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Completed

NCT Number: NCT04066829

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

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.

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Key information

Conditions

Tonsillectomy

Age range

12 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Default setting intervention

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

Secondary outcomes

  1. Overall Satisfaction Score on Pain Control During the Two Weeks After Surgery as Measured by the Post-operative Survey.

    Time frame: 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

  2. Proportion of Patients Who Reported That Their Pain Was Well-controlled as Measured by the Post-operative Survey.

    Time frame: Day 14

  3. Proportion of Patients Whose Overall Pain Control Was Rated as Much Worse or Worse Than Expected as Measured by the Post-operative Survey.

    Time frame: 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

  4. Proportion of Patients Whose Pain Has Resolved by Day 14 After Surgery as Measured by the Post-operative Survey.

    Time frame: 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.

  5. Pain in the Throat and/or Mouth Over the Past 7 Days at Its Worst as Measured by the Post-operative Survey.

    Time frame: Day 14

    Pain control is on a scale of 0-10 with higher scores indicating more pain.

  6. Pain in the Throat and/or Mouth Over the Past 7 Days on Average as Measured by the Post-operative Survey.

    Time frame: Day 14

    Pain control is on a scale of 0-10 with higher scores indicating worse pain.

  7. Proportion of Patients With Leftover Doses of Opioids as Measured by the Post-operative Survey.

    Time frame: 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?

  8. Number of Opioid Doses Taken During the Two Weeks After Surgery as Measured by the Post-operative Survey.

    Time frame: Day 14

    Patients were asked to report the number of instances in which they used opioids prescribed to them.

  9. 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.

    Time frame: Day 14

    Includes any use of opioids prescribed to others

  10. 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.

    Time frame: Day 14

    Includes taking one's own opioids in greater amounts, more often, or longer than directed by a doctor.

  11. Patient Health Questionnaire 8-item (PHQ-8) Score (Depression) as Measured by the Post-operative Survey.

    Time frame: 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

  12. Patient-Reported Outcomes Measurement Information System (PROMIS)- Pediatric Anxiety - Short Form 8a Score as Measured by the Post-operative Survey.

    Time frame: 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,

  13. Patient-Reported Outcomes Measurement Information System (PROMIS)- Sleep Disturbance - Short Form 4a Score as Measured by the Post-operative Survey.

    Time frame: 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.

  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.

    Time frame: Day 14

  15. 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.

    Time frame: Day 14

  16. 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.

    Time frame: Day 14

  17. 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.

    Time frame: Day 14

  18. Proportion of Patients With Leftover Doses Who Disposed of Them

    Time frame: 14 Days

    Proportion of patients with leftover doses who disposed of them

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 26, 2019
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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