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

Completed

• Conditions: Opioid Use

• Registration Number: NCT03836235
• Lead Sponsor: University of Florida

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.

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 50 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-02-07
• Study First Submitted QC: 2019-02-07
• Study First Posted: 2019-02-11
• Study Start: 2019-03-04
• Primary Completion: 2020-04-03
• Study Completion: 2020-04-03
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-12
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Presenting to UF JAX ED with pain or a pain-related complaint (i.e., fracture, burn, etc.)
• Patient has not used opioids 15 days or more within the last 30 days
• Patient does not have opioid medications at home
• Discharge to home with an opioid prescription

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Exclusion Criteria

• Bed-bound or uses wheelchair
• Living in skilled nursing facility or assisted living facility
• Non-English speaking
• Unable to provide consent
• Incarcerated
• Lack of reliable telephone access
• Use of opioids on most days for >3 months

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety, as measured by number of subjects with at least one fall adverse event	Up to 30 days	The study team will analyze the association between candidate risk factors and opioid adverse events (falls and OD).

Trial Locations

Locations (1)

UF Health Jacksonville; 🇺🇸 Jacksonville, Florida, United States