Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000685617
Ethics application status
Approved
Date submitted
2/06/2023
Date registered
26/06/2023
Date last updated
16/04/2024
Date data sharing statement initially provided
26/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Responsible Opioid Use for Hip and Knee Arthroplasty (Opioidhalt II) Study
Scientific title
RESPONSIBLE PRE-OPERATIVE OPIOID USE FOR HIP AND KNEE ARTHROPLASTY II (OPIOIDHALT II) STUDY: Opioid tapering in patients prior to hip or knee arthroplasty.
Secondary ID [1] 309237 0
None
Universal Trial Number (UTN)
Trial acronym
OPIOIDHALT II
Linked study record
ACTRN12621000919819, OpiodHALT Pilot study

Health condition
Health condition(s) or problem(s) studied:
opioid use
 329392 0
total knee arthroplasty
 329393 0
total hip arthroplasty 329394 0
Condition category
Condition code
Anaesthesiology 326338 326338 0 0
Pain management
Public Health 327169 327169 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a randomised controlled to establish the efficacy of an intervention on the preoperative reduction of opioid use before elective Total Hip Arthoplasty or Total Knee Arthoplasty compared to usual practice. Participants will be randomised in a 1:1 ratio to: (1) pharmacist tele-health consultation to individualise pain management and opioid tapering plans; or (2) usual care (Control).
Intervention - Pharmacist-led opioid tapering:
Pain management and opioid tapering training will be provided to pharmacists using an existing training package developed for the pilot RCT. The pharmacists will be trained at least a month before the commencement of the intervention. The anticipated duration of the training is self-directed learning of the learning package (which involves existing pain management resources developed from the OpioidHALT Pilot Study) which will last two to five hours in total. There will also be one to three one-hour training sessions. The mode of administration will be online reading of learning material and Zoom. Training will be provided by senior members of the research team who were involved in the OpioidHALT Pilot Study.
Prior to opioid tapering, a pharmacist will contact the participant’s GP to outline the intervention and address any concerns. The pharmacist will engage in shared decision-making with participants to develop an individualised biopsychosocial pain management plan and an opioid weaning plan. The opioid weaning plan will be from NPS Medicinewise and involves an individualised tapering rate of 10-25% of the original opioid dose per week for patients on opioids for less than three months. Patients taking opioids for three or more months will taper opioids at a rate of 10-25% of the original opioid dose per month. The pharmacist will engage in shared decision-making with the patient to decide upon a reduced opioid dose. Patients will receive follow-up appointments with the pharmacist one week after each opioid dose reduction. The endpoint of opioid tapering will be decided using shared decision-making and open communication with participants.
Participants will receive the intervention for approximately 3 months. Each session will be approximately 30 minutes of consultation held weekly. The opioid tapering target of greater than or equal to 50% of the baseline opioid dose was chosen as this has been shown to improve post-surgical outcomes similar to opioid-naïve participants. If this target is reached before the participant is due for surgery, the participant will continue to be followed up until the day of surgery. The intervention employs key components of the Behaviour Change Wheel to target participant behaviour change by leveraging (i) capability (by improving participants’ confidence and knowledge of effective pain management and opioid tapering), (ii) opportunity (by providing an individualised pain management and opioid tapering service that is more accessible than traditional pain clinics) and (iii) motivation (by engaging with participants through shared decision making and encouraging active involvement in participants’ own health).
The frequency of the intervention will be up to weekly as described above. Patients will receive the intervention for approximately 3 months. If the intervention ends before the patient is due for surgery, the patient will continue to be followed up by the study pharmacist until the day of surgery. Interventions will be delivered via telehealth (e.g., Zoom) or via a telephone call.
The adherence to the intervention will be monitored by asking participants to fill out a Pain Management Plan and Opioid Tapering Plan that was developed for the OpioidHALT Pilot Study. We will also collect data on medication use before patients undergo surgery by telephone call with participants and using participant pharmacy records.



Intervention code [1] 325678 0
Behaviour
Comparator / control treatment
Control - Usual care:
Usual care will serve as the control condition. Participants will continue to be contacted and reviewed by health professionals during preadmission clinics as required while awaiting Arthroplasty. Health professionals may provide patients with non-pharmacological pain management advice.
Control group
Active

Outcomes
Primary outcome [1] 334190 0
The number of patients recruited per month assessed by audit of study records
Timepoint [1] 334190 0
At trial conclusion
Primary outcome [2] 334191 0
The proportion of eligible patients recruited per month assessed by audit of study records
Timepoint [2] 334191 0
At trial conclusion
Primary outcome [3] 334192 0
Retention of participants in both arms of the study assessed by audit of study records.
Timepoint [3] 334192 0
At trial conclusion
Secondary outcome [1] 419788 0
Pain self-efficacy (Pain Self-Efficacy Questionnaire)
Timepoint [1] 419788 0
Baseline (approximately 3 months prior to surgery) and 1 to 3 days before surgery
Secondary outcome [2] 419789 0
Opioid-related adverse events (self-report via telephone call)
Timepoint [2] 419789 0
Baseline (approximately 3 months prior to surgery), 1 to 3 days before surgery and 90 days after hospital discharge.
Secondary outcome [3] 419790 0
90-day hospital readmission rate assessed by collecting data from patient medical records.
Timepoint [3] 419790 0
90 days after hospital discharge
Secondary outcome [4] 419791 0
Pain, stiffness and function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC] score) - this will be assessed as a composite outcome
Timepoint [4] 419791 0
Baseline (approximately 3 months prior to surgery), 1 to 3 days before surgery, and 90 days after hospital discharge.
Secondary outcome [5] 419792 0
Length of hospital stay (hospital records)
Timepoint [5] 419792 0
90 days after surgery
Secondary outcome [6] 422879 0
Opioid withdrawal symptoms (Short Opioid Withdrawal Scale)
Timepoint [6] 422879 0
Baseline (approximately 3 months prior to surgery) and 1 to 3 days before surgery
Secondary outcome [7] 422880 0
Health-related quality of life (EQ-5D-5L tool)
Timepoint [7] 422880 0
Baseline (approximately 3 months prior to surgery), 1 to 3 days before surgery and 90 days after hospital discharge.
Secondary outcome [8] 422881 0
Non-opioid analgesic use (self-report via telephone call)
Timepoint [8] 422881 0
Baseline (approximately 3 months prior to surgery), 1 to 3 days before surgery and 90 days after hospital discharge.
Secondary outcome [9] 422882 0
Discharge destination (patient report and hospital records to nursing staff)
Timepoint [9] 422882 0
90 days after surgery
Secondary outcome [10] 422883 0
Substance use (Australian Treatment Outcomes Profile)
Timepoint [10] 422883 0
Baseline (approximately 3 months prior to surgery), 1 to 3 days before surgery and 90 days after hospital discharge.
Secondary outcome [11] 422884 0
30-day hospital readmission rate (patient report and hospital records to nursing staff)
Timepoint [11] 422884 0
90 days after surgery
Secondary outcome [12] 422885 0
Analgesic and benzodiazepine use (self-report via telephone call+ SafeScript) - this will be assessed as a composite outcome
Timepoint [12] 422885 0
Baseline (approximately 3 months prior to surgery), 1 to 3 days before surgery and 90 days after hospital discharge.
Secondary outcome [13] 423107 0
surgical complications (self-report via telephone call)
Timepoint [13] 423107 0
90 days after hospital discharge.
Secondary outcome [14] 423108 0
Cost-effectiveness analysis
A within-trial cost-effectiveness analysis will be conducted from the health system perspective, accounting for intervention costs (pharmacist time and training), cost offsets from any change in health resources utilisation (length of stay in hospital, complications acutely and up to 3 months), and effectiveness (opioid use).
Timepoint [14] 423108 0
3 months postoperatively

Eligibility
Key inclusion criteria
Randomized Study:
Inclusion criteria: Aged 18 years or older, undergoing elective THA or TKA for osteoarthritis, speaks and reads English, uses prescription opioid analgesics daily, and has access to the internet or telephone.
Criteria for GP review: Psychological distress and suicidality will be screened using the 6-item Kessler Psychological Distress Scale (K6) and the 3-item Patient Safety Screener (PSS). Patients with: (i) a K6 score of 19 or greater AND PSS criteria 1 (feeling down, depressed, or hopeless over past two weeks); OR (ii) PSS criteria 2 (thoughts of killing yourself over past two weeks); OR (iii) PSS criteria 3 (ever attempted to kill yourself) AND report suicidality in the past 6 months will be referred to their GP to confirm whether participation in the trial is appropriate.
Minimum age
18 Years
Maximum age
105 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: Patients undergoing planned repeat surgeries (same procedure within 6 months), using opioids for cancer, palliative care, or substance use disorder, previously or already undergoing an opioid tapering program or active medication review, and major cognitive impairment.


Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
One study investigator will contact the central randomization service by telephone each time a patient is to be randomized to allow allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized in a 1:1 ratio in permuted blocks of 2 and 4 to (1) pharmacist telehealth consultation to individualize pain management and opioid tapering plans; or (2) usual care. Randomization will be conducted using a centralized randomization service to ensure allocation concealment. Randomization will be stratified by hospital site to allow for random and systematic differences in acute care practices between sites.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Post-intervention outcomes will be compared using intention-to-treat principles. A generalized estimating equation model will be used to model persistent opioid use from 1-3 days pre-surgery to 3 months post-surgery. A multilevel model will be used to model the key secondary outcome (WOMAC) from baseline to 3 months after surgery. For each model, the participant will be specified as level 2 (ie. clustering by the participant), and the individual timepoint as level 1. Independent variables in the model will be group, time, and an interaction between group and time. The primary and key outcome measures will be compared at the 3-month after-surgery timepoint based on the models. Covariates between groups will be examined for potential imbalance and will be adjusted if necessary. Sensitivity analyses using per-protocol (defined as achieving a tapering dose > 50%) and as-treated (tapered 50% or more regardless of group allocation) analyses will also be conducted.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/04/2024
Actual
Date of last participant enrolment
Anticipated
17/02/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
314
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,TAS

Funding & Sponsors
Funding source category [1] 314143 0
Government body
Name [1] 314143 0
The Commonwealth of Australia represented by the Department of Health and Aged Care (Funding Agreement managed by The Department of Industry, Science and Resources)
Country [1] 314143 0
Australia
Primary sponsor type
Government body
Name
The Commonwealth of Australia represented by the Department of Health and Aged Care (Funding Agreement managed by The Department of Industry, Science and Resources)
Address
National Office: Industry House, 10 Binara Street, Canberra (in the CBD)
Postal address: Department of Industry, Science and Resources, GPO Box 2013, Canberra, ACT, 2601
Country
Australia
Secondary sponsor category [1] 315194 0
University
Name [1] 315194 0
The University of Sydney
Address [1] 315194 0
Camperdown NSW 2006
Country [1] 315194 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312639 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 312639 0
South Western Sydney Local Health District Executive Office
Liverpool Hospital Eastern Campus
Scrivener Street
LIVERPOOL NSW 2170
Ethics committee country [1] 312639 0
Australia
Date submitted for ethics approval [1] 312639 0
02/06/2023
Approval date [1] 312639 0
04/07/2023
Ethics approval number [1] 312639 0

Summary
Brief summary
Although we like to think that morphine-type (opioid) drugs are strong painkillers that work for all types of pain, the story turns out to be more complicated. Opioids are commonly prescribed for the pain of hip and knee osteoarthritis where there is little evidence to support their effectiveness, yet there is evidence that they increase harms. Despite this risk, an estimated 24 to 39% of patients undergoing knee or hip arthroplasty use opioids regularly while waiting for surgery. Not only is pre-surgery opioid use not very effective for the pain of severe arthritis, but research has shown that regular use is related to worse pain at the time of the operation, more side effects, longer hospital stays and more complications after discharge from hospital compared to patients who don’t use opioids regularly before surgery.
Hip and knee replacements are among the most common elective surgeries performed in Australia, with approximately 100,000 hip or knee replacements performed in 2019. This means approximately 30,000 people annually potentially have their joint replacement outcomes undermined by opioid use.
The proposed pilot study aims to reduce these opioid-related harms by measuring whether patients are willing and able to reduce their opioid medication by at least 50% while they are on the waiting list for elective hip or knee replacement. Those patients who agree to participate will be randomized to either a usual waiting list experience or to have a pharmacist work with their General Practitioner to reduce their opioid dose very slowly. Most patients find that their pain does not increase as the doses reduce if tapering is slow and performed in partnership with the patient. Further, individualized tapering supports the patient, provides them with information relevant to their circumstances, and allows them control of the weaning phases. After the patient and pharmacist come to an agreed opioid tapering plan, an Anaesthetist will review this plan to ensure its safety and effectiveness. Whilst the aim is to measure the feasibility of a 50% taper, the patient will decide the point at which they cease to taper. Patients will receive follow-up appointments with the pharmacist one week after each opioid dose reduction.
Patients already seeing a pain specialist or undergoing opioid tapering will be invited to join an observational group.
This research will be performed at both metropolitan and regional teaching hospitals in NSW, in recognition of the increased community use of, and harms from, opioids in regional areas.
Patients who present for surgery while taking regular opioids not only have poorer outcomes but also pose a challenge for anesthetists and pain management teams. Thus, the proposed research has the potential to improve the perioperative experience for both the patients and their medical teams.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125382 0
Dr Jonathan Penm
Address 125382 0
N371, Pharmacy, and Bank Building A15
The University of Sydney, NSW, 2006
Australia
Country 125382 0
Australia
Phone 125382 0
+61 2 8627 5806
Fax 125382 0
+61 2 9351 4391
Email 125382 0
jonathan.penm@sydney.edu.au
Contact person for public queries
Name 125383 0
Dr Jonathan Penm
Address 125383 0
N371, Pharmacy, and Bank Building A15
The University of Sydney, NSW, 2006
Australia
Country 125383 0
Australia
Phone 125383 0
+61 2 8627 5806
Fax 125383 0
+61 2 9351 4391
Email 125383 0
jonathan.penm@sydney.edu.au
Contact person for scientific queries
Name 125384 0
Dr Jonathan Penm
Address 125384 0
N371, Pharmacy, and Bank Building A15
The University of Sydney, NSW, 2006
Australia
Country 125384 0
Australia
Phone 125384 0
+61 2 8627 5806
Fax 125384 0
+61 2 9351 4391
Email 125384 0
jonathan.penm@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18614Study protocol    385581-(Uploaded-18-06-2023-21-38-30)-Study-related document.docx



Results publications and other study-related documents

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