Opioid Safety Program in Pain Clinics (Op-Safe):
Development of an Innovative Opioid Safety Program in Pain Clinics (Op-Safe): A Multi-Centre Project
1 other identifier
interventional
304
1 country
5
Brief Summary
In this vital study, the investigators will develop an innovative Opioid Safety (Op-Safe) Program for use in pain clinics. The Op-Safe Program consists of two key components: Educating patients with an informative brochure and video developed by the Institute for Safe Medication Practices (ISMP) Canada, and a screening algorithm to identify unrecognized sleep apnea in patients taking opioids for chronic non-cancer pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2015
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 27, 2015
CompletedFirst Posted
Study publicly available on registry
August 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedJuly 8, 2019
July 1, 2019
3.6 years
May 27, 2015
July 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Predictive performance of screening algorithm for sleep disordered breathing
Predictive performance (sensitivity, specificity, positive predictive value, negative predictive value, and the area under receiver operating characteristic \[ROC\] curve) of screening algorithm for sleep disordered breathing. A paired t-test will be used to evaluate the changes in opioid related knowledge.
30 days
Study Arms (2)
Pre-education intervention
EXPERIMENTALAll study participants will be tested with a questionnaire (POEM; Patient Opioids Education Measurement) on their opioid knowledge during 1st visit at the pain clinic.
Post-education intervention
OTHERAll study participants will be educated on opioids via an education sheet, pamphlet and video from the Institute for Safe Medication Practices (ISMP) Canada. They will repeat the questionnaire (POEM) after this education on opioid knowledge on the same day.
Interventions
All study participants will be tested with a questionnaire (POEM; Patient Opioids Education Measurement) on their opioid knowledge during 1st visit at the pain clinic.
All study participants will be educated on opioids via an education sheet, pamphlet and video from the Institute for Safe Medication Practices (ISMP) Canada. The questionnaire (POEM) will be tested again after this education on opioid knowledge on the same day.
Eligibility Criteria
You may qualify if:
- All adult patients (≥18 years old) with cognitive capability to comprehend the educational intervention who are taking opioid medication for \>3 months for non-cancer pain.
You may not qualify if:
- Patients with chronic pain secondary to a neoplasm or metastasis as goals of care are different in this patient population.
- Patients requiring urgent sleep physician referral (within four weeks) due to serious medical conditions or safety critical-occupations according to the 2011 Canadian Thoracic Society (CTS) guidelines\[60\] e.g. unstable ischemic heart disease, recent cerebrovascular disease, congestive heart failure, refractory systemic hypertension, pulmonary hypertension, hypercapnic respiratory failure or pregnancy.
- Conditions potentially interfering with comprehension and delivery of informed consent or the educational intervention, such as neurological or psychiatric disorders.
- Patients with a prior diagnosis of sleep-related breathing disorder within the last 3 years with treatment. Patients who may have had sleep studies 3 or more years earlier may be included, if they have been lost to follow-up by a sleep physician, are not on treatment or are non-compliant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
London Health Sciences Centre
London, Ontario, ON N6A 5W9, Canada
Toronto Rehab Institute (TRI)
Toronto, Ontario, M5G 2A2, Canada
Women's College hospital
Toronto, Ontario, M5S 1B2, Canada
Toronto Western Hopsital, Pain Clinic, Dept. of Anesthesia
Toronto, Ontario, M5T2S8, Canada
Mount Sinai Hospital, Wasser pain management clinic
Toronto, Ontario, Canada
Related Publications (3)
Selvanathan J, Waseem R, Peng P, Wong J, Ryan CM, Chung F. Simple screening model for identifying the risk of sleep apnea in patients on opioids for chronic pain. Reg Anesth Pain Med. 2021 Oct;46(10):886-891. doi: 10.1136/rapm-2020-102388. Epub 2021 Aug 9.
PMID: 34373347DERIVEDWasef S, Mir S, Ryan C, Waseem R, Bellingham G, Kashgari A, Wong J, Chung F. Treatment for patients with sleep apnea on opioids for chronic pain: results of the OpSafe trial. J Clin Sleep Med. 2021 Apr 1;17(4):819-824. doi: 10.5664/jcsm.9064.
PMID: 33382032DERIVEDChung F, Wong J, Bellingham G, Lebovic G, Singh M, Waseem R, Peng P, George CFP, Furlan A, Bhatia A, Clarke H, Juurlink DN, Mamdani MM, Horner R, Orser BA, Ryan CM; Op-Safe Investigators. Predictive factors for sleep apnoea in patients on opioids for chronic pain. BMJ Open Respir Res. 2019 Dec 23;6(1):e000523. doi: 10.1136/bmjresp-2019-000523. eCollection 2019.
PMID: 31908788DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiologist
Study Record Dates
First Submitted
May 27, 2015
First Posted
August 3, 2015
Study Start
May 1, 2015
Primary Completion
December 1, 2018
Study Completion
April 1, 2019
Last Updated
July 8, 2019
Record last verified: 2019-07