Preliminary effects of a regional approached multidisciplinary educational program on healthcare utilization in patients with hip or knee osteoarthritis: an observational study

Aniek A O M Claassen
Henk J Schers
Sander Koëter
Willemijn H Van Der Laan
C A L C Keetie
Kremers-Van De Hei
Joris Botman
Vincent J J F Busch
Wim H C Rijnen
Cornelia H M Van Den Ende
Preliminary effects of a regional approached multidisciplinary educational program on healthcare utilization in patients with hip or knee osteoarthritis: an observational study
10.1186/s12875-018-0769-7R E S E A R C H A R T I C L E Open Access
Background: Providing relevant information on disease and self-management helps patients to seek timely contact with care providers and become actively involved in their own care process. Therefore, health professionals from primary care, multiple hospitals and health organisations jointly decided to develop an educational program on osteoarthritis (OA). The objective of the present study was to determine preliminary effects of this OA educational program on healthcare utilization and clinical outcomes.Methods:We developed an educational group-based program consisting of 2 meetings of 1.5 h, provided by a physiotherapist, a general practitioner (GP) and orthopaedic surgeon or specialized nurse. The program included education on OA, (expectations regarding) treatment options and self-management. Patients were recruited through searching the GPs' electronic patients records and advertisements in local newspapers. At baseline and at 3 months follow-up participating OA patients completed questionnaires. Paired-sample t-tests, McNemar's test and Wilcoxon Signed-Rank test were used to estimate the preliminary effects of the program. Results: A total of 146 participants in 3 districts attended the sessions, of whom 143 agreed to participate in this study; mean age 69.1 years (SD10.2).107 (75%) participants completed both baseline and follow up assessments. The proportion of participants who had visited their GP in the 3 months after the program was lower than 3 months previous to the program (40% versus 25%, p-value 0.01). Also, we observed a decrease in proportion of patients who visited the physioand exercise therapist, (36.1% versus 25.0%, p-value 0.02). Both illness perceptions and knowledge on OA and treatment options changed positively (Δ-1.8, 95%CI:0.4-3.4, and Δ2.4, 95%CI:-3.0 --1.6 respectively). No changes in BMI, pain, functioning and self-efficacy were found. However, a trend towards an increase in physical activity was observed.Conclusions:Our results show that a multidisciplinary educational program may result in a decrease in healthcare utilization and has a positive effect on illness perceptions and knowledge on OA due to clear and consistent information on OA and it treatment options.Trial registration: Netherlands Trial Register (NTR5472). Registered 22 September 2015.

Background

Osteoarthritis (OA) is the most prevalent form of disability of posture and movement worldwide [1]. OA of the hip and knee is characterised by pain and stiffness which can impair daily functioning, and decrease physical activity [2]. This physical and accompanying mental burden influences the quality of life in patients with OA. Although there are no curative treatment options for OA, multiple effective non-surgical and surgical treatment options for reducing pain and improving movement ability and quality of life are available [2,3].

International guidelines recommend a combination of pharmacological and non-pharmacologic modalities as primary approach for hip or knee OA [2][3][4]. Non-pharmacological treatment modalities include psycho-educational interventions to improve self-management, physical activity and exercise therapy, and weight reduction. Recommended pharmacological treatment consists of the use of acetaminophen (paracetamol), the use of non-steroidal anti-inflammatory drugs (NSAIDs) or, when the patient is not responding satisfactorily to oral analgesic/anti-inflammatory agents, intra-articular injections [2]. Once non-surgical treatments become unsuccessful, joint replacement surgery is a cost-effective procedure that can be considered for patients with severe symptoms [3]. However, joint replacement surgery is advised to be postponed as long as possible, as the lifespan of prostheses are limited [2] and the results can vary [4].

In recent years the total number of hip and knee replacement surgeries increased with 50 and 196% respectively, especially in the age group of 75-85 years [5]. Possible explanations for this overall increase are ageing of the population and increase in obesity resulting in more people suffering from symptomatic OA. Despite recommendations, conservative treatment modalities in hip or knee OA are underused [6,7] while timely usage of these treatment modalities is advocated [8] and may prevent untimely surgery.

The underuse of conservative treatment can be caused by healthcare providers related barriers for recommending conservative treatment modalities. Research shows that outcome expectations about conservative treatment options differ widely among healthcare providers and the confidence in competencies of other healthcare providers is low [9][10][11]. As a result, patients with OA may not receive consistent information about effective, conservative treatment options. Receiving conflicting information is found to be associated with undesirable outcomes like non-adherence to treatment [12,13]. Therefore, information on treatment options and strategies should be disseminated from a joint perspective of healthcare providers.

In addition, patient related factors might also influence the use of treatment modalities. Some patients are not aware of what they can do themselves and what conservative treatment options can be offered for their OA [14]. Providing relevant disease-related and self-management related information helps patients to become actively involved in their own care process [15]. Moreover, negative beliefs or unrealistic thoughts about different treatment modalities by patients might also influence the choice of treatment [16]. A recent systematic review showed that OA patients have a negative attitude towards the efficacy of conservative treatment and tend to prefer surgical treatment [17]. This emphasises the importance that patients are aware of benefits as well as possible disadvantages of both conservative and surgical treatment options, in order to have realistic expectations [4]. During a regional conference in the area of Nijmegen, the Netherlands, healthcare providers from different disciplines involved in the care for people with OA decided to develop a patient educational program with a multidisciplinary approach to tackle above outlined barriers for suboptimal care.

The aim of this program was to increase patients' knowledge on OA, to stimulate self-management, to discuss benefits and disadvantages of treatment options, to promote the stepped care approach of treatments [8] and to provide consistent answers to frequently asked questions by patients. The objective of the present study was to determine preliminary effects of this OA educational program on healthcare utilization (HCU) and clinical outcomes.

Methods

Design and setting

An observational pilot study was performed in three districts in the Nijmegen area, the Netherlands, to evaluate a knee and hip OA educational program at baseline, and 3 months after finishing the course. In the period of October 2015 -March 2016, the program was organized 11 times (3-4 times per district). According to the Central Committee on Research involving Human Subjects (CCMO), this type of study does not require approval from an ethics committee in the Netherlands. This study was approved by the local Medical Research Ethics Committee, region Arnhem-Nijmegen (protocol number. 2015-2024).

Study population

Patients were eligible for the program when they were aged 18 years or older and had a clinical diagnosis of OA in the knee or hip (diagnosed by a general practitioner (GP) or medical specialist). Exclusion criteria were inability to read or understand the Dutch language, and previous joint replacement surgery. A maximum of 20 people (including patients and their partner or other significant person) could participate in each of the 11 planned programs, in order to facilitate group interaction. We aimed to include a total of 110-132 patients with knee or hip OA (10-12 patients per program).

Procedure

GPs' and physiotherapists in the three different participating districts and several orthopaedic surgeons in de region were informed about the objectives, background and content of the study. They were asked to offer eligible patients a flyer with information about the knee and hip OA educational program. Additionally, in each district the GPs also invited patients with an already known OA diagnosis by mail. In order to minimize selection bias we selected all patients with a diagnosis code for hip or knee OA in the GP's information system. GPs manually excluded patients who already had undergone joint replacement surgery or were not capable to understand the Dutch language. Moreover, an advertisement was placed in local newsletters and a local newspaper to invite patients. Once registered, a researcher checked eligibility of those patients.

After registration for the program, eligible patients received a letter with information of the study. By filling in a reply-card, patients could sign up for the program in their district. Participants received an additional information letter and an informed consent form, accompanied by a questionnaire on baseline characteristics and outcome parameters by mail, two weeks prior to the start of the course (T0). Three months after finishing the course, participants received a second questionnaire (T1) to assess the outcome parameters again.

Intervention

The organised knee and hip OA educational program consisted of two 1.5-h meetings. The program was led by a physiotherapist and a GP, both working in the district where the program was held. Additionally, an orthopaedic surgeon or orthopaedic nurse practitioner and when available a public health advisor attended the program. One of the healthcare professionals in each of the carried out meetings was part of the research team. They were asked to approach healthcare providers in their own district to help them carrying out the meetings.

The educational program was developed by an expert group working in the field of OA. The expert group consisted of 2 orthopaedic surgeons, 1 rheumatologist, 1 nurse practitioner, 3 physiotherapists, 1 GP and 2 physiotherapist-researchers. First an inventory of frequently asked questions (FAQs) about OA was made among local health professionals. Second, a prioritising exercise was used among OA-patients and health professionals to determine the most important FAQs. Finally, the expert group discussed and formulated answers to the 20 most important FAQs until consensus was reached. A detailed description of the process of inventory and prioritising of FAQs is described in Additional file 1. The content of the program was based on this structured inventory of informational needs and on consensus-based information addressing those needs. The FAQs and answers were incorporated in the course material. In line with current guidelines on education for patients with knee or hip OA [18], the program consisted of information on: OA and its disease course, evidence based tailored conservative treatment in a stepped-care format [8], and surgical treatment options. Moreover, education was given on outcome risks of treatment options and expectation management. This information provided patients with knowledge on where to find the (treatment) help they needed, at the time they needed it, with the appropriate expectations about this treatment. Additionally, the program included information on regional options to enhance self-management and physical activity, tips, practical assignments and mottos on OA.

To support the information given during the course, participants received a booklet consisting of information, monitoring forms, course handouts, the 20 FAQs, a pedometer and a list of useful websites, mobile applications and contact information of organisations.

Data collection Baseline data

At baseline, patients' characteristics were collected on: age, gender, the number of important comorbidities (ranging from 0 to 15) according to the Dutch Arthritis Impact Measurement Scales [19], living situation (alone / living with partner and/or family), education (low / high), ethnicity (native / foreign), employment (workless/paid work), duration of symptoms (< 1 year / 1-5 years / 5-10 years / > 10 years) and location of OA (hip and/or knee), and number of painful joints (including hip, knee, neck, back, shoulders, elbows, wrists, hands, ankle and feet).

Measurement instruments

Outcome parameters at baseline and 3 months follow-up were HCU, pain medication use, pain and functioning in daily living, illness perceptions, patient activation, knowledge, physical activity and patient satisfaction with the course. HCU was assessed with a self-developed questionnaire. Patients were asked which healthcare providers they visited in the preceding 3-month period related to their hip or knee symptoms (yes/no) and to indicate the number of visits to these healthcare providers.

In addition, to record the use of pain medication, participants were asked if they used (yes/no) pain medication (paracetamol / non-steroidal anti-inflammatory drugs (NSAID) / other (i.e. tramadol, morphine)) in the past 3 months regarding their hip or knee OA.

To calculate BMI (weight/height 2 ) weight and height were self-collected.

Two subscales of the Western Ontario McMaster University Index of osteoarthritis (WOMAC) were used to assess pain and limitations in functional activities. The WOMAC is a 24-item questionnaire, subdivided in 3 subscales: pain, stiffness and physical functioning [20]. WOMAC pain and physical functioning subscales were calculated and presented as normalized scores (0 to 100, with higher scores indicating less pain and better functioning).

Participants were asked to fill out the Dutch General Self-efficacy Scale (GSES) to measure self-efficacy [21]. The GSES has 10 items of which a total score can be calculated ranging from 10 to 40. With higher scores indicating higher self-efficacy.

The Brief illness perception questionnaire (IPQ) is a 8-item scale and was used to measure illness perceptions [22]. It measures patient's cognitive and emotional perceptions with respect to their OA. The maximum score on the Brief IPQ is 80, with higher scores reflecting more threatening view of the OA.

To assess patient activation, defined as patients' knowledge, skill, and confidence for self-management, the Patient Activation Measure (PAM-13) was used [23]. A total score can be calculated ranging from 13 (low confidence for managing own health and healthcare) to 52 (high confidence for managing own health and healthcare).

Physical activity was measured using the Short Questionnaire to Asses physical activity (SQUASH) [24]. The SQUASH consists of three main questions (days per week, average time per day and intensity) per activity-category (i.e. commuting activities, leisure-time and sports activities, household activities, and activities at work and school). A total activity score in min/week was calculated.

For the WOMAC, GSES, IPQ, PAM-13 and SQUASH a change of 20% was considered clinically relevant.

Based on identified frequently asked questions on OA in a previous study and consensus-based answers to those questions, 22 statements were formulated to test knowledge of participants on OA (and treatment). Each statement could be scored as: "I totally disagree", "Disagree", "Agree", "Totally agree" or "I don't know". A total score with a maximum of 22 could be calculated by awarding each correct response with 1 point. Each incorrect or undecided ("I don't know") answer was scored as 0 points.

Patient satisfaction was measured directly after finishing the course. Patients were asked how they overall rated the course on a scale from 1 to 10.

Statistical analyses

Baseline descriptive statistics were calculated as mean and standard deviation (SD), numbers with percentages (%) or median and Interquartile range (IQR). Changes over time in contacts with different healthcare providers were analysed using the exact McNemar's test and Wilcoxon Signed-Rank test. Difference between baseline and follow-up in secondary outcomes were analysed using the exact McNemar's test or Paired sample t-tests (two-sided). For all analyses a significance level of p ≤ 0.05 was assumed.

Results

Patient characteristics

In total 146 patients with knee or hip OA and 54 of their partners participated in the educational program. Overall mean rating of satisfaction with the program was 8.0 (range 1-10). A total of 143 patients agreed to participate in the present study, 107 (75%) participants filled out both questionnaires, 4 were considered drop-outs, as they did not come to the intervention and did not want to continue with the study. Two participants had undergone surgery during the follow-up period and did not feel like to continue. One did have knee OA, but as symptoms of her hand OA were more severe, she did not feel like filling out another questionnaire. All other 29 participants were lost to follow-up without providing a reason. We found no differences on baseline characteristics between drop-out/loss to follow-up and those who completed follow-up questionnaires. Despite the exclusion criteria, 17 participants reported to have had previous joint replacement. Sensitivity analyses showed no differences on HCU regarding surgical visits. Therefore, these participants were not excluded from analysis.

The average age of participants was 69.1 years (SD 10.2), with the majority being female (62.9%). Fifty-six percent of the participants had experienced their OA symptoms for less than 5 years. Patient characteristics are presented in Table 1. Table 2 shows the HCU during the 3 months before baseline and during 3-months follow-up. Most common were visits to a physio-or exercise therapist, GP and orthopaedic surgeon regarding knee or hip OA. A significant decrease in proportion of patients who visited the physioor exercise therapist and GP in the previous 3 months was observed. Although no changes in median number of contacts were seen, the total number of contacts increased. Small but non-significant changes in proportion of patients who visited a medical specialist were found. However, median number of visits to a medical specialist showed a small decrease, which was also seen in the total number of contacts in secondary care.

Healthcare utilization

Secondary outcomes

Changes in secondary outcomes are shown in Table 3. Illness perceptions changed positively (Δ-1.8; 95% CI: 0.4-3.4), and knowledge on OA and treatment options improved (Δ2.4 95% CI: -3.0 --1.6). No changes in BMI, pain, functioning, self-efficacy and patient activation were found. However, a trend towards an increase in physical activity was seen.

Discussion

Results of the present study show a decreased HCU, the proportion of patients having contact with a physio-or exercise therapist, or general practitioner decreased after following the educational program. We found an increase in knowledge on OA and patients' perceptions towards their OA changed positively after the course. No significant changes were found in BMI, pain and functioning, physical activity, patient activation and self-efficacy.

Overall, our results are in line with the Cochrane review on self-management programs of Kroon el al. [25]; we also did not find any changes on self-efficacy, pain and functioning. This review however, did not evaluate the effect of self-management programs on illness perceptions, OA knowledge and HCU. We believe that the changes in these parameters are relevant to patients. This is in line with a recent randomized controlled trial, evaluating the effect of a patient decision aid for patients considering joint replacement, (including patient education on treatment options, benefits and risks) that reported positive results on knowledge and illness perceptions [26]. This is important to ensure realistic expectations of treatment outcomes in patients with hip or knee OA, and ultimately, to support self-management in the long-term.

The primary outcome in the evaluation of educational and self-management interventions is under debate [27][28][29]. In the review by Newman et al. (2004) some included studies used outcomes that are not specifically targeted at the intervention. They concluded that this may decrease the overall effectiveness of educational self-management programs [27]. Similarly,  argue to critically choose outcome measures which are linked to those targeted for in the intervention, in order to prevent incorrect interpretation of effectiveness [28,29]. However, in general, multiple outcome dimensions are targeted in self-management interventions. As a result across studies a wide variety of outcome measures is used to evaluate self-management interventions. Usually, pain and/or physical functioning are the primary outcome measures [25]. However, it is questionable whether changes can be expected in these outcomes, when self-management programs are aimed at providing individuals with skills how to cope with symptoms, manage their disease in daily living and navigate the healthcare system [29]. Knowledge on disease management is not the same as changing your behaviour into actually doing it yourself. Therefore, knowledge is often used as a process outcome, and seems more appropriate as secondary outcome. In contrast, HCU is more a measure for behaviour. Based on previous observations that self-management interventions can result in changes in healthcare utilization [29][30][31] and the assumption that effective self-management ultimately impacts healthcare consumption our choice to explore HCU as primary outcome seems to be appropriate.

In our program we educated patients on what they can do for themselves, when to seek guidance for conservative treatment options and helped them to form realistic thoughts on the expected results of surgical treatment. Following this perspective, changes in HCU patterns could be expected. Our results showed a decrease in patients visiting primary care providers. However, only small non-significant changes in number of patients visiting secondary care specialists were found. Both observations may be explained by the short-term follow-up and small sample of our study. First, as we educated patients on what they can do for themselves (i.e. lifestyle advice on exercise, weight reduction and medication use), some patients may not have felt the need to visit a primary care healthcare provider on short-term, because they directly can put into practice what they have learned during  the program [32]. Second, it is possible that patients were already referred to secondary care previous to the intervention, resulting in no short-term changes in secondary care use. Besides, research has shown that education in combination with exercise therapy may postpone surgery in hip OA patients in the long term [33,34]. This emphasizes the desirability to study long-term results of our educational program in a larger sample.

Remarkably, the total number of contacts in primary care increased whereas the median number of contacts did not change. This finding may reflect the great variability in HCU between participants and specifically the   Paired sample t-test, two-sided *Significant for p-value ≤0.05 difference in treatment between healthcare professionals. For example, patients will visit their GP once or twice for OA within 3 months, whereas they may visit a physiotherapist once or twice a week. This can sum up to a total of 12-24 visits over 3 months. In the present study several patients started physiotherapy treatment 1-2 weeks prior to the intervention (1-4 visits in the previous 3 months) and continued this treatment after the intervention (> 10 visits in the 3 months post-intervention) (data not shown). This may have contributed to the increased number of total visits in our sample. However, the low number of participants and short-term follow-up of the present study do not allow firm conclusions on this aspect of HCU.

We chose a multidisciplinary approach; in both the developmental process as well as in the execution of the program. This approach is based on previous research which argues to focus on the communication between healthcare providers involved in OA treatment to improve prescription of non-surgical treatment options [9]. In the process of achieving consensus on the content of the program and answering frequently asked questions on OA, we targeted differences in beliefs among healthcare providers regarding the efficacy of non-surgical treatments [9,35] and clarified roles of different healthcare providers in the management of OA-patients [11]. Consequently, this resulted in clear and consistent information that could be disseminated during the course. This could explain the increased knowledge of patients after participating in the program. So far, little research has been done on the impact of consistency of information on self-management skills across settings and across disciplines for patients with osteoarthritis. In our opinion this is an important area for future research.

We chose to adapt the program to local context and patients preferences as it is known that adapting to local context positively influences knowledge translation [32,36]. We involved local health care providers in the development and the execution of the program to support the role that health care providers have in patients' treatment consideration [37] and offering patients options for local support. This may have contributed to the accessibility of the program and may have resulted that our educational program was highly valued by participants (satisfaction score 8 on a scale 1-10).

An important factor in the set-up of our program was the option for participants to bring their partner or a significant other person. Previous studies that focused on explaining reasons for underuse of conservative treatment, underline the importance of the social environment of patients to be involved their care process [9,37]. Involving a spouse in an intervention may even enhance self-efficacy and improve coping abilities [38], and improve physical activity levels in in OA patients [39]. Our results showed no improvement in self-efficacy after the intervention and only a small, but non-significant increase in physical activity. However, only one-third of the patients who participated in the educational program indeed brought their partner. Future improvements of our intervention should focus on ways to better involve patients' social environment [9].

This study has several limitations that should be taken into account when interpreting the results. First, the uncontrolled design of the study and the small sample size urges that conclusions drawn about the effect of the intervention should be taken with caution. In our study we examined short-term preliminary effects of a multidisciplinary educational program. However, a controlled trial with long-term follow-up is needed to further explore effects on HCU behaviour in patients with hip or knee OA. Second, we had a 25% loss to follow up, despite reminder letters. The overall high age of our participants might have contributed to the loss. Last, there may be a matter of selection bias. Although we tried to minimize this in our procedure when inviting patients for our study, we have no data available of patients who did not respond to our invitation to participate in our study.

Conclusions

Our results suggest that a multidisciplinary educational program, may result in changes in HCU and have positive effects on illness perceptions and knowledge in patients with hip or knee OA. These results indicate that patients may better understand and adjust their health seeking behaviour as a result of the program. Especially, the collaboration between health professionals from different disciplines, both in developing and executing the educational program, provides in adequate and consistent information on OA, treatment and self-management options. A randomized controlled trial with long-term follow-up with larger number of patients is needed to confirm these results.

-efficacy (10-40), mean (SD) 32.1 (5.9) 32.2 (5.6) 0.85 b PAM-13, patient activation (13-52), mean (SD) 39.3 (0.5) 40.1 (0.5) 0.15 b Knowledge on OA (0-22), mean (SD) 10.5 (3.7) 12.9 (3.1) 0.00 b * a Exact McNemar significance probability b

1: A detailed description of the process of inventory and prioritising of FAQs. (DOCX 18 kb) Abbreviations BMI: body mass index; FAQ: frequently asked question; GP: general practitioner; GSES: General Self-efficacy Scale; HCU: healthcare utilization; IPQ: Illness perceptions questionnaire; NSAID: Non-steroidal anti-inflammatory drug; OA: osteoarthritis; SQUASH: Short Questionnaire to Asses physical activity; WOMAC: Western Ontario McMaster University Index of osteoarthritis

Table

Table 2
2Changes in proportion of patients visiting different healthcare providers and total number of contacts with healthcare providers between baseline and 3 months follow-up (n = 107)Baseline
Follow-up

Contacted in last
3 months
n (%)

Contacted in last
3 months
n (%)

p-value a

Table 3
3Differences between baseline and follow-up on secondary outcome measures (n = 107 complete cases)Baseline
Follow-up
p-value

AcknowledgementsWe thank Gertie Schouten, Wilma Peters and Heleen Govers (patient representatives) for their contribution to the project group. We thankTanyaHoed), Nicole Blijleven (physiotherapist, Thermion) and Mark Loeffen (physiotherapist, Thermion) for their contribution as course leaders.FundingThis project was funded by the healthcare insurance company Coöperatie VGZ.Availability of data and materialsThe datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.Authors' contributions AAOMC, CHME and HJS participated in the design of the study. All authors participated in the development of the intervention. AAOMC carried out the data collection. All authors were responsible for the analysis and interpretation of the data. AAOMC and CHME were responsible for drafting the article, all other authors critical reviewed the article. Furthermore, all authors approved the final version of the manuscript.Ethics approval and consent to participate Ethical approval for this study was asked and waived the local Medical Research Ethics Committee, region Arnhem-Nijmegen (study no. 2015-2024). All participants gave written consent to participate in the present study.Competing interestsThe authors declare that they have no competing interests.
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Evaluation of a new patient consultation initiative in community pharmacy for ear, nose and throat and eye conditions

Gillian Hall
Tania Cork
Simon White
Hayley Berry
Louise Smith
Evaluation of a new patient consultation initiative in community pharmacy for ear, nose and throat and eye conditions
10.1186/s12913-019-4125-yR E S E A R C H A R T I C L E Open Access
Background: Community pharmacy Common Ailments Services can ease the considerable workload pressures on primary and secondary care services. However, evidence is needed to determine whether there are benefits of extending such services beyond their typically limited scope. This study therefore aimed to evaluate a new community pharmacy model of a service for patients with ear, nose and throat (ENT) and eye conditions who would otherwise have had to seek primary care appointments or emergency care. Methods: People with specified ENT or eye conditions registered with General Practitioners in Staffordshire or Shropshire who presented at participating community pharmacies were offered a consultation with a pharmacist trained to provide the service. The service included provision of relevant self-care advice and, where clinically appropriate, supply of non-prescription medicines or specified prescription-only medicines (POMs), including antibiotics, under Patient Group Directions. Patients received a follow up telephone call from the pharmacist five days later. Data were collected on the characteristics of patients accessing the service, the proportion of those who were treated by the pharmacist without subsequently seeing another health professional about the same condition, and patient reported satisfaction from a questionnaire survey. Results: A total of 408 patients accessed the service, of whom 61% received a POM, 15% received advice and medicine supplied under the common ailments service, 9% received advice and purchased a medicine, 10% received advice only and 5% were referred onwards. Sore throat accounted for 45% of diagnoses where a POM was supplied, 32% were diagnosed with acute otitis media and 15% were diagnosed with acute bacterial conjunctivitis. The number of patients successfully followed up was 309 (76%), of whom 264 (85%) had not seen another health professional for the same symptoms, whilst 45 (15%) had seen another health professional, usually their GP. The questionnaire was completed by 259 patients (response rate 63%) of whom 96% reported being very satisfied or satisfied with the service. Conclusions: The study demonstrates that pharmacists can effectively diagnose and treat these conditions, with a high degree of patient satisfaction. Wider adoption of such service models could substantially benefit primary care and emergency care services.

Background

Common or Minor Ailments Services provided by community pharmacies offer an alternative location for patients to receive advice and treatment, rather than seeking treatment from their GP, out of hours provider (OOH), walk-in centre or accident and emergency department (A&E). This is part of an ongoing health policy move towards upskilling community pharmacists to provide more clinical services for patients and as a means of managing the considerable workload pressures on GPs, A&Es and OOHs [1][2][3][4][5]. In 2016-17 there were 23.4 million attendances at A&E in England, which compared to attendances in 2015-16 is an increase of 2% and an increase of 22% since 2007-08 [6]. Similarly, GPs' overall workload was found to have increased by 16% between 2007 and 2014 [7], whilst a recent Kings' Fund report found an increase in face-to-face patient contacts with GP surgeries of 2% and an increase of 24.5% in patient telephone contacts in 2016-17 compared to 2014-15 [8]. Subsequently, the GP Forward View promoted the provision of evidence-based common ailments services from community pharmacies [9].

The evidence to date suggests that when common ailments are managed by community pharmacists most patients' symptoms resolve, few patients subsequently consult another health professional for the same condition and the cost of the pharmacist consultation is substantially lower than a consultation with a GP or attendance at A&E or OOH [10][11][12][13][14][15][16][17][18][19][20][21][22][23]. In a systematic review of 31 evaluations of minor ailment services, it was found that rates of symptom resolution ranged from 68 to 94% and reconsultation rates ranged from 2.4 to 23.4% [10]. A study published in 2015 compared the costs of consultations with community pharmacists with GP appointments and A&E attendances, and found the mean cost of community pharmacist consultations to be £29. 30, which was nearly a third of the mean cost of GP appointments (£82.10) and nearly five times less than the mean cost of A&E attendances (£147,09) [11]. In a study that determined costs from where patients said they would have gone had the common ailment service not been available, it was estimated that the service resulted in a substantial reduction in local health care costs [12].

The range of common ailments eligible for management under common ailments services previously evaluated in the literature varies considerably, but does not usually include conditions for which antibiotics or other Prescription Only Medicines (POMs) may be supplied for, except in a minority of services [22]. These services only appear to have included infective conjunctivitis and uncomplicated urinary tract infection where antibiotics could be supplied [22]. The limited formulary that pharmacists may supply medicines from under common ailments schemes has been previously reported to be a barrier to patient care [23], which suggests that extension of such services to include common conditions requiring supply of antibiotics and other POMs may be beneficial.

However, an evaluation of an extended common ailments service that includes conditions requiring antibiotics or other POMs does not appear to have previously been reported in the literature and so we report an evaluation of such an extended service for common ear, nose and throat (ENT) conditions and bacterial conjunctivitis. The evaluation aimed to assess the outcomes of the extended service in terms of patient reported satisfaction, patient uptake characteristics and the proportion of patients accessing the service who could be treated by the pharmacist without them subsequently seeing another health professional about the same condition.

