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

NCT ID: NCT03836235

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-04
• Study Completion Date: 2020-04-03

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

Conditions

Opioid Use

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Department of Health and Human Services

FED

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sophia Sheikh, MD

Role: PRINCIPAL_INVESTIGATOR

UF College of Medicine--Jacksonville

Locations

UF Health Jacksonville

Jacksonville, Florida, United States

Countries

United States

Other Identifiers

R33AG056540

Identifier Type: NIH

Identifier Source: secondary_id

View Link

JAX ASCENT Junior Scholar

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB201802137- N

Identifier Type: -

Identifier Source: org_study_id