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Trial registered on ANZCTR


Registration number
ACTRN12621000919819
Ethics application status
Approved
Date submitted
8/06/2021
Date registered
15/07/2021
Date last updated
7/10/2023
Date data sharing statement initially provided
15/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Responsible opioid use before hip and knee replacement surgery
Scientific title
Feasibility of responsible pre-operative opioid use for Hip and knee ArthropLasTy (OpioidHALT) pilot study
Secondary ID [1] 303894 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
opioid use 321533 0
total knee arthroplasty 321534 0
total hip arthroplasty 321535 0
Condition category
Condition code
Anaesthesiology 319285 319285 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
OpioidHALT:
This will be a randomised controlled pilot study to establish the feasibility and acceptability of an intervention on the preoperative reduction of opioid use before elective THA or TKA 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:
A pharmacist will contact the patient's General Practitioner (GP) by telephone to outline the intervention and address any concerns raised. With the GP’s approval for his/her patient to participate in the trial, the pharmacist will proceed to contact the participant.

Participants will receive tele-health consultations with a Home Medicines Review accredited pharmacist. Pharmacist consultations will be based off the Behaviour Change Wheel for behaviour change interventions. The pharmacist will complete a pain management plan and an opioid weaning plan with the patient. We will use the pain management plan from NPS Medicinewise Australia, which will be tailored to the individual. A pharmacist trained in pain self-management will provide education on the development of pain self-management skills such as participating in physical exercise, learning relaxation techniques and implementing sleep hygiene practices. Necessary referrals to other health care professionals, such as physiotherapists, will be communicated to the patient’s GP to coordinate the patient’s care. The NPS opioid weaning plan will be used 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 rate and end-point of opioid tapering will be guided by the pharmacist but will be patient-led, and individualised for dose, length of use and patient circumstances. The pharmacist will educate the patient on specific steps for the management of potential opioid withdrawal effects or increased pain. For example, if withdrawal effects are experienced, the patient will be instructed to pause tapering their opioid dose. If pain is experienced, the patient will be instructed to employ pain self-management strategies. If these effects persist, the patient will be instructed to increase their opioid dose. If withdrawal effects or pain persist beyond this, the patient will be instructed to see their GP. The completed pain management plan and opioid tapering plan will be reviewed by an Anaesthetist to ensure safety and effectiveness before they are sent to the patient’s GP to ensure continuity of care. Patients will receive follow-up appointments with the pharmacist one week after each opioid dose reduction to review tapering progress, address any difficulties encountered and adjust the opioid tapering plan as required. Opioid dose reduction will continue until a target of > 50% of the original daily opioid dose is tapered and the patient is clinically stable, without experiencing physical or psychological discomfort.

The intervention will be administered a minimum of 3 and maximum of 12 months before surgery. Each telehealth consultation will be administered as at least 4 weekly sessions. Each session will approximately be 30 minutes in duration. Patients will receive a minimum of 3 sessions over approximately 3 months. Adherence to the intervention will be monitored using session attendance checklists and standard documentation forms. If the intervention ends before the patient is due for surgery, the patient will be asked to continue tapering their opioid dose with their GP using the given plans until the day of surgery.

