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

NCT ID: NCT04066829

Last Updated: 2022-11-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2021-07-31

Brief Summary

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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

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Conditions

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Tonsillectomy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Intervention is assigned based on location. Participants and providers are 'nudged' but not masked.

Study Groups

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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.

Group Type EXPERIMENTAL

Default setting intervention

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Default setting intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Kao-Ping Chua

Assistant Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kao-Ping Chua

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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The University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35771572 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1K08DA048110

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00159821

Identifier Type: -

Identifier Source: org_study_id

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