Default Dosing Settings for Opioid Prescriptions to Adolescents and Young Adults After Tonsillectomy

Not Applicable

Completed

• Conditions: Tonsillectomy
• Interventions: Behavioral: Default setting intervention

• Registration Number: NCT04066829
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-08-22
• Study First Posted: 2019-08-26
• Study Start: 2019-10-01
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Results First Submitted: 2022-07-27
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-31
• Last Update Submitted: 2022-10-31
• Results First Posted: 2022-11-01
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Default setting intervention	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.

Primary Outcome Measures

Name	Time	Method
Number of Doses in the Initial Discharge Opioid Prescription	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	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	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	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	Day 14	Detailed in electronic health record. Excludes emergency department visits and hospitalizations for pain.

Secondary Outcome Measures

Name	Time	Method
Pain in the Throat and/or Mouth Over the Past 7 Days on Average as Measured by the Post-operative Survey.	Day 14	Pain control is on a scale of 0-10 with higher scores indicating worse pain.
Patient Health Questionnaire 8-item (PHQ-8) Score (Depression) as Measured by the Post-operative Survey.	Day 14	This is an 8-item self-report scale, all items are rated on a score of 0-3, for a total range of 0-24. Higher scores indicate more depressive symptoms
Proportion of Patients With Leftover Doses Who Disposed of Them	14 Days	Proportion of patients with leftover doses who disposed of them
Overall Satisfaction Score on Pain Control During the Two Weeks After Surgery as Measured by the Post-operative Survey.	Day 14	Participants were surveyed on Day 14 and asked to report level of satisfaction with pain control since their surgery.; Pain control satisfaction is on a scale of 1-10 with higher scores indicating higher satisfaction
Proportion of Patients Whose Pain Has Resolved by Day 14 After Surgery as Measured by the Post-operative Survey.	Day 14	Survey asked participant on what day pain had resolved. If participants indicated pain had resolved by Day 14, then they were coded as 1, and 0 otherwise.
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	Includes taking one's own opioids in greater amounts, more often, or longer than directed by a doctor.
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	Survey was comprised of 5 options: * Much worse than you expected; * Worse than you expected; * About what you expected; * Better than you expected; * Much better than you expected
Proportion of Patients With Leftover Doses of Opioids as Measured by the Post-operative Survey.	Day 14	Participants who answered 'No' to the following question: Did you take all of the opioid pain medications that were prescribed to you during the two weeks after surgery?
Number of Opioid Doses Taken During the Two Weeks After Surgery as Measured by the Post-operative Survey.	Day 14	Patients were asked to report the number of instances in which they used opioids prescribed to them.
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	Includes any use of opioids prescribed to others
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	Pain control is on a scale of 0-10 with higher scores indicating more pain.
Patient-Reported Outcomes Measurement Information System (PROMIS)- Pediatric Anxiety - Short Form 8a Score as Measured by the Post-operative Survey.	Day 14	This measure is 8 items each scored from 1 to 5 points, with the lowest possible raw score being 8 and the highest possible raw score being 40. Higher scores indicate greater anxiety,
Patient-Reported Outcomes Measurement Information System (PROMIS)- Sleep Disturbance - Short Form 4a Score as Measured by the Post-operative Survey.	Day 14	This measure is 4 items each scored from 1 to 5 points, with the lowest possible raw score being 8 and the highest possible raw score being 40. Higher scores indicate greater sleep disturbance, i.e. worse sleep.
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

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States