Patients who are ineligible for participation in the trial due to attendance at a pain clinic or those who are eligible but decline participation in the randomised trial will be invited to join an observation group. From the observation group, we will collect data by telephone at 3 months before surgery, 1 to 3 days before surgery, as well as information related to hospital stay upon hospital discharge from the electronic health record as outlined above. Patients will be offered a $50 gift card by email or by postage per telephone interview in return for their time. The value of the Observational arm is to provide a snapshot of opioid use of patients currently being managed by pain clinics. We will be able to see if opioid use among such patients increases or decreases whilst under the care of the clinic, thus providing indirect evidence of the need for an alternative intervention to help lower opioid use. In addition, there is a possibility we will recruit the people most keen to wean off their medications. By capturing data and following those who are eligible but are reluctant to participate in the randomize trial, we can compare whether those who refused have different characteristics to those who agree, and also obtain information about whether people are self-weaning or, conversely, actually increasing their opioid intake, and what happens to them.
Intervention code [1] 320250 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] 327163 0
The proportion of patients weaned by at least 50% of their daily opioid dose before surgery assessed by audit of study records
Timepoint [1] 327163 0
At trial conclusion
Primary outcome [2] 327164 0
The proportion of eligible patients recruited per month assessed by audit of study records
Timepoint [2] 327164 0
At trial conclusion
Primary outcome [3] 327165 0
Retention of participants in both arms of the study assessed by audit of study records
Timepoint [3] 327165 0
At trial conclusion
Secondary outcome [1] 394022 0
The number of patients recruited per month assessed by audit of study records
Timepoint [1] 394022 0
At trial conclusion
Secondary outcome [2] 394023 0
The proportion of patients taking low (less than 60 mg morphine milligram equivalents) or high doses (greater than or equal to 60 mg morphine milligram equivalents) of opioids per day before surgery assessed by audit of study records [composite secondary outcome]
Timepoint [2] 394023 0
At trial conclusion
Secondary outcome [3] 394024 0
Length of hospital stay assessed by collecting data from patient medical records.
Timepoint [3] 394024 0
On the day of hospital discharge
Secondary outcome [4] 394025 0
30-day hospital readmission rate assessed by collecting data from patient medical records.
Timepoint [4] 394025 0
30 days after hospital discharge
Secondary outcome [5] 394026 0
90-day hospital readmission rate assessed by collecting data from patient medical records.
Timepoint [5] 394026 0
90 days after hospital discharge
Secondary outcome [6] 394027 0
Patient-reported health-related quality of life using the Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Timepoint [6] 394027 0
1 to 3 days before surgery and 90 days after hospital discharge.
Secondary outcome [7] 394028 0
Index joint pain using 11 point numeric rating scale
Timepoint [7] 394028 0
1 to 3 days before surgery and 90 days after hospital discharge.
Secondary outcome [8] 394029 0
Total body pain using 11 point numeric rating scale
Timepoint [8] 394029 0
1 to 3 days before surgery and 90 days after hospital discharge.
Secondary outcome [9] 394030 0
Physical function using Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Timepoint [9] 394030 0
1 to 3 days before surgery and 90 days after hospital discharge.
Secondary outcome [10] 394031 0
Analgesic and benzodiazepine use assessed by collecting data from patient medical records.
Timepoint [10] 394031 0
1 to 3 days before surgery and 90 days after hospital discharge.
Secondary outcome [11] 394032 0
Proportion of patients using opioids regularly (every day), assessed by audit of study records
Timepoint [11] 394032 0
1 to 3 days before surgery and 90 days after hospital discharge.
Secondary outcome [12] 394033 0
Incidence of opioid-related adverse events such as constipation, falls or sedation; assessed by audit of study records
Timepoint [12] 394033 0
1 to 3 days before surgery and 90 days after hospital discharge.
Secondary outcome [13] 405695 0
Pain catastrophising assessed using the Pain Catastrophising Tool
Timepoint [13] 405695 0
1 to 3 days before surgery and 90 days after hospital discharge
Secondary outcome [14] 405696 0
Incidence of opioid withdrawal assessed using the Short Opioid Withdrawal Scale
Timepoint [14] 405696 0
1 to 3 days before surgery and 90 days after hospital discharge
Secondary outcome [15] 405697 0
Complications during hospital stay assessed by collecting data from patient medical records. These complications include: major joint (deep surgical site infection, wound bleed/haemarthrosis, dehiscence, nerve injury, dislocation, intraoperative fracture); minor joint (persistent wound ooze, suspected surgical site infection, blistering); major non-joint (death, myocardial infarction, symptomatic venous thromboembolism (VTE), aspiration, chest infection, excessive non-joint bleeding.
Timepoint [15] 405697 0
30 days after hospital discharge
Secondary outcome [16] 405698 0
Discharge destination assessed by collecting data from patient medical records (home/usual/relative residence vs. inpatient rehabilitation)
Timepoint [16] 405698 0
30 days after hospital discharge
Secondary outcome [17] 405699 0
Opioid Dependency using the Overuse, Worrying, Losing Interest in usual activities due to opioid medicines (OWLS) Tool.
Timepoint [17] 405699 0
3 months before surgery, 1-3 days before surgery and. 3 months after surgery.

Eligibility
Key inclusion criteria
Randomised Study:
Aged 18 years or older, undergoing elective THA or TKA for osteoarthritis, speaks and reads English, uses opioid analgesics daily, has access to internet or telephone.

