Patient Recall and Comprehension of Informed Consent for Surgical Procedures in Otolaryngology Save

Date Added
September 19th, 2017
PRO Number
Pro00064396
Researcher
Krishna Patel
Keywords
Healthy Volunteer Studies
Summary

This study will look at patients or caregivers who sign consent for surgical procedures to determine how well they remember key elements of the surgical consent. Participants will be identified from MUSC Otolaryngology (ENT) clinics. Any patient or caregiver for a patient for is scheduled to undergo a surgical procedure may be considered for the study. All potential subjects will undergo a pre-operative visit where all details of the surgery will be discussed and consent for surgery is signed. Potential subjects will be contacted by telephone between 3-10 days after the pre-operative visit. During this telephone call, subjects who would like to participate in the study are enrolled and complete a questionnaire over the phone regarding the information covered during the consent for surgery. Subjects will again be contacted between two to three weeks after the surgery to complete a satisfaction survey of the consent process. The data will be collected and stored in a secure database. Goals of the study are to evaluate patient or caregiver?s recall of details discussed during the surgical consent process, to identify factors that may influence patient or caregiver recall of details of the surgical consent, and to evaluate patient satisfaction with the consent process to determine areas for improvement.

Institution
MUSC
Recruitment Contact
Alexander Murphey
7068361987
murphey@musc.edu

Psycho?social and quality-of-life impact of chemodenervation in patients with unilateral facial paresis. Save

Date Added
November 17th, 2013
PRO Number
Pro00025742
Researcher
Krishna Patel
Keywords
Muscle, Nerve
Summary

This study will be a chart review and FaCE questionnaire developed for patients who have undergone chemodenervation for unilateral facial paresis. Patients who come in to the PI's clinic and undergo chemodenervation clinically until 2016 will be included. We anticipate that this cohort will include approximately 50 patients ranging in age from 18 to 85. Information collected will include patient name, MRN, diagnosis, dates of therapy, comorbidities, gender, race questionnaire results-drinking from a cup, ability to make specific sounds, ability to keep food in mouth, eye tearing, difficulty brushing teeth, isolating themselves, calmness, irritability with others, social activities, tension/pain/spasms on affected side of face, ability to move face (pucker lips, smile raise eyebrows), treatment by others. The effects of chemodenervation gradually decrease over several months after administration, which requires a continuous readministration as needed. Questionnaire will be delivered prior to chemodenervation and after chemodenervation. Each patient will be asked to undergo the study process(pre- and post- survey) through one chemodenervation treatment randomly. The pre-treatment questionnaire will be filled out in writing prior to the procedure in clinic. Then, approximately 2-6 weeks post-injection, the patients will be called and asked to conduct the same questionnaire verbally over the phone as a post-treatment survey. The data will be collected, deidentified and stored in an Excel spreadsheet for analysis. Analysis will involve assessing if patients have improved functionality and quality of life for undergoing chemodenervation. Chemodenervation is a standard treatment these patients routinely undergo. Study is only adding a survey to assess the outcomes from the patients perspective.

Institution
MUSC
Recruitment Contact
Krishna Patel
843-876-0922
patelkg@musc.edu

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