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

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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Acute Pain
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals of Cleveland Case Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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: PGx Testing; IDgenetix Neuro Test
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of patient well-being measured by OBAS score between the two study groups.	Comparison of patient well-being between experimental and control group as measured by Overall Benefit of Analgesics (OBAS) score.	From date of surgery until last follow-up visit, assessed at 30 days post-surgery
Comparison of length of post-surgical hospital stay between the two study groups	Comparison of duration of post-surgical hospital stay between experimental and control group.	From date of surgery until hospital discharge, assessed up to 1 month
Comparison of patient well-being measured by BPI score between the two study groups	Comparison of patient well-being between experimental and control group as measured by Brief Pain Inventory-Short Form score.	From date of surgery until last follow-up visit, assessed at 30 days post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of post-operative narcotic consumption between the two study groups	Comparison of post-operative narcotic consumption between the two study groups	From date of surgery until last follow-up visit, assessed at 30 days post-surgery
Comparison of time to mobilization between the two study groups	Comparison of time to mobilization between the two study groups	From date of surgery to mobilization, assessed up to 30 days post-surgery

Collaborators and Investigators

• Sponsor: AltheaDx
• Collaborators: University Hospitals Cleveland Medical Center
• Investigators: Principal Investigator: Anthony J Senagore, MD, University Hospitals Case Medical Centers

Publications and helpful links

Helpful Links

• IDgenetix gives you the power to offer personalized medicine to your patients through a combination of comprehensive pharmacogenetic testing and a proprietary algorithmic screening process.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: November 6, 2015
• First Submitted That Met QC Criteria: November 13, 2015
• First Posted (Estimate): November 16, 2015

Study Record Updates

• Last Update Posted (Estimate): June 6, 2016
• Last Update Submitted That Met QC Criteria: June 2, 2016
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Pain Management; PGx; pharmacogenetic testing; AltheaDx; Post-Operative Pain Management
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: CLP0006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO