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Prospective Observational Clinical Study to Evaluate Patient Outcomes Following Pharmacogenetic Testing of Patients Undergoing Elective Surgical Procedures

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ClinicalTrials.gov Identifier: NCT02605343
Recruitment Status : Completed
First Posted : November 16, 2015
Last Update Posted : June 6, 2016
Sponsor:
Collaborator:
University Hospitals Cleveland Medical Center
Information provided by (Responsible Party):
AltheaDx

Brief Summary:
The purpose of this study is to evaluate the effect of pharmacogenetics (PGx) guided treatment when implemented into the pre-operative process for patients undergoing bowel surgery, major urologic procedure, or major ventral hernia repair and requiring post-operative acute pain management in an inpatient basis, as compared to a group of subjects with the same attributes without the guidance of PGx testing (historical control group). This study will also evaluate the frequency with which the standard analgesic care plan is adjusted by test results.

Condition or disease Intervention/treatment
Acute Pain Surgery Other: NeuroIDgenetix Test Panel

Detailed Description:

The incidence of opioid-related adverse drug events can reach as high as 50% in surgical patients and poor pain management is a significant risk factor for early readmission. In addition, the rate of non- response to certain analgesics is double in patients who are poor metabolizers as demonstrated by mutations in both CPY26D alleles. There is a growing body of literature that indicate that ineffective acute pain management contributes significantly to the risk of chronic pain syndromes. Genetics and drug interactions can alter both the pharmacokinetics and pharmacodynamics of a multitude of drug compounds and in turn influence both the safety and efficacy of selected therapeutic regimens.

Pharmacogenetic-guided therapy selection can enhance patient response by facilitating the selection of the most appropriate medication at the most effective dose in the shortest possible time.

In this prospective, observational, single-blind study, the investigators will evaluate the clinical impact of pharmacogenetics-guided treatment on patient well-being as determined by post-op pain assessments and the frequency of changes in analgesics predicted by testing results. Additionally, the impact of PGx-guided treatment on narcotic consumption, time to mobilization, number of adverse events, length of stay, and re-admission rates compared to historical data will be evaluated during the duration of the study.


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Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective Observational Clinical Study to Evaluate Patient Outcomes Following Pharmacogenetic Testing of Patients Undergoing Elective Surgical Procedures Compared to Historical Data
Study Start Date : August 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2016

Group/Cohort Intervention/treatment
NeuroIDgenetix-guided Pain Management
The medical provider for the NeuroIDgenetix-guided group will make post-operative pain management recommendations based on test results. Patient outcomes, narcotic consumption, opioid-related adverse effects, time to mobilization, number of adverse drug events and number of hospital and/or medical visits will be measured throughout the study.
Other: NeuroIDgenetix Test Panel
The NeuroIDgenetix Test Panel is used to make recommendations on post-operative pain medication therapy that may be impacted by the genetic background of the patient.
Other Names:
  • IDgenetix Neuro Test
  • PGx Testing

Historical Control
The retrospective chart review will utilize patient outcomes from patients meeting the study inclusion/exclusion criteria. The medical provider for the control group will not have received the NeuroIDgenetix Test Panel results and would have made post-operative pain management recommendations per standard of care.



Primary Outcome Measures :
  1. Comparison of patient well-being measured by OBAS score between the two study groups. [ Time Frame: From date of surgery until last follow-up visit, assessed at 30 days post-surgery ]
    Comparison of patient well-being between experimental and control group as measured by Overall Benefit of Analgesics (OBAS) score.

  2. Comparison of length of post-surgical hospital stay between the two study groups [ Time Frame: From date of surgery until hospital discharge, assessed up to 1 month ]
    Comparison of duration of post-surgical hospital stay between experimental and control group.

  3. Comparison of patient well-being measured by BPI score between the two study groups [ Time Frame: From date of surgery until last follow-up visit, assessed at 30 days post-surgery ]
    Comparison of patient well-being between experimental and control group as measured by Brief Pain Inventory-Short Form score.


Secondary Outcome Measures :
  1. Comparison of post-operative narcotic consumption between the two study groups [ Time Frame: From date of surgery until last follow-up visit, assessed at 30 days post-surgery ]
    Comparison of post-operative narcotic consumption between the two study groups

  2. Comparison of time to mobilization between the two study groups [ Time Frame: From date of surgery to mobilization, assessed up to 30 days post-surgery ]
    Comparison of time to mobilization between the two study groups



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to the site for a prep-op visit prior to undergoing a major bowel surgery, major urologic procedure or major ventral hernia repair. The pre-op visit must occur at least 3 days prior to the surgical procedure.
Criteria

Inclusion Criteria:

  • Male or female subjects over the age of 18
  • Presenting to the site for a prep-op visit prior to undergoing a major bowel surgery, major urologic procedure or major ventral hernia repair. The pre-op visit must occur at least 3 days prior to the surgical procedure.
  • Willing and able to comply with study procedures
  • Able to provide written informed consent

Exclusion Criteria:

  • Unwilling or unable to provide written informed consent and to comply with study procedures;
  • Unwilling or unable to provide buccal swab sample
  • History of chronic renal dysfunction, Chronic Kidney Disease (Stage 4 or 5);
  • New York Heart Classification >3
  • Abnormal hepatic function within the last 2 years (INR >1.2 not attributable to anticoagulant medications, AST/aspartate aminotransferase or ALT/alanine aminotransferase >1.5x normal, or suspected cirrhosis);
  • History of malabsorption (short gut syndrome);
  • Gastric or small bowel surgery less than 3 months prior to study enrollment;

Information from the National Library of Medicine

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): NCT02605343


Locations
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United States, Ohio
University Hospitals of Cleveland Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
AltheaDx
University Hospitals Cleveland Medical Center
Investigators
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Principal Investigator: Anthony J Senagore, MD University Hospitals Case Medical Centers

Additional Information:
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Responsible Party: AltheaDx
ClinicalTrials.gov Identifier: NCT02605343     History of Changes
Other Study ID Numbers: CLP0006
First Posted: November 16, 2015    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: November 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by AltheaDx:
PGx
pharmacogenetic testing
Pain Management
AltheaDx
Post-Operative Pain Management
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms