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

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University of Michigan

Status

Completed

Conditions

Tonsillectomy

Treatments

Behavioral: Default setting intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04066829
1K08DA048110 (U.S. NIH Grant/Contract)
HUM00159821

Details and patient eligibility

About

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.

Enrollment

198 patients

Sex

All

Ages

12 to 25 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

198 participants in 2 patient groups

Experimental: Default setting intervention
Experimental group
Description:
The arm will include all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
Treatment:
Behavioral: Default setting intervention
No Intervention: Control (Usual Care)
No Intervention group
Description:
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.

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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