Observational Arm:
Aged 18 years or older, undergoing elective THA or TKA for osteoarthritis, speaks and reads English, uses opioid analgesics daily, has access to internet or telephone, attending pain clinic, under the care of a pain specialist or already undergoing opioid tapering or previously participated in an opioid tapering study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Randomised Study:
Patients undergoing repeat surgeries (same procedure within 6 months), using opioids for oncology, palliative care or substance use disorder, already undergoing or previously participated in an opioid tapering study, comorbid cognitive impairment or intellectual disability, currently attending a pain clinic or under the care of a pain specialist.

Observational Arm:
Patients undergoing repeat surgeries (same procedure within 6 months), using opioids for oncology, palliative care or substance use disorder, comorbid cognitive impairment or intellectual disability.

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 randomisation service by telephone each time a patient is to be randomised to allow allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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. Randomisation will be conducted using a centralised, telephone-based randomisation service. Randomisation of participants will be stratified by hospital site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other
Other design features
Patients who are ineligible for participation in the trial due to attendance at a pain clinic or those who are eligible but decline participation in the randomised trial will be invited to join an observation group. From the observation group, we will collect data by telephone at 3 months before surgery, 1 to 3 days before surgery, as well as information related to hospital stay upon hospital discharge from the electronic health record.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Primary outcome: We will detect between-group differences in the extent of opioid tapering using inferential statistics. As appropriate for detecting differences in between-group proportions, we will use the Chi-square statistic and report the risk ratio with its 95% confidence interval (CI).

Secondary clinical outcomes: Our study will not be powered to detect statistically significant differences in the secondary outcomes. We will report differences between groups for continuous outcomes as mean difference and estimated 95% CI. Nominal variables will be reported as percentage differences and estimated 95% CIs.

Feasibility outcomes: Descriptive analysis will be used to report feasibility outcomes.

Statistical analyses will be conducted on the basis of intention to treat, per-protocol and as-treated principles using SPSS Version 25 (IBM Corporation, Armonk, NY, USA) in consultation with a biostatistician.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/01/2022
Actual
27/12/2021
Date of last participant enrolment
Anticipated
Actual
22/09/2022
Date of last data collection
Anticipated
Actual
30/06/2023
Sample size
Target
60
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 308285 0
Other Collaborative groups
Name [1] 308285 0
International Pharmaceutical Federation
Country [1] 308285 0
Netherlands
Funding source category [2] 309000 0
Other
Name [2] 309000 0
AVANT Foundation
Country [2] 309000 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 309087 0
Government body
Name [1] 309087 0
South Western Sydney Local Health District
Address [1] 309087 0
South Western Sydney Local Health District Executive Office
Liverpool Hospital Eastern Campus
Scrivener Street
LIVERPOOL NSW 2170
Country [1] 309087 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308259 0
South Western Sydney Local Health District
Ethics committee address [1] 308259 0
Ethics committee country [1] 308259 0
Australia
Date submitted for ethics approval [1] 308259 0
26/02/2021
Approval date [1] 308259 0
31/03/2021
Ethics approval number [1] 308259 0
2021/ETH00343

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

Contacts
Principal investigator
Name 110110 0
Dr Jonathan Penm
Address 110110 0
N371, Pharmacy and Bank Building A15
The University of Sydney, NSW, 2006
Country 110110 0
Australia
Phone 110110 0
+61 2 8627 5806
Fax 110110 0
+61 2 9351 4391
Email 110110 0
jonathan.penm@sydney.edu.au
Contact person for public queries
Name 110111 0
Shania Liu
Address 110111 0
N372, Pharmacy and Bank Building A15
The University of Sydney, NSW, 2006
Country 110111 0
Australia
Phone 110111 0
+61 2 9351 6972
Fax 110111 0
Email 110111 0
sliu9823@uni.sydney.edu.au
Contact person for scientific queries
Name 110112 0
Shania Liu
Address 110112 0
N372, Pharmacy and Bank Building A15
The University of Sydney, NSW, 2006
Country 110112 0
Australia
Phone 110112 0
+61 2 9351 6972
Fax 110112 0
Email 110112 0
sliu9823@uni.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
11359Study protocol  sliu9823@uni.sydney.edu.au



Results publications and other study-related documents

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