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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Glenn S. Murphy, MD, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier:
NCT01546194
First received: February 28, 2012
Last updated: November 7, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention
Informed Consent
Other: Phone call explaining the research project

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by NorthShore University HealthSystem Research Institute:

Primary Outcome Measures:
  • Overall patient satisfaction with the same-day consent process-total number of questions answered with a score of 4 or 5 (on a 5-point scale from 1=strongly disagree to 5=strongly agree). [ Time Frame: Third postoperative day ] [ Designated as safety issue: No ]
    Subjects will reply using a 5-point scale from 1=strongly disagree to 5=strongly agree.


Secondary Outcome Measures:
  • Individual scores relating to six areas of informed consent; comprehension, situation (privacy/time), obligation (pressure) motivation, compunction (regrets), and satisfaction [ Time Frame: Third postoperative day ] [ Designated as safety issue: No ]
    Subjects will reply using a 5-point scale from 1=strongly disagree to 5=strongly agree.


Enrollment: 220
Study Start Date: September 2009
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Morning consent
Consent process consisting of information only provided on the morning of surgery
Other: 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
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
A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546194

Locations
United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
NorthShore University HealthSystem Research Institute
Investigators
Principal Investigator: Glenn S. Murphy, MD NorthShore University HealthSystem
  More Information

No publications provided

Responsible Party: Glenn S. Murphy, MD, Director, Cardiac Anesthesia and Clinical Research, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier: NCT01546194     History of Changes
Other Study ID Numbers: EH09-533
Study First Received: February 28, 2012
Last Updated: November 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by NorthShore University HealthSystem Research Institute:
Informed consent
Perioperative period
Morning of surgery
Anesthesiology

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014