Electronic Confirmed Versus Conventional Consenting Process (ECCCO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- COMRADE Questionnaire
研究概览
简要总结
· 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women >18 and <50
- •Plan for scheduled elective Cesarean
- •English speaking
排除标准
- •Patient unwilling or unable to provide consent
- •Incarcerated patients
- •Unable to complete e-confirmed consent (not able to access the confirmed consent from home)
研究组 & 干预措施
Study Group II
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.
干预措施: Study Group II (Other)
Control Group
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.
干预措施: Control Group (Other)
Study Group I
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.
干预措施: Study Group I (Other)
结局指标
主要结局
COMRADE Questionnaire
时间窗: Up to 7 days after delivery
a survey assessing understanding of procedure and satisfaction,
次要结局
- Understanding Survey(Up to 7 days after delivery)