Clinical trial NCT06350409: Adolescent Outcomes of Post-operative Opioid EXposure
Official title: Adolescent Outcomes of Post-operative Opioid EXposure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Opioid Use Disorder
Pain, Chronic
Keywords: Adolescent Opioid Use
Post operative pain
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institutes of Health (NIH)
First posted: 2024-04-05
Enrollment: 20000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study aims to recruit a convenience sample of approximately 10,000 dyads of adolescent (12-17 years, inclusive) patients and one parent (Total N=20,000). Adolescent participants will be undergoing scheduled surgeries with a greater than 90% likelihood of requiring opioid analgesia for at least 48 hours post-operatively (as an inpatient) or discharged home with at least a 48-hour supply of prescription opioids.

Opioid prescribing practices vary by institution; therefore, eligible surgical procedures will be determined on a site-by-site basis. Exemplar surgeries at BCH and CCHMC sites include spinal fusion surgery, Nuss procedure, and anterior cruciate ligament reconstruction. Both inpatient and outpatient surgical procedures will be considered.

All adolescent participants will be aged 12-17 at the time of enrollment and are children as defined by the NIH Policy on I

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.

Eligibility criteria: Adolescent Inclusion Criteria

1. Adolescents between the ages of 12 to 17 years old, inclusive, who are scheduled to undergo a scheduled surgical procedure with a greater than 90% likelihood of requiring opioid analgesia for at least 48 hours post-operatively (as an inpatient) or discharged home with at least a 48-hour supply of prescription opioids.

   • 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.

Parent/Caregiver Inclusion Criteria

1. Parent or legal guardian of an eligible adolescent.
2. Parent or legal guardian willing and able to provide written informed consent.

Adolescent Exclusion Criteria

Adolescents meeting any of the following criteria will be excluded from study participation:

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.

Parent/Caregiver Exclusion Criteria

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.

Primary outcomes:
measure: Risk of opioid use disorder due to prolonged pain that develops within the first year after surgery.
timeFrame: 12 months
measure: Risk of opioid use disorder due to prolonged opioid use that develops within the first year after surgery.
timeFrame: 12 months
measure: Risk of opioid use disorder due to postoperative non-medical use of prescription opioids (NMUPO) that develops within the first year after surgery.
timeFrame: 12 monhts
measure: Risk of opioid use disorder due to increased rate of change in substance use that develops within the first year after surgery.
timeFrame: 12 month
measure: Risk of opioid use disorder due to post-surgical trauma that develops within the first year after surgery.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: St. Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital
state: Florida
city: Boston
country: United States
facility: Boston Childrens Hopsital - Division of Addiction Medicine
state: Massachusetts
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
References: