Adolescent Outcomes of Post-operative Opioid EXposure

Pain, Chronic Clinical Trial

— APEX  

Official title:

Adolescent Outcomes of Post-operative Opioid EXposure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06350409
• Other study ID #: CTN-0146
• Secondary ID: UG1DA015831-22S4
• Status: Not yet recruiting
• Start date: August 10, 2024
• Est. completion date: October 10, 2026

Study information

• Verified date: April 2024
• Source: Boston Children's Hospital
• Contact: Sharon Levy, MD, MPH
• Phone: 857-218-4308
• Email: sharon.levy[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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: Machine learning models will be used to develop and validate screening algorithms to detect "early warning signs" or Risk factors for Opioid Use Disorder (ROUD). The features in these models will include the pre-, intra-, and post-operative EMR-derived data elements and the survey data. Models will fit 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 2: Develop and validate a prediction model designed to predict a clinical trajectory of post-surgical opioid use and pain. The model will use clustering to identify typical patient trajectories of opioid use and will use similar prediction and validation techniques as in Aim 1.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20000
• Est. completion date: October 10, 2026
• Est. primary completion date: September 10, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Adolescent Inclusion Criteria

1. Be between the ages of 12 to 17 years old, inclusive, and scheduled to undergo a selected surgical procedure, including but not limited to general, orthopedic, thoracic, and spinal surgeries at a participating site within SPAIN.

2. Be willing and able to provide informed assent and have a parent/caregiver willing to provide informed consent.

Parent/Caregiver inclusion criteria

1. Be a parent or legal guardian of an eligible adolescent.

2. Be willing and able to provide written informed consent.

Adolescent Participant 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, such as sickle cell disease, arthritis, or cancer.

2. Adolescents who do not have a caregiver who is willing to co-participate in the study.

3. Adolescents who cannot speak or read English at a 4th-grade level as determined by medical or research staff.

4. Adolescents that 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.

5. Adolescents that are currently in the custody of the Department of Children and Families or living with a foster family.

6. Adolescents that are currently pregnant or parenting.

7. Adolescents that self or parent report ever having been diagnosed with opioid use disorder or prescribed buprenorphine, methadone, or naltrexone to treat opioid use disorder.

Parent/Caregivers Exclusion Criteria:

Parents/Caregivers meeting any of the following criteria will be excluded from study participation:

1. Parents/Caregivers that 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.

Related Conditions & MeSH terms

• Chronic Pain
• Opioid Use Disorder
• Opioid-Related Disorders
• Pain, Chronic

Locations

Country	Name	City	State
United States	Boston Childrens Hopsital - Division of Addiction Medicine	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Sharon Levy	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of opioid use disorder due to prolonged pain that develops within the first year after surgery.	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.	12 months
Primary	Risk of opioid use disorder due to prolonged opioid use that develops within the first year after surgery.	Any adolescent self-report or parent report of opioid medication use more than 3 or more months postoperatively.	12 months
Primary	Risk of opioid use disorder due to postoperative non-medical use of prescription opioids (NMUPO) that develops within the first year after surgery.	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.	12 monhts
Primary	Risk of opioid use disorder due to increased rate of change in substance use that develops within the first year after surgery.	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	12 month
Primary	Risk of opioid use disorder due to post-surgical trauma that develops within the first year after surgery.	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.	12 months