The role of pharmacists in sleep health – a screening, awareness and monitoring program Researchers: Bandana Saini, Keith Wong, Ines Krass, Ron Grunstein Project Officer: Joanne Fuller FINAL REPORT FINAL REPORT Acknowledgements We would sincerely like to thank all the pharmacies and the staff thereof who have very kindly offered their time, energy and enthusiasm for this project. Not only have they been a pleasure to collaborate with but, without them none of this project would have been possible. Equally so, we are very grateful to all the participants for their patience in completing the screening, for providing invaluable feedback and sharing their sleep health related experiences with us. They are the real stars in this show. The members of the steering committee, Prof Glenn Salkeld, A/Prof Alex Barratt, Dr Margaret Hardy, Mr Phillip Walsh OAM, Mr David Nolte, Mr Adrian Reid, Ms Joy Hayes and Mr John Purcell, for kindly offering their valuable time, expertise and important feedback in their particular fields relative to this project. Much appreciation goes to the staff at The Woolcock Institute for Medical Research who have been a pleasure to collaborate with and who have not only offered their expertise but, also their time in analysing results for the nasal monitors used in this study. In particular we would like to extend our special gratitude to A/Prof Brendon Yee, Dr Andrew Chan, and Ms Dianne Richards who were not only dynamic in our training sessions but, willing to do so during their scarce spare time. To other staff at the Faculty of Pharmacy, The University of Sydney for support and advice during this project, especially our IT support who always solved unpredictable problems. To the students that have helped with the development and implementation of this project. The research team wish to appreciatively recognise the provision of funding needed to undertake such an endeavour by the Pharmacy Guild through the Fourth Community Pharmacy Agreement, Research and Development Program. . This report was produced with the financial assistance of the Australian Government Department of Health and Ageing. The financial assistance provided must not be taken as endorsement of the contents of this report. The Pharmacy Guild of Australia manages the Fourth Community Pharmacy Agreement Research & Development which supports research and development in the area of pharmacy practice. The funded projects are undertaken by independent researchers and therefore, the views, hypotheses and subsequent findings of the research are not necessarily those of the Pharmacy Guild. 2 FINAL REPORT Acronyms Acronym Explanation Apnoea-hypopnoea Index. An index measuring the number of apnoeas and hypopnoea per hour AHI of sleep without considering oxygen desideration. BMI Body Mass Index CHD Chronic Heart Disease CPAP Continuous Positive Air Pressure ECG Electrocardiogram EDS Excessive Daytime Sleepiness EEG Electroencephalogram Epworth Sleepiness Scale– A scale of propensity for daytime sleepiness in eight situations on a ESS scale of 0-3 IRLS International Restless Legs Syndrome International Restless Legs Syndrome Study Group – An instrument for classification and IRLSSG frequency of RLS symptoms using 3 items based on diagnostic features for RLS and one item ascertaining frequency of symptoms Insomnia Severity Index – A measurement estimating the risk of having clinical insomnia using 7 ISI criteria and potential QOL impacts of insomnia on a scale 0-4 Multivariable Apnoea Prediction Index - Probability of a respiratory disturbance index of 10 or MAPI more that is weighted using three OSA symptoms (loud snoring, gasping, choking), BMI, gender and age. nCPAP Nasal Continuous Positive Air Pressure OSA Obstructive Sleep Apnoea OSAS Obstructive Sleep Apnoea Syndrome Pharmacy Access/Remoteness Index of Australia PhARIA The Pharmacy ARIA (PhaRIA) provides a pharmacy specific measurement of remoteness for over 13000 localities around Australia PSG Polysomnography – a multi-parametric test used as a diagnostic tool in sleep studies. Respiratory Disturbance Index - An index of severity of OSA that is often used interchangeably RDI with the AHI, although there are minor technical differences between the two indices. RLS Restless Legs Syndrome SaO2 Oxygen saturation levels. SD Standard Deviation. A statistical measure of the variability of a population. Sleep Disorders Australia. A voluntary organisation that provides information and support about SDA sleep. TM SPSS Statistical Package for the Social Sciences. A computer programme used for statistical analysis. 3 FINAL REPORT Table of contents Acknowledgments Acronyms Table of contents List of Figures List of Tables List of Appendices 1.0 Introduction ................................................................................................................................................ page 7 1.1 Common Sleep Disorders ............................................................................................................... page 7 1.1.1 Obstructive Sleep Apnoea (OSA) .......................................................................................... page 7 1.1.2 Chronic insomnia.................................................................................................................... page 8 1.1.3 Restless Legs Syndrome (RLS) ............................................................................................. page 8 1.2 The Diagnostic Spectrum ................................................................................................................ page 9 1.2.1 Sleep Diaries .......................................................................................................................... page 9 1.2.2 Questionnaires ....................................................................................................................... page 9 1.2.3 Diagnostic processes and devices ......................................................................................... page 9 1.2.3.1 Class IV – Single channel monitors .................................................................................... page 9 1.2.3.2 Class I – Polysomnography (PSG) ................................................................................... page 10 1.3 Screening for sleep disorders ....................................................................................................... page 10 2.0 PROJECT OBJECTIVES ........................................................................................................................ page 12 3.0 METHODS ............................................................................................................................................... page 13 3.1 Phase 1 ......................................................................................................................................... page 13 3.1.1 Screening tool development ................................................................................................. page 13 3.1.2 Development of screening/project protocols and materials ................................................. page 13 3.1.3 Development of the pharmacist sleep health education programme................................... page 13 3.2 Feasibility Study ............................................................................................................................ page 13 3.2.1 Recruitment of participants in the feasibility study ............................................................... page 13 3.2.1.1 Sample size calculation ..................................................................................................... page 13 3.2.1.2 Recruitment Study ............................................................................................................. page 14 3.2.2 Participating pharmacist feedback ....................................................................................... page 14 3.2.3 Feasibility Study Data Analysis ............................................................................................ page 14 3.3 Research design for final study (Phases 2 & 3) ............................................................................ page 15 4 FINAL REPORT 3.3.1 Recruitment of pharmacies and patients into the final study ............................................... page 15 3.3.2 PSG sub study ..................................................................................................................... page 15 4.0 RESULTS ................................................................................................................................................ page 16 4.1 Feasibility study ............................................................................................................................. page 16 4.1.1 Feasibility study: sample ..................................................................................................... page 16 4.1.2 Prevalence of sleep disorders in the feasibility study .......................................................... page 16 4.1.3 Process feedback ................................................................................................................. page 16 4.2 Final Study (Phase 4) .................................................................................................................... page 18 4.2.1 Pharmacist recruitment and training .................................................................................... page 18 4.2.2 Sleep Health Awareness Program ....................................................................................... page 18 4.2.3 Patient recruitment and general demographics ................................................................... page 18 4.2.4 Patient health and sleep related demographics ................................................................... page 18 4.2.5 Patient risk of having or being at risk of developing key sleep disorders ............................ page 21 4.2.6 Screening process ............................................................................................................... page 23 4.2.7 Screening efficiency, comparison of screening outcomes between groups ........................ page 24 4.2.8 Comparison of results from the PSG with the POTASH ...................................................... page 28 5.0 DISCUSSION .......................................................................................................................................... page 31 6.0 CONCLUSION ......................................................................................................................................... page 34 7.0 REFERENCES ........................................................................................................................................ page 35 8.0 APPENDICES .............................................................................................................. See separate document List of Figures Figure 1: Proportion of people with mild, moderate and severe OSA based on AHI readings from page 23 the FlowWizard in the comprehensive arm of the study Figure 2: Sleep related interventions delivered by pharmacists page 24 Figure 3: Screening process outcomes in both groups page 25 Figure 4: Proportion of people who reported instigating good health practices at follow up page 29 Figure 5: Impact on sleep health understanding page 29 5 FINAL REPORT List of Tables Table 1: Demographic and lifestyle profile of the screened population page 17 Table 2: General Health Demographics of the Groups page 19 Table 3: General Sleep Related Demographics of the Groups page 20 Table 4: Medication taking history for the two groups page 21 Table 5: Risk of having /developing a sleep disorder page 22 Table 6: Comparison of OSA risk scores using the MAPI vs FlowWizardin the comprehensive arm page 22 Table 7: Screening process efficiency in both arms of the study page 26 Table 8 Sleep Disorders Diagnoses reported by patients completing follow up page 27 Table 9: Comparison of the results from the POTASH testing and PSG testing in patient subset page 28 List of Appendices – See separate document Appendix 1 The Pharmacy Tool for Assessment of Sleep Health – Basic Arm page A3 Appendix 2 The Pharmacy Tool for Assessment of Sleep Health – Comp Arm page A22 Appendix 3 The validated instruments used in the screening tool page A40 Appendix 4 Sleep Health Awareness Campaign Poster page A41 Appendix 5 Screening Protocol – Basic Arm page A42 Appendix 6 Screening Protocol – Comprehensive Arm page A44 Appendix 7 Referral Templates – GP Referral Form page A46 Appendix 8 Referral Templates – Cover Letter page A47 Appendix 9 Sleep Health Awareness Campaign Shelf Tags page A48 Appendix 10 Refusals Tally page A49 Appendix 11 HREC Approval reference #: 06-2008/10765 page A50 st nd Appendix 12 Training Workshop 1 and 2 November 2008 – Learning Objectives page A52 st nd Appendix 13 Training Workshop 1 and 2 November 2008 – Program page A54 Appendix 14 FlowWizard® information page A56 Appendix 15 Close-Out Questionnaire page A58 th Appendix 16 Training Workshop 10 January 2009 - Program page A67 Appendix 17 Recruitment Strategies page A68 Appendix 18 Clarification regarding as to why Diagnostic Accuracy Test not done page A69 6 FINAL REPORT 1.0 Introduction Sleep is a complex neurochemical process essential in humans for the maintenance of health. The exact mechanisms of sleep are not fully understood at present but, it is known that sleep restores bodily function and has a role in cerebral 1,2 changes to facilitate memory consolidation and cognitive function. Furthermore, sleep has a close relationship with, 3 and can consequently influence cardiovascular, immune and hormonal diurnal cycles. Sleep disorders may cause a deficiency of sleep and this can impact on quality of life. Insufficient sleep may manifest as an increased demand for consolidated sleep and can be detrimental to daytime performance, through cognitive 3 impairment, and negatively impacting social and occupational functioning. With insufficient sleep the capability of the brain in concentration and memory is reduced and this may lead to social and occupational problems. Occupational 4 issues that may develop include absenteeism, loss of productivity, workplace accidents and motor vehicle accidents. In a published economic report, it was estimated that 1.2 million or 6% of the Australian population experience a sleep disorder to some extent with the most prevalent disorders being obstructive sleep apnoea (OSA), insomnia, restless 5 legs syndrome (RLS) and circadian rhythm disorders. This report estimated that sleep disorders account for AUD 10.3 5,6 billion (2%) of health expenditure, a magnitude comparable to national health priorities such as asthma and diabetes. Sleep disturbances accounted for 1.1% of general practice visits in 2006/07, a similar percentage to diabetes and 7 allergic rhinitis. 1.1 Common sleep disorders 1.1.1 Obstructive Sleep Apnoea OSA is a sleep-breathing disorder associated with the repetitive reduction (hypopnoea) or cessation (apnoea) of airflow due to upper airway instability and closure. These events cause arterial oxygen desaturation terminated by brief micro- 8 arousals and are associated with changes in cardiac rate and rhythm. The frequency of apnoea and hypopnoea episodes per hour during sleep is known as the Apnoea-Hypopnoea Index (AHI). (Note: Some researchers prefer to use the Respiratory Disturbance Index (RDI) which is the number of apnoeas plus hypopnoeas plus respiratory effort- related arousals and other respiratory events per hour of sleep.) An AHI value greater than 5 is used to define the 9,10 presence of OSA, while values greater than 30 are regarded as severe OSA. OSA with manifest clinical symptoms, (known as OSA syndrome or OSAS), is estimated to be prevalent in 2-4% of the population, while the prevalence of 10-12 AHI values greater than 5 is reported as 25% for men and 9% for women. There is no strong association between the AHI and presence of symptoms (and hence OSAS). The risk of OSA is increased in people with obesity, 11 hypertension and abnormalities in craniofacial anatomy. The failure in detecting OSA has been associated with significant morbidity and mortality. OSA has been identified as a 13-18 risk factor for hypertension, cardiovascular events and insulin resistance. A strong relationship has been established between diagnosed moderate-severe OSA and the risk of mortality (adjusted hazard ratio: 6:24) in a 19 population study conducted in Busselton, Western Australia. The clinical features of OSA are snoring, witnessed 11,20 apnoeas and momentary choking during sleep but these may not be exclusive. Often sleep partner observations of loud snoring and apnoeic events lead to a suspicion of OSA. The accepted diagnostic method is considered to be a polysomnography (PSG) (See section 1.2.3.2). The main current treatments for OSA treatment are either nasal continuous positive airway pressure (nCPAP) or mandibular advancement devices. The risk of non-fatal and fatal cardiovascular events with severe OSA (RDI > 30) 21 has been shown to decrease with the introduction of CPAP therapy. However, the full clinical benefits of these devices are often not achieved because of issues relating to inconvenience, poor tolerability and subsequently, non 22 adherence. At present, there is no evidence to support the efficacy of pharmacological treatments for OSA unless 22 used in the treatment of co-morbid conditions addressing obesity, cardiovascular disease and metabolic disorders. 7 FINAL REPORT 1.1.2 Chronic insomnia Chronic insomnia is defined as a difficulty in initiating or maintaining sleep, awakening too early, or the perception of 23,24 sleep deficiency on at least three nights a week for one month, despite having an opportunity for sleep. Insomnia can be considered both a symptom as well as a disorder. In previous studies, the prevalence of chronic insomnia varied from 5% to 15% and was dependent on the criteria used to classify insomnia, the population observed and 25,26 whether insomnia was considered as a primary disorder or secondary symptom. In a recent survey of 3300 adults 27 in NSW, it was found that whilst the prevalence of insomnia was 33%, only 11% of respondents had visited a doctor. The causes of primary insomnia are idiopathic, psychophysiological or paradoxical, while secondary insomnia may be 24 contributed to by a combination of sleep hygiene issues, psychiatric disorders, medical conditions or medications. Insomnia may be a symptom of other sleep disorders, such as obstructive sleep apnoea (OSA) and restless legs syndrome (RLS), or a symptom of other medical or psychiatric disorders including depression. Insomnia may be diagnosed on the basis of clinical symptoms and patient report, by examining sleep diaries maintained by patients, and by the use of validated questionnaires. A PSG is not required for the diagnosis of insomnia, unless it is undertaken to exclude other suspected sleep disorders. Despite the prevalence and costs incurred with insomnia, a large proportion of undiagnosed cases persist in the community. Often insomnia is not brought up as a problem in a regular consultation with a physician. For example, in the survey of adults in NSW, many 27 people with insomnia reported that they had self-medicated. It is important to identify insomnia and its root causes due to its association with psychiatric, respiratory and cardiovascular diseases, which may have been previously 28 subclinical and undetected . Strategies used in the treatment of insomnia vary in effectiveness. These include cognitive behavioural therapy and hypnotics such as benzodiazepine receptor agonists, sedating antidepressants and 24,29 antihistamines. In Australia, the benzodiazepine, temazepam is the most commonly prescribed hypnotic for the short-term treatment of insomnia. In 2006, the Australian Department of Health and Ageing reported a total of 2.7 30 million temazepam products dispensed at a total cost of $18.9 million to the community. Thus, insomnia poses a significant burden on the Australian community in economic, clinical and humanistic costs. In most cases, hypnotic agents are not expected to correct the underlying causes of insomnia, but provide temporary relief by increasing sleep propensity and duration during normal sleep time. The use of hypnotics is limited by tolerance, dependence, and the potential to cause residual sedation during the daytime. Hypnotic agents may also 24,31 worsen the severity of sleep breathing disorders such as OSA. It is important therefore that insomnia complaints are brought to the attention of health care professionals, and appropriate treatment initiated with discussion of the merits of the available treatment options. 1.1.3 Restless legs syndrome (RLS) RLS is a neurological sleep disorder characterised by limb discomfort at rest and the desire to move the affected limbs 32 to provide temporary relief. Risk factors include iron deficiency, renal impairment, neuropathy and pregnancy. RLS affects 3-15% of the population, with estimates varying depending on the classification of RLS by symptoms, severity 33-35 or frequency. Owing to low awareness of the syndrome in the community, RLS is often under diagnosed or not appropriately diagnosed. Sufferers are often unaware that effective treatments are available to alleviate symptoms and hence do not seek nor receive treatment. RLS is diagnosed on clinical criteria based on the characteristic symptoms, but additional information may be of use in the assessment, including the International Restless Legs Syndrome Group rating scale (IRLS), sleep partner observations, or through tests, which measure limb movement. RLS can lead to significant morbidity with strong evidence supporting the relationship between RLS with sleep disturbances and daytime sequelae. Patients with RLS often report difficulty in initiating and maintaining sleep (61%), limb pain (59%), 33 inability to stay motionless (55%) and suboptimal daytime functioning (19-43%). The first line treatment for RLS with strong evidence to provide significant improvement in symptoms and severity consists of the use of the dopaminergic 36,37 agents: levodopa, pergolide, pramiprexole, and ropinirole. Unfortunately, the effectiveness of these agents is limited by tolerance and an unfavourable adverse effect profile including nausea/vomiting, somnolence and recently 32,36,37 there has been publicity about disorders of impulse control (e.g. gambling). 8 FINAL REPORT The significant financial health costs of sleep disorders suggest that the investment in detection, prevention, and medical supervision is inadequate. For example, it has been estimated that 90% of individuals with OSA in the United 12 States are undiagnosed. The high proportion of those with unrecognised OSA may be attributed to limited accessibility of diagnostic services, such as polysomnography (PSG). In Australia, PSG is a costly procedure and 38 accounted for AUD 26.7 million (0.3%) of public healthcare spending in 2004. During this same time frame, there was a high demand for the procedure leading to waiting periods of 3 to 16 months, potentially compounding the impact of 39 sleep disorders on individuals affected. The supply and provision of CPAP equipment and advice can be sought 40 through many different avenues. Therefore, the fragmented nature of the healthcare system may lead to many individuals in society escaping detection and treatment for sleep disorders. 1.2 The diagnostic spectrum There are a range of techniques to detect sleep disorders including the use of sleep diaries, questionnaires, portable diagnostic devices, and polysomnography. 1.2.1 Sleep Diaries Sleep diaries are self-completed and can identify symptoms of insomnia and other potential areas of concern in sleep health and hygiene. The details of the previous night’s sleep, daytime sleep, daytime fatigue and medications are 8 recorded on a daily basis for a certain, prescribed time. When used in conjunction with a patient’s history and other diagnostic techniques, a diary can aid the clinician in detecting the symptoms and possible causes of the sleep disorder. 1.2.2 Questionnaires Questionnaires ascertain symptoms and/or risk factors involved in having a certain sleep disorder. Using questionnaires to detect sleep disorder risk is advantageous due to easier integration into a range of primary health care settings and with minimal disruption to the usual service provision. 1.2.3 Diagnostic processes and devices The American Academy of Sleep Medicine classify diagnostic procedures into various classes dependent on the 8 degree of complexity, instrumentation and need for supervision during a sleep study. The categories range from Class I which involves a fully attended PSG with all possible parameters monitored, to Class IV, which comprises an 8,41 unattended sleep study conducted at home with only 1 or 2 parameters monitored. Class IV devices include wrist 8 actigraphs, oximeters and nasal airflow monitors. As the degree of complexity and instrumentation decreases, the precision and accuracy of the procedure declines, but cost is reduced and of course, there is a less significant invasion 8,41 to the patient’s lifestyle. (Note: The number of parameters monitored by a device are referred to as ‘channels’, so if a device simply detects oxygen saturations levels, it is referred to as a single channel instrument). 1.2.3.1 Class IV - Single channel monitors Oximetry involves the monitoring of arterial oxygen saturation levels (SaO2) through an oximeter, usually attached on a palm digit. The role of oximetry in diagnosing sleep disorders is in measuring the frequency and severity of apnoea and 8 hypopnoea episodes during sleep in patients suspected of having OSA. Nasal airflow monitors measure the frequency of nasal airflow cessation during sleep. Such devices can be self- administered by the person and generally require from one to three nights monitoring. (NB: The device used in this study requires continual monitoring for at least 5 hours during sleep on 3 consecutive nights). After analysis, the output 41 score represents the AHI for the period of recording. Subsequently, the data collected from the monitor can be used 41 to determine the presence and severity of OSA. While the former two types of monitors are predominantly used to detect OSA, other monitors can be used to monitor the presence of sleep or wakefulness. Wrist actigraphy collects data on limb movements during sleep. The device is 9 FINAL REPORT 36 attached to the wrist on the non-dominant arm and the detection of movement is interpreted as the absence of sleep. Following total sleep time and the frequency of disturbances during sleep can be quantified from the actigraph. 1.2.3.2 Class I - Polysomnography (PSG) PSG is the gold standard diagnostic procedure in the categorisation of sleep disorders through the measurement of 8,42 cardio-pulmonary, neurological and skeletal muscle motor parameters. The PSG is performed in a sleep laboratory and involves the observation of brain wave activity through an electroencephelogram (EEG), pulse rate, arterial oxygen saturation (SaO2), electrocardiogram (ECG), nasal airflow, respiratory effort, and the movement of skeletal limb, ocular and facial muscles. Of all the diagnostic tests the PSG collects the most quantitative data on sleep and is used to 8 determine the presence and causes of varied and often non-specific sleep disorder symptoms. In contrast, diagnostic devices and procedures such as actigraphy, oximetry, nasal airflow monitoring provide limited quantitative data on sleep. The diagnostic services require patient effort in obtaining and using the device or the inconvenience of attending a sleep laboratory and are also more expensive compared to using for example, questionnaires. Most questionnaires have been validated for the purpose of detecting probability or measuring severity of a single sleep disorder. Validation has occurred in clinical populations, most commonly attending specialist medical care, or healthy populations (i.e. students). Questionnaires have rarely been tested in primary care settings, and almost never in a pharmacy population. Recently there has been an upsurge in home-based diagnostic services, which allow patients to utilise diagnostic devices or instruments at home. 1.3 Screening for sleep disorders The detection of sleep disorders is important to facilitate earlier diagnosis and delivery of treatment, reducing the impact on associated health and societal problems. There has been inadequate evidence on the effectiveness of models in specific primary healthcare settings for detecting sleep disorders. The community pharmacy is a feasible setting for screening and intervention services, compared to many other primary healthcare settings, due to higher public exposure and accessibility. Pharmacies are often the first point of entry into the healthcare system for individuals experiencing symptoms of sleep disorders and pharmacists are well placed to check medication profiles that may be suggestive of sleep disorders. In the past, there has been a range of successfully implemented screening systems for 43-46 cardiovascular risk, diabetes, and Chlamydia trachomatis in community pharmacy. However to date, there has only been one study examining screening for sleep disorders in the pharmacy setting. This screening project was reported from Switzerland, and involved a national sleep health campaign which was organised through community pharmacies. Participating Swiss pharmacists were trained to use an online screening 44 tool to detect and refer people with possible sleep disorders. The campaign had very positive outcomes, with about one fourth of the total population screened having been identified with risk factors and provided with referrals. An exploratory study surveyed a convenience sample of community pharmacists in the greater Sydney area of New South Wales, Australia, who were suppliers of sleep-related devices such as Continuous Positive Airway Pressure (CPAP) 47 machines. The pharmacists reported that current sleep health service provision was focussed on CPAP supply, however they were keen to address wider sleep health issues ranging from participation in public health and awareness campaigns, screening, and monitoring of patients with sleep disorders. In view of the pressing need to enhance the public and health professional awareness about sleep disorders and for testing novel prevention and management strategies, community pharmacies represent an ideal point of care testing site for people with sleep disorders. Including the pharmacist as a member of the sleep disorders care team offers the opportunity to expand the reach of services spanning screening, referral, monitoring and counselling for patients with sleep disorders or those at risk of developing them. As discussed above, there are major issues in the diagnoses and detection of sleep disorders in the community. Besides low levels of public and health professional awareness, it is well known that the diagnosis of sleep disorders is 48 difficult on the basis of clinical markers alone and hence even when a sleep disorder is suspected General 10