Development of a Risk Prediction Screening Tool for Opioid-Prescription Injury (STOP Injury) in Older Adults Initiated on Opioids From the Emergency Department
Condition: Opioid Use
MeSH terms: Emergencies
Study type: Observational

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
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study will seek to enroll 200 subjects. All patients 50 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.
      
Biospecimen description: 
      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.
    
Keywords: older adults; quality of life; adverse events