TonsillectomyNCT04066829

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

A study testing Default setting intervention in people with Tonsillectomy, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 12 to 25 years
Conditions the study is for: Tonsillectomy
What is being tested?: Default setting intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 198 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2019to 31 Jul 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 25 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Conditions: Tonsillectomy
Being tested: Default setting intervention
Keywords: Default settings, Opioid prescribing, Electronic Health Record, Opioid, Opioid Use, Behavioral intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04066829
Study group	Role	What they receive
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. Receives: Behavioral: Default setting intervention
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Day 14

Secondary outcomes (18)

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
Measured: Day 14
Proportion of Patients Who Reported That Their Pain Was Well-controlled as Measured by the Post-operative Survey.
Measured: 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:
- Much worse than you expected
- Worse than you expected
- About what you expected
- Better than you expected
- Much better than you expected
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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?
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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,
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 14
Proportion of Patients With Leftover Doses Who Disposed of Them
Proportion of patients with leftover doses who disposed of them
Measured: 14 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201931 Jul 2021

First posted26 Aug 2019
Study start1 Oct 2019
Primary completion31 Jul 2021
Study completion31 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for TonsillectomyStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 198 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04066829
Sponsor's protocol ID: HUM00159821
Other IDs: 1K08DA048110
Status last verified: Oct 2022
First submitted: 22 Aug 2019
Last updated: 1 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 35771572

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Not yet recruiting
Boyle-Davis Mouth Gag Timing in Pediatric Tonsil Surgery
Tonsillectomy and Adenotonsillectomy in Children
Not yet recruitingPhase 3
Effect of Nebulized Lignocaine on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy
Emergence Agitation, Emergence Delirium
Recruiting
Coblator Wand Comparative Analysis
Tonsillectomy, Adenoidectomy
Recruiting
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All Tonsillectomy trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Default Dosing Settings for Opioid Prescriptions to Adolescents and Young Adults After Tonsillectomy
ClinicalTrials.gov ID: NCT04066829
Acronym / sponsor ID: HUM00159821
Conditions: Tonsillectomy
Keywords: Default settings, Opioid prescribing, Electronic Health Record, Opioid, Opioid Use, Behavioral intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 198 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 1 Oct 2019 (actual)
Primary completion: 31 Jul 2021 (actual)
Study completion: 31 Jul 2021 (actual)
First posted: 26 Aug 2019 (actual)
Results: Posted 1 Nov 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Experimental: Default setting intervention	Experimental	Behavioral: Default setting interventionThe 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.

Who may qualify

Ages: 12 to 25 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Default setting interventionThe new default settings will be implemented only for patients in the experimental arm.	Behavioural	Experimental: Default setting intervention

Primary outcome

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.
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.
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.
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.
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

18 secondary outcomes

Overall Satisfaction Score on Pain Control During the Two Weeks After Surgery as Measured by the Post-operative Survey.
Time frame: Day 14
Proportion of Patients Who Reported That Their Pain Was Well-controlled as Measured by the Post-operative Survey.
Time frame: 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.
Time frame: Day 14
Proportion of Patients Whose Pain Has Resolved by Day 14 After Surgery as Measured by the Post-operative Survey.
Time frame: Day 14
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 in the Throat and/or Mouth Over the Past 7 Days on Average as Measured by the Post-operative Survey.
Time frame: Day 14
Proportion of Patients With Leftover Doses of Opioids as Measured by the Post-operative Survey.
Time frame: Day 14
Number of Opioid Doses Taken During the Two Weeks After Surgery as Measured by the Post-operative Survey.
Time frame: 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.
Time frame: 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.
Time frame: Day 14
Patient Health Questionnaire 8-item (PHQ-8) Score (Depression) as Measured by the Post-operative Survey.
Time frame: Day 14
Patient-Reported Outcomes Measurement Information System (PROMIS)- Pediatric Anxiety - Short Form 8a Score as Measured by the Post-operative Survey.
Time frame: Day 14
Patient-Reported Outcomes Measurement Information System (PROMIS)- Sleep Disturbance - Short Form 4a Score as Measured by the Post-operative Survey.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 14
Proportion of Patients With Leftover Doses Who Disposed of Them
Time frame: 14 Days

Results and safety

Results posted to the registry on 1 Nov 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pediatric Otolaryngology Service (Pre-Intervention)	70	70
Pediatric Otolaryngology Service (Post-Intervention)	61	61
General Otolaryngology Service (Control, Pre-Intervention)	46	46
General Otolaryngology Service (Control, Post-Intervention)	60	60

Primary outcome: Number of Doses in the Initial Discharge Opioid Prescription

Time frame: Day of discharge, approximately 1 day. Mean (Standard Deviation). Unit: Doses

Measure	Pediatric Otolaryngology Service (Pre-Intervention) n = 70	Pediatric Otolaryngology Service (Post-Intervention) n = 61	General Otolaryngology Service (Control, Pre-Intervention) n = 46	General Otolaryngology Service (Control, Post-Intervention) n = 60
Value	22.3 (7.4)	16.1 (6.5)	33.7 (20.4)	30.4 (12.4)

Pediatric Otolaryngology Service (Pre-Intervention) vs Pediatric Otolaryngology Service (Post-Intervention) vs General Otolaryngology Service (Control, Pre-Intervention) vs General Otolaryngology Service (Control, Post-Intervention): Difference in Differences: -29.2 (95% CI -42.2 to -11.8)

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Pediatric Otolaryngology Service (Pre-Intervention) n = 70	Pediatric Otolaryngology Service (Post-Intervention) n = 61	General Otolaryngology Service (Control, Pre-Intervention) n = 46	General Otolaryngology Service (Control, Post-Intervention) n = 60
Value	1	27	2	0

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Pediatric Otolaryngology Service (Pre-Intervention) n = 70	Pediatric Otolaryngology Service (Post-Intervention) n = 61	General Otolaryngology Service (Control, Pre-Intervention) n = 46	General Otolaryngology Service (Control, Post-Intervention) n = 60
Value	10	12	25	26

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Pediatric Otolaryngology Service (Pre-Intervention) n = 70	Pediatric Otolaryngology Service (Post-Intervention) n = 61	General Otolaryngology Service (Control, Pre-Intervention) n = 46	General Otolaryngology Service (Control, Post-Intervention) n = 60
Value	2	1	0	1

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: 14 Days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pediatric Otolaryngology Service (Pre-Intervention)	0 of 70 (0%)	0 of 70 (0%)	0 of 70
Pediatric Otolaryngology Service (Post-Intervention)	0 of 61 (0%)	0 of 61 (0%)	0 of 61
General Otolaryngology Service (Control, Pre-Intervention)	0 of 46 (0%)	0 of 46 (0%)	0 of 46
General Otolaryngology Service (Control, Post-Intervention)	0 of 60 (0%)	0 of 60 (0%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35771572Chua 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kao-Ping Chua principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Default setting intervention in people with Tonsillectomy, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Doses in the Initial Discharge Opioid Prescription (time frame: Day of discharge, approximately 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04066829, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.