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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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The goal of the proposed research is to test the comparative effectiveness of AIM safety bundles for post-partum women delivered in-person vs. via text/phone to improve early detection of and timely care for complications during the first six weeks postpartum for women experiencing significant health disparities.
The purpose of the study is to learn if a program for newborn mom's can improve detection of complications after delivery and help women get medical care quickly and easily. Participants will be asked to complete a survey at the time of enrollment and at 3 additional times. All surveys can be completed via cell-phone or email. All women will be followed for 1-year after delivery. Women that enroll will be assigned to one of two groups: usual in person care OR usual in-person care PLUS a text message-based program that will ask about sign and symptoms of complications that may occur after delivery. If there is a concern, a nurse advocate will call on the phone to discuss options and help refer to care if needed. Participants will be paid for their time in completing surveys.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | AIM (AIM Alliance for Innovation on Maternal Health) safety bundles delivered in-person | |
| Usual Care plus H.E.A.R. for Mamas | Experimental | H.E.A.R. for Mamas is designed to provide the AIM (Alliance for Innovation on Maternal Health) Postpartum Discharge Transition education systematically and to frequently monitor women for signs and symptoms of postpartum complications using simple, patient-centered technology (text/phone). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H.E.A.R. for Mamas | Other | H.E.A.R. for Mamas is a patient and provider informed, multicomponent intervention that uses simple text/phone-based screenings to systematically and frequently monitor women for postpartum complications, chronic conditions and SDoH (Social Determinants of Health) and provides patients with immediate feedback and recommendations based on their screenings. |
| Measure | Description | Time Frame |
|---|---|---|
| Emergency Department (ED) visits within six weeks postpartum | Percent of postpartum women with an ED visit that occurs within six weeks following delivery | Within six weeks following the delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Outcomes (PROs) | Secondary outcomes will include PROs which will be measured at the time of study enrollment (baseline=0), and 3, 6, and 12 months postpartum. | time of study enrollment (baseline=0), and 3, 6, and 12 months postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Social Determinants of Health (SDoH), Patient Activation, Shared Decision Making | SDoH will be measured by the Accountable Health Communities-Health-Related Social Needs (HRSN) and includes assessment of economic instability, low social support, food scarcity etc. | HRSN, PAM-10, and SDM-Q-9 will be measured at study enrollment (baseline=0), 3, 6, and 12 months postpartum |
Inclusion Criteria for Postpartum Women
Exclusion Criteria for Postpartum Women
Inclusion Criteria for Obstetric Providers and Hospital Administrators
- OB provider working at a delivery hospital in SC and directly involved in the care of postpartum women; or hospital administrator working in a delivery hospital in SC and job responsibilities relate to the postpartum unit.
Exclusion Criteria for Obstetric Providers and Hospital Administrators
Postpartum woman within approximately 2 weeks of delivery Aged 16-49 years old.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Constance Guille, MD | Contact | 843-792-6489 | guille@musc.edu | |
| Ellen H Gomez, MA | Contact | 8439985635 | gomezel@musc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
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| ID | Term |
|---|---|
| C563278 | Episodic Ataxia, Type 1 |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Patient Activation | Patient activation will be measured by the Patient Activation Measure (PAM-10). | HRSN, PAM-10, and SDM-Q-9 will be measured at study enrollment (baseline=0), 3, 6, and 12 months postpartum |
| Shared Decision Making | Perception of the shared decision-making process will be measured by Shared Decision-Making Questionnaire (SDM-Q-9). | HRSN, PAM-10, and SDM-Q-9 will be measured at study enrollment (baseline=0), 3, 6, and 12 months postpartum |