Opioid UseSTOP InjuryNCT03836235
Development of a Risk Prediction Screening Tool for Opioid-Prescription Injury (STOP Injury) in Older Adults Initiated on Opioids From the Emergency Department
An observational study of Opioid Use, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 120 years
- Conditions the study is for
- Opioid Use
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2019to 3 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Keywords
- older adults, quality of life, adverse events
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, as measured by number of subjects with at least one fall adverse event
The study team will analyze the association between candidate risk factors and opioid adverse events (falls and OD).
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start4 Mar 2019
- Primary completion3 Apr 2020
- Study completion3 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Sophia Sheikh, MD, Principal investigator, UF College of Medicine--Jacksonville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836235
- Sponsor's protocol ID
- IRB201802137- N
- Other IDs
- R33AG056540, JAX ASCENT Junior Scholar
- Acronym
- STOP Injury
- Status last verified
- Oct 2020
- First submitted
- 7 Feb 2019
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03836235
- Acronym / sponsor ID
- STOP Injury / IRB201802137- N
- Conditions
- Opioid Use
- Keywords
- older adults, quality of life, adverse events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Department of Health and Human Services
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 3 Apr 2020 (actual)
- Study completion
- 3 Apr 2020 (actual)
- First posted
- 11 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Bed-bound or uses wheelchair
- Living in skilled nursing facility or assisted living facility
- Non-English speaking
- Unable to provide consent
- Incarcerated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophia Sheikh, MD principal investigator
UF College of Medicine--Jacksonville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety, as measured by number of subjects with at least one fall adverse event (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.