Reducing Opioid Use for Chronic Pain Patients Following Surgery
NCT ID: NCT03675386
Last Updated: 2024-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
210 participants
INTERVENTIONAL
2018-09-24
2024-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Karim Ladha, MD
Role: PRINCIPAL_INVESTIGATOR
Toronto General Hospital, University Health Network
Hance Clarke, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Toronto General Hospital, University Health Network
Elaheh Adly, MD
Role: PRINCIPAL_INVESTIGATOR
Hamilton Health Sciences Centre
Paul Tumber, MD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Anton Marinov, MD
Role: PRINCIPAL_INVESTIGATOR
Rouge Valley Medical Centre
Melanie Toman, MD
Role: PRINCIPAL_INVESTIGATOR
Thunder Bay Reginal Health Sciences Centre
Yuvaraj Kotteeswaran, MD
Role: PRINCIPAL_INVESTIGATOR
Thunder Bay Reginal Health Sciences Centre
Duminda Wijeysundera, MD
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Locations
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Toronto General Hospital- University Health Network
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Fletcher D, Martinez V. Opioid-induced hyperalgesia in patients after surgery: a systematic review and a meta-analysis. Br J Anaesth. 2014 Jun;112(6):991-1004. doi: 10.1093/bja/aeu137.
Savage SR. Long-term opioid therapy: assessment of consequences and risks. J Pain Symptom Manage. 1996 May;11(5):274-86. doi: 10.1016/0885-3924(95)00202-2.
Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, Dana T, Bougatsos C, Deyo RA. The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. 2015 Feb 17;162(4):276-86. doi: 10.7326/M14-2559.
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Katz J, Weinrib A, Fashler SR, Katznelzon R, Shah BR, Ladak SS, Jiang J, Li Q, McMillan K, Santa Mina D, Wentlandt K, McRae K, Tamir D, Lyn S, de Perrot M, Rao V, Grant D, Roche-Nagle G, Cleary SP, Hofer SO, Gilbert R, Wijeysundera D, Ritvo P, Janmohamed T, O'Leary G, Clarke H. The Toronto General Hospital Transitional Pain Service: development and implementation of a multidisciplinary program to prevent chronic postsurgical pain. J Pain Res. 2015 Oct 12;8:695-702. doi: 10.2147/JPR.S91924. eCollection 2015.
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Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21. doi: 10.1016/j.jpain.2007.09.005. Epub 2007 Dec 11.
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Other Identifiers
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18-5207
Identifier Type: -
Identifier Source: org_study_id
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