Opioid Safety Program in Pain Clinics (Op-Safe):

Development of an Innovative Opioid Safety Program in Pain Clinics (Op-Safe): A Multi-Centre Project

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.

Study Overview

• Status: Completed
• Conditions: Sleep Disordered Breathing
• Intervention / Treatment: Other: Pre-education intervention; Other: Post-education intervention

Detailed Description

This 2-year prospective multi-centre cohort study will be conducted at chronic pain clinics at Women's College Hospital (WCH), Toronto Western Hospital (TWH), Toronto Rehab Institute (TRI), Mount Sinai Hospital (MSH) in Toronto, and St. Joseph's Hospital (SJH) in London, Ont.

The primary aim is to develop and evaluate an Obstructive Sleep Apnea (OSA) screening algorithm against the results of polysomnography.The research assistants will approach all patients visiting chronic pain clinics for eligibility. For recruited patients, a written informed consent will be obtained. All recruited patients will undergo polysomnography at the Toronto Rehab Institute Sleep Lab or Toronto Sleep and Pulmonary Centre. An overnight oximetry by an oximeter will be collected. The sleep physician will review the polysomnography results.

All recruited patients will also complete the STOP-Bang questionnaire and Epworth Sleepiness Scale (ESS). The thyromental distance, Mallampati classification, Friedman staging,neck circumference and oxygen saturation will be measured. Demographic data, co-morbidities, medications and an overnight oximetry will be collected.

Patients will be assessed on their opioid-related knowledge via the Patient Opioid Education Measure (POEM) at the first visit. They will be educated on knowledge of opioids via education sheet, pamphlet and video from ISMP-Canada, and then repeat Patient Opioid Education Measure (POEM) 6- 8 months later during pain clinic follow up visit.

• Study Type: Interventional
• Enrollment (Actual): 304
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, ON N6A 5W9
      • London Health Sciences Centre
    • Toronto, Ontario, Canada, M5S 1B2
      • Women's College Hospital
    • Toronto, Ontario, Canada, M5G 2A2
      • Toronto Rehab Institute (TRI)
    • Toronto, Ontario, Canada, M5T2S8
      • Toronto Western Hopsital, Pain Clinic, Dept. of Anesthesia
    • Toronto, Ontario, Canada
      • Mount Sinai Hospital, Wasser pain management clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

1. Patients with chronic pain secondary to a neoplasm or metastasis as goals of care are different in this patient population.
2. 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.
3. Conditions potentially interfering with comprehension and delivery of informed consent or the educational intervention, such as neurological or psychiatric disorders.
4. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-education intervention; 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.	Other: Pre-education intervention; 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.
Other: Post-education intervention; All 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.	Other: Post-education intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Publications and helpful links

General Publications

• 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.
• Wasef 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.
• Chung 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: May 27, 2015
• First Submitted That Met QC Criteria: July 30, 2015
• First Posted (Estimate): August 3, 2015

Study Record Updates

• Last Update Posted (Actual): July 8, 2019
• Last Update Submitted That Met QC Criteria: July 5, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: opioids
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes
• Other Study ID Numbers: Version: August 17, 2016