- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03836235
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)
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Florida
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Jacksonville, Florida, Förenta staterna, 32209
- Uf Health Jacksonville
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Safety, as measured by number of subjects with at least one fall adverse event
Tidsram: Up to 30 days
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The study team will analyze the association between candidate risk factors and opioid adverse events (falls and OD).
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Up to 30 days
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Sophia Sheikh, MD, UF College of Medicine--Jacksonville
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB201802137- N
- R33AG056540 (U.S.S. NIH-anslag/kontrakt)
- JAX ASCENT Junior Scholar (Annat bidrag/finansieringsnummer: US Department of Health and Human Services)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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