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)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03836235|
Recruitment Status : Not yet recruiting
First Posted : February 11, 2019
Last Update Posted : February 11, 2019
|Condition or disease|
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 55 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
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Development of a Risk Prediction Screening Tool for Opioid-Prescription Injury (STOP Injury) in Older Adults Initiated on Opioids From the Emergency Department|
|Estimated Study Start Date :||March 2019|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
- 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).
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03836235
|Contact: Michelle Lott||904-234-1877||Michelle.Lott@jax.ufl.edu|
|United States, Florida|
|UF Health Jacksonville||Not yet recruiting|
|Jacksonville, Florida, United States, 32209|
|Principal Investigator:||Sophia Sheikh, MD||UF College of Medicine--Jacksonville|