Methods

Description of the service initiative intervention

The Pharmacy First Extended Care Service for ENT & Eye conditions aimed to provide eligible patients registered with a GP practice contracted to NHS England, Staffordshire and Shropshire Area (NHSE S&S) with access to medication via community pharmacies for the treatment of specified ENT conditions and for acute bacterial conjunctivitis not suitable for treatment under the Pharmacy First Common Ailments Service (PFCAS). The specific ENT conditions included were acute otitis externa, acute otitis media, acute bacterial sinusitis, chronic sinusitis, seasonal allergic rhinitis, and sore throat. These ENT conditions were chosen on the basis of being among the most common category of presenting conditions to the local A&E departments and the specific conditions being commonly occurring within the category. Acute bacterial conjunctivitis was included because analysis of PFCAS data indicated that it was a common reason for GP referral by community pharmacists.

Consenting patients had a consultation with a pharmacist where their symptoms and their medical and medication history were assessed (with reference to their Summary Care Record wherever possible). The pharmacist examined the patient, assessed their treatment needs and determined whether they met specific inclusion criteria to be managed under the extended care service. For patients who were included, pharmacists gave self-care advice (including what to do if their symptoms did not resolve or their condition worsened) and, where clinically appropriate, supplied non-prescription medicines either purchased by the patient or through the PFCAS. Where antibiotic treatment or other POMs appeared to be necessary the pharmacist supplied these under Patient Group Directions (PGDs) specific to each condition and the GP practice was informed. The antibiotic that could be supplied was specified in each PGD (with an alternative in case of allergy or other contraindication) at a fixed dose, frequency and duration of treatment. Antibiotic choices in PGDs complied with local antibiotic formularies to take account of local antibiotic resistance patterns. The service also allowed deferring antibiotic treatment, which meant that if the patient returned after waiting a pre-defined number of days, the antibiotic could be supplied without repeating the consultation.

As part of accessing the service, all patients agreed to be contacted by the pharmacist approximately 5 days after their consultation for a short telephone interview to follow up on how successful the treatment had been and whether they had since seen another health professional for the same condition.

The service started in late November 2017 and was provided through ten community pharmacies contracted to NHSE S&S that had signed the Service Level Agreement (SLA). These pharmacies were selected for the service on the basis of having responded to a call for expressions of interest and meeting pre-defined criteria. These included that the pharmacies had to have an accredited consultation area approved for delivery of advanced services (i.e. clearly signed as a private consultation area, where the patient and pharmacist can sit down together and talk at normal speaking volume without being overheard by staff or customers) and that two pharmacists from each pharmacy had completed bespoke, online and face-to-face training on diagnosis and management of the ENT and eye conditions. The training was developed and delivered by a team that included two GP trainers in examination skills and pharmacist facilitators. This included training pharmacists on recognising 'red flag' signs and symptoms potentially indicative of a more serious condition, diagnosis in vulnerable groups and how to use diagnostic equipment (otoscope, torch and digital ear thermometer). Participating pharmacies were supplied with the additional equipment necessary (e.g. an otoscope) and were able to provide the service to a limited number of patients each, based on the funding secured. The service was funded by the North West Midlands Urgent and Emergency Care Network, which included the training and supply of additional equipment, and project managed by Local Pharmaceutical Committees (LPCs). Additional top-up funding was awarded to the project by NHSE S&S Local Professional Network for pharmacy.

Data collection and analysis

The evaluation used two methods of data collection: PharmOutcomes to record service access data and a questionnaire survey as a means of collecting patient satisfaction data. PharmOutcomes was used as a means of collecting data about patient uptake and outcomes of the service because it is already used by community pharmacies in the study location to record and be remunerated for delivery of commissioned services. Recording modules can be written for this web-based system to match service specifications and PGDs, resources and links can be embedded into the system to allow the pharmacy team easy access to local documents and any relevant national guidance. Recording service delivery data on the system allows local and national level analysis on the effectiveness of commissioned services. All personally identifiable information was removed from the data downloaded from PharmOutcomes for the evaluation, but patient age, gender, ethnicity and the first part of their postcode were included. Anonymous patient satisfaction data were collected using a questionnaire because community pharmacy customers tend to be familiar with the format as it is commonly used by pharmacies and GP surgeries for gaining patient feedback. As a service evaluation, ethical approval was not required.

Questions were set up in PharmOutcomes for pharmacists to answer as consultations progressed to guide the consultation and ensure that standardised information was recorded. These questions were mapped to the SLA and PGDs. This included the outcome of pharmacists' consultations with patients in terms of supply of non-prescription medicine (either purchased or supplied under the PFCAS), as well as the diagnosis made and the numbers of those who were supplied with a POM, not supplied with any treatment or were referred.

For the follow up telephone interviews, pharmacists attempted to contact all patients who had received the extended care service to determine whether they had subsequently seen another health professional about the same condition within 5 days of seeing the pharmacist and, if so, which professional they had seen. This data was recorded in PharmOutcomes. Where patients had seen another health professional they were asked why and a free text response was recorded in PharmOutcomes. This data was thematically categorised and frequency counted.

Patients who received the extended care service were also given a pack containing an invitation letter, a patient satisfaction questionnaire and a pre-paid envelope. They were invited to complete the questionnaire anonymously and post it back to the pharmacy, or anonymously complete an online version. The questions were designed as fixed response rather than free text and were developed from standard questions used in numerous other evaluations according to the aims of the evaluation of the extended care service. These included whether patients would use the service again, or recommend the service to others, reasons for using the service, and how they found out about the service, as well as asking them to rate their satisfaction with the service they had received on a 5 point Likert scale.

Data recorded in PharmOutcomes were downloaded into a Microsoft Excel spreadsheet and anonymised before being sent to a researcher (SW) who was independent of the service delivery and administration. Questionnaire data was manually inputted into Excel. These data were subjected to descriptive statistical analysis.

Results

Service access data

A total of 408 patients accessed the service, of whom 247 (60.5%) were women and 161 (39.5%) were men. Patients accessed the extended care service between late November 2017 and 6th March 2018, at which point the total allocated number of patients had been reached. The majority of patients (323, 79.2%) selected White British as their ethnicity, with other White ethnic origins selected by 11 (2.7%) of respondents and 18 (4.4%) respondents selecting Black, Asian or Minority Ethnic groups. A total of 53 (13%) selected the 'prefer not to say' option about ethnicity. Table 1 shows the outcomes of consultations recorded in PharmOutcomes. The data indicates that for over 60% of patients this resulted in supply of a POM, whilst the remaining third of patients were managed with non-prescription medicines (also known as over the counter (OTC) medicines) and / or self-care advice, and only a small minority were referred for medical attention. The diagnoses made for those patients who were supplied with a POM are shown in Table 2, of which sore throat and acute otitis media were the most common. Table 3 shows the numbers and percentages of patients supplied with POMs for each indication and the numbers and percentages of deferred antibiotics.

Of the total of 408 patients who accessed the extended care service, 309 (76%) were successfully contacted by telephone approximately 5 days after their initial consultation. Of these, 264 (85%) reported that they had not seen another health professional. The other 45 (15%) patients reported that they had seen another health professional, which in the majority of cases (78%) had been a GP, but 11% reported having returned to the pharmacy and a small minority had seen a practice nurse (2%) or attended an OOH (2%). None of the patients had gone to A&E. The reasons reported by patients for this are shown in Table 4.

Patient questionnaire data

Questionnaire responses were received from 259 patients, which represents a response rate of 63%. There were nearly three times the number of female respondents (185, 73%) compared to males (65, 27%) and the mean age for women and men was 32 and 39 respectively. The age range for females was 0-77 and for 4-80 for males, indicating that parents or guardians completed the questionnaire on behalf of younger patients. Age or gender data were not recorded for 9 patients.

The vast majority of patients reported being very satisfied or satisfied with the service, with only 3 (1%) patients reporting being unsatisfied. The question was not answered by 7 patients.

In addition, 97% of respondents agreed that community pharmacies are appropriate places to provide the extended care service, 98% of respondents reported that they would use the service again and 99% of respondents reported that they would recommend the service to others. The reasons for using the service that were selected by respondents is shown in Table 5, of which not needing an appointment to access the service was the most frequently chosen.

In terms of how respondents had found out that the extended care service was being provided, 61% of respondents reported finding out from their GP surgery, 29% from a community pharmacy providing the service and 7% from word of mouth.

Discussion

Key findings from this study include that the majority of eligible patients' ENT or eye conditions could be treated by the pharmacist without them subsequently seeking care from their GP, or an OOH or A&E for the same  condition and that patient-reported satisfaction with this extended common ailments service was extremely high. Nearly half of all patients who accessed the service presented with sore throat and approximately a third had acute otitis media. Over 60% of patients seen were supplied with an antibiotic or other POM. The small proportion (15%) of patients who reported seeing another health professional for the same condition after the consultation with the pharmacist usually saw their GP and if not because they had been referred to the GP by the pharmacist, then they most likely did so because their symptoms had not resolved, despite an initial course of antibiotics. The high degree of patient satisfaction was evident in their overall satisfaction rating, but also in the very high proportion who indicated that they would use the service again and recommend it to friends and family. Being able to access the service without an appointment seemed to be a key factor for using it, but being aware that the service was available was also important and previous studies have shown low awareness among the general public about the availability of consultationbased services from community pharmacies [24]. The high proportion of patients (61%) who reported finding out about the service from their GP surgery suggests that surgeries were actively signposting patients to the service and that this may have been a major reason for its success.

This study adds to what is already known about community pharmacists being able to effectively   undertake patient consultations and reduce workload pressures on GPs and A&Es. Previous studies of common ailments services have shown that despite variation in service quality [25], community pharmacists can effectively treat eligible conditions, with low reconsultation rates [10][11][12]26] and high patient acceptability [27][28][29]. The Pharmacy First Extended Care Service for ENT and Eye conditions included infective or chronic conditions that have not been included in previous types of common ailment service. Exceptions to this have included bacterial conjunctivitis treated with chloramphenicol eye drops which has been included in a minority of services [22], and a feasibility study of community pharmacy screening and treating streptococcal sore throat with antibiotics has also been reported [26]. This significantly adds to the range of conditions that can be diagnosed and treated in community pharmacies.

Previous studies have shown that common ailments services cost less than GP appointments or A&E attendances [10-12, 16, 18]. It was beyond the scope of this study to undertake a full economic evaluation of the Pharmacy First Extended Care Service for ENT and Eye conditions, but the service did appear to reduce GP and A&E workload, and so savings were likely to have been made as the majority of patients would otherwise have had to see a GP or attend an OOH or A&E for antibiotic treatment.

The key strength of this study is that it reports on a substantially extended model of a common ailments service, which requires pharmacists to have advanced clinical examination skills, using diagnostic equipment such as otoscopes. This is an important step in the further development in the management of common ailments in community pharmacy, especially as the conditions covered in the service were broadly included in a list of ailments appropriate for management in community pharmacy recently developed using consensus methodology, which supports the rationale for their inclusion [30]. Developments of this nature are all the more important as many areas in England have now decommissioned their traditional common ailments services following publication of recent guidance from NHS England on OTC products that should not be routinely prescribed in primary care [31]. This guidance includes products used for minor ailments and applies to patients who are exempt from paying prescription charges who may no longer be able to be supplied with these products under common ailments services unless their minor ailment meets specific criteria.

A weakness of the study is that the majority of patients who accessed the service reported themselves to be White British and so it is not known whether similar results would be found in a more diverse patient population. Other limiting factors include that the pharmacists had to express interest in order to participate and so may have been more motivated to provide the service than may be found if the service were more widely rolled out. The service requires appropriately trained pharmacists and participating pharmacies to have appropriate facilities, including appropriate diagnostic equipment, which has a cost implication for wider roll out. Successful implementation also requires patients to be aware that the service is available, but the findings of this study suggest that this can be effectively done by GP surgeries actively signposting patients to it.

However, whilst the data presented here suggest benefit for patients, as well as workload pressure reduction for GPs, evaluating the full benefit for patients and the health economy of any wider uptake of the service would require an appropriately designed clinical trial, with economic evaluation. A feasibility study would likely be needed first to refine the conditions to include in the service and identify viable primary and secondary outcomes to determine the effectiveness of the service. The economic evaluation should include clinical and humanistic outcomes in addition to economic outcomes [32]. Qualitative exploration of community pharmacists' and GPs' perspectives on the quality of the service provided might also yield useful insights.

Conclusions

The study demonstrates that pharmacists can effectively treat these specific ENT and eye conditions, with a high degree of patient satisfaction and a low proportion of patients subsequently seeing another health professional for the same condition. This extends what is already known about community pharmacists being able to effectively undertake patient consultations and reduce workload pressures on GPs and A&Es. Wider uptake of this service model would be expected to be beneficial for patients and the health economy, but this would need to be confirmed by an appropriately designed clinical trial with economic evaluation. This may represent a natural evolution for community pharmacy common ailment schemes and further integrate pharmacy into multidisciplinary primary healthcare provision.

Abbreviations A&E: Accident and Emergency Department; ENT: Ear, nose and throat; GP: General (medical) practitioner; LPC: Local Pharmaceutical Committee; NHSE S&S: National Health Service England, Staffordshire and Shropshire Area; OOH: Out-of-Hours (medical service); PFCAS: Pharmacy first common ailments scheme; PGD: Patient Group Direction; POM: Prescription only medicine; SLA: Service Level Agreement

Table 1
1Patient outcomes from pharmacist consultationsOutcomes
No. (%)

POM supplied
249 (61)

Advice + OTC medicine supplied via PFCAS
60 (15)

Advice only (no medicines supplied)
41 (10)

Advice + OTC medicine purchased
38 (9)

Onward referral
20 (5)

Total
408 (100)

Table 2
2Indications for POMs suppliedOutcomes
No. (%)

Sore throat
112 (45)

Acute otitis media
79 (32)

Acute bacterial conjunctivitis
36 (15)

Acute bacterial sinusitis
16 (6)

Acute otitis externa with suspected secondary infection
3 (1)

Chronic sinusitis
3 (1)

Total
249 (100)

Table 3
3The number of patients supplied with POMs for each indication and the percentage of deferred antibioticsIndication for POM supply
POM supplied
No. & % patients treated for
that condition

Acute bacterial conjunctivitis
Chloramphenicol eye drops 0.5%
29 (80%)

Chloramphenicol eye drops 0.5% (deferred)
1 (3%)

Fusidic acid eye drops 1%
6 (17%)

Fusidic acid eye drops 1% (deferred)
0

Acute otitis externa with suspected secondary infection
Clioquinol and flumetasone ear drops
3 (100%)

Acute otitis media
Amoxicillin
66 (84%)

Amoxicillin (deferred)
9 (11%)

Clarithromycin
4 (5%)

Clarithromycin (deferred)
0

Acute bacterial sinusitis
Doxycycline
14 (88%)

Doxycycline (deferred)
0

Clarithromycin
2 (12%)

Clarithromycin (deferred)
0

Chronic sinusitis and seasonal affective rhinitis
Beclometasone nasal spray 50mcg
3 (100%)

Sore throat
Phenoxymethylpenicillin
93 (83%)

Phenoxymethylpenicillin (deferred)
5 (4%)

Clarithromycin
14 (13%)

Clarithromycin (deferred)
0

Table 4
4Reasons reported by patients for reconsultationsReconsultation type
Reason
No.

For GP appointments
Symptoms did not resolve
11

Was referred at initial pharmacist
consultation

8

Appointment already booked
for another matter

7

Developed more serious illness
4

Wanted second opinion
2

Needed sick note
1

For practice nurse appointment Consulted for additional matter
1

For returning to the pharmacy Symptoms did not resolve
3

For going to an out-of-hours
service

Adverse reaction to antibiotic
1

Total (reason unknown for 7 patients)
38

Table 5
5Reasons selected by patients for using the extended
care service

Reasons
No.

No need for an appointment
207

Did not have to wait for GP appointment
169

Close to home
150

Convenient opening times
134

Convenient location (near work / shops)
77

AcknowledgementsPeter Prokopa (South Staffordshire LPC), Lynne Deavin and Lindsey Fairbrother (Shropshire LPC) were involved in the design and implementation of the intervention. Andrew Pickard (NHSE S&S) allowed usto use an NHSE service specification and facilitated the preparation and authorisation of the various PGDs.FundingThe Pharmacy First Extended Care Service for ENT and Eye conditions was funded by the North West Midlands Urgent and Emergency Care Network. Additional top-up funding was awarded to the project by NHSE S&S Local Professional Network for pharmacy. The funders had no role in the design of the study, the collection, analysis and interpretation of data or in writing the manuscript.Availability of data and materials All data generated or analysed during this study are included in this published article.Authors' contributions GH and TC were involved in the design and implementation of the intervention. A team, including HB, LS and GH, developed and delivered the pharmacist training, and SW advised on the design of the evaluation. SW analysed the data, with support from GH and TC. All authors discussed the results and interpretation. SW drafted the initial text of the manuscript, with support from GH and TC. All authors were involved in revising drafts prior to submission and all approved the submission.Ethics approval and consent to participateEthical approval was not required because the study was a service evaluation. This was confirmed by the Chair of the School of Pharmacy's Research Ethics Committee. The study involved analysis of anonymised, routinely collected data and at the time of their consultation with the pharmacist, patients verbally gave their consent for collection and analysis of anonymised data about their use of the service. Pharmacists were required to confirm on PharmOutcomes whether patients had given consent, rather than asking patients to sign a consent form. This was done to allow an independent check to be made that consent had been given without revealing personally identifiable information about patients.Consent for publicationNot applicable.Competing interestsThe authors declare that they have no competing interests.
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