{
  "abstract": "Introduction Potentially inappropriate prescriptions (PIPs) in older adults, such as long-term use of benzodiazepines, proton pump inhibitors without indication or antipsychotics in dementia, are associated with adverse events and increased healthcare utilisation. Despite clinical guidelines discouraging their use, PIPs remain frequent in primary care. An audit and feedback (A&F) intervention of PIPs to general practitioners (GPs), led by pharmacists, may reduce the prescription of PIPs in primary care.Methods and analysis A two-arm, pragmatic, controlled trial will be conducted to evaluate the effectiveness of an A&F-based intervention and a pharmacist-led intervention to reduce the proportion of patients aged ≥65 years receiving inappropriate prescriptions. A total of 170 participating GPs, 85 per group, are required. GPs will be randomised into intervention or control groups (1:1). The intervention includes feedback reports, pharmacist-led academic detailing and access to online training modules. The primary outcome is the proportion of older adults receiving at least one PIP at 12 months as well as the total number of PIPs. A random effects Tobit regression model, censored at 0 and 100, will be used to estimate between-group differences adjusted for baseline prescribing. Subgroup analyses will explore heterogeneity of effect by baseline prescribing level and healthcare region. Implementation outcomes, including reach, fidelity, engagement and maintenance, will be evaluated using the Reach, Effectiveness, Adoption, Implementation and Maintenance framework, combining quantitative and qualitative data.Ethics and dissemination Ethical approval was obtained by the Balearic Island Committee Ethics (IB5219/23PI). Study findings, including primary and secondary outcomes and qualitative implementation results, will be disseminated through peer-reviewed publications and stakeholder reports.Trial registration number ISRCTN14449434.",
  "authors": [
    {
      "affiliations": [
        "Balearic Islands Health Research Institute, Balearic Islands Health Research Institute (IdISBa), Palma, Illes Balears, Spain",
        "Research Network on Chronicity, Primary Care, and Health Promotion (RICAPPS), Palma, Illes Balears, Spain",
        "Primary Care Management of Mallorca, Balearic Health Service, Palma, Spain"
      ],
      "name": "Alfonso Leiva"
    },
    {
      "affiliations": [
        "Balearic Islands Health Research Institute, Balearic Islands Health Research Institute (IdISBa), Palma, Illes Balears, Spain",
        "Research Network on Chronicity, Primary Care, and Health Promotion (RICAPPS), Palma, Illes Balears, Spain",
        "Primary Care Management of Mallorca, Balearic Health Service, Palma, Spain"
      ],
      "name": "Laura Gallardo Alfaro"
    },
    {
      "affiliations": [
        "GAPiC Camp de Tarragona, Catalan Health Institute (Institut Català de la Salut), Tarragona, Spain",
        "Emerging Research Group on Health Interventions and Community Activities (GRE ISAC",
        "2021 SGR 00884), Catalunya, Spain",
        "Research Group on Quality and Patient Safety of Tarragona (2022 6G22/035), Tarragona, Spain"
      ],
      "name": "Ferran Bejarano"
    },
    {
      "affiliations": [
        "Paterna Health Centre, Department of Health, Generalitat Valenciana, Valencia, Spain"
      ],
      "name": "Ermengol Sempere"
    },
    {
      "affiliations": [
        "Balearic Islands Health Research Institute, Balearic Islands Health Research Institute (IdISBa), Palma, Illes Balears, Spain",
        "Research Network on Chronicity, Primary Care, and Health Promotion (RICAPPS), Palma, Illes Balears, Spain",
        "Primary Care Management of Mallorca, Balearic Health Service, Palma, Spain"
      ],
      "name": "Aina Soler"
    },
    {
      "affiliations": [
        "Balearic Islands Health Research Institute, Balearic Islands Health Research Institute (IdISBa), Palma, Illes Balears, Spain",
        "Research Network on Chronicity, Primary Care, and Health Promotion (RICAPPS), Palma, Illes Balears, Spain",
        "Research Group on Global Health, University of Balearic Islands, Palma, Spain",
        "Research Group on Nursing, Community and Global Health, Health Research Institute of the Balearic Islands (IdISBa), Palma, Spain",
        "Nursing and Physiotherapy Department, University of the Balearic Islands, Palma, Islas Baleares, Spain"
      ],
      "name": "Aina Huguet"
    },
    {
      "affiliations": [
        "Biobizkaia Health Research Institute, Barakaldo, Spain",
        "Research Network on Chronicity, Primary Care, and Health Promotion (RICAPPS), Bilbao, Spain"
      ],
      "name": "Marta Llarena"
    },
    {
      "affiliations": [
        "Biobizkaia Health Research Institute, Barakaldo, Spain",
        "Research Network on Chronicity, Primary Care, and Health Promotion (RICAPPS), Bilbao, Spain",
        "Primary Care Pharmacy Unit, Ezkerraldea-Enkarterri-Cruces Integrated Health Organization, Osakidetza-Basque Health Service, Bilbao, Spain"
      ],
      "name": "Itxasne Lekue"
    },
    {
      "affiliations": [
        "GAPiC Camp de Tarragona, Catalan Health Institute (Institut Català de la Salut), Tarragona, Spain",
        "Research Group on Mental Health and Primary Care (2022 6G22/055), Catalunya, Spain"
      ],
      "name": "Cecília Campabadal Prats"
    },
    {
      "affiliations": [
        "GAPiC Camp de Tarragona, Catalan Health Institute (Institut Català de la Salut), Tarragona, Spain",
        "Research Group on Mental Health and Primary Care (2022 6G22/055), Catalunya, Spain"
      ],
      "name": "Clara Salom"
    },
    {
      "affiliations": [
        "Arnau de Vilanova–Llíria Health Department, Valencia, Spain"
      ],
      "name": "Rocío Broseta Solaz"
    },
    {
      "affiliations": [
        "Primary Care Management of Mallorca, Balearic Health Service, Palma, Spain"
      ],
      "name": "Catalina Socias Cañellas"
    },
    {
      "affiliations": [
        "Primary Care Management of Mallorca, Balearic Health Service, Palma, Spain"
      ],
      "name": "Agusti Gonzalez"
    },
    {
      "affiliations": [
        "Primary Care Management of Mallorca, Balearic Health Service, Palma, Spain"
      ],
      "name": "Guillem Marc Campins"
    },
    {
      "affiliations": [
        "Primary Care Management of Mallorca, Balearic Health Service, Palma, Spain"
      ],
      "name": "Ana Vanrell"
    },
    {
      "affiliations": [
        "Primary Care Management of Mallorca, Balearic Health Service, Palma, Spain"
      ],
      "name": "Marta Rovira"
    },
    {
      "affiliations": [
        "Primary Care Management of Mallorca, Balearic Health Service, Palma, Spain"
      ],
      "name": "Georgina Ponsa Mir"
    },
    {
      "affiliations": [
        "Research Network on Chronicity, Primary Care, and Health Promotion (RICAPPS), Palma, Illes Balears, Spain",
        "Primary Care Management of Mallorca, Balearic Health Service, Palma, Spain",
        "Son Serra-La Vileta Health Centre, Balearic health Service, Palma, Spain"
      ],
      "name": "Caterina Vicens-Caldentey"
    },
    {
      "affiliations": [],
      "name": "The AIM Group"
    }
  ],
  "title": "Study protocol for a hybrid I randomised clinical trial to evaluate an audit and feedback and a pharmacist-led intervention to reduce potentially inappropriate medications in older adults: the AIM study",
  "uid": "bdeec475-9ed9-5e5b-978d-6036084bb533"
}