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Development of a Risk Prediction Screening Tool for Opioid-Prescription Injury (STOP Injury) in Older Adults Initiated on Opioids From the Emergency Department (STOP Injury)

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ClinicalTrials.gov Identifier: NCT03836235
Recruitment Status : Not yet recruiting
First Posted : February 11, 2019
Last Update Posted : February 11, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Florida

Study Description
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Brief Summary:
The long-term goal of this project is to promote responsible opioid prescribing, immediately improving patient safety and ultimately decreasing healthcare costs by reducing older adult morbidity and mortality due to opioid-related injury. The objective of this pilot project is to gather data to inform the development of the STOP Injury tool and evaluate additional predictive factors and important outcomes relevant to prescription opioids.

Condition or disease
Opioid Use

Detailed Description:

The experience from this project will lay the groundwork on prospective validation of STOP Injury in a large appropriately powered study. Aim 1 will provide data that will help narrow inclusion of candidate variables in the STOP Injury tool to include those that are most feasible to collect and most predictive. Aim 2 will help inform the possible inclusion of genetic factors into a predictive model. Finally, Aim 3 will help identify quality of life outcomes that should be considered when assessing opioid medication adverse events.

Aim 1. Evaluate the association between prescription opioid adverse events in older adults and candidate risk prediction variables proposed for STOP Injury prediction score The study team will conduct a pilot prospective observational study of 200 patients 55 years or older who are initiated on opioids from the emergency department (ED). The investigators will analyze the association between candidate risk factors and opioid adverse events (falls and OD).

Aim 2. Evaluate the association between prescription opioid adverse events and genetic factors.

In the cohort from Aim 1, the study team will test subjects for 12 genetic single nucleotide polymorphisms related to opioid metabolism, transport, and effect.

Aim 3. Measure the impact of opioid medications on quality of life measures in older adults The investigators will implement a series of quality of life measures on a subset of patients as a pilot study to determine which measures capture the impact prescription opioids have on older adults' quality of life


Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a Risk Prediction Screening Tool for Opioid-Prescription Injury (STOP Injury) in Older Adults Initiated on Opioids From the Emergency Department
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Safety, as measured by number of subjects with at least one fall adverse event [ Time Frame: Up to 30 days ]
    The study team will analyze the association between candidate risk factors and opioid adverse events (falls and OD).


Biospecimen Retention:   Samples With DNA
Mouthwash samples will be used to test for the presence of single-nucleotide polymorphisms (CYP2D6, OPRM1, COMT, ABCB1, OCT1) in the genes that mediate opioid metabolism.

Eligibility Criteria
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Ages Eligible for Study:   55 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will seek to enroll 200 subjects. All patients 55 years or older presenting to UF JAX ED with pain or a pain-related complaint (i.e., fracture, burn, etc.) will be screened for eligibility using the inclusion and exclusion criteria listed below. To accomplish Aim 3, the investigators will enroll a convenience subset of patients by approaching every third subject enrolled with the option to consent for Aim 3.
Criteria

Inclusion Criteria:

  • Presenting to UF JAX ED with pain or a pain-related complaint (i.e., fracture, burn, etc.)
  • Patient has not been prescribed an opioid medication in previous 30 days
  • Patient does not have opioid medications at home
  • Discharge to home with an opioid prescription

Exclusion Criteria:

  • Bed-bound or uses wheelchair
  • Living in skilled nursing facility or assisted living facility
  • Non-English speaking
  • Unable to provide consent
  • Incarcerated
  • Current diagnosis of cancer (active not in remission or cured)
  • Lack of reliable telephone access
Contacts and Locations
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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): NCT03836235


Contacts
Contact: Michelle Lott 904-234-1877 Michelle.Lott@jax.ufl.edu

Locations
United States, Florida
UF Health Jacksonville Not yet recruiting
Jacksonville, Florida, United States, 32209
Sponsors and Collaborators
University of Florida
National Institute on Aging (NIA)
Investigators
Principal Investigator: Sophia Sheikh, MD UF College of Medicine--Jacksonville
More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03836235     History of Changes
Other Study ID Numbers: IRB201802137- N
R33AG056540 ( U.S. NIH Grant/Contract )
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
older adults
quality of life
adverse events

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes