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| ID | Type | Description | Link |
|---|---|---|---|
| PCORI-MMM-2022C2-27680 | Other Grant/Funding Number | PCORI |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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The purpose of this study is to compare two complex, multi-component evidence-based postpartum interventions in underserved populations of lower socioeconomic status in an effort to reduce maternal morbidity and mortality.
This large, multi-center randomized controlled trial will compare two multi-component postpartum care models via hybrid type 1 design conducted in two phases. An initial phase (phase 1) will collect baseline data and ensure patient input into final study. In phase 2, women will be randomized. Comparators are evidenced- based approaches: (1) an intensive in-person education with virtual education via push notifications using an electronic health record web portal; (2) a telehealth model using serial encounters. The "push" approach using notifications directly contrasts with the "pull" approach using telehealth visits. Both models include home visit programs. The study population includes patients delivering in two urban, inner-city health systems: Parkland (Dallas, TX) and Grady Memorial (Atlanta, GA). The primary outcome is time from hospital discharge to diagnosis and treatment of a composite of complications in the first 6 weeks. Based upon pilot data, 2349 women will demonstrate a 40% reduction (9 to 5.4 days) with 80% power and two-sided alpha of 0.05. 3500 women will be enrolled (1000 in phase 1; 2500 in phase 2) with anticipated <5% attrition at 6 weeks. Inclusion will be women who deliver liveborn infants. Secondary outcomes include mental health disorders, emergency room visits, hospital admissions, patient knowledge, quality of life and satisfaction, provider satisfaction, and social determinants of health. Women will be followed for one year postpartum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Education | Active Comparator | Women enrolled in the intensive education care model participate in intensive in-person education as well as ongoing virtual education via the electronic health record web portal in the form of strategically timed "pushes" of relevant and digestible educational elements via a "Care Companion." These virtual education "pushes" will include "to do" list reminders to check vital signs and submit them for review to the care team. Positive reinforcement will be provided when tasks are completed. |
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| Enhanced Virtual Care | Active Comparator | Women in the enhanced virtual care model will receive scheduled telehealth visits on the platform of their choice - either via video or audio-only synchronous visits. Patients in the virtual care model will check vital signs with home devices during the telehealth visit and report them directly to the provider. This "pull" approach to data collection directly contrasts with the "push" approach of comparator #1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Education | Other | Intervention will consist of virtual education and communication through scheduled push notifications |
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| Measure | Description | Time Frame |
|---|---|---|
| Composite Healthcare Outcome - time to diagnosis and treatment of postpartum complications after hospital discharge | Time to diagnosis and treatment of postpartum complications including hypertension, wound infection, and venous thromboembolism, measured in days. Lower value is considered better, representing timely care. | Up to one year postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Edinburgh Postnatal Depression Scale | screening continuous, numerical; higher value consistent with great risk of postpartum depression | enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum |
| Generalized Anxiety Disorder 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacqueline Catchings, PhD | Contact | 214-648-7413 | jacqueline.catchings@utsouthwestern.edu | |
| Lisa Moseley, RN | Contact | 214-648-2591 | lisa.moseley@utsouthwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elaine Duryea, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| David B Nelson, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University School of Medicine | Not yet recruiting | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40090665 | Derived | Zhang R, Boulet SL, Nelson DB, Goedken P, Catchings J, McIntire D, Platner M, Martin RB, Spong CY, Duryea EL. Improving Maternal Postpartum Access to Care through Telemedicine (IMPACT): A multi-center randomized controlled trial of postpartum interventions to improve access and outcome. Contemp Clin Trials. 2025 May;152:107882. doi: 10.1016/j.cct.2025.107882. Epub 2025 Mar 14. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014946 | Wound Infection |
| D008413 | Mastitis |
| D063130 | Maternal Death |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007239 | Infections |
| D011644 | Puerperal Disorders |
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| Enhanced Virtual Care | Other | Intervention will utilize a telehealth model consisting of "pull" approach of patient engagement. |
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screening tool, continuous, numerical, higher value consistent with higher risk of anxiety disorder
| enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum |
| Number of patients requiring emergency room visits, % preventable | continuous variable, preventability to be determined by preventability panel | Up to one year postpartum |
| Number of patients requiring hospital admissions, % preventable | continuous variable, preventability to be determined by preventability panel | Up to one year postpartum |
| Postpartum warning signs knowledge assessment, based on AWOHHN criteria | Percent scored correct out of 10 total questions | enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum |
| PROMIS-29 questionnaire v 2.1 | Scales 1-10 for each independent question, with numerical summary score | 6 weeks and 1 year postpartum |
| Healthy People 2030 questionnaire | categorical variables selected by the participant | 6 weeks and 1 year postpartum |
| PRAPARE questionnaire | categorical and dichotomous variables | 6 weeks and 1 year postpartum |
| Short Assessment of Patient Satisfaction (SAPS) | Scale: Extremely dissatisfied to extremely satisfied Score Range is 0-28. | 6 weeks and 1 year postpartum |
| Provider Satisfaction Survey (Quantitative) | Scale: Strong agree to strongly disagree; very good to very bad; often to never | Every 6 months throughout the study period |
| Systolic Blood Pressure | numerical, continuous | enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum |
| Diastolic Blood Pressure | numerical, continuous | enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum |
| Social Determinants of Health - Healthy People 2030 and PRAPARE questionnaire | qualitative data, each questions treated as dichotomous or categorical variables | enrollment, 6 weeks, 1 year postpartum |
| Long-term disease control - diabetes - hemoglobin A1c, LDL, HDL, total cholesterol, triglycerides | laboratory value - continuous variables | enrollment, 6 weeks, 3 months, and 1 year postpartum |
| Long-term disease control - hypertension - serum creatinine | laboratory value - continuous variable | enrollment, 6 weeks, 3 months, and 1 year postpartum |
| Long-term disease control - liver function test (AST, ALT) | laboratory value - continuous variables | enrollment, 6 weeks, 3 months, and 1 year postpartum |
| Long-term disease control - anemia - hemoglobin and hematocrit | laboratory value - continuous variables | enrollment, 6 weeks, 3 months, and 1 year postpartum |
| University of Texas Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
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| D011248 |
| Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D063129 | Parental Death |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |