Opioid UseNCT04805229
A Difference-In-Differences Analysis of New Persistent Opioid Use After Surgery
An observational study of Opioid Use, run by University of Michigan at 1 site in United States.
Trial summary
The Michigan Opioid Prescribing and Engagement Network (M-OPEN) was established in 2016 with the goal of reducing excessive opioid prescribing after surgery using evidence-based prescribing guidelines. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use
- What is being tested?
- Retrospective analysis of opioid use after surgery
- How many people
- 30,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2013to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Data for this study will be obtained from the Truven Health MarketScan database, which is a national data set of employer-based insurance claims. Patients in the database who underwent one of the eligible procedures will be identified using Current Procedural Terminology codes that correspond to the specific operations under analysis.
Who may be able to join
- Adult patients (18 years and older)
- Patients undergoing one of the following procedures: laparoscopic cholecystectomy, laparoscopic appendectomy, minor hernia repair (including laparoscopic or open inguinal, femoral, umbilical, and epigastric hernia repair), open and laparoscopic ventral/incisional hernia repair, laparoscopic colectomy, open colectomy, vaginal hysterectomy, laparoscopic hysterectomy, and open abdominal hysterectomy
- Patients who underwent surgery between January 1, 2013 and December 31, 2019
Who cannot join
- Patients who are not opioid-naive at the time of surgery, defined as filling 1 or more opioid prescriptions between the 12 months to 31 days prior to surgery
- Patients without continuous insurance enrollment for at least 12 months before and at least 6 months after the date of surgery
- Patients still in the hospital on postoperative day 30
- Patients not discharged home after surgery
- Patients who underwent another surgery within 6 months of their index operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Difference-in-Differences to Evaluate the Effect of a Statewide Quality Improvement Program on New Persistent Opioid Use After Surgery
The Michigan Opioid Prescribing and Engagement Network (M-OPEN) was established in 2016 with the goal of reducing excessive opioid prescribing after surgery using evidence-based prescribing guidelines. Beginning in July 2016, M-OPEN began a statewide quality improvement campaign to educate providers and share prescribing best practices. This retrospective study examines the effect of these efforts on new persistent opioid use after surgery compared to other states where no such program existed using a difference-in-differences approach.
Read the detailed description
In the United States, surgical care has become a gateway for chronic opioid dependence and its associated morbidity. Between 5-10% of patients who receive opioids for postoperative pain control go on to develop long-term opioid use. This translates to more than 2 million previously opioid-naïve individuals developing chronic opioid use after surgery each year. Persistent opioid use after surgery is associated with increased readmissions, healthcare utilization, and healthcare expenditures. Critically, long-term opioid use increases the risk of overdose and death in patients who, prior to their surgery, had no exposure to opioids.
Growing recognition of this problem has led to numerous efforts aimed at reducing opioid-associated morbidity after surgery. These include legislative limits on opioid prescribing for acute pain, procedure-specific prescribing guidelines based on patient-reported opioid use, and opioid-sparing pain management pathways. In Michigan specifically, the Michigan Opioid Prescribing and Engagement Network (M-OPEN) led a statewide quality improvement effort beginning in 2016 that focused on provider education using evidence-based opioid prescribing guidelines. Previously, these guidelines have been shown to significantly reduce excessive postoperative opioid prescribing across the state, however it is currently unknown whether these efforts have had any effect on the actual incidence of persistent opioid use after surgery.
Therefore, the current study will evaluate the incidence of new persistent opioid use before and after the establishment of M-OPEN in Michigan. Beginning in 2016, a statewide quality improvement initiative was undertaken in Michigan to improve postoperative opioid prescribing. In order to accomplish this goal, this study will use a difference-in-differences approach to compare new persistent opioid use in Michigan before and after 2016 to other states where no such quality improvement effort existed.
- Conditions
- Opioid Use
- Being tested
- Retrospective analysis of opioid use after surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective analysis of opioid use after surgeryOther
Retrospective analysis of opioid use after one of the following surgical procedure categories: laparoscopic cholecystectomy, laparoscopic appendectomy, minor hernia repair (including laparoscopic or open inguinal, femoral, umbilical, and epigastric hernia repair), open and laparoscopic ventral/incisional hernia repair, laparoscopic colectomy, open colectomy, vaginal hysterectomy, laparoscopic hysterectomy, and open abdominal hysterectomy.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing surgery | Retrospective cohort of patients who underwent surgery between 1/1/13 to 12/31/19 and were sampled from the Truven Health MarketScan Database. Receives: Other: Retrospective analysis of opioid use after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the incidence of new persistent opioid use before and after July 2016 in Michigan compared to all other states.
Among patients who undergo surgery, new persistent opioid use is defined as filling an opioid prescription in post-discharge days 4-90 and filling another opioid prescription in post-discharge days 91-180. This incidence will be measured from 1/1/13-6/30/16 (before M-OPEN established) and from 7/1/16-12/31/19 (after M-OPEN established) and the change before and after this date will be compared between Michigan and all other states (the difference-in-differences). Outcomes will be measured at 1 year, 2 years, and 3 years post-intervention.
Measured: Postoperative days 4 to 180
Secondary outcomes (2)
The change in the incidence of new persistent opioid use before and after July 2016 in Michigan compared to Indiana and Wisconsin
Among patients who undergo surgery, new persistent opioid use is defined as filling an opioid prescription in post-discharge days 4-90 and filling another opioid prescription in post-discharge days 91-180. This incidence will be measured from 1/1/13-6/30/16 (before M-OPEN established) and from 7/1/16-12/31/19 (after M-OPEN established) and the change before and after this date will be compared between Michigan and Indiana/Wisconsin (the difference-in-differences). Outcomes will be measured at 1 year, 2 years, and 3 years post-intervention.
Measured: Postoperative days 4 to 180
The change in the incidence of new persistent opioid use before and after July 2016 in Michigan compared to 11 other Midwest states (Illinois, Indiana, Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, Ohio, South Dakota, and Wisconsin).
Among patients who undergo surgery, new persistent opioid use is defined as filling an opioid prescription in post-discharge days 4-90 and filling another opioid prescription in post-discharge days 91-180. This incidence will be measured from 1/1/13-6/30/16 (before M-OPEN established) and from 7/1/16-12/31/19 (after M-OPEN established) and the change before and after this date will be compared between Michigan and 11 other Midwest states. Outcomes will be measured at 1 year, 2 years, and 3 years post-intervention.
Measured: Postoperative days 4 to 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start1 Jan 2013
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chad Brummett, University of Michigan
- Investigators
- Chad Brummett, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805229
- Sponsor's protocol ID
- HUM00119139
- Status last verified
- Oct 2020
- First submitted
- 15 Mar 2021
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Waljee JF, Li L, Brummett CM, Englesbe MJ. Iatrogenic Opioid Dependence in the United States: Are Surgeons the Gatekeepers? Ann Surg. 2017 Apr;265(4):728-730. doi: 10.1097/SLA.0000000000001904. No abstract available.
PubMed 27429023Hah JM, Bateman BT, Ratliff J, Curtin C, Sun E. Chronic Opioid Use After Surgery: Implications for Perioperative Management in the Face of the Opioid Epidemic. Anesth Analg. 2017 Nov;125(5):1733-1740. doi: 10.1213/ANE.0000000000002458.
PubMed 29049117Brummett 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 28403427Lee JS, Hu HM, Edelman AL, Brummett CM, Englesbe MJ, Waljee JF, Smerage JB, Griggs JJ, Nathan H, Jeruss JS, Dossett LA. New Persistent Opioid Use Among Patients With Cancer After Curative-Intent Surgery. J Clin Oncol. 2017 Dec 20;35(36):4042-4049. doi: 10.1200/JCO.2017.74.1363. Epub 2017 Oct 19.
PubMed 29048972Harbaugh CM, Lee JS, Hu HM, McCabe SE, Voepel-Lewis T, Englesbe MJ, Brummett CM, Waljee JF. Persistent Opioid Use Among Pediatric Patients After Surgery. Pediatrics. 2018 Jan;141(1):e20172439. doi: 10.1542/peds.2017-2439. Epub 2017 Dec 4.
PubMed 29203521Brescia AA, Waljee JF, Hu HM, Englesbe MJ, Brummett CM, Lagisetty PA, Lagisetty KH. Impact of Prescribing on New Persistent Opioid Use After Cardiothoracic Surgery. Ann Thorac Surg. 2019 Oct;108(4):1107-1113. doi: 10.1016/j.athoracsur.2019.06.019. Epub 2019 Aug 22.
PubMed 31447051Lee JS, Vu JV, Edelman AL, Gunaseelan V, Brummett CM, Englesbe MJ, Waljee JF. Health Care Spending and New Persistent Opioid Use After Surgery. Ann Surg. 2020 Jul;272(1):99-104. doi: 10.1097/SLA.0000000000003399.
PubMed 31851641Babu KM, Brent J, Juurlink DN. Prevention of Opioid Overdose. N Engl J Med. 2019 Jun 6;380(23):2246-2255. doi: 10.1056/NEJMra1807054. No abstract available.
PubMed 31167053Howard R, Waljee J, Brummett C, Englesbe M, Lee J. Reduction in Opioid Prescribing Through Evidence-Based Prescribing Guidelines. JAMA Surg. 2018 Mar 1;153(3):285-287. doi: 10.1001/jamasurg.2017.4436.
PubMed 29214318Overton 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 30118896Hallway A, Vu J, Lee J, Palazzolo W, Waljee J, Brummett C, Englesbe M, Howard R. Patient Satisfaction and Pain Control Using an Opioid-Sparing Postoperative Pathway. J Am Coll Surg. 2019 Sep;229(3):316-322. doi: 10.1016/j.jamcollsurg.2019.04.020. Epub 2019 May 30.
PubMed 31154092Vu JV, Howard RA, Gunaseelan V, Brummett CM, Waljee JF, Englesbe MJ. Statewide Implementation of Postoperative Opioid Prescribing Guidelines. N Engl J Med. 2019 Aug 15;381(7):680-682. doi: 10.1056/NEJMc1905045. No abstract available.
PubMed 31412184Brown CS, Vu JV, Howard RA, Gunaseelan V, Brummett CM, Waljee J, Englesbe M. Assessment of a quality improvement intervention to decrease opioid prescribing in a regional health system. BMJ Qual Saf. 2021 Mar;30(3):251-259. doi: 10.1136/bmjqs-2020-011295. Epub 2020 Sep 16.
PubMed 32938775Hill MV, Stucke RS, Billmeier SE, Kelly JL, Barth RJ Jr. Guideline for Discharge Opioid Prescriptions after Inpatient General Surgical Procedures. J Am Coll Surg. 2018 Jun;226(6):996-1003. doi: 10.1016/j.jamcollsurg.2017.10.012. Epub 2017 Nov 30.
PubMed 29198638
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Difference-in-Differences to Evaluate the Effect of a Statewide Quality Improvement Program on New Persistent Opioid Use After Surgery
- ClinicalTrials.gov ID
- NCT04805229
- Acronym / sponsor ID
- HUM00119139
- Conditions
- Opioid Use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30,000 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Michigan Opioid Prescribing and Engagement Network (M-OPEN) was established in 2016 with the goal of reducing excessive opioid prescribing after surgery using evidence-based prescribing guidelines. Beginning in July 2016, M-OPEN began a statewide quality improvement campaign to educate providers and share prescribing best practices. This retrospective study examines the effect of these efforts on new persistent opioid use after surgery compared to other states where no such program existed using a difference-in-differences approach.
Detailed description
In the United States, surgical care has become a gateway for chronic opioid dependence and its associated morbidity. Between 5-10% of patients who receive opioids for postoperative pain control go on to develop long-term opioid use. This translates to more than 2 million previously opioid-naïve individuals developing chronic opioid use after surgery each year. Persistent opioid use after surgery is associated with increased readmissions, healthcare utilization, and healthcare expenditures. Critically, long-term opioid use increases the risk of overdose and death in patients who, prior to their surgery, had no exposure to opioids.
Growing recognition of this problem has led to numerous efforts aimed at reducing opioid-associated morbidity after surgery. These include legislative limits on opioid prescribing for acute pain, procedure-specific prescribing guidelines based on patient-reported opioid use, and opioid-sparing pain management pathways. In Michigan specifically, the Michigan Opioid Prescribing and Engagement Network (M-OPEN) led a statewide quality improvement effort beginning in 2016 that focused on provider education using evidence-based opioid prescribing guidelines. Previously, these guidelines have been shown to significantly reduce excessive postoperative opioid prescribing across the state, however it is currently unknown whether these efforts have had any effect on the actual incidence of persistent opioid use after surgery.
Therefore, the current study will evaluate the incidence of new persistent opioid use before and after the establishment of M-OPEN in Michigan. Beginning in 2016, a statewide quality improvement initiative was undertaken in Michigan to improve postoperative opioid prescribing. In order to accomplish this goal, this study will use a difference-in-differences approach to compare new persistent opioid use in Michigan before and after 2016 to other states where no such quality improvement effort existed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing surgery | – | Other: Retrospective analysis of opioid use after surgeryRetrospective cohort of patients who underwent surgery between 1/1/13 to 12/31/19 and were sampled from the Truven Health MarketScan Database. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Data for this study will be obtained from the Truven Health MarketScan database, which is a national data set of employer-based insurance claims. Patients in the database who underwent one of the eligible procedures will be identified using Current Procedural Terminology codes that correspond to the specific operations under analysis.
Key inclusion criteria (3 listed)
- Adult patients (18 years and older)
- Patients undergoing one of the following procedures: laparoscopic cholecystectomy, laparoscopic appendectomy, minor hernia repair (including laparoscopic or open inguinal, femoral, umbilical, and epigastric hernia repair), open and laparoscopic ventral/incisional hernia repair, laparoscopic colectomy, open colectomy, vaginal hysterectomy, laparoscopic hysterectomy, and open abdominal hysterectomy
- Patients who underwent surgery between January 1, 2013 and December 31, 2019
Key exclusion criteria (5 listed)
- Patients who are not opioid-naive at the time of surgery, defined as filling 1 or more opioid prescriptions between the 12 months to 31 days prior to surgery
- Patients without continuous insurance enrollment for at least 12 months before and at least 6 months after the date of surgery
- Patients still in the hospital on postoperative day 30
- Patients not discharged home after surgery
- Patients who underwent another surgery within 6 months of their index operation
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 |
|---|---|---|
| Retrospective analysis of opioid use after surgeryRetrospective analysis of opioid use after one of the following surgical procedure categories: laparoscopic cholecystectomy, laparoscopic appendectomy, minor hernia repair (including laparoscopic or open inguinal, femoral, umbilical, and epigastric hernia repair), open and laparoscopic ventral/incisional hernia repair, laparoscopic colectomy, open colectomy, vaginal hysterectomy, laparoscopic hysterectomy, and open abdominal hysterectomy. | Other | Patients undergoing surgery |
Primary outcome
The change in the incidence of new persistent opioid use before and after July 2016 in Michigan compared to all other states.
Time frame: Postoperative days 4 to 180
Among patients who undergo surgery, new persistent opioid use is defined as filling an opioid prescription in post-discharge days 4-90 and filling another opioid prescription in post-discharge days 91-180. This incidence will be measured from 1/1/13-6/30/16 (before M-OPEN established) and from 7/1/16-12/31/19 (after M-OPEN established) and the change before and after this date will be compared between Michigan and all other states (the difference-in-differences). Outcomes will be measured at 1 year, 2 years, and 3 years post-intervention.
2 secondary outcomes
The change in the incidence of new persistent opioid use before and after July 2016 in Michigan compared to Indiana and Wisconsin
Time frame: Postoperative days 4 to 180
The change in the incidence of new persistent opioid use before and after July 2016 in Michigan compared to 11 other Midwest states (Illinois, Indiana, Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, Ohio, South Dakota, and Wisconsin).
