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

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.

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Key information

Conditions

Opioid Use

Age range

50 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UF Health Jacksonville

Jacksonville, Florida, 32209, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

Department of Health and Human Services
National Institute on Aging (NIA)

Registry information

Acronym: STOP Injury

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Feb 11, 2019
Registry last updated: Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed