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NCT06218355 | RECRUITING | Postpartum Complication

IMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine
Sponsor:

University of Texas Southwestern Medical Center

Information provided by (Responsible Party):

Elaine Duryea

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.

Condition or disease

Postpartum Complication

Intervention/treatment

Intensive Education

Enhanced Virtual Care

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 3500 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : IMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine
Actual Study Start Date : 2024-03-01
Estimated Primary Completion Date : 2027-09-01
Estimated Study Completion Date : 2028-09-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
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.
IMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine

Location Details

NCT06218355

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, Georgia

Emory University School of Medicine

Atlanta, Georgia, United States, 30322

RECRUITING

United States, Texas

University of Texas Southwestern Medical Center

dallas, Texas, United States, 75390