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Postpartum Video Education

Primary Purpose

Postpartum Hemorrhage, Postpartum Preeclampsia, Postpartum Sepsis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video Education
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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 have a pregnancy with multiple severe congenital anomalies with an anticipated poor prognosis
  • Patients who speak a primary language other than English or Spanish

Sites / Locations

  • Yale New Haven Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Written Discharge Education + Video Education

Written Discharge Education

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in baseline and post-education questionnaire score
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 Outcome Measures

Change in post-education and post-discharge questionnaire score
Patients will complete a post-discharge questionnaire via email. 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.
Compliance with Postpartum Care
The investigators will perform a retrospective chart review to determine if the study participant attended the 6 week postpartum visit
Healthcare utilization
The investigators will perform a retrospective chart review to determine number of phone call, clinic visits, urgent care and/or emergency room visits by each study participant
Patient satisfaction
Patients will rate their satisfaction with their knowledge and postpartum discharge on baseline and post-education questionnaires.

Full Information

First Posted
December 8, 2021
Last Updated
January 30, 2023
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT05159726
Brief Title
Postpartum Video Education
Official Title
YOU MATTER: Using Video Education to Improve Patient Knowledge of Severe Maternal Morbidity (SMM) Warning Signs
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 5, 2022 (Actual)
Primary Completion Date
August 20, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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 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 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. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage, Postpartum Preeclampsia, Postpartum Sepsis, Postpartum Depression, Patient Empowerment, Patient Education, Postpartum Care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Written Discharge Education + Video Education
Arm Type
Experimental
Arm Description
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.
Arm Title
Written Discharge Education
Arm Type
No Intervention
Arm Description
They will receive the written discharge instructions provided by nursing staff and complete the post-discharge instruction questionnaire.
Intervention Type
Other
Intervention Name(s)
Video Education
Intervention Description
12-minute educational video covering postpartum topics of hemorrhage, infection, hypertension, and depression. Created by Cicatelli Associates Inc.
Primary Outcome Measure Information:
Title
Change in baseline and post-education questionnaire score
Description
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.
Time Frame
Baseline, discharge (up to one week)
Secondary Outcome Measure Information:
Title
Change in post-education and post-discharge questionnaire score
Description
Patients will complete a post-discharge questionnaire via email. 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.
Time Frame
3-7 days
Title
Compliance with Postpartum Care
Description
The investigators will perform a retrospective chart review to determine if the study participant attended the 6 week postpartum visit
Time Frame
6 weeks
Title
Healthcare utilization
Description
The investigators will perform a retrospective chart review to determine number of phone call, clinic visits, urgent care and/or emergency room visits by each study participant
Time Frame
6 weeks
Title
Patient satisfaction
Description
Patients will rate their satisfaction with their knowledge and postpartum discharge on baseline and post-education questionnaires.
Time Frame
Baseline, post-education

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 have a pregnancy with multiple severe congenital anomalies with an anticipated poor prognosis Patients who speak a primary language other than English or Spanish
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Lipkind, MD, MPH
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Centers for Disease Control and Prevention. Pregnancy mortality surveillance system. Centers for Disease Control and Prevention, US Department of Health and Human Services; 2020. Accessed March 4, 2020. https://www.cdc.gov/reproductivehealth/maternal-mortality/pregnancy-mortality-surveillance-system.htm
Results Reference
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PubMed Identifier
31071074
Citation
Petersen EE, Davis NL, Goodman D, Cox S, Mayes N, Johnston E, Syverson C, Seed K, Shapiro-Mendoza CK, Callaghan WM, Barfield W. Vital Signs: Pregnancy-Related Deaths, United States, 2011-2015, and Strategies for Prevention, 13 States, 2013-2017. MMWR Morb Mortal Wkly Rep. 2019 May 10;68(18):423-429. doi: 10.15585/mmwr.mm6818e1.
Results Reference
background
Citation
Centers for Disease Control and Prevention. (2019). Data Brief from 14 U.S. Maternal Mortality Review Committees, 2008-2017. Retrieved from https://www.cdc.gov/reproductivehealth/maternal-mortality/erase-mm/mmr-data-brief.html
Results Reference
background
Citation
Human Resources & Services Administration. (2019). Maternal Morbidity & Mortality. Retrieved from https://www.hrsa.gov/maternal-mortality/index.html#about)
Results Reference
background
Citation
Centers for Disease Control and Prevention. Severe Maternal Morbidity. Retrieved from https://www.cdc.gov/reproductivehealth/maternalinfanthealth/severematernalmorbidity.html
Results Reference
background
Citation
Review to action, CDC Foundation. Capacity to review and prevent maternal deaths. report from nine maternal mortality review committees. 2018. http://reviewtoaction.org/Reportfrom_Nine_MMRCs.
Results Reference
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Citation
Krantz, T. E., et al. (2015). Computer graphic animation for intrauterine device contraceptive counseling in postpartum patients. Obstetrics and Gynecology 125: 68S.
Results Reference
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Citation
O'Dell, D. D., et al. (2019). A Quality Improvement Project- Standardizing Postpartum Discharge Instructions with an Educational Video. Obstetrics and Gynecology. Conference: 67th Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists. Nashville, TN United States 133(SUPPL 1).
Results Reference
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PubMed Identifier
31010174
Citation
O'Sullivan TA, Cooke J, McCafferty C, Giglia R. Online Video Instruction on Hand Expression of Colostrum in Pregnancy is an Effective Educational Tool. Nutrients. 2019 Apr 19;11(4):883. doi: 10.3390/nu11040883.
Results Reference
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PubMed Identifier
32546944
Citation
Wisely CE, Robbins CB, Stinnett S, Kim T, Vann RR, Gupta PK. Impact of Preoperative Video Education for Cataract Surgery on Patient Learning Outcomes. Clin Ophthalmol. 2020 May 20;14:1365-1371. doi: 10.2147/OPTH.S248080. eCollection 2020.
Results Reference
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PubMed Identifier
32265432
Citation
Che YJ, Gao YL, Jing J, Kuang Y, Zhang M. Effects of an Informational Video About Anesthesia on Pre- and Post-Elective Cesarean Section Anxiety and Recovery: A Randomized Controlled Trial. Med Sci Monit. 2020 Apr 8;26:e920428. doi: 10.12659/MSM.920428.
Results Reference
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Postpartum Video Education

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