Opioid Reduction Strategy South Western Ontario

NCT04944225 | Not Yet Recruiting

• 1 other identifier: MN ORS
• Study Type: interventional
• Target: 100,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pain is a major risk factor for chronic postoperative pain. Adequate perioperative pain relief is an important metric for patient satisfaction and to achieve good recovery outcomes. Opioids remain the primary systemic pharmacotherapy for intraoperative and postoperative analgesia, particularly for moderate to severe pain. When used judiciously, opioids are effective in reducing suffering and helping patients cope with postoperative pain. However, there are challenges - a) side effects can result in harm, like respiratory depression; b) over-reliance on opioids can increase drug dependency; c) over-prescription can encourage addiction, overdose and death, leading to a human and financial burden from both, an individual, and public health standpoint. Over-prescription of opioids for acute pain is strongly linked to patient morbidity and mortality. For example, a new opioid prescription raises the risk of lethal or non-lethal overdose, as well as the conversion from opioid-naive to chronic user. Canadian Institute of Health Information (CIHI), and Public Health Agency of Canada (PHAC) data emphasize the public health need to reduce reliance on opioids: "From January 2016 to June 2018, more than 9,000 Canadians died from apparent opioid related harms. In 2017, an average of 17 Canadians were hospitalized for opioid poisonings each day - an increase from 16 per day in 2016". Prescription opioid use appears to be an early driver of the current crisis. Given the local and national severity of the opioid crisis, there is need for a pragmatic, timely, and scalable intervention to reduce reliance on opioids as we strive to improve healthcare for patients and alleviate the economic burden on the medical system. This proposal for a stepped-wedge randomized trial of a multi-faceted opioid-use reduction strategy addresses key drivers of the opioid crisis and has the potential to reduce patient exposure to opioids and, thereby, improve morbidity and mortality. Hospitals involved in this study will all eventually participate in an opioid reduction strategy that will limit the access and prescription of opioids to surgical patients and will incorporate various opioid reduction strategies at both a patient and hospital level.

Conditions

Opioid Use

Keywords

Opioid Use; Opioid Reduction

Outcome Measures

Primary Outcomes (1)

• total morphine milliequivalents (MME)

  The total morphone milliequivalents (MME) prescribed for each patient will be recorded by extracting this data from the ICES administrative healthcare database.

  Time of discharge up to 30 days postoperatively

Secondary Outcomes (6)

• Number of serious opioid-related events

  Time of discharge up to 30 days postoperatively

• Readmission to hospital

  Time of discharge up to 90 days postoperatively

• Time of discharge

  Up to 90 days post operatively

• Conversion from opioid naïve to chronic user

  90 days post operatively

• Total opioid community exposure

  90 days post operatively

Study Arms (2)

Control group: Pain management during the standard of care phase

NO INTERVENTION

In the standard of care phase, anesthetic and surgical care will be as per standard practice (according to local hospital protocol) for both the control and the intervention group. Generally, this means patients will be maintained on a more liberal opioid regime than in the opioid reduction strategy phase and will receive opioid and other medications for the acute postoperative pain. The choice of opioids will be at the discretion of the managing team. There will be a minimum 2-month baseline period before entry of the first randomized cluster to the intervention arm.

Intervention group: Pain management in the opioid reduction strategy phase

EXPERIMENTAL

The intervention will involve a multi-faceted 3 component approach involving 1) opioid prescription caps (default maximum number of tablets for discharge prescriptions, as defined by evidence-based guidelines) 2) patient education tools (e.g. What is a normal pain trajectory? How to manage the pain? Benefits and potential harms of pharmacologic analgesia. Non-pharmacologic analgesia management? What to do if pain is excessive?), 3) provider education tools (e.g. including procedure-specific evidence-based recommendations for multi-modal analgesia; comparison of local baseline prescribing patterns with exemplary prescribing patterns; defining targeted reduction if baseline prescribing is at odds with best evidence; review of best evidence about optimal analgesia perioperatively), and 4) bi-weekly cumulative prescriber feedback on opioid prescribing patterns post-intervention and until end-of-study.

Other: Opioid Reduction Strategy

Interventions

Opioid Reduction Strategy OTHER

The intervention will involve a multi-faceted 3 component approach involving 1) opioid prescription caps (default maximum number of tablets for discharge prescriptions, as defined by evidence-based guidelines) 2) patient education tools (e.g. What is a normal pain trajectory? How to manage the pain? Benefits and potential harms of pharmacologic analgesia. Non-pharmacologic analgesia management? What to do if pain is excessive?), 3) provider education tools (e.g. including procedure-specific evidence-based recommendations for multi-modal analgesia; comparison of local baseline prescribing patterns with exemplary prescribing patterns; defining targeted reduction if baseline prescribing is at odds with best evidence; review of best evidence about optimal analgesia perioperatively), and 4) bi-weekly cumulative prescriber feedback on opioid prescribing patterns post-intervention and until end-of-study.

Intervention group: Pain management in the opioid reduction strategy phase

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years of age
• Undergoing elective surgery during the study period

You may not qualify if:

• None

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Related Publications (17)

• Canadian Centre on Substance Abuse and Addiction. Canadian Drug Summary: Prescription Opioids. 2017.

  BACKGROUND

• Canadian Institute for Health Information. Opioid-Related Harms in Canada, December 2018

  BACKGROUND

• Ontario Agency for Health Protection and Promotion (Public Health Ontario); Office of the Chief Coroner; Ontario Forensic Pathology Service; Ontario Drug Policy Research Network. Opioid mortality surveillance report: Anal opioid-related deaths Ontario July 2017-June 2018 Toronto, Queen's Print Ontario 2019

  BACKGROUND

• Nagappa M, Weingarten TN, Montandon G, Sprung J, Chung F. Opioids, respiratory depression, and sleep-disordered breathing. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):469-485. doi: 10.1016/j.bpa.2017.05.004. Epub 2017 May 22.

  PMID: 29739536 BACKGROUND

• Cozowicz C, Chung F, Doufas AG, Nagappa M, Memtsoudis SG. Opioids for Acute Pain Management in Patients With Obstructive Sleep Apnea: A Systematic Review. Anesth Analg. 2018 Oct;127(4):988-1001. doi: 10.1213/ANE.0000000000003549.

  PMID: 29958218 BACKGROUND

• Gupta K, Nagappa M, Prasad A, Abrahamyan L, Wong J, Weingarten TN, Chung F. Risk factors for opioid-induced respiratory depression in surgical patients: a systematic review and meta-analyses. BMJ Open. 2018 Dec 14;8(12):e024086. doi: 10.1136/bmjopen-2018-024086.

  PMID: 30552274 BACKGROUND

• Subramani Y, Nagappa M, Wong J, Patra J, Chung F. Death or near-death in patients with obstructive sleep apnoea: a compendium of case reports of critical complications. Br J Anaesth. 2017 Nov 1;119(5):885-899. doi: 10.1093/bja/aex341.

  PMID: 29077813 BACKGROUND

• Gupta K, Prasad A, Nagappa M, Wong J, Abrahamyan L, Chung FF. Risk factors for opioid-induced respiratory depression and failure to rescue: a review. Curr Opin Anaesthesiol. 2018 Feb;31(1):110-119. doi: 10.1097/ACO.0000000000000541.

  PMID: 29120929 BACKGROUND

• Bohnert ASB, Ilgen MA. Understanding Links among Opioid Use, Overdose, and Suicide. N Engl J Med. 2019 Jan 3;380(1):71-79. doi: 10.1056/NEJMra1802148. No abstract available.

  PMID: 30601750 BACKGROUND

• Shah A, Hayes CJ, Martin BC. Characteristics of Initial Prescription Episodes and Likelihood of Long-Term Opioid Use - United States, 2006-2015. MMWR Morb Mortal Wkly Rep. 2017 Mar 17;66(10):265-269. doi: 10.15585/mmwr.mm6610a1.

  PMID: 28301454 BACKGROUND

• Kharasch ED, Brunt LM. Perioperative Opioids and Public Health. Anesthesiology. 2016 Apr;124(4):960-5. doi: 10.1097/ALN.0000000000001012. No abstract available.

  PMID: 26808634 BACKGROUND

• CIHI Opioid Prescribing in Canada: How Are Practices Changing? (cihi.ca) Ottawa. 2019

  BACKGROUND

• Opioids. Special Advisory Committee on the Epidemic of Opioid Overdoses. National report: Apparent opioid-related deaths in Canada (January 2016 to March 2019). Web Based Report. Ottawa Public Heal Agency Canada; Sept 2019 https//health-infobase.canada.ca/datalab/national-surveillance-opioid-mortality.html

  BACKGROUND

• Bachhuber MA, Nash D, Southern WN, Heo M, Berger M, Schepis M, Cunningham CO. Reducing the default dispense quantity for new opioid analgesic prescriptions: study protocol for a cluster randomised controlled trial. BMJ Open. 2018 Apr 20;8(4):e019559. doi: 10.1136/bmjopen-2017-019559.

  PMID: 29678969 BACKGROUND

• Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ. 2015 Feb 6;350:h391. doi: 10.1136/bmj.h391. No abstract available.

  PMID: 25662947 BACKGROUND

• Rennert L, Heo M, Litwin AH, De Gruttola V. Accounting for external factors and early intervention adoption in the design and analysis of stepped-wedge designs: Application to a proposed study design to reduce opioid-related mortality. medRxiv [Preprint]. 2020 Jul 29:2020.07.26.20162297. doi: 10.1101/2020.07.26.20162297.

  PMID: 32766601 BACKGROUND

• Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007 Feb;28(2):182-91. doi: 10.1016/j.cct.2006.05.007. Epub 2006 Jul 7.

  PMID: 16829207 BACKGROUND

Study Officials

• Mahesh Nagappa, MD

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahesh Nagappa, MD

CONTACT

5196588500; mahesh.nagappa@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: It is not possible to blind clinicians or study staff to hospital allocation because the appropriate pain/opioid management must be transparently applied upon entry to the intervention phase of the study, and therefore the unit of randomization is at the hospital level. Outcome adjudicators will be blinded and patients will remain blinded.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Anesthesiologist

Model Details: Stepped-Wedge Cluster Randomized Trial. In this trial, the unit of randomization is the cluster (i,e each of the hospital) and the unit of analysis is the patient.This will entail the roll out of the intervention in a randomized fashion and "sequential crossover of clusters from control to intervention until all clusters are exposed".

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 29, 2021
• Study Start: November 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share