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Reducing Opioid Use for Chronic Pain Patients Following Surgery (RECOUP)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675386
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
Patients with chronic pain are often prescribed long-term opioid therapy, despite the serious risks and growing concerns related to opioid use. The Toronto General Hospital has created the world's first multidisciplinary perioperative Transitional Pain Service Program (TPSP) aimed at reducing the incidence and severity of chronic post-surgical pain. The TPSP incorporates a variety of mechanisms and interventions to help patients manage pain and to wean off opioids. The approach consists of: pain education, Acceptance and Commitment Therapy (ACT), and an e-mobile self- management tool to help patients manage chronic pain more effectively. With the TPSP team, the investigators hope to continually assist patients to achieve a balance between the benefits and potential harms of opioid use to promote long-term health and well-being.

Condition or disease Intervention/treatment Phase
Chronic Pain Opioid Use Postoperative Pain Opioid Dependence Other: Interventional Group Other: Control Intervention Not Applicable

Detailed Description:
The proposed research program encompasses several study designs to evaluate the effectiveness and potential implementation of the TPSP across Ontario. The investigators will use three approaches to create a comprehensive evidence-base that can be used to guide future policy and programs related to the management of surgical patients with complex pain and chronic opioid use. In the first phase, a multicenter randomized controlled trial will be conducted in 5 hospital sites to evaluate the effectiveness and potential implementation of TPSP across Ontario. The aim is to recruit a total of 210 patients who are currently taking opioids and also undergoing a surgical intervention (e.g., spinal fusion, hip or knee arthroplasty, major cardiac surgery, hysterectomy, colectomy, cholecystectomy, major vascular surgery, hernia repairs, bariatric surgery, and thyroidectomies). The randomized controlled trial will determine the effectiveness of the TPSP at weaning patients completely off opioids while still managing pain after one year. Secondly, an economic and healthcare utilization analysis of the program via linkage to provincial administrative databases will be carried out to understand the impact the TPSP program has on the healthcare system as a whole. Lastly, a qualitative study will be conducted on both the treatment and control groups. The investigators hope to capture further insight to understand patients and providers experiences of the TPSP intervention.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Ontario Transitional Pain and Opioid Safety Program: Improving Pain and Opioid Practices for Complex Chronic Pain Patients Following Surgery
Actual Study Start Date : September 24, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Active Comparator: Control Group
Patients in the control group will receive standard care, which involves standard postoperative follow-up with their surgeon/primary care provider. Patients will also be sent with a link for an online multimedia tool during each follow-up time point that will provide information and education regarding non-pharmacologic techniques for managing pain. At the end, all patients in the control arm will be invited to join the TPSP after one year of follow-up if they are still taking opioids.
Other: Control Intervention
Patients in the control group will receive standard care, which involves standard postoperative follow-up with their surgeon/primary care provider. Patients will also be sent with a link for an online multimedia tool during each follow-up time point that will provide information and education regarding non-pharmacologic techniques for managing pain. At the end, all patients in the control arm will be invited to join the TPSP after one year of follow-up if they are still taking opioids.

Experimental: Interventional Group
Patients in the interventional group will be given a Transitional Pain Service follow-up appointment at the following postoperative time points (2 to 6 visits for the first two months, and then 1 to 2 visits on a monthly basis until one year). At each visit, patients will meet with the clinical psychologist and chronic pain specialist. Patients in the intervention group will have access to the Manage My Pain (MMP) App. which allows people living with pain to quickly and easily track their pain and function on a daily basis on their smartphones or a browser on their desktop or mobile device. One-page clinical reports will capture the changes in patients' outcome data between clinical visits over the course in time.Clinic visits can be offered in person at the hospital or over telehealth (video conference) based on the patient's preference and clinician's judgment for telehealth suitability.
Other: Interventional Group
The Transitional Pain Service Program enables targeted, mechanism-based, treatment innovations aimed at reducing the incidence and severity of chronic post-surgical pain, disability and enabling safe opioid prescribing/ weaning after major surgery. The investigator's TPSP intervention uses a variety of methods to support patients to manage pain and wean off opioids. This includes physician-guided opioid and non-opioid pharmacotherapy and tapering, and clinical psychology services specializing in pain education, Acceptance & Commitment Therapy (ACT) and e-mobile self-management tools.
Other Name: Transitional Pain Service Program




Primary Outcome Measures :
  1. Portion of patients weaned off opioids [ Time Frame: 1 year ]
    Opioid weaning measured by number of patients successfully weaned off opioids comparing the intervention arm versus control arm

  2. Pain interference [ Time Frame: One year ]
    Brief Pain Inventory Scale is a measure that assess the severity of pain and the impact of pain on daily functions. Measurement of this scale is rated on a 0-10 numerical-rating-scale ( 0= No Pain to 10= Pain as bad as you can imagine or 0= Does not interfere to 10= Completely interferes). The BPI assess pain at its worst, least, average, and now. Pain Severity Score is calculated by adding the scores for questions 2, 3, 4 and 5 and then dividing by 4. This gives a severity score out of 10. Pain Interference Score is calculated by adding the scores for questions 8a, b, c, d, e, f and g and then dividing by 7. This gives an interference score out of 10.



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:

  • ≥ 18 years of age
  • Taking 20 -- 200 mg of preoperative oral morphine equivalents daily
  • Any type of surgical procedure, with the exception of those with palliative intent or organ transplantation
  • Able to read and understand English as posed on the questionnaire surveys prior to informed consent
  • Must be taking opioids for at least one month prior to their operation
  • Must have a personal email address for the set-up of the Manage My Pain (MMP) App or online multimedia tool

Exclusion Criteria:

• Subjects who are undergoing palliative care or procedures, organ transplantation, or prescribed with Methadone/Buprenorphine will be excluded from the trial


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): NCT03675386


Contacts
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Contact: Karim Ladha, MD 416-719-0030 Karim.Ladha@uhn.ca
Contact: Hance Clarke, MD, PhD 416-340-4800 ext 6649 Hance.Clarke@uhn.ca

Locations
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Canada, Ontario
Toronto General Hospital- University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2N2
Contact: Karim Ladha, MD    (416) 719-0030    karim.ladha@uhn.ca   
Contact: Hance Clarke, MD, PhD    (416) 340-4800    hance.clarke@uhn.ca   
Principal Investigator: Elaheh Adly, MD         
Sub-Investigator: Ramesh Zacharias, MD         
Principal Investigator: Anton Marinov, MD         
Sub-Investigator: Pawan Basati, MD         
Principal Investigator: Paul Tumber, MD         
Principal Investigator: Melanie Toman, MD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Karim Ladha, MD Toronto General Hospital, University Health Network
Principal Investigator: Hance Clarke, MD, PhD Toronto General Hospital, University Health Network
Principal Investigator: Elaheh Adly, MD Hamilton Health Sciences Centre
Principal Investigator: Paul Tumber, MD University Health Network, Toronto
Principal Investigator: Anton Marinov, MD Rouge Valley Medical Centre
Principal Investigator: Melanie Toman, MD Thunder Bay Reginal Health Sciences Centre
Publications:

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03675386    
Other Study ID Numbers: 18-5207
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Opioid-Related Disorders
Pain
Neurologic Manifestations
Signs and Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders