Prospective Study to Evaluate the Clinical Utility of Perioperative Pharmacogenomic Testing
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|ClinicalTrials.gov Identifier: NCT03531268|
Recruitment Status : Withdrawn (Need improve the strategy)
First Posted : May 21, 2018
Last Update Posted : January 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Perioperative/Postoperative Complications||Other: PGx Testing||Not Applicable|
Potential subjects will participate in screening with a minimum of 4 days prior to their planned surgery. The study involves obtaining mouth swab samples for genetic testing and employing standardized measures for PGx testing of subjects preoperatively.
Study staff will pre-screen potential subjects scheduled at the preoperative center or on surgeons' operative schedules. The study team member will ask the treating clinician involved with the care of a patient for permission to speak to the patient. The physician or a member of the research staff will describe the study to potentially eligible patients and a study investigator will obtain consent. After meeting inclusion and exclusion criteria, subjects who agree to participate in the study will complete study questionnaires and provide a swab sample for PGx analysis.
Trained members of the research staff will obtain a buccal swab sample from each subject who has given informed consent to participate in study procedures. The buccal swab will be packaged and shipped to an outside laboratory for processing and the conduct of the PGx testing. The results of the PGx testing will be provided in a standardized report and sent back to the research staff conducting the study. Typically, the turn-around for shipping the sample and obtaining the results will be 4 days. The results will be available to the anesthesiologist prior to the patient's surgery.
Prior to the initiation of the scheduled surgery, the anesthesiologist will be asked to complete a questionnaire about the clinical utility of PGx testing for that subject. In the perioperative group of subjects for whom clinicians find clinical utility for PGx testing (experimental group), outcomes will be compared to the remaining subjects (control group) for whom PGx testing was felt not to have any clinical utility.
After surgery, there will be two assessment periods. Clinical outcomes and the quality of the subject's recovery from surgery will be assessed postoperatively at 24 hours +/-4 hours after surgery by directly interviewing each study subject and reviewing the electronic medical record. Additional assessments of subjects will be conducted by review of the electronic medical record at 30 days +/- 3 days postoperatively.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||All subjects meeting inclusion/exclusion criteria will undergo pharmacogenomic testing. The group for which testing is thought to have clinical utility will be compared to the group for which testing is thought to have no clinical utility.|
|Masking:||None (Open Label)|
|Official Title:||Prospective Study to Evaluate the Clinical Utility of Perioperative Pharmacogenomic Testing|
|Estimated Study Start Date :||October 20, 2018|
|Estimated Primary Completion Date :||May 20, 2020|
|Estimated Study Completion Date :||May 20, 2020|
Active Comparator: PGx testing has clinical utility
These are subjects whose PGx testing is judged to have clinical utility and whose clinical care may be modified. Modifications may include altering doses or types of drugs given based on metabolic profile of the patient.
Other: PGx Testing
Pharmacogenomic (PGx) testing will be administered to all subjects. The results of PGx testing will be evaluated for clinical utility. Subjects will be evaluated based on whether PGx testing has clinical utility or has no clinical utility.
No Intervention: PGx testing has no clinical utility
These are subjects whose PGx testing is judged to have no clinical utility. Care "as usual" is provided, and there are no changes in drug selection or dosing based on the results of PGx testing.
- Clinical Utility [ Time Frame: The day of surgery or the day prior ]The anesthesiologist will be shown the results of PGx testing and will complete a "Clinical Utility Questionnaire" regarding the clinical utility of PGx testing for the subject. The responses will be rated: 0 = no utility; 1 = some utility; 2 = significant utility. The larger value (2) is considered as having a higher utility for this scale.
- Intraoperative and postoperative use of opioids [ Time Frame: 24 hrs +/- 4 hrs after surgery ]The use of intraoperative and postoperative use of opioids will be measured (morphine mg equivalents)
- Duration times (surgery, anesthesia, length of stay in PACU) [ Time Frame: 24 hrs +/- 4 hrs after surgery ]Surgical duration and anesthesia duration times, length of stay in PACU (duration will be measured in minutes)
- Pain Assessment [ Time Frame: 24 hrs +/- 4 hrs after surgery ]Pain Numeric Rating Scale, 0 - 10 (0 = no pain, 10 = maximum pain) (lower values = better outcome)
- Postoperative Nausea and Vomiting [ Time Frame: 24 hrs +/- 4 hrs after surgery ]Postoperative Nausea and Vomiting Scale (0 = no nausea/vomiting, 200 = maximal nausea/vomiting) (lower values = better outcome)
- Sedation and Delirium Assessment [ Time Frame: 24 hrs +/- 4 hrs after surgery ]Richmond Agitation and Sedation Scale (-5 = unarousable, 0 = alert and calm, +4 = combative) (values = 0 are best outcome)
- Subject Satisfaction [ Time Frame: 24 hrs +/- 4 hrs after surgery ]Subject Satisfaction Questionnaire (1 = extremely dissatisfied, 5 = extremely satisfied) (higher values = best outcome)
- Quality of Recovery [ Time Frame: 24 hrs +/- 4 hrs after surgery ]Quality of Recovery Questionnaire (0 = poor, 150 = excellent) (higher values = best outcome)
- Length of stay in hospital after surgery [ Time Frame: 30 days ]Length of stay in the hospital after surgery (days)(lower number = best outcome)
- Opioid Prescriptions [ Time Frame: 30 days ]Amount of opioids prescribed after surgery (morphine mg equivalents) (lower amount = best outcome)
- Hospital Readmissions [ Time Frame: 30 days ]Number of times readmitted to hospital within 30 days after surgery (lower number = best outcome)
- Emergency Room Visits [ Time Frame: 30 days ]Number of emergency room visits within 30 days after surgery (lower number = best outcome)
- Unscheduled Phone Calls [ Time Frame: 30 days ]Number of unscheduled phone calls to the doctor's office within 30 days after surgery (lower number = best outcome)
- Unscheduled Office Visits [ Time Frame: 30 days ]Number of unscheduled visits to the doctor's office within 30 days after surgery (lower number = best outcome)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531268
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02110|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Study Director:||Srdjan S Nedeljkovic, MD||Brigham and Women's Hospital|