IMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intensive Education, Enhanced Virtual Care.
- Who it may be relevant to
- Registry conditions: Postpartum Complication. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Intensive Education
Intervention will consist of virtual education and communication through scheduled push notifications - Other Enhanced Virtual Care
Intervention will utilize a telehealth model consisting of "pull" approach of patient engagement.
Primary outcome measures
- Composite Healthcare Outcome - time to diagnosis and treatment of postpartum complications after hospital discharge [Time frame: Up to one year postpartum]
Secondary outcome measures (12)
- Edinburgh Postnatal Depression Scale [Time frame: enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum]
- Generalized Anxiety Disorder 7 [Time frame: enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum]
- Number of patients requiring emergency room visits, % preventable [Time frame: Up to one year postpartum]
- Number of patients requiring hospital admissions, % preventable [Time frame: Up to one year postpartum]
- Postpartum warning signs knowledge assessment, based on AWOHHN criteria [Time frame: enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum]
- PROMIS-29 questionnaire v 2.1 [Time frame: 6 weeks and 1 year postpartum]
- Healthy People 2030 questionnaire [Time frame: 6 weeks and 1 year postpartum]
- PRAPARE questionnaire [Time frame: 6 weeks and 1 year postpartum]
- Short Assessment of Patient Satisfaction (SAPS) [Time frame: 6 weeks and 1 year postpartum]
- Provider Satisfaction Survey (Quantitative) [Time frame: Every 6 months throughout the study period]
- Systolic Blood Pressure [Time frame: enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum]
- Diastolic Blood Pressure [Time frame: enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 2 centers
- Emory University School of Medicine — Atlanta
- University of Texas Southwestern Medical Center — Dallas
Publications
- Zhang R, Boulet SL, Nelson DB, Goedken P, Catchings J, McIntire D, Platner M, Martin RB, Spong CY, Duryea EL. Improving Maternal Postpartum Access to Care through Telemedicine (IMPACT): A multi-center randomized controlled trial of postpartum interventions to improve access and outcome. Contemp Clin Trials. 2025 May;152:107882. doi: 10.1016/j.cct.2025.107882. Epub 2025 Mar 14. PMID 40090665
Identifiers
NCT: NCT06218355 · STU-2023-0332 · PCORI-MMM-2022C2-27680