Tonsillectomy
Conditions
Keywords
Default settings, Opioid prescribing, Electronic Health Record, Opioid, Opioid Use, Behavioral intervention
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.
Interventions
BEHAVIORALDefault setting intervention
The new default settings will be implemented only for patients in the experimental arm.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Michigan
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
Intervention is assigned based on location. Participants and providers are 'nudged' but not masked.
Eligibility
Sex/Gender
ALL
Age
12 Years to 25 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Doses in the Initial Discharge Opioid Prescription | 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. |
| Proportion of Patients for Whom the Number of Doses in the Discharge Opioid Prescription Equals the Number of Doses in the New Default Settings | 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. |
| Proportion of Participants Who Had at Least One Opioid Prescription Refill From University of Michigan During the Two Weeks After Surgery | 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. |
| Proportion of Patients Who Visited or Saw a University of Michigan Provider Due to Pain During the Two Weeks After Surgery | Day 14 | Detailed in electronic health record. Excludes emergency department visits and hospitalizations for pain. |
| Proportion of Patients With at Least One Emergency Department and/or Hospitalization at University of Michigan for Pain During the Two Weeks After Surgery | Day 14 | Detailed in electronic health record |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain in the Throat and/or Mouth Over the Past 7 Days on Average as Measured by the Post-operative Survey. | Day 14 | Pain control is on a scale of 0-10 with higher scores indicating worse pain. |
| Proportion of Patients With Leftover Doses of Opioids as Measured by the Post-operative Survey. | 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? |
| Number of Opioid Doses Taken During the Two Weeks After Surgery as Measured by the Post-operative Survey. | Day 14 | Patients were asked to report the number of instances in which they used opioids prescribed to them. |
| 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. | Day 14 | Includes any use of opioids prescribed to others |
| 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. | Day 14 | Includes taking one's own opioids in greater amounts, more often, or longer than directed by a doctor. |
| Patient Health Questionnaire 8-item (PHQ-8) Score (Depression) as Measured by the Post-operative Survey. | 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 |
| Overall Satisfaction Score on Pain Control During the Two Weeks After Surgery as Measured by the Post-operative Survey. | 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 |
| Patient-Reported Outcomes Measurement Information System (PROMIS)- Sleep Disturbance - Short Form 4a Score as Measured by the Post-operative Survey. | 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. |
| 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. | Day 14 | — |
| 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. | Day 14 | — |
| 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. | Day 14 | — |
| 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. | Day 14 | — |
| Proportion of Patients With Leftover Doses Who Disposed of Them | 14 Days | Proportion of patients with leftover doses who disposed of them |
| Patient-Reported Outcomes Measurement Information System (PROMIS)- Pediatric Anxiety - Short Form 8a Score as Measured by the Post-operative Survey. | 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, |
| 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 | 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 |
| Proportion of Patients Whose Pain Has Resolved by Day 14 After Surgery as Measured by the Post-operative Survey. | 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. |
| Pain in the Throat and/or Mouth Over the Past 7 Days at Its Worst as Measured by the Post-operative Survey. | Day 14 | Pain control is on a scale of 0-10 with higher scores indicating more pain. |
Countries
United States
Participant flow
Recruitment details
282 participants were eligible of whom data from 237 participants was used. 198 consented; the other 39 could not be approached for consent. The IRB approved analysis of Electronic Medical Record data for these patients for the primary outcomes only, determining that review of electronic medical record data was no more than minimal risk and was justified to maximize sample size and power in light of decreased tonsillectomy volume at the University of Michigan owing to COVID-19.
Pre-assignment details
45 participants who were initially eligible to participate in the study were excluded because they declined to participate, withdrew or did not undergo a tonsillectomy, did not receive a discharge opioid prescription, had prior opioid use, or opted for an opioid sparing pathway.
