Clinical Trials Directory

Trials / Suspended

SuspendedNCT06310720

Postpartum Video Education in High Risk Populations

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

Status
Suspended
Phase
N/A
Study type
Interventional
Enrollment
150 (estimated)
Sponsor
Weill Medical College of Cornell University · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERVideo Education12-minute educational video covering postpartum topics of hemorrhage, infection, hypertension, and depression. Created by Cicatelli Associates Inc.

Timeline

Start date
2024-05-09
Primary completion
2027-12-01
Completion
2027-12-01
First posted
2024-03-15
Last updated
2025-08-28

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06310720. Inclusion in this directory is not an endorsement.