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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

Tracking Information
First Submitted Date  ICMJE May 27, 2015
First Posted Date  ICMJE August 3, 2015
Last Update Posted Date July 8, 2019
Actual Study Start Date  ICMJE May 2015
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Opioid Safety Program in Pain Clinics (Op-Safe):
Official Title  ICMJE Development of an Innovative Opioid Safety Program in Pain Clinics (Op-Safe): A Multi-Centre Project
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Sleep Disordered Breathing
Intervention  ICMJE
  • 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. The questionnaire (POEM) will be tested again after this education on opioid knowledge on the same day.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Pre-education intervention
  • 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.
    Intervention: Other: Post-education intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 30, 2015)
304
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2019
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02513836
Other Study ID Numbers  ICMJE Version: August 17, 2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Frances Chung, University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Health Network, Toronto
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP