Postpartum Video Education

Sponsor
Yale University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05159726
Collaborator
(none)
200
1
2
4.9
40.9

Study Details

Study Description

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. 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 increase patient's knowledge of severe maternal morbidity warning signs.

Detailed Description

During postpartum admission, a designated staff person will approach eligible patients and review the objectives of the study. If patients are willing to participate, they will be handed a tablet that includes the consent form and the baseline questionnaire. The baseline questionnaire will assess patient knowledge on postpartum hemorrhage, infection, hypertensive disorders of pregnancy, and depression. Randomization will follow.

Randomization will be done in a 1:1 allocation ratio between written discharge instructions + video education vs. written discharge instructions (standard of care at YNHH). 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.

On day of discharge, nursing staff will notify the research team that a discharge order has been placed and discharge education has begun. At this time, the designated staff member will approach consented and randomized patients.

Group 1 will be the written discharge education + video education group (intervention group). These patients will view a 10-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.

Patients' antepartum, delivery, and postpartum course will be reviewed until 1 year 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 Yale 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
YOU MATTER: Using Video Education to Improve Patient Knowledge of Severe Maternal Morbidity (SMM) Warning Signs
Actual Study Start Date :
Jul 5, 2022
Anticipated Primary Completion Date :
Aug 20, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Written Discharge Education + Video Education

These patients will view a 10-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.

Other: Video Education
10-minute educational video covering postpartum topics of hemorrhage, infection, hypertension, and depression. Created by Citerelli Associates Inc.

No Intervention: Written Discharge Education

They will receive the written discharge instructions provided by nursing staff and complete the post-discharge instruction questionnaire.

Outcome Measures

Primary Outcome Measures

  1. Change in postpartum education questionnaire [Baseline, discharge (up to one week)]

    Patients will complete a baseline and post-discharge 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.

Secondary Outcome Measures

  1. Post-discharge postpartum education questionnaire [3 days]

    Patients will complete a post-discharge questionnaire over the phone. The 15-item questionnaire 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.

  2. Compliance with Postpartum Care [6 weeks]

    The investigators will perform a retrospective chart review to determine if the study participant attended the 6 week postpartum visit

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Age >18 years

  • Speaks English or Spanish

  • Informed and written consent

  • Delivered at Yale New Haven Hospital (YNHH)

  • Received prenatal, and will receive postpartum, care through a YNHH-affiliated obstetric and/or midwifery practice

Exclusion Criteria:
  • Patients who do not plan to receive postpartum care within the YNHH system

  • Patients who experience an intrauterine fetal demise

  • Patients who speak a primary language other than English or Spanish

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yale New Haven Hospital New Haven Connecticut United States 06510

Sponsors and Collaborators

  • Yale University

Investigators

  • Principal Investigator: Heather Lipkind, MD, MPH, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT05159726
Other Study ID Numbers:
  • 2000031817
First Posted:
Dec 16, 2021
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 25, 2022