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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04066829
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : October 5, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kao-Ping Chua, 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.

Condition or disease Intervention/treatment Phase
Tonsillectomy Behavioral: Default setting intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Intervention is assigned based on location. Participants and providers are 'nudged' but not masked.
Primary Purpose: Health Services Research
Official Title: Default Dosing Settings for Opioid Prescriptions to Adolescents and Young Adults After Tonsillectomy
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arm Intervention/treatment
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.
Behavioral: Default setting intervention
All patients in the treatment group (patients undergoing tonsillectomy at Mott by pediatric otolaryngology attendings) will have clinicians who are exposed to the new default settings.

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.



Primary Outcome Measures :
  1. Number of doses in the initial discharge opioid prescription [ Time Frame: Day of discharge, approximately 1 day ]
    Detailed in 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 ]
    Detailed in electronic health record

  3. Proportion of patients who had at least one opioid prescription refill from University of Michigan during the two weeks after surgery [ Time Frame: Day 14 ]
    Detailed in electronic health record

  4. Proportion of patients who saw a University of Michigan provider in an office due to pain during the two weeks after surgery [ Time Frame: Day 14 ]
    Detailed in electronic health record

  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 Outcome Measures :
  1. Overall satisfaction score on pain control during the two weeks after surgery as measured by the post-operative survey. [ Time Frame: Day 14 ]
    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 ]
  4. Proportion of patients whose pain has resolved by day 14 after surgery as measured by the post-operative survey. [ Time Frame: Day 14 ]
  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 ]
  8. Number of opioid doses taken during the two weeks after surgery as measured by the post-operative survey. [ Time Frame: Day 14 ]
  9. Proportion of patients who misused opioids prescribed to others or 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 any use of opioids prescribed to others or taking one's own opioids in greater amounts, more often, or longer than directed by a doctor

  10. 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

  11. 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.

  12. 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

  13. 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,

  14. Patient-Reported Outcomes Measurement Information System (PROMIS)- Sleep Disturbance - 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 sleep disturbance, i.e. worse sleep.

  15. 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 ]
  16. 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 ]
  17. 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 ]
  18. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  • Surgeon belongs to the Department of Otolaryngology at the University of Michigan Medical School

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 (10 doses)
  • Patients with hospitalization with length of stay > 1 day after surgery
  • Patients who do not give consent (cannot reach them to enroll, decline to enroll, or non-English speaking)
  • Additional exclusion criteria for secondary analysis: Patients who do not complete the baseline and post-operative day 14 surveys

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066829


Contacts
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Contact: Study Coordinator 734-232-0234 OPATstudy@med.umich.edu

Locations
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United States, Michigan
The University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Study Coordinator    734-232-0234    OPATstudy@med.umich.edu   
Principal Investigator: Kao-Ping Chua, MD, PhD         
Sponsors and Collaborators
University of Michigan
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Kao-Ping Chua University of Michigan
  Study Documents (Full-Text)

Documents provided by Kao-Ping Chua, University of Michigan:
Study Protocol  [PDF] September 28, 2020

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Responsible Party: Kao-Ping Chua, Assistant Professor of Pediatrics, University of Michigan
ClinicalTrials.gov Identifier: NCT04066829    
Other Study ID Numbers: HUM00159821
1K08DA048110 ( U.S. NIH Grant/Contract )
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kao-Ping Chua, University of Michigan:
Default settings
Opioid prescribing
Electronic Health Record
Opioid
Opioid Use
Behavioral intervention