Condition category
Mental and Behavioural Disorders
Date applied
26/05/2018
Date assigned
17/06/2018
Last edited
12/06/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Canadians are the second highest per-person users of opioids in the world. One of the main contributing factors is the increase in opioid prescriptions in the last 20 years. Furthermore, deaths related to opioids have more than doubled since 1990. Long-term use of opioids has been recorded in up to 35% of trauma patients. Education and counseling interventions show promise in decreasing use in post-surgery and long-term pain patients. However, no successfully proven intervention has been designed yet for trauma patients. The Tapering Opioids Prescription Program in Trauma (TOPP-Trauma) was developed to support patients at risk for long-term use of opioids in order to decrease their consumption after hospital discharge.

Who can participate?
Adult trauma patients who are assessed as at risk of long-term opioid use.

What does the study involve?
Patients in the intervention group will have a teaching session while still in hospital. Then after discharge, they will receive six guidance sessions at 2-week intervals on reducing opioid use gradually.

What are the possible benefits and risks of participating?
This study might help to reduce long-term use of opioids and its associated effects, but we cannot guarantee it. The results gathered will help determine if the tools selected and adapted to provide support and guidance in opioid weaning performs as well as for patients who will receive standard of care (pharmacological prescription and educational pamphlet). TOPP-Trauma is not known to be associated with any adverse events. However, such events will be documented if they emerge throughout the study.

Where is the study run from?
Ciusss-du-Nord-de-l'île-de-Montréal (Hôpital Sacré-Coeur de Montréal)

When is the study starting and how long is it expected to run for?
June 2018 to December 2020

Who is funding the study?
Trauma Association of Canada

Who is the main contact?
Melanie Berube, melanie.berube2@mail.mcgill.ca

Trial website

N/A

Contact information

Type

Scientific

Primary contact

Miss Melanie Berube

ORCID ID

Contact details

5400 Boul Gouin O
Montréal
QC
Montreal
H4J 1C5
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Tapering Opioids Prescription Program for Trauma patients at high risk of chronic consumption (TOPP-Trauma): A pilot randomized controlled trial

Acronym

TOPP-Trauma

Study hypothesis

Although no research hypothesis is generally proposed for a pilot RCT, we believe that patients who will receive TOPP-trauma (experimental group) will consume less opioids than patients who don't receive TOPP-Trauma (control group) at 12 weeks after the beginning of the intervention. Moreover, we hypothesize that more patients in the experimental group will stop consuming opioids at 12 weeks compared with patients in the experimental group. Finally, we expect that the experimental group will have comparable pain intensity and pain interference with activities at 12 weeks in contrast to the control group.

Ethics approval

The research proposal was submitted to the CIUSSS du Nord-de-l'Île-de-Montreal ethics board on May 7th, 2018.

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

No participant information sheet available

Condition

Opioid dependence in trauma patients

Intervention

Two groups will be studied in parallel and followed according to the study time points. In addition to usual care, the control group will receive a pamphlet, while the experimental group will receive a pamphlet and follow TOPP-Trauma.

Participants in the experimental group will receive TOPP-Trauma as well as standard pain management interventions. The biopsychological model of pain, empirical data from previously tested opioid tapering interventions and clinical knowledge on the trauma patient population guided the development of TOPP-Trauma; more specifically components, activities, dosages, and delivery modes. The TOPP-Trauma combines a 20-minute teaching session to be provided the week prior to hospital discharge and a maximum of six 15-minute opioid tapering guidance sessions given every 2 weeks. An expert trauma nurse or the trauma service pharmacist will provide the teaching and guidance sessions. The teaching session will be based on the information included in the educational pamphlet that will also be distributed to the control group. Guidance sessions will be initiated one week after hospital discharge and will be stopped before the maximum planned sessions if patients cease opioid use. An Intervention Feasibility Evaluation Logbook (Appendix B) will be used to guide expert trauma nurse and the trauma pharmacist to provide the guidance sessions. The treating surgeon will be informed on the participant opioid tapering plan during their appointment at the outpatient clinic to ensure treatment consistency. The number and frequency of guidance sessions was determined based on the established timing for transitioning towards chronic consumption of opioids (i.e. 3 months). Considering that trauma patients admitted in the trauma center where the study will be conducted come from various regions, guidance sessions will be provided individually over the phone or face-to-face at the outpatient clinic at the time of follow-up appointment with the treating surgeon.

The randomization sequence will be generated by a coordinating center to keep researchers blinded. A computerized random-number generator will produce the sequence. Randomization will be undertaken in permuted blocks of 4 to decrease allocation predictability. Tickets will be placed in sealed, opaque, sequentially numbered envelopes to randomize study participants to either the control or experimental group. Participants will be randomized after obtaining baseline data.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Morphine equivalent dose (MED) per day at 12 weeks after the beginning of TOPP-Trauma.

Secondary outcome measures

1. MED per day at 6 weeks after the beginning of TOPP-Trauma, since some study findings indicated that a great proportion of trauma do not use opioids beyond this period of time
2. Pain intensity and pain interference with activities assessed using the Brief Pain Inventory at baseline and 6 and 12 weeks after the start of the intervention

Overall trial start date

01/03/2018

Overall trial end date

01/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 years and over
2. Able to read and speak French or English
3. ≥2 doses/day of opioids during the 3 previous days
4. At least one risk factor for chronic consumption. The risks factors for chronic consumption are:
4.1. Annual income ≤$40,000
4.2. Injury Severity Score (ISS) ≥12
4.3. Pre-injury use of opioids or substance abuse (Alcohol, Smoking and Substance Involvement Screening Test–version 3.0 ≥11 for alcohol and ≥4 for other substance)
4.4. Anxiety or depression symptoms (scores ≥11 on the Hospital Anxiety and Depression Scale)
4.5. Pain catastrophizing score ≥20 on the Pain Catastrophizing Scale
4.6. Pain self-efficacy score <17 on the Pain Self-Efficacy Questionnaire
5. Discharged directly from hospital to home

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

Cognitive impairment (i.e. moderate-severe traumatic brain injury (TBI) – Glasgow Coma Scale score <13/15, dementia and severe psychiatric disorder) affecting the capacity to participate in the study. In some equivocal situations, where the cognitive function improved during hospitalization, the neurospychologist will provide an evaluation stipulating that patients with moderate TBI can participate in this study.

Recruitment start date

15/06/2018

Recruitment end date

31/08/2020

Locations

Countries of recruitment

Canada

Trial participating centre

Ciusss-du-Nord-de-l'île-de-Montréal (Hôpital Sacré-Coeur de Montréal)
5400 Boul Gouin O, Montréal, QC
Montreal
H4J 1C5
Canada

Sponsor information

Organisation

Trauma Association of Canada

Sponsor details

Kate Mahon (Executive Director)
Trauma Association of Canada
PO Box 8862
Halifax
NS
Halifax
B3K 5M5
Canada

Sponsor type

Other

Website

https://www.traumacanada.org

Funders

Funder type

Not defined

Funder name

Trauma Association of Canada

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The research proposal will be submitted to the Canadian Journal of Surgery in June 2018. The results will be submitted for publication in 2019 or 2020 depending of the feasibility of patient recruitment.

IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

31/12/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes