A pragmatic trial seeking to implement an improved model of care for people with either insomnia or obstructive sleep apnoea (OSA) within an Australian primary care setting, in order to increase access to evidence-based therapies

INTERVENTION: Design: Cluster‐randomised, wait‐list controlled pragmatic implementation trial SLEEP HEALTH PACKAGES to guide the management of insomnia and obstructive sleep apnea (OSA) in Primary Care (PC) will be provided to participating intervention‐arm clinics: A. EDUCATION & CLINICAL PRACTICE GUIDELINES (CPGs) (1) Online education modules: Developed/updated in conjunction with the Royal Australian College of General Practitioners (RACGP) and Australasian Sleep Association. Our 2 RACGP gpLearning Modules (Insomnia and OSA Management in General Practice) are self‐administered education modules, designed to provide general practitioners (GPs) with evidence‐based information on the identification, diagnosis, management, and follow‐up of patients with insomnia and OSA in a PC‐setting. The insomnia module takes about 1 hour and includes 'slides' with information and diagrams, multiple‐choice questions, and short‐answer questions. It is divided into 4 sections: definitions, diagnosis, management, and a case scenario. Content includes: the most recent (i.e. 2014) International Classification of Sleep Disorders (ICSD) diagnostic criteria; differentiating acute and chronic insomnia; types of insomnia‐related daytime functioning impairments; standardised tools to assess insomnia and daytime/related symptoms; ways to administer and access cognitive behavioural therapy for insomnia (CBTi); information and cautions regarding sedative‐hypnotic prescribing; RACGP CPG recommendations on insomnia management; and a case‐scenario with example questionnaires and sleep diaries, sleep restriction therapy, stimulus control therapy, and sleep education information. The OSA module covers: OSA definition; case studies; differentiation between simple snoring and OSA; economic cost CONDITION: Insomnia;Obstructive sleep apnea (OSA); ; Insomnia ; Obstructive sleep apnea (OSA) Mental Health ‐ Other mental health disorders Respiratory ‐ Sleep apnoea PRIMARY OUTCOME: Insomnia: Difference in rate of sedative/hypnotic pharmacotherapy prescription/use in insomnia encounters compared with the TAU (control) group.; ; GP consent will be obtained to access the relevant MBS/PBS data focussed on prescribing of the most commonly used pharmacological agents for insomnia, which include benzodiazepines (BZDs; e.g. temazepam, oxazepam, nitrazepam), non‐BZD hypnotics (‘z‐drugs’; e.g. zopiclone, zolpidem), and antidepressants/antipsychotics (e.g. trazodone, amitriptyline, mirtazapine, quetiapine). We will also collect data on melatonin use via prescriptions and via patient self‐report.[12‐month period post intervention commencement; ; ] OSA: Difference in rate of external medical referrals (i.e. to a sleep clinic or respiratory physician), assessed using electronic medical records, compared with the TAU (control) group. [12‐month period post intervention commencement] ; [After study follow‐up is completed.] Cost‐effectiveness ; INCLUSION CRITERIA: General Practitioners: We will include GPs who are currently practising in Australia and give written informed consent. Insomnia: To be eligible for inclusion, a potential participant with insomnia must meet diagnostic criteria based on a Sleep Condition Indicator (SCI) questionnaire score of less than or equal to 16 (which has been shown to correctly identify 89% of patients with insomnia, and correctly exclude 82% of those without) i.e. a higher SCI score indicates better sleep. Obstructive Sleep Apnea (OSA): To be eligible for inclusion, a potential participant must meet the following criteria: • Apnea Link devices (simple overnight sleep study to screen for probable OSA) will be used to confirm the OSA diagnosis (accord SECONDARY OUTCOME: Assessment of Quality of Life‐4D (AQoL‐4D): 12‐item measure of health‐related quality of life, which specifically asks about sleep disturbances, and can be used for cost‐utility studies. [Baseline, 3 months, 6 months, 12 months] Case identification rate: We will measure the proportion of patients attending GP appointments who are identified to have a sleep disorder in the intervention period compared with the treatment as usual period using electronic practice records.[Entire intervention period (i.e. from baseline to 12‐months post‐intervention commencement).] Clinician/practice manager views in relation to feasibility and acceptability (composite outcome) of the model of care will be assessed by conducting qualitative interviews of participating GPs/nurses/practice managers. This qualitative research will incorporate a variety of data collection methods, including audio‐recorded semi‐structured one‐on‐one interviews (of 30 minutes duration), focus groups and reflection diaries. • OSA‐50 questionnaire score of greater than or equal to 5 (indicating high probability of OSA) AND Epworth sleepiness scale (ESS) score of greater than or equal to 8 (indicating at least mild symptoms of sleepiness). ; The cost‐effectiveness of the intervention relative to TAU will be determined using a decision‐analytic model. Within‐trial incremental health‐system costs will be estimated using MBS, pharmaceutical benefits scheme (PBS), and diagnosis‐related group (DRG) data with patient private costs collected using a resource use questionnaire. Within‐trial effectiveness will be modelled using the primary outcomes (for OSA and insomnia) and QALYs (estimated using patient responses to the AQoL‐4D). To determine beyond‐trial cost‐effectiveness, a comprehensive systematic literature search will be carried out to identify longer‐term published cost and utility data for the model. Costs associated with development and delivery of the intervention will be estimated using administrative data collected as part of the trial. The health economics analysis will include cost‐effectiveness, acceptability, cost‐savings, expected net loss curves to inform decision makers of the optimal strategy at any threshold for different subgroups and the uncertainty around this decision. We will also collect data on the length of time for appointments required in order to estimate the appropriate level of MBS funding to aid a future Medicare Advisory Service Committee (MSAC) application.[After study follow‐up is completed.] Epworth Sleepiness Scale: Respondents rate, on a 4‐point scale (0‐3), their usual chances of dozing off or falling asleep while engaged in 8 activities. [Baseline, 3 months, 6 months, 12 months] Generalised Anxiety Disorder‐7: 7 item scale for anxiety symptoms. [Baseline, 3 months, 6 months, 12 months] Length of time for appointments will be collected in order to estimate the appropriate level of MBS funding to aid a future Medicare Advisory Service Committee (MSAC) application [After study follow‐up is completed.] Patient Health Questionnaire‐9: 9‐item scale for diagnosing and evaluating depression. [Baseline, 3 months, 6 months, 12 months] Patient satisfaction visual analogue scale[3 months, 6 months, 12 months] Sleep Condition Indicator Questionnaire: 8‐item rating scale that was developed to screen for insomnia disorder based on DSM‐5 criteria. [Baseline, 3 months, 6 months, 12 months] Use of Hospital and Primary Health Care Services: Healthcare utilisation measure developed by AESOPS Trial team. 13‐items, recording healthcare use in the last 6 months. [Baseline, 6 months, 12 months]