Satisfaction, Patient Clinical Trial
Official title:
How Will an Educational Video About the Induction of Labor Process Impact Patient's Knowledge of and Satisfaction With the Induction Process
The investigators have created a brief, 3-minute video that discusses the induction of labor
process. The aim of this study is to evaluate, via a randomized method, how this educational
video impact's patients' knowledge and satisfaction with the induction of labor process.
Purpose: Evaluate how an educational video impacts patients' knowledge and satisfaction with
the induction of labor process
Research questions:
1. Does a brief educational video improve patients' baseline knowledge of the induction of
labor process when compared to patients' who receive traditional care?
2. Does a brief educational video improve patients' overall satisfaction with their
delivery course when compared to patients' who received the standard care? Hypothesis:
Those patients' shown a brief educational video will have a higher baseline knowledge
about the induction process and higher satisfaction with their delivery course compared
to patients who received the standard in-office counseling.
Recruitment and Data Collection:
Patients were screened for study enrollment during routine prenatal visits at the George
Washington University Hospital. A trained research team member met with and spoke to eligible
patients about the randomized study at the time of their scheduled induction of labor visit.
There was an induction of labor schedule that is created monthly, which the research team
members had access to and determined when eligible participants had their induction of labor
visit scheduled.
Informed consent was obtained from the patient if they were interested in participating.
Privacy and confidentiality were assured as approved team members were the only individuals
with access to patient records and maintained strict confidentiality. All consent forms were
kept in a locked cabinet and survey responses were de-identified. Patients were able to ask
questions and/or opt out of the study at any time.
The research team member assessed patient's understanding of the information and
participation by asking them to describe in their own words what they were consenting to.
Signed informed consent were obtained prior to study enrollment.
Once a patient was enrolled, they were randomized to the control group (no intervention) or
the intervention group (3-minute educational video intervention). The randomization schedule
was predetermined. The enrolled participant was given a pre-randomized study envelope that
contained a unique Study ID number, randomization group, and paper surveys.
The control group took the knowledge-based survey. Twenty-four to forty-eight hours after
delivery, at a time convenient to the participant during the postpartum stay at GW, a
research team member asked the participant to fill out a second survey, focused on
satisfaction with the labor and delivery process.
The intervention group had the opportunity to watch the 3-minute educational video. The video
shown to these participants is linked here: https://youtu.be/Pc9tcIV4Dm8. After watching the
video, the participant was asked to take the knowledge-based survey. Twenty-four to
forty-eight hours after delivery, at a time convenient to the participant during the
postpartum stay at GW, a research team member asked the participant to fill out a second
survey, focused on satisfaction.
If the patient ultimately chose not to participate in the study following the signing of
informed consent, all their data was destroyed. All of the surveys were stored in a locked
cabinet, secured. No one but the research team members had access to the collected data and
none of the stored paper copies had any identifying information. The basic demographic
information, as well as the outcome of the induction of labor process, was collected using
the hospital's electronic medical record. Some of the information (race and ethnicity) was
collected by self-report. Emails were obtained by self-report on a voluntary basis. They were
only collected if patients wished to be entered into the raffle for the Amazon gift card.
Recruitment goal:
At minimum, the goal was an n= of 106 total, 53 per arm. This was powered based on an alpha
of 0.05, 80% power, 10% attrition rate to accurately detect a 20% difference given 96%
correct in the intervention group.
Data entry:
After enrollment and completion of study surveys, a member of the research team entered in
all of the information collected into a de-identified Redcap database using the unique Study
ID numbers. The research team also collected data from the patient's electronic medical
record about the enrolled participant's induction of labor process, including gravity,
parity, pregnancy complications, induction agents utilized, and delivery method (vaginal vs
cesarean delivery). All of this data was entered into the de-identified Redcap database.
Access to the participant's medical record was only available to the research team through
the MFA's HIPAA compliant, password protected, firewalled electronic medical record
(Allscripts) and GW hospitals' EMR (Cerner).
After the data was entered into Redcap, a second and different member of the research team
re-checked the entry to ensure the answers were correctly captured into the system.
Statistical Analysis:
The investigators used specific methods to address our hypothesis: Those patients' shown a
brief educational video will have a higher baseline knowledge about the induction process and
higher satisfaction with their delivery course compared to patients who received the standard
in-office counseling.
1. Does a brief educational video improve patients' baseline knowledge of the induction of
labor process when compared to patients' who receive the traditional care?
The investigators used mean, standard deviation, and analysis via Mann-Whitney U tests.
2. Does a brief educational video improve patients' overall satisfaction with their
delivery course when compared to patients' who received the standard care?
The investigators used mean, standard deviation, and analysis via Mann-Whitney U, Chi-Square,
and Fisher's exact tests.
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