Electronic Confirmed Versus Conventional Consenting Process: A Randomized Controlled Trial

NCT03510260 | Completed

• 1 other identifier: 18-0063
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cesarean, Consent, Electronic, Satisfaction

Outcome Measures

Primary Outcomes (1)

• COMRADE Questionnaire

  a survey assessing understanding of procedure and satisfaction,

  Up to 7 days after delivery

Secondary Outcomes (1)

• Understanding Survey

  Up to 7 days after delivery

Study Arms (3)

Control Group

PLACEBO COMPARATOR

Subject will undergo regular consenting only. At our unit consent for an elective cesarean delivery occurs in the same day of surgery, few hours before the procedure in a private room in labor and delivery while awaiting surgery. The COMRADE questionnaire (our primary outcome) will be obtained after the completion of the paper consent form.

Other: Control Group

Study Group I

EXPERIMENTAL

Subject 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. The COMRADE questionnaire (our primary outcome) will be obtained prior to the initiation of the traditional consent (as in control group) before the completion of the paper consent form, in order to assess satisfaction and understanding of the e-confirmed consenting process completed before the procedure. After completion of the survey, the subject will sign the regular paper consent for the procedure as standard in our institution.

Other: Study Group I

Study Group II

EXPERIMENTAL

Subject will undergo the same intervention as group II but the COMRADE survey questionnaire will be obtained after the paper consent is obtained in order to assess whether both methods combined together improve the subjects' satisfaction of the consenting methods and better understanding of the surgical procedure.

Other: Study Group II

Interventions

Study Group I OTHER

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).

Also known as: e-confirmed consent

Study Group I

Study Group II OTHER

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

Also known as: e-confirmed consent plus paper consent

Study Group II

Control Group OTHER

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

Also known as: Standard paper consent only

Control Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Obstetrical population
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women \>18 and \<50
• Plan for scheduled elective Cesarean
• English speaking

You may not qualify if:

• Patient unwilling or unable to provide consent
• Incarcerated patients
• Unable to complete e-confirmed consent (not able to access the confirmed consent from home)

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

UTMB Galveston

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Personal Satisfaction; Risk Reduction Behavior

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Unblinded randomized clinical trial.

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: April 27, 2018
• Study Start: May 8, 2018
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: October 26, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)