Clinical trial NCT06310720: Postpartum Video Education in High Risk Populations
Official title: You Matter: Using Video Education to Improve Patient Knowledge of Severe Maternal Morbidity Warning Signs in High Risk Populations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Hemorrhage
Postpartum Depression
Postpartum Sepsis
Postpartum Preeclampsia
Patient Empowerment
Patient Education
Postpartum Care
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in baseline and post-education questionnaire score
timeFrame: Baseline, post-discharge (up to one week)
Secondary outcomes:
measure: Change in post-education and post-discharge questionnaire score
timeFrame: 3-7 days
measure: Number of participants who attended 6 week postpartum visit
timeFrame: 6 weeks
measure: Healthcare utilization: Number of clinic visits
timeFrame: 6 weeks
measure: Healthcare utilization: Number of phone calls
timeFrame: 6 weeks
measure: Healthcare utilization: Number of urgent care/emergency room visits
timeFrame: 6 weeks
measure: Mean difference in patient satisfaction rating
timeFrame: Discharge (day 1 of study)
Other outcomes:
Locations:
city: New York
country: United States
facility: Alexandra Cohen Hospital for Women and Newborns
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Heather Lipkind, MD, MSce
role: PRINCIPAL_INVESTIGATOR
References:
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