maternal anemia and other adverse pregnancy outcomes. The BETTER intervention includes one motivational interviewing session and bi-weekly text messages to encourage patients to connect with resources that address their social needs, including housing, food, and transportation. Quantitative data will be used to study participant outcomes, including surveys, and electronic health record data.
There are more than 3.5 million births per year in the United States. A substantial portion of these births (approximately 25-30%) occur in the context of significant adverse pregnancy outcomes (APOs) including preterm birth (PTB), hypertensive disorders of pregnancy (HDP), small-for-gestational-age birth (SGA), and intrauterine fetal demise (IUFD). Moreover, these complications significantly increase the risk of both maternal and perinatal morbidity and mortality and are associated with adverse health consequences throughout the life course of both individuals. Anemia in pregnancy has been consistently cited as an important factor in and upstream of APOs such as PTB and HDP, severe maternal morbidity, and maternal mortality, and for disparities in these outcomes as well.
This study will expand our understanding of addressing SDoH, including linkage to services that mitigate SDoH. This information can inform future interventions that address SDoH. Creating new tools to address the needs and strengths of obstetric patients, and encouraging their use, will improve the management of patient care during and after pregnancy.
The patient sample will include obstetric patients receiving care at the OSUWMC McCampbell OB/GYN clinic or the OSUWMC Outpatient Care East OB/GYN clinic. A total of 550 patients will participate in the study and be randomly assigned to either the intervention or control group. We will collect maternal and child health outcome data using patient electronic health records and surveys.
At the time of randomization at the patient's prenatal appointment, a researcher will use a survey to collect participant baseline data, including patient demographics and patient-reported outcomes. This information will be collected again during a study visit during the patient's prenatal appointment when the patient is 28-32 weeks gestation.
Final data collection from patient records will occur after delivery (for both intervention and control groups). Research staff will extract information from patients' and their baby's medical records, including maternal and perinatal outcomes.
The intervention includes one motivational interviewing session that encourages the patient to address their social needs. Following the intervention, patients will receive bi-weekly text messages with links to help them address social needs; these links are: (1) to a patient portal to enable them connect with their care team, (2) to Health Impact Ohio, a local organization that can help patients address social needs; and (3) to "findhelp.org," a site that can provide a list of resources based on zip code.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BETTER Intervention | Experimental | Patients in the intervention group will receive one motivational interviewing session immediately after randomization and biweekly text messages until delivery to encourage them to connect to resources to address their social needs. |
|
| Standard of care | Active Comparator | No motivational interviewing or text messages will be provided. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BETTER: motivational interviewing and text messaging | Behavioral | Motivational interviewing to encourage individuals to address their social needs and engage with text messages that allow individuals to connect to their care team, a local organization that can help them address their social needs, and/or a resource that enables them to find help to address their needs based on their zip code. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of maternal anemia | Hemoglobin < 11.0 g/dL | At delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Pre-term birth | Delivery prior to 37 weeks of gestation | At delivery |
| Incidence of Hypertensive disorders of pregnancy | Antepartum gestational hypertension or preeclampsia of any severity through the postpartum |
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Inclusion Criteria
Exclusion Criteria
This study is restricted to pregnant individuals.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ann McAlearney, ScD, MS | Contact | 614-293-3716 | Ann.McAlearney@osumc.edu | |
| Nicole Thomas, PhD | Contact | 614-247-6228 | Nicole.Thomas3@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| William Grobman, MD, MBA | Ohio State University | Principal Investigator |
| Ann McAlearney, ScD, MS | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Outpatient Care East | Recruiting | Columbus | Ohio | 43203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40533225 | Derived | McAlearney AS, MacEwan SR, Huerta TR, Thomas NR, Sova LN, Roth L, Bartholomew A, Rush LJ, Johnson KF, Grobman WA. Patient-informed outpatient intervention to improve pregnancy outcomes through connections to social services: protocol for the BETTER randomised controlled trial. BMJ Open. 2025 Jun 18;15(6):e096119. doi: 10.1136/bmjopen-2024-096119. |
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| ID | Term |
|---|---|
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of care | Behavioral | No motivational interviewing or text messages will be provided. |
|
| Through study completion, approximately 6 months |
| Incidence of infection | As determined by clinical diagnosis (e.g., chorioamnionitis, endometritis, pyelonephritis); intrapartum and postpartum | Through study completion, approximately 6 months |
| Incidence of Cesarean Delivery | Delivery by Cesarean section | At delivery |
| Incidence of Postpartum hemorrhage | Blood loss >1000cc | Through study completion, approximately 6 months |
| Incidence Severe maternal morbidity | >3 units of packed red blood cell transfusion or ICU admission | Through study completion, approximately 6 months |
| Incidence of maternal mortality | Death | Through study completion, approximately 6 months |
| Incidence of Small for gestational age birth | <10th percentile for gestational age | At birth |
| Incidence of Large for gestational age | >90th percentile for gestational age | At birth |
| Incidence of NICU admission | Admission to the NICU | Through study completion, approximately 6 months |
| Incidence of Perinatal mortality | Intrauterine or neonatal death | Through study completion, approximately 6 months |
| Incidence of Prenatal care visits | Number of prenatal care visits | From randomization through delivery |
| Incidence of Antepartum admission | Hospital admission other than for delivery | From randomization through delivery |
| Length of stay (days) | Length of hospital stay at delivery admission | Immediately after discharge from the delivery hospitalization |
| Postpartum re-admission | Hospital admission after postpartum discharge | From delivery discharge through 6 weeks post partum |
| McCampbell Hall | Recruiting | Columbus | Ohio | 43210 | United States |
|
| The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine | Recruiting | Columbus | Ohio | 43210 | United States |
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