Default Dosing Settings for Opioid Prescriptions to Adolescents and Young Adults After Tonsillectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 198
- Locations
- 1
- Primary Endpoint
- Number of Doses in the Initial Discharge Opioid Prescription
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Masking Description
Intervention is assigned based on location. Participants and providers are 'nudged' but not masked.
Eligibility Criteria
- Ages
- 12 Years to 25 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Experimental: Default setting intervention
The arm will include all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
Intervention: Default setting intervention (Behavioral)
No Intervention: Control (Usual Care)
The arm will include all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
Outcomes
Primary Outcomes
Number of Doses in the Initial Discharge Opioid Prescription
Time Frame: Day of discharge, approximately 1 day
Doses are defined as the maximum number of instances a patient could take opioids if they took them as prescribed. Number of doses are calculated from the electronic health record.
Proportion of Participants Who Had at Least One Opioid Prescription Refill From University of Michigan During the Two Weeks After Surgery
Time Frame: Day 14
Doses are defined as the maximum number of instances a patient could take opioids if they took them as prescribed. Number of doses are calculated from the electronic health record.
Proportion of Patients for Whom the Number of Doses in the Discharge Opioid Prescription Equals the Number of Doses in the New Default Settings
Time Frame: Day of discharge, approximately 1 day
The new default settings called for 12 doses in the discharge prescription. This measure assesses the proportion of participants with 12 doses in the discharge prescription, regardless of which arm they were in. Doses are defined as the maximum number of instances a patient could take opioids if they took them as prescribed. Number of doses are calculated from the electronic health record.
Proportion of Patients With at Least One Emergency Department and/or Hospitalization at University of Michigan for Pain During the Two Weeks After Surgery
Time Frame: Day 14
Detailed in electronic health record
Proportion of Patients Who Visited or Saw a University of Michigan Provider Due to Pain During the Two Weeks After Surgery
Time Frame: Day 14
Detailed in electronic health record. Excludes emergency department visits and hospitalizations for pain.
Secondary Outcomes
- Pain in the Throat and/or Mouth Over the Past 7 Days on Average as Measured by the Post-operative Survey.(Day 14)
- Patient Health Questionnaire 8-item (PHQ-8) Score (Depression) as Measured by the Post-operative Survey.(Day 14)
- Proportion of Patients With Leftover Doses Who Disposed of Them(14 Days)
- Overall Satisfaction Score on Pain Control During the Two Weeks After Surgery as Measured by the Post-operative Survey.(Day 14)
- Proportion of Patients Whose Pain Has Resolved by Day 14 After Surgery as Measured by the Post-operative Survey.(Day 14)
- 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.(Day 14)
- 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.(Day 14)
- 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.(Day 14)
- Proportion of Patients Whose Overall Pain Control Was Rated as Much Worse or Worse Than Expected as Measured by the Post-operative Survey.(Day 14)
- Proportion of Patients With Leftover Doses of Opioids as Measured by the Post-operative Survey.(Day 14)
- Number of Opioid Doses Taken During the Two Weeks After Surgery as Measured by the Post-operative Survey.(Day 14)
- 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.(Day 14)
- 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.(Day 14)
- Proportion of Patients Who Reported That Their Pain Was Well-controlled as Measured by the Post-operative Survey.(Day 14)
- Pain in the Throat and/or Mouth Over the Past 7 Days at Its Worst as Measured by the Post-operative Survey.(Day 14)
- Patient-Reported Outcomes Measurement Information System (PROMIS)- Pediatric Anxiety - Short Form 8a Score as Measured by the Post-operative Survey.(Day 14)
- Patient-Reported Outcomes Measurement Information System (PROMIS)- Sleep Disturbance - Short Form 4a Score as Measured by the Post-operative Survey.(Day 14)
- 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.(Day 14)
Investigators
Kao-Ping Chua
Assistant Professor of Pediatrics
University of Michigan