Clinical trial NCT06218355: IMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine
Official title: IMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Complication
Keywords: telemedicine
hypertension
wound infection
readmission
metritis
mastitis
maternal mortality
postpartum complications
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2024-01-23
Enrollment: 3500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Composite Healthcare Outcome - time to diagnosis and treatment of postpartum complications after hospital discharge
timeFrame: Up to one year postpartum
Secondary outcomes:
measure: Edinburgh Postnatal Depression Scale
timeFrame: enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum
measure: Generalized Anxiety Disorder 7
timeFrame: enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum
measure: Number of patients requiring emergency room visits, % preventable
timeFrame: Up to one year postpartum
measure: Number of patients requiring hospital admissions, % preventable
timeFrame: Up to one year postpartum
measure: Postpartum warning signs knowledge assessment, based on AWOHHN criteria
timeFrame: enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum
measure: PROMIS-29 questionnaire v 2.1
timeFrame: 6 weeks and 1 year postpartum
measure: Healthy People 2030 questionnaire
timeFrame: 6 weeks and 1 year postpartum
measure: PRAPARE questionnaire
timeFrame: 6 weeks and 1 year postpartum
measure: Short Assessment of Patient Satisfaction (SAPS)
timeFrame: 6 weeks and 1 year postpartum
measure: Provider Satisfaction Survey (Quantitative)
timeFrame: Every 6 months throughout the study period
measure: Systolic Blood Pressure
timeFrame: enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum
measure: Diastolic Blood Pressure
timeFrame: enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum
measure: Social Determinants of Health - Healthy People 2030 and PRAPARE questionnaire
timeFrame: enrollment, 6 weeks, 1 year postpartum
measure: Long-term disease control - diabetes - hemoglobin A1c, LDL, HDL, total cholesterol, triglycerides
timeFrame: enrollment, 6 weeks, 3 months, and 1 year postpartum
measure: Long-term disease control - hypertension - serum creatinine
timeFrame: enrollment, 6 weeks, 3 months, and 1 year postpartum
measure: Long-term disease control - liver function test (AST, ALT)
timeFrame: enrollment, 6 weeks, 3 months, and 1 year postpartum
measure: Long-term disease control - anemia - hemoglobin and hematocrit
timeFrame: enrollment, 6 weeks, 3 months, and 1 year postpartum
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Elaine Duryea, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UT Southwestern Medical Center
name: David B Nelson, MD
role: PRINCIPAL_INVESTIGATOR
References: