Adolescent Outcomes of Post-operative Opioid EXposure
- Conditions
- Pain, ChronicOpioid Use Disorder
- Registration Number
- NCT06350409
- Lead Sponsor
- Sharon Levy
- Brief Summary
The goal of this observational study is to examine the factors associated with the transition from medical exposure to opioids with "signposts" of future opioid use disorder among adolescent surgical patients. The main question aims to identify factors (moderators, mediators, and covariates) associated with risk factors for opioid use disorder (ROUD) in the 12 months following major surgery with opioid exposure among adolescents aged 12-17. Participants will be asked to complete electronic surveys pre- and post-operatively and approve the collection of peri-operative data from the Electronic Medical Record to assess correlations.
- Detailed Description
This project will collect data from a diverse sample of 10,000 dyads, including adolescent (aged 12-17 years, inclusive) patients undergoing major surgery with planned post-operative opioid analgesic use. and a parent (Total N=20,000) to identify ROUD that may occur within the 12 months after surgery. The resulting data repository will allow clinician scientists and physicians to develop research-informed pain management protocols for adolescent surgical patients to reduce the risk of OUD in this vulnerable population.
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Risk of opioid use disorder due to postoperative non-medical use of prescription opioids (NMUPO) that develops within the first year after surgery. 12 monhts Any adolescent self-report or parent report of use of opioid medication that is \> than prescribed, or more frequently than prescribed, or not prescribed to the adolescent.
Risk of opioid use disorder due to post-surgical trauma that develops within the first year after surgery. 12 months Adolescent self-report of post-surgical trauma and stress as measured by \>11 on the Child PTSD Symptom Scale (CPSS) 3 or more months postoperatively.
Risk of opioid use disorder due to prolonged opioid use that develops within the first year after surgery. 12 months Any adolescent self-report or parent report of opioid medication use more than 3 or more months postoperatively.
Risk of opioid use disorder due to prolonged pain that develops within the first year after surgery. 12 months The patient self-report an average pain score of more than 3/10 in the last 7 days on the Brief Pain Inventory (BPI) at 3 or more months postoperatively.
Risk of opioid use disorder due to increased rate of change in substance use that develops within the first year after surgery. 12 month Adolescent self-report of rate of increase of substance use frequency greater than the 75th percentile of an age- and sex-matched cohort compared to nationally representative data
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Johns Hopkins All Children's Hospital
🇺🇸St. Petersburg, Florida, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Boston Childrens Hopsital - Division of Addiction Medicine
🇺🇸Boston, Massachusetts, United States