Time frame: Postoperative days 4 to 180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Background: PubMed 27429023Waljee JF, Li L, Brummett CM, Englesbe MJ. Iatrogenic Opioid Dependence in the United States: Are Surgeons the Gatekeepers? Ann Surg. 2017 Apr;265(4):728-730. doi: 10.1097/SLA.0000000000001904. No abstract available.
- Background: PubMed 29049117Hah JM, Bateman BT, Ratliff J, Curtin C, Sun E. Chronic Opioid Use After Surgery: Implications for Perioperative Management in the Face of the Opioid Epidemic. Anesth Analg. 2017 Nov;125(5):1733-1740. doi: 10.1213/ANE.0000000000002458.
- 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 29048972Lee JS, Hu HM, Edelman AL, Brummett CM, Englesbe MJ, Waljee JF, Smerage JB, Griggs JJ, Nathan H, Jeruss JS, Dossett LA. New Persistent Opioid Use Among Patients With Cancer After Curative-Intent Surgery. J Clin Oncol. 2017 Dec 20;35(36):4042-4049. doi: 10.1200/JCO.2017.74.1363. Epub 2017 Oct 19.
- Background: PubMed 29203521Harbaugh CM, Lee JS, Hu HM, McCabe SE, Voepel-Lewis T, Englesbe MJ, Brummett CM, Waljee JF. Persistent Opioid Use Among Pediatric Patients After Surgery. Pediatrics. 2018 Jan;141(1):e20172439. doi: 10.1542/peds.2017-2439. Epub 2017 Dec 4.
- Background: PubMed 31447051Brescia AA, Waljee JF, Hu HM, Englesbe MJ, Brummett CM, Lagisetty PA, Lagisetty KH. Impact of Prescribing on New Persistent Opioid Use After Cardiothoracic Surgery. Ann Thorac Surg. 2019 Oct;108(4):1107-1113. doi: 10.1016/j.athoracsur.2019.06.019. Epub 2019 Aug 22.
- Background: PubMed 31851641Lee JS, Vu JV, Edelman AL, Gunaseelan V, Brummett CM, Englesbe MJ, Waljee JF. Health Care Spending and New Persistent Opioid Use After Surgery. Ann Surg. 2020 Jul;272(1):99-104. doi: 10.1097/SLA.0000000000003399.
- Background: PubMed 31167053Babu KM, Brent J, Juurlink DN. Prevention of Opioid Overdose. N Engl J Med. 2019 Jun 6;380(23):2246-2255. doi: 10.1056/NEJMra1807054. No abstract available.
- Background: PubMed 29214318Howard R, Waljee J, Brummett C, Englesbe M, Lee J. Reduction in Opioid Prescribing Through Evidence-Based Prescribing Guidelines. JAMA Surg. 2018 Mar 1;153(3):285-287. doi: 10.1001/jamasurg.2017.4436.
- 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 31154092Hallway A, Vu J, Lee J, Palazzolo W, Waljee J, Brummett C, Englesbe M, Howard R. Patient Satisfaction and Pain Control Using an Opioid-Sparing Postoperative Pathway. J Am Coll Surg. 2019 Sep;229(3):316-322. doi: 10.1016/j.jamcollsurg.2019.04.020. Epub 2019 May 30.
- Background: PubMed 31412184Vu JV, Howard RA, Gunaseelan V, Brummett CM, Waljee JF, Englesbe MJ. Statewide Implementation of Postoperative Opioid Prescribing Guidelines. N Engl J Med. 2019 Aug 15;381(7):680-682. doi: 10.1056/NEJMc1905045. No abstract available.
- 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.
Chad Brummett, MD 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?
An observational study of Opioid Use, 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 5 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 18 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The change in the incidence of new persistent opioid use before and after July 2016 in Michigan compared to all other states. (time frame: Postoperative days 4 to 180). 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 NCT04805229, which also lists 14 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 18 Mar 2021; AzTrials last refreshed its copy on 27 Oct 2026.