Informed Consent
Conditions
Keywords
Informed consent, Perioperative period, Morning of surgery, Anesthesiology
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.
Interventions
OTHERPhone 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
Sponsors
Endeavor Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | First postoperative day | Subjects will reply using a 11-point scale from 0=strongly disagree to 10=strongly agree. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Morning Consent Consent process consisting of information only provided on the morning of surgery
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 | 64 |
| 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: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial | 65 |
| Total | 129 |
Baseline characteristics
| Characteristic | Morning Consent | Phone Call and Morning Consent | Total |
|---|---|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 10 | 56 years STANDARD_DEVIATION 11 | 56 years STANDARD_DEVIATION 10 |
| Sex: Female, Male Female | 64 Participants | 31 Participants | 95 Participants |
| Sex: Female, Male Male | 0 Participants | 34 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 64 | 0 / 65 |
| serious Total, serious adverse events | 0 / 64 | 0 / 65 |
Outcome results
Primary
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.
Time frame: First postoperative day
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Morning Consent | 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). | 9.5 units on a scale |
| Phone Call and Morning Consent | 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). | 10 units on a scale |