IMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine
- Conditions
- Postpartum Complication
- Interventions
- Other: Intensive EducationOther: Enhanced Virtual Care
- Registration Number
- NCT06218355
- Lead Sponsor
- University of Texas Southwestern Medical Center
- 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) 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 3500
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intensive Education Intensive Education 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. Enhanced Virtual Care Enhanced Virtual Care 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method PROMIS-29 questionnaire v 2.1 6 weeks and 1 year postpartum Scales 1-10 for each independent question, with numerical summary score
Systolic Blood Pressure enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum numerical, continuous
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
Number of patients requiring emergency room visits, % preventable Up to one year postpartum continuous variable, preventability to be determined by preventability panel
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
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
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 - anemia - hemoglobin and hematocrit enrollment, 6 weeks, 3 months, and 1 year postpartum laboratory value - continuous variables
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 hospital admissions, % preventable Up to one year postpartum continuous variable, preventability to be determined by preventability panel
Diastolic Blood Pressure enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum numerical, continuous
Long-term disease control - hypertension - serum creatinine enrollment, 6 weeks, 3 months, and 1 year postpartum laboratory value - continuous variable
Short Assessment of Patient Satisfaction (SAPS) 6 weeks and 1 year postpartum Scale: Extremely dissatisfied to extremely satisfied Score Range is 0-28.
Long-term disease control - liver function test (AST, ALT) enrollment, 6 weeks, 3 months, and 1 year postpartum laboratory value - continuous variables
Trial Locations
- Locations (2)
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States