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

NCT01546194 | Completed Results

• 1 other identifier: EH09-533
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Informed Consent

Keywords

Informed consent; Perioperative period; Morning of surgery; Anesthesiology

Outcome Measures

Primary Outcomes (1)

• Overall Patient Satisfaction With the Same-day Consent Process-total Number of Questions Answered With a Score of 0 to 10 (on a 11-point Scale From 0=Strongly Disagree to 10=Strongly Agree).

  Subjects will reply using a 11-point scale from 0=strongly disagree to 10=strongly agree.

  First postoperative day

Study Arms (2)

Morning consent

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

Other: Phone call explaining the research project

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

Other: Phone call explaining the research project

Interventions

Phone call explaining the research project OTHER

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

Morning consent; Phone call and morning consent

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients participating in approved, minimal risk clinical research projects in the Department of Anesthesiology at NorthShore University HealthSystem will be approached by the study investigators.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Results Point of Contact

• Title: Glenn Murphy
• Organization: NorthShore University HealthSystem

dgmurphy2@yahoo.com

847-570-2760

Study Officials

• Glenn S. Murphy, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiac Anesthesia and Clinical Research

Study Record Dates

• First Submitted: February 28, 2012
• First Posted: March 7, 2012
• Study Start: September 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: September 16, 2019
• Results First Posted: September 25, 2015

Record last verified: 2019-09

Locations

US (1)