Otitis media is known to be associated with a significant burden of disease, particularly in early childhood (Monasta et al. 2012), yet access to specialist otolaryngology (ORL) services is often impeded by lack of capacity, medical shortages, and high demand (Yates 2001; Hofstetter et al. 2010; Caffery et al. 2016; Patil et al. 2016; Pokorny et al. 2019). The expansion of the scopes of practice of some healthcare workers by the substitution of a medical specialist or surgeon with a nonmedical healthcare worker is a concept that has the potential to reduce waitlists and wait times (Belthur et al. 2003; Blackburn et al. 2009; Walsh et al. 2014; O Mir et al. 2016), make better use of specialist skillsets, and reduce costs of service provision, all while providing conservative and appropriate treatment with improved or equivalent clinical outcomes (Hourigan & Weatherley 1994). Allied health practitioners working in these areas of expanded scopes of practice are known by a variety of terms including Consultant Practitioners, Specialist Practitioners, Extended Scope Practitioners, and Advanced Practitioners (McPherson et al., Reference Note 1; Ruston 2008; O Mir et al. 2018). Despite inconsistencies in terminology, there is general agreement that these roles encompass a more advanced clinical skill level, autonomous practice, and require additional training and competency (Government of Western Australia, Department of Health 2015).
There is a growing body of evidence to support the use of allied health practitioner-led services in adult services (particularly from the fields of physiotherapy and orthopedic surgical outpatient services) to manage nonsurgical patients independently through to discharge (Pearse et al. 2006; Blackburn et al. 2009; Bonanno et al. 2014; O’Farrell et al. 2014; O Mir et al. 2016; Wood et al. 2016). These initiatives report increased proportions of patients seen by the specialist who are then booked for surgery (surgical conversion rate) compared with traditional models (Boissonnault et al. 2010; Bath & Pahwa 2012; Homeming et al. 2012; Napier et al. 2013; Wood et al. 2016). In the field of ORL, physiotherapy- and audiology-led services for adults referred to ORL for the management of dizziness have resulted in approximately half of patients treated and discharged at a single appointment (Kasbekar et al. 2014) without requiring assessment or treatment by an otolaryngologist.
These examples in adult services suggest that similar success could be achieved in the closely aligned fields of audiology and ORL in the management of pediatric middle ear and hearing issues, a concept that has not previously been tested. It is common practice in large teaching hospital-based services for ORL outpatient clinics to be staffed by ORL specialists, trainee doctors undergoing ORL specialist training, and junior doctors with a range of experience and expertise. This structure allows a high volume of patients to be seen through the service while providing teaching opportunities for trainee and junior doctors. ORL outpatient clinics that are concerned with ear disease generally also require the support of audiology services in providing hearing assessment and diagnoses. Audiologists working independently in an expanded scope of practice to postoperatively review children receiving ventilation tubes (grommets) have been reported to reduce ORL workload by up to 54% (Davies-Husband et al. 2012); however, there have been no studies to date investigating audiologists providing first point of contact services for children referred to ORL services. Recently, we have reported that a first point of contact service led by audiologists with advanced training has the potential to provide significant benefits to the ORL service with up to 45% of semi-urgent outpatient pediatric ORL referrals meeting eligibility criteria to be diverted to an Advanced Audiology (AA)-led service, which could potentially result in an overall increase in ORL pediatric outpatient capacity of up to 77% (Pokorny et al. 2019).
In light of these potential benefits, the present study was undertaken to determine whether such an AA-led service colocated within the existing ORL outpatient service was able to provide a safe and effective triage service for children referred to pediatric ORL services with middle ear or hearing concerns and to compare the postoperative grommet care provided by these audiologists with advanced training to the standard medical ORL service. The primary aim of this study was to determine whether effectiveness (as measured by the proportion of children seen by the otolaryngologist that required surgical treatment, also known as the surgical conversion rate) was improved by using an AA-led service in a first point of contact triaging role. Secondary aims were to compare the two services after grommet insertion and to monitor safety of the AA-led service only (as measured by the number of recorded adverse events).
MATERIALS AND METHODS
This study was a prospective single-site clinical study comparing the current standard of care (existing ORL service) with a new AA-led service (intervention). The study was conducted in the ORL outpatient department of a large secondary hospital in Queensland, Australia. Recruitment of participants occurred from June 1, 2014, to March 30, 2015 (10 mo). Data were collected for all participants until January 31, 2018.
Services and Clinical Staffing
The pediatric ORL outpatient service was staffed by one senior otolaryngologist, two trainee doctors undergoing ORL surgical training, and up to five junior doctors. The senior otolaryngologist had over 30 years of pediatric ORL experience in Australia, South Africa, and the United Kingdom. This pediatric ORL service accepts referrals only from primary care providers and other medical specialists for all children with signs and symptoms of ear, nose, and throat disease and/or hearing, balance, breathing, or swallowing difficulties.
The AA-led service was colocated and ran independently, but concurrently, with existing ORL outpatient clinics. It was staffed by two experienced audiologists who had completed the training described later. Each held a Master’s degree in Audiology and had 5 to 10 years full-time clinical experience in hospital settings. Children who meet referral eligibility criteria were accepted into this service directly from the ORL pediatric outpatient waitlist and from inpatient theater services for postoperative grommet review. The eligibility criteria included the following: (1) from 2 years 4 mo to 17 years 0 mo of age; (2) reason for referral being middle ear, hearing, or speech concerns; and (3) routine grommet insertion (with or without adenoidectomy). Referrals for complex middle ear disease, otitis externa, diagnosed sensorineural hearing loss, or wax impaction are deemed unsuitable for the AA-led service and remained on the ORL waitlist to be seen by the standard medical service. Children younger than 28 mo of age were not eligible to be seen by the AA-led service due to the recognition of the greater complexity of middle ear disease and differences in guidelines for treating otitis media in younger children, as well as the difficulties assessing hearing thresholds in this younger age group (normally requiring two audiologists for the assessment process).
Audiology Competency Assessment and Training
A local, specific advanced training program for audiologists identified as experienced and highly skilled was incorporated into clinical practice. The training took place over a period of 6 to 12 mo, through clinical observation, theoretical and practical assessment (involving at least 40 new and postoperative grommet review ORL patients) overseen and supervised by a senior otolaryngologist. Formal competency sign off (in the room assessment) was conducted by the senior otolaryngologist followed by application for credentialing in advanced scope of practice (pediatric ORL services) through the Metro-South Credentialing and Scope of Clinical Practice Committee within Queensland Health. Audiologists at this facility who are credentialed and practice in this field are called advanced audiologists in recognition of the higher level of expertise and training required to provide these services.
A total of 131 children met the above referral eligibility criteria for referral to the AA-led service. These children were allocated to either the standard ORL service or the AA-led service. Working forward in chronologic order of referral date to the ORL waitlist, alternate eligible referrals were redirected to the AA waitlist to form the AA study group with those remaining on the ORL waitlist forming the ORL study group. Other than ensuring that referrals met inclusion/exclusion criteria, there was no other screening of referrals to determine study grouping. An exact 1:1 allocation ratio was unable to be maintained due to service-level demands and the known lengthy waiting times for ORL services in this facility as previously reported (Pokorny et al. 2019). This resulted in greater number of eligible referrals being redirected to the AA group instead of waiting for treatment through the standard medical ORL service.
Of the 131 eligible participants, 48 were allocated to the ORL service and 83 to the AA-led service. Informed consent was sought for inclusion in this study, and 4 participants from the ORL group and 7 participants from the AA group declined to allow their data to be included in the study. All of the participants allocated to the AA-led service were offered the option to decline this service and return to the ORL waitlist. No participants declined the provision of this service.
All children were provided with normal clinical care according to the service they were attending (Fig. 1). Children attending the ORL outpatient services received audiometry and tympanometry as a separate appointment (but usually within the same clinic) by the on-site general audiologist. Postoperative grommet review appointments usually also included a second separate appointment to include audiometry and tympanometry provided by the on-site general audiologist. Requests by junior doctors for second opinions from more senior ORL staff occurring within the single medical appointment were recorded in the clinical notes and defined in this study as “second opinion requests.”
The AA-led service provided video-otoscopy and all clinical testing within a single appointment. These tasks were completed independently or with the advice and/or assistance from the ORL medical staff present in the clinic. Requests for advice or assistance from medical staff occurring within the single appointment were recorded in the clinical notes and defined in this study as “second opinion requests.” The tasks of prescribing medications and booking children for surgery fell outside the audiologist’ scope of practice; however, they were able to refer directly to the otolaryngologist to be seen with high priority in a separate second appointment. All decisions for surgery bookings were made at the discretion of the treating doctor. In both services, the number of postoperative grommet review appointments and discharge schedule was at the discretion of the treating clinician (audiologist or ORL doctor).
All results and clinical diagnoses were recorded in the individual electronic medical charts.
Participating clinicians were not blinded; however, the participating children formed part of the normal clinical load of both services and were not easily identifiable by those providing treatment.
Data were extracted from the individual electronic medical charts including the following: (1) demographics: age, gender, and Aboriginal and/or Torres Strait Islander (ATSI) ethnicity (ATSI status); (2) service information: dates of appointments, surgery, discharge, and new referrals; and (3) clinical data: primary and additional clinician(s) seen/consulted, clinical test results, management plan, and surgery type. Clinical incidents and adverse events data were collected from the Queensland state-wide risk monitoring database (Riskman) for children attending the AA-led service. Study data were collected and managed using Research Electronic Data Capture tools hosted at the University of Queensland (Harris et al. 2009).
Categorical variables were described by frequency and valid percentages and analyzed inferentially using Chi-square testing for differences between the two groups. Continuous variables were analyzed for normality of distribution using Shapiro–Wilks testing at the 5% level. As multiple continuous variables showed significant breaches of normality, differences between the groups on these variables were assessed using nonparametric Mann–Whitney U testing. A binary logistic regression analysis was conducted to find any association between the likelihood of children who were seen by the otolaryngologist requiring surgery and the independent variables of group allocation (AA or ORL), gender (female or male), age at referral, and season at the time of referral (not winter or winter). Winter months were defined as June–August (southern hemisphere winter definition). Odds ratios were calculated with their 95% confidence interval for each independent variable. Variables with p < 0.05 were considered significant. All statistical analysis was performed using the Statistical Package for Social Sciences, version 25.0 (SPSS Inc, an IBM Company, Chicago, IL).
Ethical clearance was provided by the Metro-South Human Research Ethics Committee within Queensland Health (HREC/13/QPAH/688) and the University of Queensland Human Research Ethics Committee.
Of the 120 children enrolled in the study, 44 were offered initial appointments in the standard medical ORL service and 76 were offered initial appointments in the AA-led service. Two children from the ORL group and 3 from the AA group were subsequently removed from analysis due to diagnosis of permanent sensorineural or mixed hearing loss. Of the total number of appointments attended through the ORL service (134), 63% were seen by junior doctors and the remainder by the otolaryngologist or ORL trainee doctors.
There were no significant differences between the two groups for gender, ATSI status (p = 0.646 and p = 0.919, respectively), median age (p = 0.727 at referral and p = 0.297 at first appointment), and proportion that were booked for surgery and discharged from the service due to nonattendance or not requiring any treatment (p = 0.289) (Table 1).
Effect of AA-Led Service on Proportion of Children in ORL Clinic Proceeding to Surgery
Of the 115 children described earlier, 30 were discharged due to nonattendance and were removed from further analyses, leaving results from 28 children in the ORL group and 57 in the AA group. Thirty-three of the 57 (58%) AA group children were referred to the ORL clinic to be treated by the otolaryngologist. The proportion of this group who were subsequently booked for surgery (81.8%) was significantly higher (p = 0.035) than the proportion of children seen by the ORL service directly from the waitlist (57.1%), with the children from the AA group being 3.6 times more likely than children in the ORL group to receive surgery (Table 2).
Independent Management of Nontreated Children by Audiologists
Forty-two children (49.4%) were discharged back to primary care providers without any treatment provided in any of the attended appointments. Twenty-four of these children were discharged by the audiologists, 12 by junior doctors, and 6 by the otolaryngologist or ORL trainee doctors. Significantly more of these 42 nontreated children (p = 0.006) were discharged without the assistance of a second medical opinion when seen by the AA-led service (100%) compared with the ORL service (72.2%).
All 42 nontreated children either had audiometry conducted at discharge (n = 35) showing bilateral normal hearing (≤20 dBHL thresholds at 500, 1000, 2000, and 4000 Hz) and bilateral type A tympanogram variation (middle ear pressure ≤100 daPa; peak admittance ≥0.1 mL) and/or type C tympanograms (middle ear pressure ≥100 daPa), or alternatively, audiology was not conducted, but otoscopy was reported in the medical records as normal bilateral tympanic membranes (n = 6), or bilateral patent and in situ grommets (n = 1). None of these 42 children re-entered the service after discharge, up to 3 years later (monitored until the end of data collection, January 31, 2018).
Postoperative Grommet Review
Thirty children received grommets: 22 in the AA group and 8 in the ORL group. These children were reviewed postoperatively by the AA-led service (n = 13) or the ORL service (n = 17) with 2 children in the AA review group and 3 children in the ORL review group not attending any follow-up appointments and subsequently being discharged. A further 3 children in the ORL review group were under ongoing ORL review at the end of study data collection period, and 4 children from this group were discharged for nonclinical reasons. In total, 45 grommets were inserted and reviewed with audiometry, on at least one occasion. The majority (77%) of the postoperative grommet review appointments in the ORL service were conducted by junior doctors.
The median time from surgery to first postoperative grommet review (51.5 days for the ORL group and 51 days for the AA group) was not significantly different (p = 0.978); however, children in the AA group had significantly higher rates of discharge at the first review compared with children in the ORL group (91% versus 14%; p < 0.001), despite the majority of both groups having normal clinical results (Table 3; 10/14 for the ORL group and 9/11 for the AA group).
Of the 18 children discharged upon completion of treatment by the end of the study data collection (11 in the AA group and 7 in the ORL review group), the audiologists were more likely to discharge children without a second medical opinion (1-sec opinion requested; p = 0.002, Fishers exact test) compared with the ORL service (6-sec opinions requested; all of whom were discharged by junior doctors). One child who had completed treatment re-entered the system through a new referral within 6 mo of discharge by the AA-led service.
Follow-up results at approximately 18 mo after grommet insertion were obtained on 9 children in each group, either through specific recall after discharge or as part of ongoing clinic review. Of the 35 grommets inserted and reviewed at this time period (17 bilateral and 1 unilateral), 31 had extruded (with 2 residual tympanic membrane perforations), 2 were in situ and patent, and 2 were unable to be viewed due to wax obstruction. All children had normal hearing (defined as ≤20 dBHL threshold at all of 500, 1000, 2000, and 4000 Hz) in one or both ears, except for two in the ORL review group who had bilateral conductive hearing loss (≥25 dBHL).
Four (16%) of the 25 children reviewed after initial booked grommet surgery went on to require a second operation booked within the study data collection period (Table 4). The elapsed time from grommet surgery to end of data collection ranged from 224 to 1092 days with a mean of 826 days (approximately 2 years 3 mo).
There were no adverse events or serious clinical incidents recorded for any children in the AA group at least 2 mo and up to 3 years after discharge from this service.
This is the first study in the field of pediatric ORL service delivery to investigate an audiology expanded scope of practice providing care to children referred to ORL outpatient services with middle ear disease or hearing concerns. The majority of ORL outpatient consultations in this facility were provided by junior doctors under the supervision of more senior ORL specialists and trainee doctors, as is common in many teaching hospital facilities. Compared with the standard medical ORL service, the AA-led service functioned as an effective triaging service with higher rates of independent discharge of nontreated children and appropriate referrals to ORL of children requiring surgery.
Surgical Conversion Rate
The surgical conversion rate can be used to measure the effective use of surgical resources. In ORL practice (as in most surgical specializations), surgeons divide their time between outpatient and inpatient settings. In pediatric ORL, the majority of common procedures are conducted in an inpatient or short-stay surgical theater under general anesthesia (to ensure child safety) by ORL specialists, ORL trainee doctors, and junior doctors under supervision. It is important for health services to maximize the use of this specialized ORL skillset. The AA-led service described in this study was able to significantly improve the proportion of children seen for surgery by otolaryngologists from 57% to 82%, with children from the AA group being 3.6 times more likely than children in the ORL group to receive surgery. This effect was independent of age, season, and gender, and the large confidence interval for the odds ratio for participant group was thought to reflect the lower sample size and the large proportion of all children receiving surgery. The predicted flow-on effect is an improved utilization of specialist time in the outpatient setting. Similar improvements in the surgical conversion rates have been reported in orthopedic adult outpatient services using physiotherapy-led triage (Napier et al. 2013).
Management of Normal Children
A large proportion (49%) of children referred to the ORL service with middle ear disease or hearing concerns were assessed and discharged back to primary care with no requirement for medical treatment, suggesting that these children were able to be managed conservatively and/or were no longer symptomatic at the point of presentation. The present study demonstrated that audiologists working in an advanced capacity were able to independently discharge normal children without the assistance of a second medical opinion, whereas the junior doctors were more likely to request a second opinion at the discharge appointment. All children who were discharged without treatment had normal audiometry and normal tympanometry and/or otoscopy, and none of these children were re-referred to the service up to 3 years later, suggesting that they were correctly identified as not requiring ORL treatment. The impact of removing normal children in the older age range (over 28 mo of age) from the ORL outpatient workload by using an audiology-led triage service would likely increase the capacity of the ORL service to provide more timely medical and surgical treatment for the more complex younger children, as well as the medically complex cases, and subsequently this would improve learning opportunities for the junior doctors under supervision.
Postoperative Grommet Review
A secondary aim of the present study was to compare the services provided by the AA-led service versus the ORL service after grommet insertion, particularly given previous reports of the successful use of audiologists to reduce ORL workload for postoperative grommet review (Davies-Husband et al. 2012). Overall, the AA-led service provided an effective means of reviewing children who receive grommets and independently managing noncomplex cases appropriately. These conclusions were drawn from several findings.
In the present study’s small cohort of 25 children who were followed up after grommet insertion, much of the workload was noncomplex with normal clinical results. In addition, a large proportion of the ORL service postoperative grommet review workload was managed by junior doctors rather than senior otolaryngologists or ORL trainee doctors. The audiologists working in the AA-led service were significantly more likely to independently discharge children after grommet insertion with bilateral normal hearing and patent grommets, compared with the junior doctors who mostly sought a second medical opinion. In addition, almost all the children reviewed by the AA-led service were discharged at the first review appointment, compared with only 14% of those reviewed by the ORL service. This was despite the majority of both groups having bilateral normal hearing and grommets in situ and patent at this first review. Before the implementation of the AA-led service at the facility that hosted the present study, all postoperative grommet review appointments were conducted by the ORL service, and while the review schedule is at the discretion of the treating doctor, it would have been uncommon for discharge at the first review to occur.
Concerns regarding postoperative complications generally include the risks of granuloma formation, persistent otorrhea, early extrusion, and recurrent otitis media with effusion after extrusion requiring repeat set of grommets. The findings from this study demonstrated that 4/45 (9%) grommets were blocked or extruded early at a median follow-up time of 51 days. There were no cases of otorrhea at the first review appointment. These concerns were appropriately managed by the AA-led service by inspecting the ears of the children, providing counseling, written information, and instructions to the primary care provider for treatment of otorrhea, and providing an open access service for up to 12 mo after discharge whereby the child could be scheduled into the next available appointment upon request from the caregiver or any concerned doctor.
Of the children who attended a review at 18 mo after surgery, the majority of grommets had extruded, with only 2 out of 35 remaining in situ. Two children who saw ORL and no children who saw an audiologist had bilateral mild conductive hearing loss at this 18 mo review. Due to the episodic nature of otitis media throughout childhood, a certain proportion of the population is expected to develop recurrence after grommet extrusion. Of the 25 children reviewed after grommet surgery in this study, there were only 3 cases where a second ear-related surgery was booked within the study period with the period of time from initial surgery to the end of the study ranging up to almost 3 years.
The ability of the AA-led service to effectively review and monitor children who received grommets could reduce the number of normal clinical cases on the otolaryngologists’ workload. This would allow those otolaryngologists to focus on more complex cases requiring their specialized skillset.
The AA-led service was safe with no clinical incident or adverse events reported for any of its participants. The risk of misdiagnosis or inappropriate discharge was minimal with only one repeat referral from a primary care provider (with this child having normal hearing and bilateral in situ and patent grommets at the time of discharge), and no presentations to the Emergency Department for children managed by the audiologists in the AA-led service. Providing an AA-led service at the same time and location as ORL outpatient services (with a mutual understanding that ORL expertise is able to be sought as required) helps mitigate the concerns that ORL may have regarding safety. This study demonstrated that nontreated children and children with normal clinical results after grommet insertion were safely discharged without affecting ORL resources as medical opinions were generally not required. In addition, children suspected of requiring ORL treatment were appropriately referred with only small numbers assessed by the ORL as not requiring surgical treatment. Multiple studies in other health science fields have reported similar findings demonstrating that advanced practitioners are able to discharge patients independently and appropriately (Samsson & Larsson 2014; Wood et al. 2016; Chang et al. 2017) without adverse events in relation to the advanced scope services (Seabrook et al. 2019).
Audiology testing is an integral part of the assessment process for children referred with middle ear or hearing concerns, with the American Academy of Otolaryngology-Head and Neck Surgery recommending that hearing testing is performed by an audiologist for children who have persistent otitis media with effusion (> 3 mo) and for all children at risk of developmental or educational delays (Rosenfeld et al. 2016). A significant proportion of children referred for ORL services may in fact be asymptomatic at the time of assessment due to the transient nature of otitis media and the difficulties diagnosing hearing deficits in the primary care setting, particularly in young children. As best practice involves an audiologist in the assessment of these children, there is the opportunity to improve the utilization of the ORL skillset by extending the scope of audiologists with advanced training to assess and manage children not requiring treatment and children requiring routine review after grommet insertion. This study has shown that audiologists with this type of training are able to work effectively and can independently manage a substantial proportion of ORL outpatient referrals for hearing and middle ear disorders.
In more global terms, the shortages of ear and hearing specialists are most severe in low and lower-middle income countries (World Health Organization 2013) despite the incidence of middle ear disease being higher in these regions (Monasta et al. 2012). Task sharing is now being highlighted as a concept that may be beneficial in counteracting these service gaps (Mulwafu et al. 2017; Bhutta et al. 2019). Although there may be anecdotal reports to support the use of community health providers to improve access to ear and hearing care, the ability of nonspecialist health providers to independently assess and manage ear and hearing disorders has not been reported (Bhutta et al. 2019). This study provides the first evidence that specifically addresses this research gap and demonstrates the successful outcomes from using audiologists in a task-sharing role, albeit in a high-income population.
This study had a relatively small sample size with restricted participant follow-up which limits the generalizability of its results. Further investigation into the acceptability of the AA-led service to patients and stakeholders should include evaluation of patient satisfaction levels and long-term patient health outcomes.
An AA-led pediatric ORL service is a novel service delivery model that has been shown to improve the effectiveness of outpatient pediatric ORL services without compromising patient safety.
The authors thank Professor Elizabeth Ward for her advice and assistance in the early stages of the development of this project, Sally-Ann Schilt for her clinical input and oversight of the advanced audiology concept, and Arier Lee and Asad Khan for their advice on statistical analysis and interpretation.
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