Clinical trial NCT03953534: Quantity of Opioids for Acute Pain and Limit Unused Medication
Official title: Quantity of Opioids for Acute Pain and Limit Unused Medication (OPUM Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pain
Keywords: Opioids
Acute Pain
Lead sponsor: Hopital du Sacre-Coeur de Montreal
Sponsor class: OTHER
Collaborators: name: Queen's University
name: Maisonneuve-Rosemont Hospital
name: Sunnybrook Health Sciences Centre
name: Hopital de l'Enfant-Jesus
First posted: 2019-05-16
Enrollment: 2240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A cohort of consecutive ED patients aged 18 years or more, treated for an acute pain condition present for less than 2 weeks (usual acute pain definition),and discharged with an opioid prescription will be included.

In accordance to our pragmatic approach, we will exclude only patients with current use of opioids or chronic pain medication for a pre-existing condition or disease (e.g., cancer), because opioid dosage and/or pain mechanisms differ in these circumstances.

Brief summary: Opioids (morphine and morphine-like substances) are often prescribed to patients to manage pain after an emergency department visit. In the past 20 years, opioid prescriptions have risen sharply, accompanied by a significant rise in opioid misuse (e.g., recreational or non-medical use, potentially leading to addiction or overdose). One explanation for this crisis is the availability and easy access of leftover opioid pills in Canadian homes, allowing family members (including children) and friends to take them for reasons other than pain relief.

Canada has no recommendations for the dosage, duration, or quantity of opioids that physicians should prescribe to manage acute pain at home. Physicians are therefore left guessing as to how much to prescribe when a patient with a condition like a fracture or renal colic is discharged from the emergency department. Our preliminary study showed that two-thirds of the pills from the initial opioid prescription to treat acute pain actually remained unused and were therefore available for potential misuse.

The investigators propose to determine how many opioid pills are consumed by patients who suffer from acute pain as they recover at home. The investigators will ask 2,560 patients (from 6 Canadian hospitals) to record their pain medication consumption in a 14-day diary. The investigators will also determine, their pain intensity level, whether or not they had new opioid prescriptions, and health services revisits. In case of missing information, patients will be contacted by phone at 2 weeks. The overall aim is to help emergency department physicians prescribe the right number of pills in order to manage patients' pain and at the same time reduce substantially leftovers available for potential misuse.

Detailed description: Introduction

Prescription opioid overdoses have quadrupled in the last 15 years, and are now the leading cause of accidental death, surpassing motor vehicle accidents. The drastic rise in opioid prescription rates in Canada and the US could be the driving force behind this higher mortality. It was shown that 71% of opioid misusers (i.e., intentional users for nonmedical purposes) received their drugs through the diversion of unused prescribed opioids (transfer of opioids to someone other than the holder of the initial prescription). Emergency department (ED) physicians are among the top opioid prescribers for patients under 40, and there are currently no prospective studies on how many opioid pills should be prescribed to patients discharged from the ED with common pain conditions in order to limit unused pills. Preliminary results from our group revealed that two-thirds of the total prescribed opioids were not consumed and remained available for misuse.

Objectives

The ultimate goal of this research program is to decrease opioid misuse by lowering the quantity of unused medications. The primary objective of this project is to determine the quantity of opioids consumed during the acute pain phase (2 weeks) by ED-discharged patients treated for an acute pain condition. The secondary objectives are to inventory the quantity of opioids prescribed and unused after ED visits, use of co-analgesics, pain intensity, health services revisits during the 2-week follow-up, and chronic pain prevalence at 3 months.

Methods

The investigators propose a multicentre prospective observational cohort study in 2,560 consecutive ED patients recruited from 6 Canadian hospitals. The study will include patients aged ≥18 years, treated for an acute pain condition present for less than 2 weeks (usual acute pain definition), and discharged from the ED with an opioid prescription. Pain at triage and at ED discharged, diagnosis, and complete pain medication prescription will be initially listed. Patients will complete a 14-day electronic diary using the REDCap web-based system to document their daily pain medication consumption, pain intensity, new opioid prescriptions, and health services revisits. Patients will also answer questionnaires at 2 weeks and 3 months for our various secondary objectives. To validate the patient self-report opioid consumption, a randomized subset of patients will come back to the emergency for a follow-up visit and a manual count of the remaining opioids. As mitigation strategies (validated in our pilot study), non-responders to the diary will be contacted by phone at 2 weeks to answered questions summing diary information, and paper versions will be available for patients without Internet access.

Sample size estimation

The sample size was calculated to obtain an accurate estimate of the mean quantity of 5 mg morphine pill equivalent that patients will consume during the first 2 weeks after ED visit for each pain condition (primary objective). Our preliminary study was used to determine the standard deviation of opioids consumed after discharge from ED (SD=16). To estimate the mean 5 mg morphine pill equivalent consumed for each of the five pain conditions (acute back pain, fracture, sprain/contusion, renal colic, and other) with a 95%CI margin of error of 1.5 pills (or \~10% of the SD) with a standard deviation of 16 pills, each diagnostic category requires 440 patients. With the 14% attrition rate observed during our pilot study at two weeks, a total of 2,560 patients will be recruited (512 patients - 72 lost to follow-up = 440 patients per pain condition). Sample size calculations were performed using PASS (Power Analysis \& Sample Size software, version 11.0: NCSS Statistical Software).

Feasibility

The investigators demonstrated the study feasibility in a successful pilot study with 627 patients at our academic ED. Additionally, our project brings together a committed, multidisciplinary research team, and all proposed study sites have collaborated previously on large multicentre studies. Finally, all instruments have been successfully tested, allowing rapid study implementation.

Impact

Our results will determine the quantity of opioids consumed during the acute pain phase (2 weeks) to ED-discharged patients treated for acute pain conditions. Our team members from relevant provincial and national stakeholders and patient associations, our strong evidence, and our extensive knowledge transfer strategy have the potential to impact physicians' opioid prescription practices. Consequently, fewer unused prescription opioids should lead to a substantial decrease in the currently high rate of opioid misuse.

Eligibility criteria: Inclusion Criteria:

* Opioid prescription at discharge
* Acute pain for less than 2 weeks

Exclusion Criteria:

* Language barrier
* Chronic pain under treatment
* Active Neoplasia
* Follow-up impossible / Unable to complete agenda
* Already on opioids

Primary outcomes:
measure: Quantity of opioids consumed during the acute pain phase (2 weeks) following ED discharge for each pain condition
timeFrame: During 14 days
Secondary outcomes:
measure: Quantity of opioids prescribed to ED-discharged patients treated for different acute pain conditions
timeFrame: Baseline
measure: Quantity of opioids to sufficiently supply a given percentage of patients for each pain condition
timeFrame: During 14 days
measure: Quantity of unused opioids
timeFrame: At day 14
measure: Quantity of patients that filled (initial or other) opioid prescriptions
timeFrame: At day 14
measure: Quantity of patients using of coanalgesics or other substances (alcohol, cannabis…) to manage pain
timeFrame: During 14 days
measure: Qualitative evaluation of the participants' reasons for stopping opioid consumption
timeFrame: During 14 days
measure: Incidence and type of medication side effects during the 2-week period
timeFrame: During 14 days
measure: Quantity of patients who revisit health services to obtain new prescription
timeFrame: During 14 days
measure: Quantitive validation of the patients' self-report opioid consumption
timeFrame: At day 14
measure: Group-based trajectory modeling to determine pain intensity trajectory for each pain condition during the acute phase
timeFrame: During 14 days
measure: Evaluate the chronic pain prevalence at 3 months among study participants assessed if certain profiles of pain intensity evolution over the14-day after emergency department (ED) discharge are predictive of chronic pain 3 months later.
timeFrame: 3 months
measure: Assessed if certain profiles of pain intensity evolution over the14-day after emergency department (ED) discharge are predictive of chronic pain 3 months later
timeFrame: 3 months
Other outcomes:
measure: Qualitative evaluation of participant's opioids storage and disposal
timeFrame: At day 14
measure: Evaluate the participants' perception of opioid analgesia (patient, physician, nurse, and pharmacist) with a likert scale type survey
timeFrame: Baseline
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Montréal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
city: Montréal
country: Canada
facility: Hôpital du Sacré-Coeur de Montréal
state: Quebec
city: Saint-Jérôme
country: Canada
facility: Hôpital régional de Saint-Jérôme
state: Quebec
city: Québec
country: Canada
facility: Hôpital de l'Enfant-Jésus
Study officials:
affiliation: Université de Montréal
name: Raoul Daoust, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Daoust R, Paquet J, Williamson D, Perry JJ, Iseppon M, Castonguay V, Morris J, Cournoyer A. Accuracy of a self-report prescription opioid use diary for patients discharge from the emergency department with acute pain: a multicentre prospective cohort study. BMJ Open. 2022 Oct 28;12(10):e062984. doi: 10.1136/bmjopen-2022-062984.