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Electronic Confirmed Versus Conventional Consenting Process: A Randomized Controlled Trial

NCT03510260 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2020-10-26

No results posted yet for this study

Summary

· 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.

Conditions

  • Satisfaction
  • Risk Reduction

Interventions

OTHER

Study Group I

Study group I (e-confirmed consent only) will receive an electronic invitation to complete the consent process electronically.The COMRADE questionnaire (our primary outcome) will be obtained prior to the initiation of the traditional consent (as in control group).

OTHER

Study Group II

The study group II will undergo the same intervention as group II but the COMRADE survey questionnaire will be obtained after the paper consent

OTHER

Control Group

Subject will go through the consenting process at the day of surgery at the preop visit as standard in our institution only.

Sponsors & Collaborators

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-08
Primary Completion
2020-08-01
Completion
2020-08-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03510260 on ClinicalTrials.gov