Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
20000 participants
OBSERVATIONAL
2024-11-12
2028-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Opioid Use After Traumatic Injury in Adolescents
NCT03628846
The Effects of Opioid Taper on Opioid-Induced Hyperalgesia
NCT03063905
Effect of Standard of Care Reduced Dose Versus Full Dose Buprenorphine/Naloxone in the Perioperative Period on Pain Control and Post-Operative Opioid Use Disorder Symptoms
NCT04091009
Sensory Outcomes in Active Substance Users
NCT06639438
Effect of Buprenorphine/Naloxone Continuation on Pain Control and Opioid Use
NCT03266445
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Using a novel combination of data sources (electronic medical records (EMR), patient-reported outcomes, and parent-reported outcomes), this study investigates the twin problems of postoperative pain and ROUD in adolescent surgical patients. Using real-world evidence to evaluate longitudinal behaviors and outcomes.
This project will provide insights into the associations between post-operative pain management and ROUD in adolescents. Findings could yield information about potential risks, which may inform future studies and ultimately lead to new screening tools to assess risk before opioid prescribing, updated protocols for managing pain intra-operatively and post-operatively in high-risk populations, updated patient and family education materials to reduce risks for those undergoing painful procedures, and revised recommendations for monitoring for patients being treated for pain. Furthermore, the project enables the establishment of an infrastructure among pediatric surgical centers that can be used for future projects to evaluate the best postoperative outcomes for youth.
Aim 1: Determine the frequency of ROUD. Because this is a novel measure of ROUD, we will use the first 1,000 samples to estimate the incidence of ROUD developing among adolescents in the year following surgery with post-operative opioid analgesia.
Aim 2: We will use machine learning models to develop and validate screening algorithms designed to detect "early warning signs" or Risk factors for Opioid Use Disorder (ROUD). The features in these models will include the pre-, intra- and postoperative EMR-derived data elements, as well as the survey data. We will fit the models against the primary outcome described above. Model evaluation will be done via cross-validation, where the models will be fit on a randomly selected training set of patients and evaluated on the remaining held-out subset of the patients to be used exclusively for testing the performance of the final models.
Aim 3: Developing and validating a prediction model designed to predict a clinical trajectory of post-surgical opioid use and pain. We will use clustering to identify typical patient trajectories of opioid use, and we will use similar prediction and validation techniques as in Aim 1 to build a prediction model for these trajectories.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
• Opioid prescribing practices vary by institution; therefore, eligible surgical procedures will be determined on a site-by-site basis.
2. Adolescents willing and able to provide informed assent and have a parent/caregiver willing to provide informed consent.
1. Parent or legal guardian of an eligible adolescent.
2. Parent or legal guardian willing and able to provide written informed consent.
Exclusion Criteria
1. Adolescents who have been prescribed opioids in the past 2 years for pain due to a chronic medical condition.
2. Adolescents who have a current chronic medical condition that requires ongoing opioid pain management and treatment such as sickle cell disease, arthritis, or cancer.
3. Adolescents who do not have a caregiver who is willing to co-participate in the study.
4. Adolescents who cannot speak or read English at a 4th-grade level as determined by medical or research staff.
5. Adolescents who are currently in the custody of the Department of Youth Services, jail/prison, or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities.
6. Adolescents who are currently in the custody of the Department of Children and Families or living with a foster family.
7. Adolescents who are currently pregnant or parenting.
8. Adolescents that self or parent report of ever having been diagnosed with opioid use disorder, or prescribed buprenorphine, methadone, or naltrexone to treat opioid use disorder.
9. Adolescents who are currently enrolled in an intervention study that aims to impact opioid prescription or pain management pre-, peri-, or post-operatively.
Parents/Caregivers meeting any of the following criteria will be excluded from study participation:
1. Parents/Caregivers who cannot speak or read English or Spanish at a 4th grade level as determined by medical or research staff.
2. Parents/Caregivers that are currently incarcerated.
3. Parents/Caregivers that are in physical or mental distress that precludes study participation as determined by clinical or study staff.
12 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Drug Abuse (NIDA)
NIH
National Institutes of Health (NIH)
NIH
Sharon Levy
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sharon Levy
Chief, Division of Addiction Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's Hospital Colorado
Aurora, Colorado, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Boston Childrens Hopsital - Division of Addiction Medicine
Boston, Massachusetts, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Related Links
Access external resources that provide additional context or updates about the study.
APEX study information website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.