Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04902547 |
| Other study ID # |
HS23962 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2021 |
| Est. completion date |
January 2023 |
Study information
| Verified date |
May 2022 |
| Source |
University of Manitoba |
| Contact |
Dana A Turcotte, PhD |
| Phone |
204-272-3170 |
| Email |
dana.turcotte[@]umanitoba.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Chronic pain management is complex, with healthcare providers historically relying on
prescribing opioid medications such as morphine. Although opioids may partially improve pain,
there are risks associated with them as well, including pain worsening, side effects,
addiction and overdose. It is now understood that the management of chronic pain is more
effective when multiple healthcare team members work together and incorporate multiple
strategies instead of focusing solely on medications. An example of an effective, non-drug
strategy for pain is a service offered by clinical psychologists called "Acceptance and
Commitment Therapy" - or ACT - which empowers individuals, to implement alternative ways of
thinking about and reacting to pain and its effect on their lives.
Canada has responded to the opioid overdose crisis with new guidelines that encourage
physicians and those suffering from chronic pain to aim for lower opioid doses whenever
possible, a process often referred to as "tapering." Unsurprisingly, tapering opioids is
often difficult for patients to consider, primarily due to misconceptions that it will cause
more harm than good.
This project aims to address these misconceptions by developing and offering an all-day
educational workshop for patients, co-presented by a healthcare team (clinical psychologists,
pharmacists and physicians), to provide in-depth information on opioid related risks and
misconceptions, as well as a large component focusing on ACT training. Investigators then
want to see if these sessions change individual attitudes towards opioid tapering and if it
improves willingness and ability to successfully reduce opioid doses to a safer level.
Description:
Study Objectives:
1. To evaluate the impact of a patient-centered, multidisciplinary opioid tapering program
on overall opioid consumption in individuals with chronic pain on long-term opioid
therapy.
2. To implement opioid patient education workshops to be used in conjunction with the
opioid tapering program and evaluate their preliminary feasibility and overall patient
acceptance.
As Canada continues to witness a growing opioid crisis, the role of non-opioid medications
and non-pharmacological strategies for pain, including behavioral treatments, is becoming
more apparent. There is a great need to develop multidisciplinary clinical programs to assist
individuals on long term opioid therapy to safely and effectively taper to safer doses of
these potentially harmful medications. The use of nonpharmacological modalities will be
integral to this process.
All patients enrolled in this project will be given the opportunity to take part in an
informed and targeted multidisciplinary opioid tapering program (MTP). As well, half of the
study population will be randomly assigned to also take part in a comprehensive opioid
education and chronic pain workshop (Patient Education Workshop; PEW).
Abbreviated Methodology:
Individuals on LTOT at recruitment sites will be informed about the project by a member of
their care team and those who show interest will be contacted and screened based on
inclusion/exclusion criteria. Those who meet these criteria and consent to participate will
be randomized to either the PEW + MTP cohort or the MTP only cohort. Depending on
randomization, patients will then be invited to first attend a PEW or to attend a care visit
to begin their tapering program. Participants completing the workshop will then begin the
same tapering program at the MTP only cohort.
Multidisciplinary Tapering Program: Participants who have completed the Informed Consent Form
("MTP + PEW" and "MTP only" cohorts) will be included in the MTP, which will be conducted in
collaboration with the patient's referring physician. All referring physicians from
recruitment sites will be made aware of their role requirements in this study should their
patients continue on to the MTP phase. Tapering programs will be individualized for all
patients based on their current dose of opioid and clinical picture, and tapering planning
will be co-managed by Drs. Amadeo and Turcotte, with the implementation and monitoring
assistance of Pain Clinic nurses and Karin Ens (Clinical Pharmacist - ACCESS Winnipeg West).
All participants will be asked to complete a battery of self-report measures of pain
disability, pain, depression, anxiety, quality of life, pain acceptance, and valued living
prior to the initiation of their tapering program (Baseline Visit) and again at 3-, 6-, and
12-month follow-up periods. Follow up has been identified as a crucial component of the MTP
and will be managed by the clinical study team and clearly outlined in the detailed taper
plan provided to referring physicians. Tapering plans and approaches may be changed (slowed,
increased, halted etc.) based on results of this follow up at the discretion of study
clinicians. Any changes/updates discussed with participants will be communicated to the
referring physician with updated prescription or schedule changes. Like the tapering plan,
the follow-up will be flexible and will depend on the patient's response to reductions and
subsequent rate of taper. Follow up will include a combination of in-person and phone visits.
Patient Education Workshops: PEWs will be held as a full day session (approximately 9:30am to
3:30pm) and offerings will alternate between weekday and Saturday options to ensure
flexibility for participants. Sessions will be offered monthly, or more often if the demand
exists. The PEWs have been developed through a highly collaborative and interprofessional
process and include some adaptations of previous work (used with permission) in order to
create a session that is multidisciplinary, patient-centred and applicable to various forms
of CNCP. The comprehensive workshops will include a combination of didactic and interactive
content on general pain and opioid education (1 hour workshop session to be co-presented by
Drs Ryan Amadeo and Dana Turcotte, and Karin Ens) along with significant psychological
content (co-presented by Drs Brigitte Sabourin and Gregg Tkachuk) making up the remainder of
the day-long workshop. Content presented in PEWs will include opioid-related risks,
identifying motivation for (or barriers to) tapering, goal setting, pain self-management,
sleep hygiene and comprehensive focus on ACT and rethinking pain. During the
interprofessionally co-facilitated sessions, participants will be provided with workbooks
that will contain session specific content as well as take-home activities and information
for their own use.
Study Significance: The project will develop educational material aimed at furthering the
understanding of both appropriate and inappropriate opioid prescribing in CNCP. This material
will be available for consumption, beyond the project, with the knowledge users described.
This will be undertaken at academic conferences, as well as at administrative gatherings in
both academic and clinical settings. The knowledge created from this project, both in the
program undertaken as well as in the collection and analysis of the endpoints outline, will
allow for improved dialogue at all levels of health care. Both in the care of individual
patients and in the public health approach to LTOT and opioid weaning, there will be improved
understanding and process that will be accessible in broader primary care environments.
