Electronic Confirmed Versus Conventional Consenting Process: A Randomized Controlled Trial
Condition: Satisfaction; Risk Reduction
Study type: Interventional

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.
    

Detailed description: 
      4.1 Screening, Recruitment, and Consenting:

        -  Under the direction of the PI, trained research staff will be available 24/7 to screen
           and con-sent patients according to study protocol. Patients will be enrolled at the time
           a decision for planned repeat cesarean after VBAC counseling is made in clinic.

        -  After informed consent is obtained, the patient will be randomized to the study group or
           the control group. A screening log will be used to track all patients approached for the
           study. Women will only be randomized in clinic.

        -  Recruitment: We will recruit all pregnant patient's decision was made for scheduled
           cesarean after VBAC counseling made by their managing clinical team who do not meet any
           of the ex-clusion criteria listed below. Once the inclusion criteria for our study are
           met, the primary team will inform the patient about the study and ask her authorization
           to contact one of the study personnel.

        -  Consenting process: Written consent will be obtained by direct person-to-person contact.
           The principal investigator, study coordinator, or a collaborator will be responsible for
           the informed consent. Non-English-speaking subjects are anticipated to be part of the
           study population and informed consent will be provided in their primary language.

      The data collected will not be used for clinical diagnosis or treatment purposes.

      Subjects will be reassured that participation in the study is voluntary and will not
      interfere with diag-nose or treatment of her condition.

      The subjects will receive the same care and expertise as any other patient treated in our
      institution.

      4.2. Randomization and Masking A confidential computer-generated simple randomization scheme
      (using STATA 14, Dallas, TX) will be prepared and provided on an ongoing basis to our study
      coordinator. A randomization log with group assignment, subject name, and medical record
      number will be used to track the randomization process.

      The subject will be included in the analysis by intent-to-treat once the randomization
      assignment has been made.

      4.3. Interventions The control group will undergo regular consenting only. At our unit
      consent for an elective ce-sarean 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.

      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. 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.

      The study group II 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.

      4.4. Survey Collection This is our primary outcome. Before the subject has the procedure, our
      research staff will be collecting a survey assessing understanding of procedure and
      satisfaction, please see attached survey with appli-cation. This survey will be obtained
      according to the interventions detailed in sections 3 & 4.3
    

Intervention name(s): Study Group I; Study Group II; Control Group
Intervention type(s): Other; Other; Other
Intervention description(s): 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).; The study group II will undergo the same intervention as group II but the COMRADE survey questionnaire will be obtained after the paper consent; Subject will go through the consenting process at the day of surgery at the preop visit as standard in our institution only.
Other intervention name(s): e-confirmed consent; e-confirmed consent plus paper consent; Standard paper consent only
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Unblinded randomized clinical trial.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cesarean, Consent, Electronic, Satisfaction