Clinical trial NCT04066829: Default Dosing Settings for Opioid Prescriptions to Adolescents and Young Adults After Tonsillectomy
Official title: Default Dosing Settings for Opioid Prescriptions to Adolescents and Young Adults After Tonsillectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tonsillectomy
Keywords: Default settings
Opioid prescribing
Electronic Health Record
Opioid
Opioid Use
Behavioral intervention
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-08-26
Enrollment: 198
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will evaluate whether lowering the default number of doses for opioid prescriptions written in an electronic health record system can decrease opioid prescribing without causing unintended consequences such as worsened pain control.


Eligibility criteria: Inclusion Criteria:

* Adolescents and young adults aged 12-25 years undergoing tonsillectomy at C.S. Mott Hospital, University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care from October 2019-July 2021, excluding April-May 2020 (owing to suspension of elective procedures due to COVID-19).
* Surgeon belongs to the Department of Otolaryngology at the University of Michigan Medical School
* Patients are not any of the following: patients living in foster care or with a legal guardian, patients with medical complexity or developmental delays, non-English speaking patients, patients with recent suicidal ideation documented in their chart, or patients undergoing emergent tonsillectomy.

Exclusion Criteria:

* Patients with prescription opioid use prior to surgery
* Patients undergoing additional procedures at the same time as tonsillectomy (other than minor procedures such as tympanostomy tube placement)
* Patients enrolled in another study
* Patients who are not prescribed opioids post-operatively at discharge
* Patients who are enrolled in the Michigan Pain-control Optimization Pathway (M-POP), which includes education about pain management and a small initial opioid prescription
* Patients with hospitalization with length of stay \> 1 day after surgery
* Patients who decline to enroll
* Additional exclusion criteria for secondary analysis: Patients who do not complete the baseline and post-operative day 14 surveys

Primary outcomes:
measure: Number of Doses in the Initial Discharge Opioid Prescription
timeFrame: Day of discharge, approximately 1 day
measure: Proportion of Patients for Whom the Number of Doses in the Discharge Opioid Prescription Equals the Number of Doses in the New Default Settings
timeFrame: Day of discharge, approximately 1 day
measure: Proportion of Participants Who Had at Least One Opioid Prescription Refill From University of Michigan During the Two Weeks After Surgery
timeFrame: Day 14
measure: Proportion of Patients Who Visited or Saw a University of Michigan Provider Due to Pain During the Two Weeks After Surgery
timeFrame: Day 14
measure: Proportion of Patients With at Least One Emergency Department and/or Hospitalization at University of Michigan for Pain During the Two Weeks After Surgery
timeFrame: Day 14
Secondary outcomes:
measure: Overall Satisfaction Score on Pain Control During the Two Weeks After Surgery as Measured by the Post-operative Survey.
timeFrame: Day 14
measure: Proportion of Patients Who Reported That Their Pain Was Well-controlled as Measured by the Post-operative Survey.
timeFrame: Day 14
measure: Proportion of Patients Whose Overall Pain Control Was Rated as Much Worse or Worse Than Expected as Measured by the Post-operative Survey.
timeFrame: Day 14
measure: Proportion of Patients Whose Pain Has Resolved by Day 14 After Surgery as Measured by the Post-operative Survey.
timeFrame: Day 14
measure: Pain in the Throat and/or Mouth Over the Past 7 Days at Its Worst as Measured by the Post-operative Survey.
timeFrame: Day 14
measure: Pain in the Throat and/or Mouth Over the Past 7 Days on Average as Measured by the Post-operative Survey.
timeFrame: Day 14
measure: Proportion of Patients With Leftover Doses of Opioids as Measured by the Post-operative Survey.
timeFrame: Day 14
measure: Number of Opioid Doses Taken During the Two Weeks After Surgery as Measured by the Post-operative Survey.
timeFrame: Day 14
measure: Proportion of Patients Who Misused Opioids Prescribed to Others at Least Once During the Two Weeks After Surgery as Measured by the Post-operative Survey.
timeFrame: Day 14
measure: Proportion of Patients Who Misused Opioids Prescribed to Them at Least Once During the Two Weeks After Surgery as Measured by the Post-operative Survey.
timeFrame: Day 14
measure: Patient Health Questionnaire 8-item (PHQ-8) Score (Depression) as Measured by the Post-operative Survey.
timeFrame: Day 14
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)- Pediatric Anxiety - Short Form 8a Score as Measured by the Post-operative Survey.
timeFrame: Day 14
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)- Sleep Disturbance - Short Form 4a Score as Measured by the Post-operative Survey.
timeFrame: Day 14
measure: Proportion of Patients Who Saw Their Primary Care Doctor (or a Colleague) in the Office Due to Pain at Least Once During the Two Weeks After Surgery as Measured by the Post-operative Survey.
timeFrame: Day 14
measure: Proportion of Patients Who Visited a Retail Clinic Due to Pain at Least Once During the Two Weeks After Surgery as Measured by the Post-operative Survey.
timeFrame: Day 14
measure: Proportion of Patients Who Visited an Urgent Care Center Due to Pain at Least Once During the Two Weeks After Surgery as Measured by the Post-operative Survey.
timeFrame: Day 14
measure: Proportion of Patients Who Visited an Emergency Department and/or Were Hospitalized Due to Poorly Controlled Pain at Least Once During the Two Weeks After Surgery as Measured by the Post-operative Survey.
timeFrame: Day 14
measure: Proportion of Patients With Leftover Doses Who Disposed of Them
timeFrame: 14 Days
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Kao-Ping Chua
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chua KP, Thorne MC, Ng S, Donahue M, Brummett CM. Association Between Default Number of Opioid Doses in Electronic Health Record Systems and Opioid Prescribing to Adolescents and Young Adults Undergoing Tonsillectomy. JAMA Netw Open. 2022 Jun 1;5(6):e2219701. doi: 10.1001/jamanetworkopen.2022.19701.