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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Recruitment Status : Withdrawn (Need improve the strategy)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
Sponsor:
Collaborator:
CQuentia NGS, LLC
Information provided by (Responsible Party):
Srdjan Nedeljkovic, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE April 24, 2018
First Posted Date  ICMJE May 21, 2018
Last Update Posted Date January 17, 2019
Estimated Study Start Date  ICMJE October 20, 2018
Estimated Primary Completion Date May 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03531268 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2018)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Study to Evaluate the Clinical Utility of Perioperative Pharmacogenomic Testing
Official Title  ICMJE Prospective Study to Evaluate the Clinical Utility of Perioperative Pharmacogenomic Testing
Brief Summary In the perioperative realm, studies have demonstrated an association of genotype with efficacy of medications applicable to the surgical setting. A clinical association exists between the genotype of various genes and with opioid efficacy and toxicity - specifically for drugs such as oxycodone, codeine, morphine, fentanyl, and tramadol. More studies are needed to assess the effects of personalized dosing of analgesics during the perioperative process for various surgical procedures. The application of Pharmacogenomic testing (PGx) to perioperative medicine is novel, has much potential for growth and may potentially improve outcomes. However, successful implementation of a system to evaluate PGx and integrate results into clinical decision-making is challenging and has not been adequately assessed. The investigators propose to conduct PGx testing for patients undergoing surgery, evaluate its clinical utility, and assess outcomes. The investigators hypothesize that PGx testing may ultimately lead to a decrease in adverse events and improved outcomes in the perioperative period.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
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)
Primary Purpose: Screening
Condition  ICMJE Perioperative/Postoperative Complications
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: PGx Testing
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 15, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2018)
1000
Estimated Study Completion Date  ICMJE May 20, 2020
Estimated Primary Completion Date May 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adults 18 years of age or older at screening.
  2. Adults with qualifying insurance coverage.
  3. Subjects scheduled to undergo elective surgery with an expected hospitalization 24 hrs =/- 4 hrs after surgery.
  4. American Society of Anesthesiology (ASA) physical status 1, 2, or 3.
  5. One or more of the following:

    • Subjects prescribed 4 or more medications at time of surgery.
    • Any subject prescribed any one of the following medication categories: opioid, benzodiazepine, antidepressant, antipsychotic, stimulant, mood stabilizer, NSAIDs, anti-epileptic drugs.
    • Any subject prescribed any one of the following medication categories: antiplatelet therapy, anticoagulant drugs.
  6. Able to provide informed consent, adhere to the study protocol, and complete all study assessments.

Exclusion Criteria:

  1. Subjects who do not have insurance coverage for PGx testing.
  2. Subjects who are expected to have surgery prior to the ability to obtain the results of the pharmacogenomic testing (generally it takes 4 days to obtain the results of testing).
  3. Subjects who are not being prescribed 4 or more medications, or who are not receiving any of the medication categories noted in the inclusion criteria.
  4. Planned multiple surgical procedures within the 30-day study follow up period.
  5. Clinically significant medical or psychiatric disease that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other disease that would cause the subject to be unable to comply with the study requirements.
  6. Administration of an investigational drug within 30 days prior to providing PGx testing, or planned administration of an investigational product during the subject's participation in this study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03531268
Other Study ID Numbers  ICMJE 2018P000454
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Srdjan Nedeljkovic, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE CQuentia NGS, LLC
Investigators  ICMJE
Study Director: Srdjan S Nedeljkovic, MD Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP