ThyroidectomyNCT04955444
Opioid Use After Thyroid and Parathyroid Surgeries
A study testing Quality improvement bundle in people with Thyroidectomy and Parathyroidectomy, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
Unnecessary opioid prescriptions for postoperative pain can increase the risk for new, persistent opioid use and dependence. Published literature suggests that most patients undergoing thyroid or parathyroid surgery can have their pain effectively managed without opioids following hospital discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroidectomy, Parathyroidectomy, Opioid Use
- What is being tested?
- Quality improvement bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2021to 31 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing a primary thyroidectomy or parathyroidectomy procedure at Houston Methodist Hospital during the study period. Only index surgeries during the study time frame were included.
Who cannot join
- Patients with a hospital length of stay after surgery >2 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimization of Opioid Discharge Prescriptions Following Thyroid and Parathyroid Surgeries
Unnecessary opioid prescriptions for postoperative pain can increase the risk for new, persistent opioid use and dependence. Published literature suggests that most patients undergoing thyroid or parathyroid surgery can have their pain effectively managed without opioids following hospital discharge. The purpose of this quasi-experimental, quality improvement study is to develop, implement, and measure the impact of a quality improvement bundle that consists of (1) patient education, (2) provider education, and (3) electronic health record (EHR) enhancements. The proportion of patients who receive new opioid discharge prescriptions for pain management following thyroid or parathyroid surgery at Houston Methodist Hospital for up to 6 months following bundle implementation will be compared to a historical control group.
Read the detailed description
BACKGROUND: New and persistent opioid use after minor and major surgery is common, and the duration of opioid use following surgery is associated with opioid dependence, abuse, and overdose. Most patients undergoing thyroid or parathyroid surgery do not require opioid discharge prescriptions for effective pain management. If opioids are prescribed for these surgeries, up to 7% of patients will use opioids 3 to 6 months after surgery. Previously published quality programs that optimized perioperative multimodal analgesia (MMA) regimens, provider education, patient education, and shared decision making successfully reduced the proportion of patients discharged with opioid prescriptions to less than 5% following thyroid and parathyroid surgery.
STUDY DESIGN: This quasi-experimental, quality improvement study compares opioid discharge prescribing practices before and after implementation of the quality improvement bundle. The quality improvement bundle includes patient education, provider education, and EHR enhancements. Patients who undergo a thyroidectomy or parathyroidectomy procedure will be included in the study. The historical control group includes patients treated prior to bundle implementation. The post-implementation group includes patients treated within 4 to 6 months following bundle implementation. The primary outcome is the proportion of patients who receive new opioid discharge prescriptions at discharge following a thyroidectomy or parathyroidectomy procedure. This outcome excludes the continuation of previous, chronic opioid therapy.
- Conditions
- Thyroidectomy, Parathyroidectomy, Opioid Use, Pain, Postoperative
- Being tested
- Quality improvement bundle
- Keywords
- Thyroidectomy, Parathyroidectomy, Opioid, Postoperative pain, Multimodal anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality improvement bundleOther
The quality improvement bundle consists of (1) patient education, (2) provider education, and (3) EHR enhancements including order sets and best practice alerts.
| Study group | Role | What they receive |
|---|---|---|
| Historical control group | No intervention | The historical control group underwent a thyroidectomy or parathyroidectomy procedure prior to implementation of the quality improvement bundle. |
| Post-implementation group | Experimental | The post-implementation group will have a thyroidectomy or parathyroidectomy procedure after bundle implementation and will receive care that is enhanced by the quality improvement bundle. Receives: Other: Quality improvement bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
New Opioid Discharge Prescriptions
Proportion of patients who receive new opioid discharge prescriptions at discharge following a thyroidectomy or parathyroidectomy procedure. This outcome excludes continuation of previous, chronic opioid therapy.
Measured: Up to 2 days
Secondary outcomes (4)
Opioid Discharge Prescriptions Exceeding 112.5 Oral Morphine Milligram Equivalents (MMEs)
Proportion of thyroidectomy and parathyroidectomy postoperative patients with opioid discharge prescriptions exceeding the recommended dose of 112.5 oral MMEs
Measured: Up to 2 days
Opioid Discharge Prescriptions Exceeding 5 Days
Proportion of thyroidectomy and parathyroidectomy postoperative patients with opioid discharge prescriptions exceeding 5 days of therapy
Measured: Up to 2 days
New Opioid Prescriptions From the Surgeon's Office Within 7 Days of Surgery
Proportion of thyroidectomy and parathyroidectomy postoperative patients who receive new opioid prescriptions from the surgeon's office within 7 days of surgery including discharge prescriptions. This outcome excludes continuation of previous, chronic opioid therapy.
Measured: Up to 7 days
Opioid Prescriptions Exceeding 50 Oral MMEs/Day When New Discharge Prescriptions Are Added to Existing Opioid Therapy
Proportion of thyroidectomy and parathyroidectomy postoperative patients with opioid prescriptions exceeding 50 oral MMEs/day when new, postoperative discharge prescriptions are added to existing opioid therapy
Measured: Up to 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start14 Jun 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 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 (12)Papers the sponsor has linked to this study.
- Other trials for ThyroidectomyStudies of the same condition, open and under way.
- 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
- Sequential
- Model description
- The study consists of 2 groups: (1) the historical control group and (2) the post-implementation group. The historical control group includes 160 patients who underwent a thyroidectomy or a parathyroidectomy procedure from January 2018 to December 2019 (20 patients randomly sampled from each quarter prior to bundle implementation). The quality improvement bundle will be implemented at Houston Methodist Hospital in June 2021. The post-implementation group will include the first 80 eligible patients accrued over 4 to 6 months following bundle implementation. An estimated sample size of 80 patients in the post-implementation group and 160 patients in the historical control group will provide 80% power to detect an absolute decrease of 20% in the primary endpoint using a two-sided alpha of 0.05.
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Houston
- Responsible party
- Principal investigator, Elsie Rizk, The Methodist Hospital Research Institute
- Investigators
- Elsie Rizk, PharmD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955444
- Sponsor's protocol ID
- Pro000023276
- Status last verified
- Oct 2022
- First submitted
- 18 Jun 2021
- Last updated
- 5 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
PubMed 28403427Brat GA, Agniel D, Beam A, Yorkgitis B, Bicket M, Homer M, Fox KP, Knecht DB, McMahill-Walraven CN, Palmer N, Kohane I. Postsurgical prescriptions for opioid naive patients and association with overdose and misuse: retrospective cohort study. BMJ. 2018 Jan 17;360:j5790. doi: 10.1136/bmj.j5790.
PubMed 29343479Jena AB, Goldman D, Karaca-Mandic P. Hospital Prescribing of Opioids to Medicare Beneficiaries. JAMA Intern Med. 2016 Jul 1;176(7):990-7. doi: 10.1001/jamainternmed.2016.2737.
PubMed 27294595Lou I, Chennell TB, Schaefer SC, Chen H, Sippel RS, Balentine C, Schneider DF, Moalem J. Optimizing Outpatient Pain Management After Thyroid and Parathyroid Surgery: A Two-Institution Experience. Ann Surg Oncol. 2017 Jul;24(7):1951-1957. doi: 10.1245/s10434-017-5781-y. Epub 2017 Feb 3.
PubMed 28160140Ruffolo LI, Jackson KM, Juviler P, Kaur R, Chennell T, Glover DM, Linehan DC, Moalem J. Narcotic Free Cervical Endocrine Surgery: A Shift in Paradigm. Ann Surg. 2021 Aug 1;274(2):e143-e149. doi: 10.1097/SLA.0000000000003443.
PubMed 31356280Oltman J, Militsakh O, D'Agostino M, Kauffman B, Lindau R, Coughlin A, Lydiatt W, Lydiatt D, Smith R, Panwar A. Multimodal Analgesia in Outpatient Head and Neck Surgery: A Feasibility and Safety Study. JAMA Otolaryngol Head Neck Surg. 2017 Dec 1;143(12):1207-1212. doi: 10.1001/jamaoto.2017.1773.
PubMed 29049548Militsakh O, Lydiatt W, Lydiatt D, Interval E, Lindau R, Coughlin A, Panwar A. Development of Multimodal Analgesia Pathways in Outpatient Thyroid and Parathyroid Surgery and Association With Postoperative Opioid Prescription Patterns. JAMA Otolaryngol Head Neck Surg. 2018 Nov 1;144(11):1023-1029. doi: 10.1001/jamaoto.2018.0987.
PubMed 30027221Shindo M, Lim J, Leon E, Moneta L, Li R, Quintanilla-Dieck L. Opioid Prescribing Practice and Needs in Thyroid and Parathyroid Surgery. JAMA Otolaryngol Head Neck Surg. 2018 Dec 1;144(12):1098-1103. doi: 10.1001/jamaoto.2018.2427.
PubMed 30422170Sada A, Ubl DS, Thiels CA, Cronin PA, Dy BM, Lyden ML, Thompson GB, McKenzie TJ, Habermann EB. Optimizing Opioid-Prescribing Practices After Parathyroidectomy. J Surg Res. 2020 Jan;245:107-114. doi: 10.1016/j.jss.2019.07.039. Epub 2019 Aug 12.
PubMed 31415931Overton HN, Hanna MN, Bruhn WE, Hutfless S, Bicket MC, Makary MA; Opioids After Surgery Workgroup. Opioid-Prescribing Guidelines for Common Surgical Procedures: An Expert Panel Consensus. J Am Coll Surg. 2018 Oct;227(4):411-418. doi: 10.1016/j.jamcollsurg.2018.07.659. Epub 2018 Aug 14.
PubMed 30118896Rizk E, Swan JT, Cheon O, Colavecchia AC, Bui LN, Kash BA, Chokshi SP, Chen H, Johnson ML, Liebl MG, Fink E. Quality indicators to measure the effect of opioid stewardship interventions in hospital and emergency department settings. Am J Health Syst Pharm. 2019 Feb 1;76(4):225-235. doi: 10.1093/ajhp/zxy042.
PubMed 30715186Rizk E, Yuan F, Zheng F, Fink E, Kaur N, Tran AT, Iso T, Mohyuddin NG, Thekdi AA, Jackson GL, Wanat MA, Thornton JD, Swan JT. Optimization of Opioid Discharge Prescriptions Following Thyroid and Parathyroid Surgery. Otolaryngol Head Neck Surg. 2023 Jul;169(1):176-184. doi: 10.1177/01945998221121626. Epub 2023 Jan 29.
PubMed 36040827
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Opioid Discharge Prescriptions Following Thyroid and Parathyroid Surgeries
- ClinicalTrials.gov ID
- NCT04955444
- Acronym / sponsor ID
- Pro000023276
- Conditions
- Thyroidectomy, Parathyroidectomy, Opioid Use, Pain, Postoperative
- Keywords
- Thyroidectomy, Parathyroidectomy, Opioid, Postoperative pain, Multimodal anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Collaborators
- University of Houston
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Jul 2021 (actual)
- Results
- Posted 5 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Unnecessary opioid prescriptions for postoperative pain can increase the risk for new, persistent opioid use and dependence. Published literature suggests that most patients undergoing thyroid or parathyroid surgery can have their pain effectively managed without opioids following hospital discharge. The purpose of this quasi-experimental, quality improvement study is to develop, implement, and measure the impact of a quality improvement bundle that consists of (1) patient education, (2) provider education, and (3) electronic health record (EHR) enhancements. The proportion of patients who receive new opioid discharge prescriptions for pain management following thyroid or parathyroid surgery at Houston Methodist Hospital for up to 6 months following bundle implementation will be compared to a historical control group.
Detailed description
BACKGROUND: New and persistent opioid use after minor and major surgery is common, and the duration of opioid use following surgery is associated with opioid dependence, abuse, and overdose. Most patients undergoing thyroid or parathyroid surgery do not require opioid discharge prescriptions for effective pain management. If opioids are prescribed for these surgeries, up to 7% of patients will use opioids 3 to 6 months after surgery. Previously published quality programs that optimized perioperative multimodal analgesia (MMA) regimens, provider education, patient education, and shared decision making successfully reduced the proportion of patients discharged with opioid prescriptions to less than 5% following thyroid and parathyroid surgery.
STUDY DESIGN: This quasi-experimental, quality improvement study compares opioid discharge prescribing practices before and after implementation of the quality improvement bundle. The quality improvement bundle includes patient education, provider education, and EHR enhancements. Patients who undergo a thyroidectomy or parathyroidectomy procedure will be included in the study. The historical control group includes patients treated prior to bundle implementation. The post-implementation group includes patients treated within 4 to 6 months following bundle implementation. The primary outcome is the proportion of patients who receive new opioid discharge prescriptions at discharge following a thyroidectomy or parathyroidectomy procedure. This outcome excludes the continuation of previous, chronic opioid therapy.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study consists of 2 groups: (1) the historical control group and (2) the post-implementation group. The historical control group includes 160 patients who underwent a thyroidectomy or a parathyroidectomy procedure from January 2018 to December 2019 (20 patients randomly sampled from each quarter prior to bundle implementation). The quality improvement bundle will be implemented at Houston Methodist Hospital in June 2021. The post-implementation group will include the first 80 eligible patients accrued over 4 to 6 months following bundle implementation. An estimated sample size of 80 patients in the post-implementation group and 160 patients in the historical control group will provide 80% power to detect an absolute decrease of 20% in the primary endpoint using a two-sided alpha of 0.05.
| Arm | Type | Receives |
|---|---|---|
| Historical control group | No intervention | –The historical control group underwent a thyroidectomy or parathyroidectomy procedure prior to implementation of the quality improvement bundle. |
| Post-implementation group | Experimental | Other: Quality improvement bundleThe post-implementation group will have a thyroidectomy or parathyroidectomy procedure after bundle implementation and will receive care that is enhanced by the quality improvement bundle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing a primary thyroidectomy or parathyroidectomy procedure at Houston Methodist Hospital during the study period. Only index surgeries during the study time frame were included.
Key exclusion criteria (1 listed)
- Patients with a hospital length of stay after surgery >2 days
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 |
|---|---|---|
| Quality improvement bundleThe quality improvement bundle consists of (1) patient education, (2) provider education, and (3) EHR enhancements including order sets and best practice alerts. | Other | Post-implementation group |
Primary outcome
New Opioid Discharge Prescriptions
Time frame: Up to 2 days
Proportion of patients who receive new opioid discharge prescriptions at discharge following a thyroidectomy or parathyroidectomy procedure. This outcome excludes continuation of previous, chronic opioid therapy.
4 secondary outcomes
Opioid Discharge Prescriptions Exceeding 112.5 Oral Morphine Milligram Equivalents (MMEs)
Time frame: Up to 2 days
Opioid Discharge Prescriptions Exceeding 5 Days
Time frame: Up to 2 days
New Opioid Prescriptions From the Surgeon's Office Within 7 Days of Surgery
Time frame: Up to 7 days
Opioid Prescriptions Exceeding 50 Oral MMEs/Day When New Discharge Prescriptions Are Added to Existing Opioid Therapy
Time frame: Up to 2 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28403427Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
- Background: PubMed 29343479Brat GA, Agniel D, Beam A, Yorkgitis B, Bicket M, Homer M, Fox KP, Knecht DB, McMahill-Walraven CN, Palmer N, Kohane I. Postsurgical prescriptions for opioid naive patients and association with overdose and misuse: retrospective cohort study. BMJ. 2018 Jan 17;360:j5790. doi: 10.1136/bmj.j5790.
- Background: PubMed 27294595Jena AB, Goldman D, Karaca-Mandic P. Hospital Prescribing of Opioids to Medicare Beneficiaries. JAMA Intern Med. 2016 Jul 1;176(7):990-7. doi: 10.1001/jamainternmed.2016.2737.
- Background: PubMed 28160140Lou I, Chennell TB, Schaefer SC, Chen H, Sippel RS, Balentine C, Schneider DF, Moalem J. Optimizing Outpatient Pain Management After Thyroid and Parathyroid Surgery: A Two-Institution Experience. Ann Surg Oncol. 2017 Jul;24(7):1951-1957. doi: 10.1245/s10434-017-5781-y. Epub 2017 Feb 3.
- Background: PubMed 31356280Ruffolo LI, Jackson KM, Juviler P, Kaur R, Chennell T, Glover DM, Linehan DC, Moalem J. Narcotic Free Cervical Endocrine Surgery: A Shift in Paradigm. Ann Surg. 2021 Aug 1;274(2):e143-e149. doi: 10.1097/SLA.0000000000003443.
- Background: PubMed 29049548Oltman J, Militsakh O, D'Agostino M, Kauffman B, Lindau R, Coughlin A, Lydiatt W, Lydiatt D, Smith R, Panwar A. Multimodal Analgesia in Outpatient Head and Neck Surgery: A Feasibility and Safety Study. JAMA Otolaryngol Head Neck Surg. 2017 Dec 1;143(12):1207-1212. doi: 10.1001/jamaoto.2017.1773.
- Background: PubMed 30027221Militsakh O, Lydiatt W, Lydiatt D, Interval E, Lindau R, Coughlin A, Panwar A. Development of Multimodal Analgesia Pathways in Outpatient Thyroid and Parathyroid Surgery and Association With Postoperative Opioid Prescription Patterns. JAMA Otolaryngol Head Neck Surg. 2018 Nov 1;144(11):1023-1029. doi: 10.1001/jamaoto.2018.0987.
- Background: PubMed 30422170Shindo M, Lim J, Leon E, Moneta L, Li R, Quintanilla-Dieck L. Opioid Prescribing Practice and Needs in Thyroid and Parathyroid Surgery. JAMA Otolaryngol Head Neck Surg. 2018 Dec 1;144(12):1098-1103. doi: 10.1001/jamaoto.2018.2427.
- Background: PubMed 31415931Sada A, Ubl DS, Thiels CA, Cronin PA, Dy BM, Lyden ML, Thompson GB, McKenzie TJ, Habermann EB. Optimizing Opioid-Prescribing Practices After Parathyroidectomy. J Surg Res. 2020 Jan;245:107-114. doi: 10.1016/j.jss.2019.07.039. Epub 2019 Aug 12.
- Background: PubMed 30118896Overton HN, Hanna MN, Bruhn WE, Hutfless S, Bicket MC, Makary MA; Opioids After Surgery Workgroup. Opioid-Prescribing Guidelines for Common Surgical Procedures: An Expert Panel Consensus. J Am Coll Surg. 2018 Oct;227(4):411-418. doi: 10.1016/j.jamcollsurg.2018.07.659. Epub 2018 Aug 14.
- Background: PubMed 30715186Rizk E, Swan JT, Cheon O, Colavecchia AC, Bui LN, Kash BA, Chokshi SP, Chen H, Johnson ML, Liebl MG, Fink E. Quality indicators to measure the effect of opioid stewardship interventions in hospital and emergency department settings. Am J Health Syst Pharm. 2019 Feb 1;76(4):225-235. doi: 10.1093/ajhp/zxy042.
- Results publication: PubMed 36040827Rizk E, Yuan F, Zheng F, Fink E, Kaur N, Tran AT, Iso T, Mohyuddin NG, Thekdi AA, Jackson GL, Wanat MA, Thornton JD, Swan JT. Optimization of Opioid Discharge Prescriptions Following Thyroid and Parathyroid Surgery. Otolaryngol Head Neck Surg. 2023 Jul;169(1):176-184. doi: 10.1177/01945998221121626. Epub 2023 Jan 29.
- 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.
Elsie Rizk, PharmD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality improvement bundle in people with Thyroidectomy and Parathyroidectomy, run by The Methodist Hospital Research Institute 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 1 inclusion and 1 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 5 Sep 2023. 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 5 Sep 2023). 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?
New Opioid Discharge Prescriptions (time frame: Up to 2 days). 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 NCT04955444, which also lists 12 linked publications.
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 5 Sep 2023.