A Survey of Patient's Attitudes Towards Consent For Clinical Research In Anesthesiology

NCT ID: NCT01546194

Last Updated: 2019-09-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-11-30

Brief Summary

In most current academic anesthesia groups, it appears that consent for research is acquired on the day of surgery. This practice raises concerns because the hospital may be regarded as a coercive environment and there may be the possibility that the immediate preoperative environment prohibits adequate time for understanding the research project and making an informed decision about participation. However, this is often the only opportunity for anesthesiologists to obtain research consent. The aim of the present investigation is to utilize a survey study to determine if patients at Evanston Hospital are comfortable consenting for research on the day of surgery

Detailed Description

Patients participating in approved, minimal risk clinical research projects will be approached by the study investigators. Consent for clinical research will be obtained on the day of surgery in the ambulatory surgery unit. In addition, some patients will be contacted by telephone on the day prior to surgery to be informed that they will be approached about participation in a research project. If patients agree to participate in the clinical trial, they will be provided with a self-addressed envelope containing the survey and a brief cover letter. The research team member will explain the purpose of the survey (to determine patients' attitudes towards research consent on the day of surgery). Subjects will be requested to complete the survey within a week of the surgical procedure. Two days after surgery, the research team will provide a follow-up call to determine if there are any questions about completing the survey. Although patient names will not be identified on the survey packet, all surveys will be coded with the subjects study number for subsequent analysis.

Questions are designed to investigate six areas of potential concern relating to informed consent; comprehension, situation (privacy/time), obligation (pressure) motivation, compunction (regrets), and satisfaction. Subjects will reply using a 5-point scale from 1=strongly disagree to 5=strongly agree.

Conditions

Informed Consent

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Morning consent

Consent process consisting of information only provided on the morning of surgery

Phone call explaining the research project

Intervention Type: OTHER

A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial

Phone call and morning consent

Consent process consisting of information provided on the morning of surgery. In addition, a phone call on the day prior to surgery will be provided to subjects explaining that they will be approached about participation in a clinical research project

Phone call explaining the research project

Intervention Type: OTHER

A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial

Interventions

Phone call explaining the research project

A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients participating in approved, minimal risk clinical research projects will be approached by the study investigators

Exclusion Criteria

• Inability to speak English
• Refusal to participate in the clinical research projects

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endeavor Health

OTHER

Sponsor Role: lead

Responsible Party

Glenn Murphy

Director, Cardiac Anesthesia and Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Glenn S. Murphy, MD

Role: PRINCIPAL_INVESTIGATOR

Endeavor Health

Locations

NorthShore University HealthSystem

Evanston, Illinois, United States

Countries

United States

Other Identifiers

EH09-533

Identifier Type: -

Identifier Source: org_study_id