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Clinical Trials/NCT06310720
NCT06310720
Suspended
Not Applicable

You Matter: Using Video Education to Improve Patient Knowledge of Severe Maternal Morbidity Warning Signs in High Risk Populations

Weill Medical College of Cornell University1 site in 1 country150 target enrollmentMay 9, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postpartum Hemorrhage
Sponsor
Weill Medical College of Cornell University
Enrollment
150
Locations
1
Primary Endpoint
Change in baseline and post-education questionnaire score
Status
Suspended
Last Updated
8 months ago

Overview

Brief Summary

This is a prospective, single-center, randomized control study to determine if video education at the time of postpartum discharge improves patient knowledge on the warning signs for the top three causes of severe maternal morbidity (infection, hemorrhage, and blood pressure disorders) in the first seven days following delivery for self-identified, Black, Latinx, other with two or more self-identified races, Medicaid, and/or uninsured postpartum individuals. Participants will be randomized to written discharge education + video education (intervention) vs standard discharge education (control). They will complete a baseline questionnaire and a post-discharge education questionnaire during their postpartum stay to assess for knowledge improvement. The investigators hypothesize that video education will improve patient's knowledge of severe maternal morbidity warning signs.

Detailed Description

Prior to the day of postpartum discharge, a designated staff person will approach eligible patients and review the objectives of the study. If patients are willing to participate, they will complete a consent form and the baseline questionnaire. The baseline questionnaire will assess patient knowledge on postpartum hemorrhage, infection, hypertensive disorders of pregnancy, and depression. Following delivery, patients will be randomized. Randomization will be done in a 1:1 allocation ratio between written discharge instructions + video education vs. written discharge instructions (standard of care at WCM). A computer algorithm will assign participant based on random permuted blocks design with block size between 2-4. Each participant will have an assigned Study ID number that is linked to their random assignment. Group 1 will be the written discharge + video education group (intervention group). Group 2 will be the written discharge education (control group). On the day of discharge, the nursing staff will provide discharge education based on their randomized group: Group 1 will be the written discharge education + video education group (intervention group). These patients will view a 12-minute educational video on SMM warning signs, in addition to the written discharge instructions provided by nursing staff. At the completion of the video, they will complete a post-video questionnaire to assess their knowledge on the covered topics. Group 2 will be the written discharge instruction group (control group). They will receive the written discharge instructions provided by nursing staff and complete the post-discharge instruction questionnaire. Following discharge, patients will complete a post-discharge questionnaire to assess knowledge retention on the covered topics. Patients' antepartum, delivery, and postpartum course will be reviewed 6 months postpartum, including outpatient visits, emergency department visits, and any hospitalizations. All subjects will be assigned a unique study ID code upon enrollment. Data will be collected from patients' medical records and from self-report. It will be recorded/stored in REDCap and on a Weill Cornell Medicine server accessible only to members of the research team. All data will be de-identified at the conclusion of chart review. Data analysts will have access to only de-identified information.

Registry
clinicaltrials.gov
Start Date
May 9, 2024
End Date
December 1, 2027
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age \>18 years
  • Speaks English or Spanish
  • Informed and written consent
  • Delivered at WCM
  • Received prenatal, and will receive postpartum, care through a WCM-affiliated obstetric and/or midwifery practice
  • Self-identified as Black, Latinx, other and/or Medicaid or Uninsured

Exclusion Criteria

  • Patients who do not plan to receive postpartum care within the WCM system
  • Patients who experience an intrauterine fetal demise
  • Patients who speak a primary language other than English or Spanish

Outcomes

Primary Outcomes

Change in baseline and post-education questionnaire score

Time Frame: Baseline, post-discharge (up to one week)

Patients will complete a baseline and post-discharge education 15 item questionnaire that will assess knowledge on postpartum hemorrhage, infection, hypertensive disorders of pregnancy, and depression. The questionnaire will be scored 0-15 based on the number of correct responses. A lower score indicates lower knowledge, while a higher score indicates a better knowledge of the subject items. Outcome will be binary based on whether or not the patient improved their score between the two questionnaires.

Secondary Outcomes

  • Change in post-education and post-discharge questionnaire score(3-7 days)
  • Number of participants who attended 6 week postpartum visit(6 weeks)
  • Healthcare utilization: Number of urgent care/emergency room visits(6 weeks)
  • Healthcare utilization: Number of clinic visits(6 weeks)
  • Mean difference in patient satisfaction rating(Discharge (day 1 of study))
  • Healthcare utilization: Number of phone calls(6 weeks)

Study Sites (1)

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