IMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine
Overview
- Phase
- Not Applicable
- Intervention
- Intensive Education
- Conditions
- Postpartum Complication
- Sponsor
- University of Texas Southwestern Medical Center
- Enrollment
- 3500
- Locations
- 2
- Primary Endpoint
- Composite Healthcare Outcome - time to diagnosis and treatment of postpartum complications after hospital discharge
- Status
- Recruiting
- Last Updated
- last month
Overview
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.
Investigators
Elaine Duryea
Associate Professor
University of Texas Southwestern Medical Center
Eligibility Criteria
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.
Arms & Interventions
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.
Intervention: Intensive Education
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.
Intervention: Enhanced Virtual Care
Outcomes
Primary Outcomes
Composite Healthcare Outcome - time to diagnosis and treatment of postpartum complications after hospital discharge
Time Frame: 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 Outcomes
- PROMIS-29 questionnaire v 2.1(6 weeks and 1 year postpartum)
- Systolic Blood Pressure(enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum)
- Postpartum warning signs knowledge assessment, based on AWOHHN criteria(enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum)
- Number of patients requiring emergency room visits, % preventable(Up to one year postpartum)
- Healthy People 2030 questionnaire(6 weeks and 1 year postpartum)
- PRAPARE questionnaire(6 weeks and 1 year postpartum)
- Provider Satisfaction Survey (Quantitative)(Every 6 months throughout the study period)
- Social Determinants of Health - Healthy People 2030 and PRAPARE questionnaire(enrollment, 6 weeks, 1 year postpartum)
- Long-term disease control - diabetes - hemoglobin A1c, LDL, HDL, total cholesterol, triglycerides(enrollment, 6 weeks, 3 months, and 1 year postpartum)
- Long-term disease control - anemia - hemoglobin and hematocrit(enrollment, 6 weeks, 3 months, and 1 year postpartum)
- Edinburgh Postnatal Depression Scale(enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum)
- Generalized Anxiety Disorder 7(enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum)
- Number of patients requiring hospital admissions, % preventable(Up to one year postpartum)
- Diastolic Blood Pressure(enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum)
- Long-term disease control - hypertension - serum creatinine(enrollment, 6 weeks, 3 months, and 1 year postpartum)
- Short Assessment of Patient Satisfaction (SAPS)(6 weeks and 1 year postpartum)
- Long-term disease control - liver function test (AST, ALT)(enrollment, 6 weeks, 3 months, and 1 year postpartum)