IMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Texas Southwestern Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intensive Education

    Other intervention

    Intervention will consist of virtual education and communication through scheduled push notifications

  • Enhanced Virtual Care

    Other intervention

    Intervention will utilize a telehealth model consisting of "pull" approach of patient engagement.

Treatment groups

3,500 Participants
are divided into 2 treatment groups
Group A: Intensive EducationActive comparator 1 intervention
Group B: Enhanced Virtual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Composite Healthcare Outcome - time to diagnosis and treatment of postpartum complications after hospital discharge

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.

Time frame
Up to one year postpartum

Secondary outcomes

1

Edinburgh Postnatal Depression Scale

screening continuous, numerical; higher value consistent with great risk of postpartum depression

Time frame
enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum
2

Generalized Anxiety Disorder 7

screening tool, continuous, numerical, higher value consistent with higher risk of anxiety disorder

Time frame
enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum
3

Number of patients requiring emergency room visits, % preventable

continuous variable, preventability to be determined by preventability panel

Time frame
Up to one year postpartum
4

Number of patients requiring hospital admissions, % preventable

continuous variable, preventability to be determined by preventability panel

Time frame
Up to one year postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas Southwestern Medical Center

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

Emory University

Collaborator