Participants by arm
| Arm | Count |
|---|---|
| Pediatric Otolaryngology Service (Pre-Intervention) October 1, 2019 - September 30, 2020 The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan. | 70 |
| Pediatric Otolaryngology Service (Post-Intervention) October 1, 2020 - July 31, 2021 The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan. | 61 |
| General Otolaryngology Service (Control, Pre-Intervention) October 1, 2019 - September 30, 2020 The arm included 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. | 46 |
| General Otolaryngology Service (Control, Post-Intervention) October 1, 2020 - July 31, 2021 The arm included 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. | 60 |
| Total | 237 |
Baseline characteristics
| Characteristic | Pediatric Otolaryngology Service (Pre-Intervention) | Pediatric Otolaryngology Service (Post-Intervention) | General Otolaryngology Service (Control, Pre-Intervention) | General Otolaryngology Service (Control, Post-Intervention) | Total |
|---|---|---|---|---|---|
| Age, Customized Ages 12 years to 17 years | 62 Participants | 57 Participants | 3 Participants | 5 Participants | 127 Participants |
| Age, Customized Ages 18 years to 25 years | 8 Participants | 4 Participants | 43 Participants | 55 Participants | 110 Participants |
| Race/Ethnicity, Customized Asian/Non-Hispanic | 4 Participants | 0 Participants | 2 Participants | 1 Participants | 7 Participants |
| Race/Ethnicity, Customized Black/Non-Hispanic | 5 Participants | 7 Participants | 2 Participants | 7 Participants | 21 Participants |
| Race/Ethnicity, Customized Hispanic/Any Race | 3 Participants | 6 Participants | 3 Participants | 3 Participants | 15 Participants |
| Race/Ethnicity, Customized Other/Multi-Racial/Non-Hispanic | 3 Participants | 1 Participants | 1 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized Unknown Race or Ethnicity | 1 Participants | 3 Participants | 1 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized White/Non-Hispanic | 54 Participants | 44 Participants | 37 Participants | 46 Participants | 181 Participants |
| Region of Enrollment United States | 70 Participants | 61 Participants | 46 Participants | 60 Participants | 237 Participants |
| Sex/Gender, Customized Female | 40 Participants | 34 Participants | 30 Participants | 43 Participants | 147 Participants |
| Sex/Gender, Customized Male | 28 Participants | 27 Participants | 16 Participants | 16 Participants | 87 Participants |
| Sex/Gender, Customized Other | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 61 | 0 / 46 | 0 / 60 |
| other Total, other adverse events | 0 / 70 | 0 / 61 | 0 / 46 | 0 / 60 |
| serious Total, serious adverse events | 0 / 70 | 0 / 61 | 0 / 46 | 0 / 60 |
Outcome results
Primary
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.
Time frame: Day of discharge, approximately 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pediatric Otolaryngology Service (Pre-Intervention) | Number of Doses in the Initial Discharge Opioid Prescription | 22.3 Doses | Standard Deviation 7.4 |
| Pediatric Otolaryngology Service (Post-Intervention) | Number of Doses in the Initial Discharge Opioid Prescription | 16.1 Doses | Standard Deviation 6.5 |
| General Otolaryngology Service (Control, Pre-Intervention) | Number of Doses in the Initial Discharge Opioid Prescription | 33.7 Doses | Standard Deviation 20.4 |
| General Otolaryngology Service (Control, Post-Intervention) | Number of Doses in the Initial Discharge Opioid Prescription | 30.4 Doses | Standard Deviation 12.4 |
Comparison: Pre and post difference in the treatment group as compared to the control group. A log transformation was used.95% CI: [-42.2, -11.8]
Primary
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.
Time frame: Day 14
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pediatric Otolaryngology Service (Pre-Intervention) | Proportion of Participants Who Had at Least One Opioid Prescription Refill From University of Michigan During the Two Weeks After Surgery | 10 Participants |
| Pediatric Otolaryngology Service (Post-Intervention) | Proportion of Participants Who Had at Least One Opioid Prescription Refill From University of Michigan During the Two Weeks After Surgery | 12 Participants |
| General Otolaryngology Service (Control, Pre-Intervention) | Proportion of Participants Who Had at Least One Opioid Prescription Refill From University of Michigan During the Two Weeks After Surgery | 25 Participants |
| General Otolaryngology Service (Control, Post-Intervention) | Proportion of Participants Who Had at Least One Opioid Prescription Refill From University of Michigan During the Two Weeks After Surgery | 26 Participants |
Primary
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.
Time frame: Day of discharge, approximately 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pediatric Otolaryngology Service (Pre-Intervention) | Proportion of Patients for Whom the Number of Doses in the Discharge Opioid Prescription Equals the Number of Doses in the New Default Settings | 1 Participants |
| Pediatric Otolaryngology Service (Post-Intervention) | Proportion of Patients for Whom the Number of Doses in the Discharge Opioid Prescription Equals the Number of Doses in the New Default Settings | 27 Participants |
| General Otolaryngology Service (Control, Pre-Intervention) | Proportion of Patients for Whom the Number of Doses in the Discharge Opioid Prescription Equals the Number of Doses in the New Default Settings | 2 Participants |
| General Otolaryngology Service (Control, Post-Intervention) | Proportion of Patients for Whom the Number of Doses in the Discharge Opioid Prescription Equals the Number of Doses in the New Default Settings | 0 Participants |
Primary
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.
Time frame: Day 14
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pediatric Otolaryngology Service (Pre-Intervention) | Proportion of Patients Who Visited or Saw a University of Michigan Provider Due to Pain During the Two Weeks After Surgery | 2 Participants |
| Pediatric Otolaryngology Service (Post-Intervention) | Proportion of Patients Who Visited or Saw a University of Michigan Provider Due to Pain During the Two Weeks After Surgery | 1 Participants |
| General Otolaryngology Service (Control, Pre-Intervention) | Proportion of Patients Who Visited or Saw a University of Michigan Provider Due to Pain During the Two Weeks After Surgery | 0 Participants |
| General Otolaryngology Service (Control, Post-Intervention) | Proportion of Patients Who Visited or Saw a University of Michigan Provider Due to Pain During the Two Weeks After Surgery | 1 Participants |
Primary
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
Time frame: Day 14
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pediatric Otolaryngology Service (Pre-Intervention) | Proportion of Patients With at Least One Emergency Department and/or Hospitalization at University of Michigan for Pain During the Two Weeks After Surgery | 3 Participants |
| Pediatric Otolaryngology Service (Post-Intervention) | Proportion of Patients With at Least One Emergency Department and/or Hospitalization at University of Michigan for Pain During the Two Weeks After Surgery | 2 Participants |
| General Otolaryngology Service (Control, Pre-Intervention) | Proportion of Patients With at Least One Emergency Department and/or Hospitalization at University of Michigan for Pain During the Two Weeks After Surgery | 2 Participants |
| General Otolaryngology Service (Control, Post-Intervention) | Proportion of Patients With at Least One Emergency Department and/or Hospitalization at University of Michigan for Pain During the Two Weeks After Surgery | 3 Participants |
Secondary
Number of Opioid Doses Taken During the Two Weeks After Surgery as Measured by the Post-operative Survey.
Patients were asked to report the number of instances in which they used opioids prescribed to them.
Time frame: Day 14
Population: The numbers above reflect the number of participants with complete data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pediatric Otolaryngology Service (Pre-Intervention) | Number of Opioid Doses Taken During the Two Weeks After Surgery as Measured by the Post-operative Survey. | 7.2 Opioid Doses Consumed | Standard Deviation 8 |
| Pediatric Otolaryngology Service (Post-Intervention) | Number of Opioid Doses Taken During the Two Weeks After Surgery as Measured by the Post-operative Survey. | 9.5 Opioid Doses Consumed | Standard Deviation 9.6 |
| General Otolaryngology Service (Control, Pre-Intervention) | Number of Opioid Doses Taken During the Two Weeks After Surgery as Measured by the Post-operative Survey. | 27.3 Opioid Doses Consumed | Standard Deviation 18.7 |
| General Otolaryngology Service (Control, Post-Intervention) | Number of Opioid Doses Taken During the Two Weeks After Surgery as Measured by the Post-operative Survey. | 23.3 Opioid Doses Consumed | Standard Deviation 23.4 |
Secondary
Overall Satisfaction Score on Pain Control During the Two Weeks After Surgery as Measured by the Post-operative Survey.
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
Time frame: Day 14
Population: The numbers above reflect the number of participants with complete data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pediatric Otolaryngology Service (Pre-Intervention) | Overall Satisfaction Score on Pain Control During the Two Weeks After Surgery as Measured by the Post-operative Survey. | 7.4 units on a scale | Standard Deviation 2.4 |
| Pediatric Otolaryngology Service (Post-Intervention) | Overall Satisfaction Score on Pain Control During the Two Weeks After Surgery as Measured by the Post-operative Survey. | 7.4 units on a scale | Standard Deviation 2.4 |
| General Otolaryngology Service (Control, Pre-Intervention) | Overall Satisfaction Score on Pain Control During the Two Weeks After Surgery as Measured by the Post-operative Survey. | 6.5 units on a scale | Standard Deviation 2.5 |
| General Otolaryngology Service (Control, Post-Intervention) | Overall Satisfaction Score on Pain Control During the Two Weeks After Surgery as Measured by the Post-operative Survey. | 6.7 units on a scale | Standard Deviation 7 |
Secondary
Pain in the Throat and/or Mouth Over the Past 7 Days at Its Worst as Measured by the Post-operative Survey.
Pain control is on a scale of 0-10 with higher scores indicating more pain.
Time frame: Day 14
Population: The numbers above reflect the number of participants with complete data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pediatric Otolaryngology Service (Pre-Intervention) | Pain in the Throat and/or Mouth Over the Past 7 Days at Its Worst as Measured by the Post-operative Survey. | 5.3 score on a scale | Standard Deviation 2.8 |
| Pediatric Otolaryngology Service (Post-Intervention) | Pain in the Throat and/or Mouth Over the Past 7 Days at Its Worst as Measured by the Post-operative Survey. | 5.4 score on a scale | Standard Deviation 3.2 |
| General Otolaryngology Service (Control, Pre-Intervention) | Pain in the Throat and/or Mouth Over the Past 7 Days at Its Worst as Measured by the Post-operative Survey. | 7.1 score on a scale | Standard Deviation 2 |
| General Otolaryngology Service (Control, Post-Intervention) | Pain in the Throat and/or Mouth Over the Past 7 Days at Its Worst as Measured by the Post-operative Survey. | 6.4 score on a scale | Standard Deviation 3.1 |
Secondary
Pain in the Throat and/or Mouth Over the Past 7 Days on Average as Measured by the Post-operative Survey.
Pain control is on a scale of 0-10 with higher scores indicating worse pain.
Time frame: Day 14
Population: The numbers above reflect the number of participants with complete data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pediatric Otolaryngology Service (Pre-Intervention) | Pain in the Throat and/or Mouth Over the Past 7 Days on Average as Measured by the Post-operative Survey. | 3.3 score on a scale | Standard Deviation 2.1 |
| Pediatric Otolaryngology Service (Post-Intervention) | Pain in the Throat and/or Mouth Over the Past 7 Days on Average as Measured by the Post-operative Survey. | 3.3 score on a scale | Standard Deviation 3 |
| General Otolaryngology Service (Control, Pre-Intervention) | Pain in the Throat and/or Mouth Over the Past 7 Days on Average as Measured by the Post-operative Survey. | 4.4 score on a scale | Standard Deviation 2 |
| General Otolaryngology Service (Control, Post-Intervention) | Pain in the Throat and/or Mouth Over the Past 7 Days on Average as Measured by the Post-operative Survey. | 3.9 score on a scale | Standard Deviation 2.2 |
Secondary
Patient Health Questionnaire 8-item (PHQ-8) Score (Depression) as Measured by the Post-operative Survey.
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
Time frame: Day 14
Population: The numbers above reflect the number of participants with complete data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pediatric Otolaryngology Service (Pre-Intervention) | Patient Health Questionnaire 8-item (PHQ-8) Score (Depression) as Measured by the Post-operative Survey. | 5.1 score on a scale | Standard Deviation 5.6 |
| Pediatric Otolaryngology Service (Post-Intervention) | Patient Health Questionnaire 8-item (PHQ-8) Score (Depression) as Measured by the Post-operative Survey. | 5.6 score on a scale | Standard Deviation 4.9 |
| General Otolaryngology Service (Control, Pre-Intervention) | Patient Health Questionnaire 8-item (PHQ-8) Score (Depression) as Measured by the Post-operative Survey. | 7.4 score on a scale | Standard Deviation 4.4 |
| General Otolaryngology Service (Control, Post-Intervention) | Patient Health Questionnaire 8-item (PHQ-8) Score (Depression) as Measured by the Post-operative Survey. | 7.6 score on a scale | Standard Deviation 5.1 |
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS)- Pediatric Anxiety - Short Form 8a Score as Measured by the Post-operative Survey.
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,
Time frame: Day 14
Population: The numbers above reflect the number of participants with complete data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pediatric Otolaryngology Service (Pre-Intervention) | Patient-Reported Outcomes Measurement Information System (PROMIS)- Pediatric Anxiety - Short Form 8a Score as Measured by the Post-operative Survey. | 11.2 score on a scale | Standard Deviation 4.6 |
| Pediatric Otolaryngology Service (Post-Intervention) | Patient-Reported Outcomes Measurement Information System (PROMIS)- Pediatric Anxiety - Short Form 8a Score as Measured by the Post-operative Survey. | 12.4 score on a scale | Standard Deviation 6.1 |
| General Otolaryngology Service (Control, Pre-Intervention) | Patient-Reported Outcomes Measurement Information System (PROMIS)- Pediatric Anxiety - Short Form 8a Score as Measured by the Post-operative Survey. | 15.9 score on a scale | Standard Deviation 8.1 |
| General Otolaryngology Service (Control, Post-Intervention) | Patient-Reported Outcomes Measurement Information System (PROMIS)- Pediatric Anxiety - Short Form 8a Score as Measured by the Post-operative Survey. | 13.4 score on a scale | Standard Deviation 7.2 |
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS)- Sleep Disturbance - Short Form 4a Score as Measured by the Post-operative Survey.
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.
Time frame: Day 14
Population: The numbers above reflect the number of participants with complete data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pediatric Otolaryngology Service (Pre-Intervention) | Patient-Reported Outcomes Measurement Information System (PROMIS)- Sleep Disturbance - Short Form 4a Score as Measured by the Post-operative Survey. | 8.4 score on a scale | Standard Deviation 2.9 |
| Pediatric Otolaryngology Service (Post-Intervention) | Patient-Reported Outcomes Measurement Information System (PROMIS)- Sleep Disturbance - Short Form 4a Score as Measured by the Post-operative Survey. | 9.7 score on a scale | Standard Deviation 3.7 |
| General Otolaryngology Service (Control, Pre-Intervention) | Patient-Reported Outcomes Measurement Information System (PROMIS)- Sleep Disturbance - Short Form 4a Score as Measured by the Post-operative Survey. | 12.2 score on a scale | Standard Deviation 4 |
| General Otolaryngology Service (Control, Post-Intervention) | Patient-Reported Outcomes Measurement Information System (PROMIS)- Sleep Disturbance - Short Form 4a Score as Measured by the Post-operative Survey. | 11.2 score on a scale | Standard Deviation 42 |
Secondary
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.
Includes any use of opioids prescribed to others
Time frame: Day 14
Population: The numbers above reflect the number of participants with complete data for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pediatric Otolaryngology Service (Pre-Intervention) | 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. | 0 Participants |
| Pediatric Otolaryngology Service (Post-Intervention) | 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. | 0 Participants |
| General Otolaryngology Service (Control, Pre-Intervention) | 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. | 0 Participants |
| General Otolaryngology Service (Control, Post-Intervention) | 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. | 0 Participants |
Secondary
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.
Includes taking one's own opioids in greater amounts, more often, or longer than directed by a doctor.
Time frame: Day 14
Population: The numbers above reflect the number of participants with complete data for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pediatric Otolaryngology Service (Pre-Intervention) | 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. | 0 Participants |
| Pediatric Otolaryngology Service (Post-Intervention) | 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. | 0 Participants |
| General Otolaryngology Service (Control, Pre-Intervention) | 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. | 0 Participants |
| General Otolaryngology Service (Control, Post-Intervention) | 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. | 0 Participants |
Secondary
Proportion of Patients Who Reported That Their Pain Was Well-controlled as Measured by the Post-operative Survey.
Time frame: Day 14
Population: The numbers above reflect the number of participants with complete data for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pediatric Otolaryngology Service (Pre-Intervention) | Proportion of Patients Who Reported That Their Pain Was Well-controlled as Measured by the Post-operative Survey. | 32 Participants |
| Pediatric Otolaryngology Service (Post-Intervention) | Proportion of Patients Who Reported That Their Pain Was Well-controlled as Measured by the Post-operative Survey. | 25 Participants |
| General Otolaryngology Service (Control, Pre-Intervention) | Proportion of Patients Who Reported That Their Pain Was Well-controlled as Measured by the Post-operative Survey. | 11 Participants |
| General Otolaryngology Service (Control, Post-Intervention) | Proportion of Patients Who Reported That Their Pain Was Well-controlled as Measured by the Post-operative Survey. | 18 Participants |
Secondary
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
Population: The numbers above reflect the number of participants with complete data for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pediatric Otolaryngology Service (Pre-Intervention) | 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. | 3 Participants |
| Pediatric Otolaryngology Service (Post-Intervention) | 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. | 0 Participants |
| General Otolaryngology Service (Control, Pre-Intervention) | 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. | 1 Participants |
| General Otolaryngology Service (Control, Post-Intervention) | 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. | 0 Participants |
Secondary
Proportion of Patients Whose Overall Pain Control Was Rated as Much Worse or Worse Than Expected as Measured by the Post-operative Survey.
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
Time frame: Day 14
Population: The numbers above reflect the number of participants with complete data for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pediatric Otolaryngology Service (Pre-Intervention) | Proportion of Patients Whose Overall Pain Control Was Rated as Much Worse or Worse Than Expected as Measured by the Post-operative Survey. | 15 Participants |
| Pediatric Otolaryngology Service (Post-Intervention) | Proportion of Patients Whose Overall Pain Control Was Rated as Much Worse or Worse Than Expected as Measured by the Post-operative Survey. | 11 Participants |
| General Otolaryngology Service (Control, Pre-Intervention) | Proportion of Patients Whose Overall Pain Control Was Rated as Much Worse or Worse Than Expected as Measured by the Post-operative Survey. | 11 Participants |
| General Otolaryngology Service (Control, Post-Intervention) | Proportion of Patients Whose Overall Pain Control Was Rated as Much Worse or Worse Than Expected as Measured by the Post-operative Survey. | 18 Participants |
Secondary
Proportion of Patients Whose Pain Has Resolved by Day 14 After Surgery as Measured by the Post-operative Survey.
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.
Time frame: Day 14
Population: The numbers above reflect the number of participants with complete data for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pediatric Otolaryngology Service (Pre-Intervention) | Proportion of Patients Whose Pain Has Resolved by Day 14 After Surgery as Measured by the Post-operative Survey. | 32 Participants |
| Pediatric Otolaryngology Service (Post-Intervention) | Proportion of Patients Whose Pain Has Resolved by Day 14 After Surgery as Measured by the Post-operative Survey. | 34 Participants |
| General Otolaryngology Service (Control, Pre-Intervention) | Proportion of Patients Whose Pain Has Resolved by Day 14 After Surgery as Measured by the Post-operative Survey. | 17 Participants |
| General Otolaryngology Service (Control, Post-Intervention) | Proportion of Patients Whose Pain Has Resolved by Day 14 After Surgery as Measured by the Post-operative Survey. | 24 Participants |
Secondary
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
Population: The numbers above reflect the number of participants with complete data for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pediatric Otolaryngology Service (Pre-Intervention) | 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. | 3 Participants |
| Pediatric Otolaryngology Service (Post-Intervention) | 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. | 0 Participants |
| General Otolaryngology Service (Control, Pre-Intervention) | 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. | 4 Participants |
| General Otolaryngology Service (Control, Post-Intervention) | 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. | 3 Participants |
Secondary
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
Population: The numbers above reflect the number of participants with complete data for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pediatric Otolaryngology Service (Pre-Intervention) | 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. | 1 Participants |
| Pediatric Otolaryngology Service (Post-Intervention) | 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. | 0 Participants |
| General Otolaryngology Service (Control, Pre-Intervention) | 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. | 3 Participants |
| General Otolaryngology Service (Control, Post-Intervention) | 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. | 0 Participants |
Secondary
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
Population: The numbers above reflect the number of participants with complete data for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pediatric Otolaryngology Service (Pre-Intervention) | 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. | 1 Participants |
| Pediatric Otolaryngology Service (Post-Intervention) | 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. | 1 Participants |
| General Otolaryngology Service (Control, Pre-Intervention) | 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. | 0 Participants |
| General Otolaryngology Service (Control, Post-Intervention) | 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. | 1 Participants |
Secondary
Proportion of Patients With Leftover Doses of Opioids as Measured by the Post-operative Survey.
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?
Time frame: Day 14
Population: The numbers above reflect the number of participants with complete data for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pediatric Otolaryngology Service (Pre-Intervention) | Proportion of Patients With Leftover Doses of Opioids as Measured by the Post-operative Survey. | 35 Participants |
| Pediatric Otolaryngology Service (Post-Intervention) | Proportion of Patients With Leftover Doses of Opioids as Measured by the Post-operative Survey. | 28 Participants |
| General Otolaryngology Service (Control, Pre-Intervention) | Proportion of Patients With Leftover Doses of Opioids as Measured by the Post-operative Survey. | 21 Participants |
| General Otolaryngology Service (Control, Post-Intervention) | Proportion of Patients With Leftover Doses of Opioids as Measured by the Post-operative Survey. | 24 Participants |
Secondary
Proportion of Patients With Leftover Doses Who Disposed of Them
Proportion of patients with leftover doses who disposed of them
Time frame: 14 Days
Population: The numbers above reflect the number of participants with complete data for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pediatric Otolaryngology Service (Pre-Intervention) | Proportion of Patients With Leftover Doses Who Disposed of Them | 28 Participants |
| Pediatric Otolaryngology Service (Post-Intervention) | Proportion of Patients With Leftover Doses Who Disposed of Them | 17 Participants |
| General Otolaryngology Service (Control, Pre-Intervention) | Proportion of Patients With Leftover Doses Who Disposed of Them | 13 Participants |
| General Otolaryngology Service (Control, Post-Intervention) | Proportion of Patients With Leftover Doses Who Disposed of Them | 17 Participants |