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Completed

NCT Number: NCT05159726

Postpartum Video Education

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.

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Key information

Conditions

Postpartum Hemorrhage Behavior Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Health Behavior Hemorrhage Infections Mental Disorders Mood Disorders Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Education Patient Empowerment Patient Participation Postpartum Care Postpartum Depression Postpartum Preeclampsia Postpartum Sepsis Pregnancy Complications Pregnancy Complications, Infectious Puerperal Disorders Puerperal Infection Treatment Adherence and Compliance Urogenital Diseases Uterine Hemorrhage

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video education

Other

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

Primary outcomes

  1. Change in baseline and post-education questionnaire score

    Time frame: Baseline, 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

  1. Change in post-education and post-discharge questionnaire score

    Time frame: 3-7 days

    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.

  2. Compliance with Postpartum Care

    Time frame: 6 weeks

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

  3. Healthcare utilization

    Time frame: 6 weeks

    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

  4. Patient satisfaction

    Time frame: Baseline, post-education

    Patients will rate their satisfaction with their knowledge and postpartum discharge on baseline and post-education questionnaires.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

YOU MATTER: Using Video Education to Improve Patient Knowledge of Severe Maternal Morbidity (SMM) Warning Signs

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 16, 2021
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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