{
  "abstract": "Introduction Despite limited evidence of efficacy, opioid analgesics are frequently used by patients for chronic pain while awaiting total hip or knee arthroplasty (THA or TKA). Preoperative use of opioids is problematic as it increases the likelihood of postoperative opioid-related adverse drug events and postoperative complications and is the strongest predictor of persistent opioid use post surgery. Opioid tapering prior to elective surgery has been proposed as a strategy for mitigating harms and improving postoperative outcomes. This protocol describes a randomised clinical trial, which aims to determine the effectiveness of a preoperative pharmacist-partnered opioid tapering programme compared with standard care for patients awaiting elective THA or TKA on postoperative outcomes including persistent opioid use.Method and analysis Eligible participants must be aged ≥18 years; awaiting elective unilateral or bilateral THA or TKA; speak and read English; use prescription opioid analgesics at least 4 days a week and have access to internet or telephone. The participants will be excluded if they are undergoing a repeat surgery (same procedure within 6 months), are using opioids for cancer, palliative care or substance use disorder; have previously or are currently undergoing an opioid tapering programme or active medication review or have cognitive impairment. Enrolled participants will be randomised in a 1:1 ratio in permuted blocks of two and four to: (1) intervention or (2) standard care. A total of 314 participants will be recruited into the study. The intervention will include a pharmacist-partnered opioid tapering programme in which a pharmacist will work with participants to reduce their opioid dose over a 3-month period before surgery. Standard care will involve review by the hospital preadmission clinic multidisciplinary team to assess medical, physical and psychological health prior to surgery and education sessions for preoperative and postoperative care. The primary outcome assessed is persistent opioid use 3 months post surgery. The key secondary outcome is total Western Ontario and McMaster Universities Arthritis Index score. Data analysis will be performed using an estimand framework, with a generalised estimating equation model for the primary outcome from 1 day to 3 days presurgery to 3 months post surgery and a multilevel model for the main secondary outcome from baseline to 3 months after surgery. Cost-effectiveness and cost-utility analyses will be conducted to determine whether the intervention is cost-effective from the healthcare system perspective.Ethics and dissemination Ethics approval for this study was granted by a Human Research Ethics Committee (approval number: 2023/ETH01042). Results will be disseminated in peer reviewed journals, at international scientific meetings as well as meetings with key stakeholders and via the media.Trial registration number ACTRN12623000685617.",
  "authors": [
    {
      "affiliations": [
        "The University of Sydney, Faculty of Medicine and Health, School of Pharmacy, Sydney, New South Wales, Australia",
        "Department of Pharmacy, Prince of Wales Hospital, Randwick, New South Wales, Australia"
      ],
      "name": "Jonathan Penm"
    },
    {
      "affiliations": [
        "The University of Sydney, Faculty of Medicine and Health, School of Pharmacy, Sydney, New South Wales, Australia"
      ],
      "name": "Shania Liu"
    },
    {
      "affiliations": [
        "St George & Sutherland Clinical Campuses, School of Clinical Medicine, UNSW Medicine & Health, Sydney, New South Wales, Australia"
      ],
      "name": "Sam Adie"
    },
    {
      "affiliations": [
        "The University of Sydney, Faculty of Medicine and Health, School of Medicine, Sydney, New South Wales, Australia"
      ],
      "name": "Claire E Ashton-James"
    },
    {
      "affiliations": [
        "School of Medicine and Public Health, The University of Newcastle, Newcastle, New South Wales, Australia"
      ],
      "name": "Kylie A Bailey"
    },
    {
      "affiliations": [
        "Ingham Institute for Applied Medical Research, Liverpool, New South Wales, Australia",
        "South Western Sydney Local Health District, Sydney, New South Wales, Australia",
        "School of Health Sciences, Faculty of Health, Western Sydney University, Campbelltown, New South Wales, Australia",
        "The University of Sydney, Faculty of Medicine and Health, School of Health Sciences, Sydney, New South Wales, Australia"
      ],
      "name": "Bernadette Brady"
    },
    {
      "affiliations": [
        "The University of Sydney, Faculty of Medicine and Health, School of Pharmacy, Sydney, New South Wales, Australia"
      ],
      "name": "Betty Chaar"
    },
    {
      "affiliations": [
        "The University of Sydney, Faculty of Medicine and Health, School of Pharmacy, Sydney, New South Wales, Australia"
      ],
      "name": "Jenny Chen"
    },
    {
      "affiliations": [
        "Ingham Institute for Applied Medical Research, Liverpool, New South Wales, Australia",
        "South West Sydney Clinical Campuses, School of Clinical Medicine, UNSW Medicine & Health, Sydney, New South Wales, Australia"
      ],
      "name": "Joseph Descallar"
    },
    {
      "affiliations": [
        "The University of Sydney, Faculty of Medicine and Health, School of Pharmacy, Sydney, New South Wales, Australia"
      ],
      "name": "Klaudia Englezos"
    },
    {
      "affiliations": [
        "St George & Sutherland Clinical Campuses, School of Clinical Medicine, UNSW Medicine & Health, Sydney, New South Wales, Australia",
        "Whitlam Orthopaedic Research Centre, Ingham Institute, Liverpool, New South Wales, Australia"
      ],
      "name": "Furkan Genel"
    },
    {
      "affiliations": [
        "Coffs Harbour Base Hospital, Coffs Harbour, New South Wales, Australia"
      ],
      "name": "David Gillespie"
    },
    {
      "affiliations": [
        "The University of Sydney, Faculty of Medicine and Health, School of Pharmacy, Sydney, New South Wales, Australia"
      ],
      "name": "Danijela Gnjidic"
    },
    {
      "affiliations": [
        "South Western Sydney Local Health District, Liverpool, New South Wales, Australia"
      ],
      "name": "Thomas Hoang"
    },
    {
      "affiliations": [
        "Western New South Wales Local Health District, Orange, New South Wales, Australia"
      ],
      "name": "Anders Jansson"
    },
    {
      "affiliations": [
        "The University of Sydney, Faculty of Medicine and Health, School of Pharmacy, Sydney, New South Wales, Australia",
        "Department of Pharmacy, Campbelltown Hospital, Campbelltown, New South Wales, Australia"
      ],
      "name": "Katelyn J Jauregui"
    },
    {
      "affiliations": [
        "Central Coast Local Health District, Gosford, New South Wales, Australia"
      ],
      "name": "Mary Keehan"
    },
    {
      "affiliations": [
        "Institute for Musculoskeletal Health, Sydney Local Health District, Sydney, New South Wales, Australia",
        "Sydney Musculoskeletal Health, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia"
      ],
      "name": "Chung-Wei Christine Lin"
    },
    {
      "affiliations": [
        "New South Wales Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Sydney, New South Wales, Australia",
        "Drug and Alcohol Services, South Eastern Sydney Local Health District, Surry Hills, New South Wales, Australia",
        "Specialty of Addiction Medicine, The University of Sydney, Sydney, New South Wales, Australia"
      ],
      "name": "Nicholas Lintzeris"
    },
    {
      "affiliations": [
        "Sydney Partnership of Health Education Research and Enterprise (SPHERE), Maridulu Budyari Gumal, Sydney, New South Wales, Australia"
      ],
      "name": "Kate Luckie"
    },
    {
      "affiliations": [
        "The University of Sydney, Faculty of Medicine and Health, School of Pharmacy, Sydney, New South Wales, Australia",
        "School of Public Health, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia"
      ],
      "name": "Stephanie Mathieson"
    },
    {
      "affiliations": [
        "The University of Sydney, Faculty of Medicine and Health, School of Pharmacy, Sydney, New South Wales, Australia"
      ],
      "name": "Rebekah J Moles"
    },
    {
      "affiliations": [
        "Launceston General Hospital, Launceston, Tasmania, Australia"
      ],
      "name": "Jonathan Mulford"
    },
    {
      "affiliations": [
        "South Eastern Sydney Local Health District, Sydney, New South Wales, Australia"
      ],
      "name": "Lisa Nealon"
    },
    {
      "affiliations": [
        "The University of Sydney, Faculty of Medicine and Health, School of Pharmacy, Sydney, New South Wales, Australia"
      ],
      "name": "Claire L O’Reilly"
    },
    {
      "affiliations": [
        "Central Coast Local Health District, Gosford, New South Wales, Australia"
      ],
      "name": "Frances Page"
    },
    {
      "affiliations": [
        "The University of Sydney, Faculty of Medicine and Health, School of Pharmacy, Sydney, New South Wales, Australia",
        "Department of Pharmacy, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia"
      ],
      "name": "Asad E Patanwala"
    },
    {
      "affiliations": [
        "Redfern Station Medical Centre, Redfern, New South Wales, Australia"
      ],
      "name": "Michelle Penm"
    },
    {
      "affiliations": [
        "The University of Sydney, Faculty of Medicine and Health, School of Pharmacy, Sydney, New South Wales, Australia"
      ],
      "name": "Renee Quirk"
    },
    {
      "affiliations": [
        "The University of Sydney, Faculty of Medicine and Health, School of Pharmacy, Sydney, New South Wales, Australia"
      ],
      "name": "Ganga Ratnanayagam"
    },
    {
      "affiliations": [
        "The University of Sydney, Faculty of Medicine and Health, School of Pharmacy, Sydney, New South Wales, Australia"
      ],
      "name": "Frank Schaper"
    },
    {
      "affiliations": [
        "The University of Sydney, Faculty of Medicine and Health, School of Pharmacy, Sydney, New South Wales, Australia"
      ],
      "name": "Carl R Schneider"
    },
    {
      "affiliations": [
        "Western New South Wales Local Health District, Dubbo, New South Wales, Australia"
      ],
      "name": "Andrew Sefton"
    },
    {
      "affiliations": [
        "School of Health Sciences, Faculty of Health, Western Sydney University, Campbelltown, New South Wales, Australia"
      ],
      "name": "Lei Si"
    },
    {
      "affiliations": [
        "St Vincent’s Clinical Campus, School of Clinical Medicine, UNSW Medicine & Health, Sydney, New South Wales, Australia",
        "University of Notre Dame, Sydney, New South Wales, Australia"
      ],
      "name": "Jennifer Stevens"
    },
    {
      "affiliations": [
        "Illawarra Shoalhaven Local Health District, Wollongong, New South Wales, Australia"
      ],
      "name": "Karin Sylvester"
    },
    {
      "affiliations": [
        "The University of Sydney, Faculty of Medicine and Health, School of Pharmacy, Sydney, New South Wales, Australia"
      ],
      "name": "Shumin Tan"
    },
    {
      "affiliations": [
        "The University of Sydney, Faculty of Medicine and Health, School of Pharmacy, Sydney, New South Wales, Australia"
      ],
      "name": "Chi Tran"
    },
    {
      "affiliations": [
        "South West Sydney Clinical Campuses, School of Clinical Medicine, UNSW Medicine & Health, Sydney, New South Wales, Australia",
        "Whitlam Orthopaedic Research Centre, Ingham Institute, Liverpool, New South Wales, Australia"
      ],
      "name": "Justine M Naylor"
    }
  ],
  "title": "Responsible preoperative opioid use for hip or knee arthroplasty (OpioidHALT): a protocol for a randomised clinical trial of pharmacist-partnered opioid tapering prior to hip or knee arthroplasty",
  "uid": "64e5ec33-202f-5c62-a519-078aae6f0c3b"
}