SatisfactionECCCONCT03510260
Electronic Confirmed Versus Conventional Consenting Process: A Randomized Controlled Trial
A study testing Study Group I and Study Group II in people with Satisfaction and Risk Reduction, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Satisfaction, Risk Reduction
- What is being tested?
- Study Group I and Study Group II
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2018to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women >18 and <50
- Plan for scheduled elective Cesarean
- English speaking
Who cannot join
- Patient unwilling or unable to provide consent
- Incarcerated patients
- Unable to complete e-confirmed consent (not able to access the confirmed consent from home)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electronic Confirmed Versus Conventional Consenting Process (ECCCO)
- 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.
Read more
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.
Read the 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
- Conditions
- Satisfaction, Risk Reduction
- Being tested
- Study Group I, Study Group II, Control Group
- Keywords
- Cesarean, Consent, Electronic, Satisfaction
- Medical subject headings
- Personal Satisfaction, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Group IOther
Also called e-confirmed consent
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).
Study Group IIOther
Also called e-confirmed consent plus paper consent
The study group II will undergo the same intervention as group II but the COMRADE survey questionnaire will be obtained after the paper consent
Control GroupOther
Also called Standard paper consent only
Subject will go through the consenting process at the day of surgery at the preop visit as standard in our institution only.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Study Group II |
What is being measured
The primary outcome is the main question the study is designed to answer.
COMRADE Questionnaire
a survey assessing understanding of procedure and satisfaction,
Measured: Up to 7 days after delivery
Secondary outcomes (1)
Understanding Survey
Survey or questionnaire to assess subject's understanding of the planned procedure
Measured: Up to 7 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start8 May 2018
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SatisfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Unblinded randomized clinical trial.
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510260
- Sponsor's protocol ID
- 18-0063
- Acronym
- ECCCO
- Status last verified
- Oct 2020
- First submitted
- 16 Apr 2018
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Confirmed Versus Conventional Consenting Process (ECCCO)
- ClinicalTrials.gov ID
- NCT03510260
- Acronym / sponsor ID
- ECCCO / 18-0063
- Conditions
- Satisfaction, Risk Reduction
- Keywords
- Cesarean, Consent, Electronic, Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 8 May 2018 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 27 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Unblinded randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: Control GroupSubject 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. |
| Study Group I | Experimental | Other: Study Group ISubject 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. |
| Study Group II | Experimental | Other: Study Group IISubject 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women >18 and <50
- Plan for scheduled elective Cesarean
- English speaking
Key exclusion criteria (3 listed)
- Patient unwilling or unable to provide consent
- Incarcerated patients
- Unable to complete e-confirmed consent (not able to access the confirmed consent from home)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study Group IAlso: e-confirmed consentStudy 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 I |
| Study Group IIAlso: e-confirmed consent plus paper consentThe study group II will undergo the same intervention as group II but the COMRADE survey questionnaire will be obtained after the paper consent | Other | Study Group II |
| Control GroupAlso: Standard paper consent onlySubject will go through the consenting process at the day of surgery at the preop visit as standard in our institution only. | Other | Control Group |
Primary outcome
COMRADE Questionnaire
Time frame: Up to 7 days after delivery
a survey assessing understanding of procedure and satisfaction,
1 secondary outcome
Understanding Survey
Time frame: Up to 7 days after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Group I and Study Group II in people with Satisfaction and Risk Reduction, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COMRADE Questionnaire (time frame: Up to 7 days after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2020.