Opioid Reduction Strategy South Western Ontario

NCT04944225 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100000

Last updated 2024-02-28

No results posted yet for this study

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

Interventions

OTHER

Opioid Reduction Strategy

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Mahesh Nagappa, MD · Western University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-01-01
Completion
2025-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04944225 on ClinicalTrials.gov