Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310720
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-03-07
Brief Title:
Postpartum Video Education in High Risk Populations
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
You Matter Using Video Education to Improve Patient Knowledge of Severe Maternal Morbidity Warning Signs in High Risk Populations
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 patients 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 11 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 recordedstored 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
Following delivery patients will be randomized Randomization will be done in a 11 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 recordedstored 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None