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

NCT02605343 | Completed

• 1 other identifier: CLP0006
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain; Surgery

Keywords

PGx; pharmacogenetic testing; Pain Management; AltheaDx; Post-Operative Pain Management

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

  From date of surgery to mobilization, assessed up to 30 days post-surgery

Study Arms (2)

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

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.

Interventions

NeuroIDgenetix Test Panel OTHER

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.

Also known as: IDgenetix Neuro Test, PGx Testing

NeuroIDgenetix-guided Pain Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• AltheaDx: lead
• University Hospitals Cleveland Medical Center: collaborator

Study Sites (1)

University Hospitals of Cleveland Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Acute Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Anthony J Senagore, MD

  University Hospitals Case Medical Centers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: November 16, 2015
• Study Start: August 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 6, 2016

Record last verified: 2015-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)