Consent for a clinical anesthesia research trial is frequently sought in hospital on the day of surgery. This time is often associated with increased anxiety, diminished privacy, and limited opportunity for reflection. Our objective was to determine whether a preadmission telephone call on the day before surgery resulted in greater satisfaction compared to the traditional practice of initiating the consent process on the day of surgery. We randomized 124 patients eligible for participation in a minimal-risk clinical anesthesia trial to receive either a preadmission telephone call on the day before surgery to initiate consent (Telephone group; n = 62), or no telephone call (Control group; n = 62). In the Telephone group, 21 patients (33.9%) were successfully contacted by telephone, whereas 41 patients (66.1%) were not contacted. Both the Telephone and Control groups reported similar understanding regarding the purpose of the trial. Both groups similarly agreed that the time and setting of recruitment and consent were appropriate. Patients in both groups reported having enough time to consider their participation in the trial. Few patients in either group reported feeling anxious at the time of consent or pressured to participate in the trial. Finally, patients in both groups were equally satisfied with the consent process. Implications: A preadmission telephone call on the day before surgery to initiate the consent process for a minimal-risk clinical anesthesia research trial does not improve satisfaction among consenting patients compared to initiating consent in hospital on the day of surgery, and can be an impractical method to initiate the consent process.
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Appendix I: Telephone Script
Hello. My name is Jane Lipnitsky from the Department of Anesthesia at the Hospital for Special Surgery. You are scheduled for shoulder surgery tomorrow, and I'm calling to tell you about an important study that our Department is conducting.
The anesthetic of choice for shoulder surgery at our hospital is a nerve block, meaning that we anesthetize the nerves that supply the shoulder with an injection of local anesthetic. There are two main techniques to locate the shoulder nerves for the injection: The first technique uses verbal feedback from the patient, and the second technique uses a small stimulating current. Both techniques are very safe and effective, and both techniques are commonly used by anesthesiologists at our hospital and around the world. Because both techniques are so highly successful and safe, we don't know for certain which technique is best. The point of our study is to answer—once and for all—which technique to locate the shoulder nerves is the very best for our patients.
If your anesthesiologist, whom you will meet tomorrow, decides that you are eligible for our study, he/she may ask you to participate. Your participation is completely voluntary. Your medical care will not be affected whether or not you choose to participate. If you do choose to participate, the technique used to locate your shoulder nerves will be determined at random—much like a coin toss.
There will be no inconvenience to you as a result of your participation, aside from a brief physical exam and few questions for you to answer while you are in hospital. If you choose not to participate, your anesthesiologist will select one of these two main techniques on your behalf.
Regardless of whether or not you choose to participate in our study, your anesthesiologist will answer your questions and discuss your options tomorrow before surgery.
Thank you for your time and we look forward to seeing you tomorrow.
Appendix II: Information Letter
You have recently been asked to participate in one of our important anesthesia research studies currently underway at the Department of Anesthesia at the Hospital for Special Surgery.
We are writing to find out how you felt about the research procedures at the Hospital for Special Surgery. We ask that you kindly complete this short questionnaire (attached) and return it in the self-addressed, stamped envelope provided.
There will be no inconvenience or risk to you from completing this questionnaire, aside from the 5–10 minutes which are needed to answer the questionnaire. The results from this questionnaire may not benefit you directly; however, the knowledge gained will help us with future patients.
Your responses to this questionnaire will remain confidential. Any reports or publications resulting from this research will not contain information which identifies you or any other patient in this study.
You may choose not to complete this questionnaire without affecting your future medical care. In no way does completing this questionnaire waive your legal rights nor does it relieve the investigators or involved institution from their legal and professional responsibilities.
If you have any questions about this questionnaire, you may call Dr. Jacques YaDeau at (212) 606–1206. If you would like to discuss your rights as a research subject and/or your participation in this study with an institutional representative, you can call the Administrator, Institutional Research Board at (212) 774–2456.
Thank you for your cooperation.
Jacques T. YaDeau, MD, PhD
Department of Anesthesia
Hospital for Special Surgery
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Brull, R., YaDeau, J.T., Lipnitsky, J.Y. et al. A Preadmission Telephone Call to Initiate the Consent Process for Clinical Anesthesia Research. HSS Jrnl 2, 42–48 (2006). https://doi.org/10.1007/s11420-005-0132-0