Electronic Confirmed Versus Conventional Consenting Process: A Randomized Controlled Trial

Completed · Not applicable

Conditions studied: Satisfaction, Risk Reduction

In brief

· The target population for our study is women who present in their last clinic visit before delivery and are scheduled for an elective cesarean section. In that visit, the provider will notify the research team in order for the subject to be screened for the study. If the subject consents to participation, written informed consent will be obtained by person-to-person contact. The PI, study coordinator, or a collaborator will be responsible for the informed consent. After in-formed consent is obtained, the patient will be randomized to the following study groups: The control group will undergo regular consenting only. Study group I (e-confirmed consent only) will receive an electronic invitation to complete the consent process electronically and will proceed through the Confirmed Consent system prior to arrival to labor and delivery on day of surgery, which is the routine patient flow at this time. After completion of the survey, the subject will sign the regular paper consent for the procedure as standard in our institution. The study group II will undergo the same intervention as group II but the COMRADE survey questionnaire will be obtained by phone or in person after the completion of the paper consent form.

Key facts

Study ID
NCT03510260
Run by
The University of Texas Medical Branch, Galveston
People needed
105
Starts
2018-05-08
Expected to finish
2020-08-01
Last updated by the study team
2020-10-26

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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