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Trial registered on ANZCTR


Registration number
ACTRN12618000588291
Ethics application status
Approved
Date submitted
23/03/2018
Date registered
17/04/2018
Date last updated
31/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the effectiveness and feasibility of RADAR (Reducing Analgesic Drugs and Re-engaging) opioid tapering group program – Pilot Study
Scientific title
Examining the effectiveness and feasibility of RADAR (Reducing Analgesic Drugs and Re-engaging) opioid tapering group program – Pilot Study
Secondary ID [1] 294439 0
none
Universal Trial Number (UTN)
U1111-1211-3305
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opioid Analgesics 307187 0
Persistent Pain 307188 0
Condition category
Condition code
Musculoskeletal 306300 306300 0 0
Other muscular and skeletal disorders
Anaesthesiology 306356 306356 0 0
Pain management
Mental Health 306357 306357 0 0
Addiction
Neurological 306358 306358 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will conduct a pragmatic mixed methods research project where data collection for both the quantitative and qualitative parts will be carried out in parallel. For the quantitative part of the study, we will conduct a parallel group intervention study. For the qualitative part, we will conduct in-depth interviews of study participants selected purposively. Thus, a subset of client volunteers participating in the quantitative part of the study will also take part in the qualitative assessment.

The study participants will belong to the following three groups based on their self-selection.
Group 1; clients attending a practitioner supported group opioid reduction programme; RADAR (Reducing Analgesic Drugs and Re-engaging)
Group 2; Individual pharmacist support or
Group 3; GP care.


Participant selection will be pragmatic, as this is a pilot study with the aim of determining the feasibility, acceptability and effectiveness of RADAR. This will allow us to determine a priori sample sizes that will allow a future study to be adequately powered.

All patients referred to NQPPMS first attend our introductory pain education program. The introductory programme consists of an initial 90 minute education session on pain neurophysiology and pain management techniques in a group of 10 - 20 patients and a second "Screen and Skills" 2 hour exercise, education and mobility assessment group of up to 10 patients. These are delivered by medical and allied health staff at the Ross river Road clinic as well as at outreach clinics in Cairns, Mackay and Mount Isa.
All clients referred to our pain service on an OMEDD greater than 60mg will be seen by a pain specialist for a routine 1 hour NQPPMS new patient appointment,
The pain specialist will make a recommendation to the client’s GP for a reduction in opioid, including a tapering plan to limit withdrawal symptoms and seek their consent to enrol in the research project either in Group 1 RADAR, Group 2; Individual pharmacist support or Group 3; GP care.

Patients with a history of aberrant drug use may be referred to ATODS, according to clinicians judgement and patient wishes.

For patients selecting the RADAR option, NQPPMS administration staff will invite 6-10 participants per group to attend three 90 minute sessions as follows
Session 1; Motivational interviewing, discussion around hopes and expectations to elicit commitment to tapering Education about:
1) the limited evidence of the long term efficacy of opioids in chronic non-cancer pain
2) risks and side-effects associated with chronic opioid therapy (COT)
3) possible opioid withdrawal symptoms and ways to manage these
Determine OMEDD
EQ5D5L
Session 2; ( 2 weeks after session 1)
Introduction to basic withdrawal management skills including relaxation, distraction, activity scheduling, mindfulness and thought management. Agree plan for opioid reduction to be communicated with GP.
Session 3; (6 weeks after session1)
Sleep management, Review of progress, Provide support, Group discussion encouraged
Determine OMEDD
3 month review 90mins
Review of progress, Trouble-shooting, Determine OMEDD EQ5D5L
Our pharmacist will liaise with patients' GP's to verify OMEDD doses.
To monitor adherence to the treatment intervention, patients will record their opioid doses and strategies they can use to manage withdrawal symptoms and pain in their diary "My Opioid Reduction Plan." Page 1 allows patients to record dose, withdrawal symptoms and improvements noted. Page 2 records strategies that patients have found useful.
Intervention code [1] 300730 0
Rehabilitation
Intervention code [2] 300771 0
Prevention
Comparator / control treatment
Group 2; patients who receive individual telephone support from the pharmacist; and

Group 3; clients who do not wish to participate in either group or individual support; will receive normal medical care via GP with advice via a letter from the Pain Specialist stating that the pain service does not endorse the use of high dose opioids for persistent pain and recommending to their GP to taper the opioid/s.
Control group
Active

