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| ID | Type | Description | Link |
|---|---|---|---|
| 1K08DA048110 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Default setting intervention | Behavioral | The new default settings will be implemented only for patients in the experimental arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kao-Ping Chua | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35771572 | Derived | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Pediatric Otolaryngology Service (Post-Intervention) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Doses | Day of discharge, approximately 1 day |
|
14 Days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kao-Ping Chua | University of Michigan | (734) 615-8169 | chuak@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 8, 2021 | Jul 26, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 6, 2020 | Sep 15, 2022 | ICF_002.pdf |
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Intervention is assigned based on location. Participants and providers are 'nudged' but not masked.
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| 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. | Survey was comprised of 5 options:
| Day 14 |
| 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. | Day 14 |
| 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. | Day 14 |
| 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. | Day 14 |
| 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? | Day 14 |
| 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. | Day 14 |
| 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 | Day 14 |
| 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. | Day 14 |
| 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 | Day 14 |
| 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, | Day 14 |
| 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. | Day 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. | 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 | Proportion of patients with leftover doses who disposed of them | 14 Days |
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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG002 | 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. |
| OG003 | 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. |
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|
|
| 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. | Posted | Count of Participants | Participants | Day of discharge, approximately 1 day |
|
|
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| 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. | Posted | Count of Participants | Participants | Day 14 |
|
|
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| 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. | Posted | Count of Participants | Participants | Day 14 |
|
|
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| 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 | Posted | Count of Participants | Participants | Day 14 |
|
|
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| 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 | The numbers above reflect the number of participants with complete data for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Day 14 |
|
|
|
| Secondary | Proportion of Patients Who Reported That Their Pain Was Well-controlled as Measured by the Post-operative Survey. | The numbers above reflect the number of participants with complete data for this outcome measure. | Posted | Count of Participants | Participants | Day 14 |
|
|
|
| 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:
| The numbers above reflect the number of participants with complete data for this outcome measure. | Posted | Count of Participants | Participants | Day 14 |
|
|
|
| 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. | The numbers above reflect the number of participants with complete data for this outcome measure. | Posted | Count of Participants | Participants | Day 14 |
|
|
|
| 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. | The numbers above reflect the number of participants with complete data for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Day 14 |
|
|
|
| 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. | The numbers above reflect the number of participants with complete data for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Day 14 |
|
|
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| 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? | The numbers above reflect the number of participants with complete data for this outcome measure. | Posted | Count of Participants | Participants | Day 14 |
|
|
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| 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. | The numbers above reflect the number of participants with complete data for this outcome measure. | Posted | Mean | Standard Deviation | Opioid Doses Consumed | Day 14 |
|
|
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| 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 | The numbers above reflect the number of participants with complete data for this outcome measure. | Posted | Count of Participants | Participants | Day 14 |
|
|
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| 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. | The numbers above reflect the number of participants with complete data for this outcome measure. | Posted | Count of Participants | Participants | Day 14 |
|
|
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| 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 | The numbers above reflect the number of participants with complete data for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Day 14 |
|
|
|
| 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, | The numbers above reflect the number of participants with complete data for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Day 14 |
|
|
|
| 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. | The numbers above reflect the number of participants with complete data for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Day 14 |
|
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| 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. | The numbers above reflect the number of participants with complete data for this outcome measure. | Posted | Count of Participants | Participants | Day 14 |
|
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| 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. | The numbers above reflect the number of participants with complete data for this outcome measure. | Posted | Count of Participants | Participants | Day 14 |
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| 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. | The numbers above reflect the number of participants with complete data for this outcome measure. | Posted | Count of Participants | Participants | Day 14 |
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| 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. | The numbers above reflect the number of participants with complete data for this outcome measure. | Posted | Count of Participants | Participants | Day 14 |
|
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| Secondary | Proportion of Patients With Leftover Doses Who Disposed of Them | Proportion of patients with leftover doses who disposed of them | The numbers above reflect the number of participants with complete data for this outcome measure. | Posted | Count of Participants | Participants | 14 Days |
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| 0 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | 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. | 0 | 61 | 0 | 61 | 0 | 61 |
| EG002 | 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. | 0 | 46 | 0 | 46 | 0 | 46 |
| EG003 | 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. | 0 | 60 | 0 | 60 | 0 | 60 |
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