None listed
Conditions
Brief summary
This novel implementation study represents a major step towards improving management of sleep disorders in primary care (PC). The two most common sleep disorders, chronic insomnia and obstructive sleep apnea (OSA), affect >4 million Australians, and are associated with broad ranging negative physical and mental health outcomes, as well as reduced safety and productivity, costing over $66 billion annually. People with sleep disorders commonly receive care that is far from best practice and potentially dangerous. A lack of sleep-specific training for GPs contributes to widespread under recognition of sleep disorders, and an over-reliance on specialist care. Long waiting periods for specialist OSA care have led to a rise in vertically integrated business models from pharmacy/corporate treatment device suppliers, without adequate medical input to manage these disorders, and often complete separation from a person’s usual medical care. Our research group and others, have demonstrated in randomised trials that GPs and PNs can manage OSA, producing equivalent patient outcomes to those in specialist centres at significantly lower cost. Similarly, for insomnia, despite clinical guidelines recommending cognitive behavioural therapy (CBTi) as the first line treatment, the majority of patients receive sedative/hypnotic drugs with potentially dangerous side effects, and do not get access to the CBTi that would address the underlying cause of their insomnia. To address this, our study will utilise a simplified Model of Care for screening, diagnosis and treatment of OSA and chronic insomnia in PC, and a suite of practice change support tools. These tools are currently being developed and will be translated through our NHMRC CRE (GNT1134954) – National Centre for Sleep Health Services Research, and include simple clinical guidelines, education modules, eHealth decision support tools, and referral pathways. This will facilitate and demonstrate the uptake, efficacy and cost-effectiveness of the new sleep health services model. We hypothesise that our implementation strategy for improving sleep disorder management in PC settings will result in management that is: a) better aligned with recommendations of evidence based clinical guidelines; b) more cost-effective in terms of patient outcomes/waiting times and cost when compared with usual care; c) feasible and acceptable from the perspective of GPs, PNs and patients, indicating viability for up-scaling the project.
Interventions
Design: Cluster-randomised controlled pragmatic implementation trial
SLEEP HEALTH PACKAGES to guide the management of chronic 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) Education for GPs and Practice Nurses (PNs): Approximately 6 hours (2-hours on chronic insomnia and 4-hours on sleep apnoea) (GPs/PNs) and 1-week of in-service training (PNs). The ~6-hour course
Design: Cluster-randomised controlled pragmatic implementation trial SLEEP HEALTH PACKAGES to guide the management of chronic 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) Education for GPs and Practice Nurses (PNs): Approximately 6 hours (2-hours on chronic insomnia and 4-hours on sleep apnoea) (GPs/PNs) and 1-week of in-service training (PNs). The ~6-hour course will be delivered in-person to groups of PC-clinicians by a Specialist Sleep Physician (SSP), a Specialist Sleep Nurse (SSN), and a Specialist Sleep Psychologist. This education will have a similar format to that of our team’s RCT comparing OSA management in a PC versus specialist setting (Chai-Coetzer et al. 2013 JAMA), and consists of educational lectures and a hands-on workshop where clinicians learn more about diagnostic tests and treatments for OSA and insomnia. We will discuss and provide attendees with a copy of our PC CPGs. In-service training will be led by a SSN, take place in a sleep clinic setting and will incorporate CPAP set-up and follow-up. (2) Online CPGs: User-friendly PC guidelines. These CPGs have been developed by a senior academic/clinical GP and have been edited by our multi-disciplinary National Centre for Sleep Health Services Research team. The purpose is to provide a user-friendly, PC-specific guide to insomnia and OSA for clinicians, which complements our online education modules and in-person training. (3) (Optional) Online education modules will be made available: 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. Each module takes about 1 hour to complete. The insomnia module includes 'slides' with information and diagrams, multiple-choice questions, and short-answer questions about the definitions, diagnosis, management, and a case scenario about insomnia management. The OSA module covers: OSA definition, differentiation between simple snoring and OSA, economic cost of sleep disorders in Australia, prevalence, pathophysiology, risk factors, consequences of OSA, assessment, treatment and referral options. B. SCREENING & POINT-OF-CARE TESTING Eligibility will require: Chronic Insomnia, diagnosed via Sleep Condition Indicator questionnaire or high-risk of symptomatic moderate-severe OSA, diagnosed using a combination of questionnaires (OSA50 and Epworth Sleepiness Scale i.e. ESS). C) TREATMENT & ACCESS/REFERRAL PATHWAYS. Those diagnosed with chronic insomnia and/or OSA will be offered the treatment options described below, with specific strategies to monitor adherence. INSOMNIA: GP/PN brief CBTi: We provide training for PNs in this brief behavioural intervention as part of our 1-week education program. Brief CBTi is a manualized intervention delivered over 4 weeks, which can be delivered during a combination of in-person and phone/tele-health appointments. The first session is 45 minutes, and the follow-up sessions are approximately 30-45 minutes. Adherence to brief CBTi will be defined as the number of sessions completed. Briefly, the topics covered are: basic information about insomnia, the processes which control sleep (sleep drive and circadian processes), an overview of insomnia (prevalence, characteristics, symptoms), and healthy sleep hygiene behaviours. This information is important to ensure the patient understands the rationale for the behavioural therapies (bedtime restriction therapy and stimulus control therapy) which are introduced and adjusted over the subsequent 3 sessions. Online CBTi: Sleepio is a leading digital sleep-improvement program, based on CBTi techniques. Sleepio’s core program consists of 6 weekly sessions in which a virtual sleep expert talks the participant through personalised techniques. Each session lasts about 20 minutes, and is tailored to progress and problems. Between sessions, participants complete a Sleep Diary to track progress and are sent reminders to aid adherence. Throughout, participants are supported by a community of other users, 10 online tools and a library of over 100 articles. Adherence will be defined as the number of sessions completed. PNs will contact patients approximately 3 weeks after referral for Sleepio, to check on program commencement and offer motivational advice to continue with CBTi recommendations. CBTi from a Specialist Sleep Psychologist: This is current best practice for insomnia management but remains underutilised. GPs may refer patients to existing local sleep psychologists. Our specialist centre has psychologists who will provide this service in-person/via telemedicine. The service will consist of a 6-week individually tailored program. Adherence will be defined as the number of sessions attended. During CBTi, a patient is provided with information to ensure that they understand the rationale for the main component of this therapy, bedtime restriction therapy, which aims to modify the bedtime routine/behaviours over several weeks to gradually increase sleep pressure/drive in the evening, promote more rapid sleep onset, reduce the duration of nocturnal awakenings, and reduce the conditioned relationship between the bedroom/bedtime routine and an insomnia response. Therapy is personalised based on self-reported nightly sleep patterns and bedtime routine over the past 1-2 weeks and often begins by reducing the amount of time spent in bed to match perceived sleep duration, then maintaining this routine over the next 1-2 weeks. After sleep becomes more consolidated, time spent in bed is gradually extended until a comfortable equilibrium between sleep time, time in bed, and sleepiness is achieved. Participant flow: After insomnia is confirmed, the participant will be offered brief CBTi or online CBTi. If a poor response is noted at the GP follow-up (within 1 month), they will be offered referral to a psychologist. OSA: (1) Patients with a high-risk of symptomatic, moderate-severe OSA based on the OSA50 and ESS questionnaires will be referred for a single-night at-home ApneaLink sleep study to confirm OSA. Patients with no/mild OSA (3% Oxygen desaturation index <16) will receive ongoing management but will not be eligible for CPAP therapy. Patients with moderate or severe OSA (oxygen desaturation index =>16) will be eligible for CPAP therapy. Participants with mild and moderate-severe OSA will be provided lifestyle advice via written information (e.g. weight loss, minimise alcohol intake, avoid sedative-hypnotics, supine avoidance, good sleep hygiene, etc.). (2) Continuous Positive Airways Pressure (CPAP): Healthcare card holders and pension card holders will be offered nurse-delivered CPAP equipment, setup and review appointments in the general practice clinic. Non-healthcare/pension card holders will receive initial determination of required CPAP pressure in the general practice setting and will be referred to private CPAP clinics for CPAP setup and ongoing management. The initial visit will take one hour. In that session, the patient will receive information about why CPAP is needed, how it works, mask fitting, CPAP safety and side effects and how to operate and maintain equipment, then invite the participant to return at 2 weeks. For most participants, follow-up will be undertaken at three-monthly intervals thereafter. CPAP adherence will be defined as average nightly use of CPAP. Patients with private health insurance will be reimbursed $600 toward their purchase of CPAP. This is to reflect average private rebate for CPAP therapy from private insurers. (3) Mandibular Advancement Splints (MAS): MAS devices (and equivalent) move the lower jaw forward during sleep to increase the pharyngeal airway space and prevent collapse of the pharynx, and are effective for most patients. A list of preferred providers will be given to GPs. Adherence to these devices will be measured via self-report of nightly use. (4) Referral to a SSP: Eligible patients who refuse treatment or have treatment failure in the trial are recommended for referral to SSP. Treatment/adherence monitoring will be in accordance with usual SSP protocols. Participant flow: After moderate-severe OSA is confirmed on the ApneaLink study, participants will be offered CPAP therapy and lifestyle advice. If CPAP is refused, ineffective or poorly tolerated, then referral to a dentist for a MAS will be recommended. If MAS is refused, ineffective or poorly tolerated, referral to a SSP will be recommended. Patients can be referred at any time as required at the discretion of the GP. A total 6-month follow-up is planned. Practices, GPs, PNs, Practice Managers, and patients will be reimbursed for trial-related activities, including attendance at educational programs, throughout the trial that are in addition to usual care. Intervention patients will be reimbursed $20 per questionnaire completed, and $20 for (optional) qualitative interviews (~$80).
Sponsors
Flinders University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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 chronic 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) and report insomnia symptoms for at least 3 months i.e. a higher SCI score indicates better sleep. The SCI scale has been reverse-coded on GP screening forms, to align with the other questionnaires (higher scores = worse symptoms/health). Obstructive Sleep Apnea (OSA): To be eligible for inclusion, a potential participant must meet the following criteria: • OSA-50 questionnaire score of greater than or equal to 5 (indicating high probability of moderate-severe OSA) AND Epworth sleepiness scale (ESS) score of greater than or equal to 8 (indicating at least mild symptoms of sleepiness). Additional general eligibility criteria: Inclusions: At least 18 years of age, able to provide informed consent and complete patient questionnaires, currently living in Australia.
Exclusion criteria
General exclusion criteria: Drug/alcohol problems, terminal illness, unstable or poorly controlled psychiatric illness or significant cognitive impairment which would affect patient’s ability to understand or comply with study requirements, epilepsy or muscle spasms requiring benzodiazepine, women who are currently pregnant, limited English comprehension, no access to MBS-PBS (e.g. not Australian resident or citizen), or Department of Veterans Affairs card holder. Previous investigation for OSA in the past 10 years, with or without treatment (for patients being considered for the OSA pathway). Condition specific exclusion criteria are then applied to potentially eligible patients to identify those with complex OSA or complex insomnia who are not suitable for simplified management in the primary care setting and should be treated as usual/referred for specialist care. OSA treatment pathway exclusion criteria: BMI>=50 Kg/m2; Chronic opioid use; Hospitalisation in past 3 months for MI, unstable angina, cardiac failure, or CVA or New York Heart Association class III or IV symptoms; Neuromuscular disease; Lung disease & wake oxygen saturation <92%; Using supplemental oxygen; Confirmed/suspected sleep hypoventilation syndromes; Previous sleepiness-related motor-vehicle accident. Insomnia treatment pathway exclusion criteria: Epworth Sleepiness Scale score of 16-24, average time in bed <6h; average perceived total sleep time <3h; Shift work (rotating, nights); Circadian rhythm disorder (evidence of advanced or delayed sleep wake phase disorder).
Outcome results
None listed