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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02513836
Recruitment Status : Completed
First Posted : August 3, 2015
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Frances Chung, University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Sleep Disordered Breathing Other: Pre-education intervention Other: Post-education intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Development of an Innovative Opioid Safety Program in Pain Clinics (Op-Safe): A Multi-Centre Project
Actual Study Start Date : May 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : April 2019

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.

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.




Primary Outcome Measures :
  1. Predictive performance of screening algorithm for sleep disordered breathing [ Time Frame: 30 days ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02513836


Locations
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Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, ON N6A 5W9
Toronto Rehab Institute (TRI)
Toronto, Ontario, Canada, M5G 2A2
Women's College hospital
Toronto, Ontario, Canada, M5S 1B2
Toronto Western Hopsital, Pain Clinic, Dept. of Anesthesia
Toronto, Ontario, Canada, M5T2S8
Mount Sinai Hospital, Wasser pain management clinic
Toronto, Ontario, Canada
Sponsors and Collaborators
University Health Network, Toronto
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Frances Chung, Anesthesiologist, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02513836    
Other Study ID Numbers: Version: August 17, 2016
First Posted: August 3, 2015    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Keywords provided by Dr. Frances Chung, University Health Network, Toronto:
opioids
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases