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

NCT04066829 | Completed Results

• 2 other identifiers: HUM001598211K08DA048110
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Tonsillectomy

Keywords

Default settings; Opioid prescribing; Electronic Health Record; Opioid; Opioid Use; Behavioral intervention

Outcome Measures

Primary Outcomes (5)

• Number of Doses in the Initial Discharge Opioid Prescription

  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.

  Day of discharge, approximately 1 day

• Proportion of Patients for Whom the Number of Doses in the Discharge Opioid Prescription Equals the Number of Doses in the New Default Settings

  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.

  Day of discharge, approximately 1 day

• Proportion of Participants Who Had at Least One Opioid Prescription Refill From University of Michigan During the Two Weeks After Surgery

  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.

  Day 14

• Proportion of Patients Who Visited or Saw a University of Michigan Provider Due to Pain During the Two Weeks After Surgery

  Detailed in electronic health record. Excludes emergency department visits and hospitalizations for pain.

  Day 14

• Proportion of Patients With at Least One Emergency Department and/or Hospitalization at University of Michigan for Pain During the Two Weeks After Surgery

  Detailed in electronic health record

  Day 14

Secondary Outcomes (18)

• Overall Satisfaction Score on Pain Control 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

• 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 Whose Pain Has Resolved by Day 14 After Surgery 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

Study Arms (2)

Experimental: Default setting intervention

EXPERIMENTAL

The arm will include all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.

Behavioral: Default setting intervention

No Intervention: Control (Usual Care)

NO INTERVENTION

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.

Interventions

Default setting intervention BEHAVIORAL

The new default settings will be implemented only for patients in the experimental arm.

Experimental: Default setting intervention

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 35771572 DERIVED

Results Point of Contact

• Title: Kao-Ping Chua
• Organization: University of Michigan

chuak@med.umich.edu

(734) 615-8169

Study Officials

• Kao-Ping Chua

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Intervention is assigned based on location. Participants and providers are 'nudged' but not masked.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 26, 2019
• Study Start: October 1, 2019
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: November 1, 2022
• Results First Posted: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)