Outcomes
Primary outcome [1] 305304 0
Change in Oral morphine equivalent daily dose
OMEDD is calculated using the Faculty of Pain Medicine opioid convertor http://www.opioidcalculator.com.au/opioidsource.html and the patients' report verified with their GP
Timepoint [1] 305304 0
3 months, 6 months and 1 year after starting the RADAR programme or after entering the trial for Groups 2 and 3.
Secondary outcome [1] 345060 0
Feasibilty and acceptability will be assessed with an evaluation questionnaire, designed for the study, after session 3. This is a composite outcome.
Timepoint [1] 345060 0
This will be assessed for Group 1 at end session 3
Secondary outcome [2] 345061 0
Other data recorded will be attendance at sessions and follow ups using an attendance register.
Timepoint [2] 345061 0
at enrolment, and at follow up appointments at 3, 6, and 12 months
Secondary outcome [3] 345569 0
Patients will keep a diary of their prescription, withdrawal symptoms and the management techniques they have used.
Timepoint [3] 345569 0
3 and 6 months and at one year
Secondary outcome [4] 345570 0
EQ5D-5L
Timepoint [4] 345570 0
At enrolment, 3-month and 6 month follow-up and at 1 year

Eligibility
Key inclusion criteria
Clients with persistent pain referred to the NQPPMS, on opioid medication/s (OMEDD above 60mg/day).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active drug addiction
cognitive impairment
under 18

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
We will conduct a pragmatic mixed methods research project where data collection for both the quantitative and qualitative parts will be carried out in parallel. For the quantitative part of the study, we will conduct a parallel group intervention study. For the qualitative part, we will conduct in-depth interviews of study participants selected purposively. Thus, a subset of client volunteers participating in the quantitative part of the study will also take part in the qualitative assessment.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A priori calculations of patient outcomes will allow determination of power calculations to inform sample sizes for future research. We will also collect qualitative data on patient experience, to supplement the quantitative outcomes. This will be gathered by a Research Assistant in person and by telephone. We will conduct in-depth interviews of at least one participant in each group selected purposively.

Data analysis plan
Baseline data analyses will be descriptive in nature in order to obtain an understanding of who is participating in each of the three treatment groups relative to this study. Inferential statistics will be run after data collection is completed, with mixed factorial analyses examining the differences in patient outcomes across groups and over time. All analyses will be conducted using SPSS v24, with significance determined at the 0.05 level.

The qualitative interviews will be audio-recorded, which will then be transcribed by professional transcribers. We will use NVivo software (https://www.qsrinternational.com/nvivo/home) for management and analysis of the qualitative data. We will look for themes emerging from the in-depth interviews. We will also identify quotes elucidating the insiders’ view regarding opioid tapering and participation in the RADAR programmes or usual care.

We will integrate the findings from the quantitative and qualitative data while writing the results.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2018
Actual
Date of last participant enrolment
Anticipated
1/08/2019
Actual
Date of last data collection
Anticipated
10/10/2019
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 10473 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 22186 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 299068 0
Hospital
Name [1] 299068 0
North Queensland Persistent Pain Management service
Country [1] 299068 0
Australia
Primary sponsor type
Hospital
Name
Townsville Hospital
Address
North Queensland persistent pain management Service,
IMB 14, PO Box 670
Medilink Building 2nd Floor
Townsville Hospital,
100 Angus Smith Drive
Douglas, Townsville QLD 4814
Country
Australia
Secondary sponsor category [1] 298356 0
None
Name [1] 298356 0
Address [1] 298356 0
Country [1] 298356 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300001 0
Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 300001 0
Ethics committee country [1] 300001 0
Australia
Date submitted for ethics approval [1] 300001 0
26/03/2018
Approval date [1] 300001 0
02/05/2018
Ethics approval number [1] 300001 0
HREC/18/QTHS/75

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82226 0
Dr Stephen Gilbert
Address 82226 0
North Queensland Persistent Pain Management Service
Medilink Retail Building 2nd Floor,
Townsville Hospital
100 Angus Smith Drive,
Douglas
Townsville
QLD 4814
IMB 14, PO Box 670 Townsville QLD 4810
Country 82226 0
Australia
Phone 82226 0
+61456777734
Fax 82226 0
Email 82226 0
163gilbert@gmail.com
Contact person for public queries
Name 82227 0
Lily Taylor
Address 82227 0
North Queensland Persistent Pain Management Service
Medilink Retail Building 2nd Floor,
Townsville Hospital
100 Angus Smith Drive,
Douglas
Townsville
QLD 4814
IMB 14, PO Box 670 Townsville QLD 4810
Country 82227 0
Australia
Phone 82227 0
+6144335300
Fax 82227 0
Email 82227 0
lily.taylor@health.qld.gov.au
Contact person for scientific queries
Name 82228 0
Stephen Gilbert
Address 82228 0
North Queensland Persistent Pain Management Service
Medilink Retail Building 2nd Floor,
Townsville Hospital
100 Angus Smith Drive,
Douglas
Townsville
QLD 4814
IMB 14, PO Box 670 Townsville QLD 4810
Country 82228 0
Australia
Phone 82228 0
+61456777734
Fax 82228 0
Email 82228 0
163gilbert@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.