Postpartum Complication
Conditions
Keywords
telemedicine, hypertension, wound infection, readmission, metritis, mastitis, maternal mortality, postpartum complications
Brief summary
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.
Detailed description
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) under the direction of Drs. Duryea and Nelson (UT Southwestern PIs) and Grady Memorial (Atlanta, GA) under the direction of Dr. Newton-Levinson (Emory PI). 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.
Interventions
OTHERIntensive Education
Intervention will consist of virtual education and communication through scheduled push notifications
OTHEREnhanced Virtual Care
Intervention will utilize a telehealth model consisting of "pull" approach of patient engagement.
Sponsors
University of Texas Southwestern Medical Center
Patient-Centered Outcomes Research Institute
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Postpartum women who deliver a live born infant at Parkland Hospital or Grady Health and receive postpartum care at dedicated community clinics. * Due to the nature of the study, all will be women, and all will be postpartum, thus of reproductive age. Postpartum women 18 years of age and older will be considered for inclusion if informed consent can be obtained.
Exclusion criteria
* Postpartum women who do not deliver at Parkland Hospital or Grady Health will not receive postpartum care in the pre-specified community clinics for Parkland health systems. * Patients with a primary language other than English or Spanish.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Healthcare Outcome - time to diagnosis and treatment of postpartum complications after hospital discharge | Up to one year postpartum | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Edinburgh Postnatal Depression Scale | enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum | screening continuous, numerical; higher value consistent with great risk of postpartum depression |
| Generalized Anxiety Disorder 7 | enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum | screening tool, continuous, numerical, higher value consistent with higher risk of anxiety disorder |
| Number of patients requiring emergency room visits, % preventable | Up to one year postpartum | continuous variable, preventability to be determined by preventability panel |
| Number of patients requiring hospital admissions, % preventable | Up to one year postpartum | continuous variable, preventability to be determined by preventability panel |
| Postpartum warning signs knowledge assessment, based on AWOHHN criteria | enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum | Percent scored correct out of 10 total questions |
| PROMIS-29 questionnaire v 2.1 | 6 weeks and 1 year postpartum | Scales 1-10 for each independent question, with numerical summary score |
| Healthy People 2030 questionnaire | 6 weeks and 1 year postpartum | categorical variables selected by the participant |
| PRAPARE questionnaire | 6 weeks and 1 year postpartum | categorical and dichotomous variables |
| Short Assessment of Patient Satisfaction (SAPS) | 6 weeks and 1 year postpartum | Scale: Extremely dissatisfied to extremely satisfied Score Range is 0-28. |
| Provider Satisfaction Survey (Quantitative) | Every 6 months throughout the study period | Scale: Strong agree to strongly disagree; very good to very bad; often to never |
| Systolic Blood Pressure | enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum | numerical, continuous |
| Diastolic Blood Pressure | enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum | numerical, continuous |
| Social Determinants of Health - Healthy People 2030 and PRAPARE questionnaire | enrollment, 6 weeks, 1 year postpartum | qualitative data, each questions treated as dichotomous or categorical variables |
| Long-term disease control - diabetes - hemoglobin A1c, LDL, HDL, total cholesterol, triglycerides | enrollment, 6 weeks, 3 months, and 1 year postpartum | laboratory value - continuous variables |
| Long-term disease control - hypertension - serum creatinine | enrollment, 6 weeks, 3 months, and 1 year postpartum | laboratory value - continuous variable |
| Long-term disease control - liver function test (AST, ALT) | enrollment, 6 weeks, 3 months, and 1 year postpartum | laboratory value - continuous variables |
| Long-term disease control - anemia - hemoglobin and hematocrit | enrollment, 6 weeks, 3 months, and 1 year postpartum | laboratory value - continuous variables |
Countries
United States
Contacts
CONTACTJacqueline Catchings, PhD
CONTACTLisa Moseley, RN
PRINCIPAL_INVESTIGATORElaine Duryea, MD
University of Texas Southwestern Medical Center
PRINCIPAL_INVESTIGATORDavid B Nelson, MD
University of Texas Southwestern Medical Center
Outcome results
None listed