Healthcare professional versus patient goal setting in intermittent allergic rhinitis

1.1. Allergic rhinitis 

In Australia it is estimated that by 2020 chronic disease will be responsible for 80% of the total burden of disease [1]. In response to this projected burden there is a need for more effective management involving the patient. Given the significant impact that chronic disease has on longevity and quality of life, research has focused on conditions such as diabetes, coronary heart disease and respiratory disorders. Consequently, very little attention has been paid to those chronic illnesses which, whilst having low mortality rates nevertheless result in significant morbidity and require regular self-management.

Allergic rhinitis (AR) is an inflammatory disorder of the nasal mucosa, in response to allergen exposure [2]. It is acknowledged as a global health problem of increasing prevalence. This has been the case in Australia, with 16% of the population currently diagnosed with AR. AR is classified either as ‘intermittent’, with symptoms lasting less than 4 or more weeks continuously in a given year or 4 or more days per week at a time, or as ‘persistent’ with symptoms lasting more than 4 or more weeks continuously in a given year or for 4 or more days per week at a given time [2]. Symptoms associated with AR include a watery, runny nose; sneezing, nasal pruritis and congestion [3]. However, the scope of the illness has been broadened to also recognise ocular, respiratory and even sleep disturbances as related symptoms [4].

AR can have a considerable effect on quality of life, leading to impaired performance of daily activities, cognitive function and classroom productivity, and reduced psychosocial well being [5]. AR also creates a significant economic burden: studies reveal substantial direct and indirect costs to the individual and the health care system in terms of consults, diagnostic tests, medication, management of co-morbidities and loss of work-related productivity [6], [7]. Not only can AR be a significant health issue on its own, but there is evidence supporting a strong pathological, physiological and epidemiological relationship between AR and asthma [2], [8], [9], [10]. Hence appropriate management of AR becomes increasingly important for those with co-morbid conditions.

A comprehensive approach to AR management includes early recognition of symptoms, use of symptom relieving or preventative medications, in combination with identification and avoidance, where possible, of allergens or triggers [2]. Given the wide range of readily available over the counter medications,1 patients do not always seek advice regarding their treatment or management of the condition, and up to two-thirds of sufferers do not consult a clinician for their current treatment [3]. Thus, the development of effective AR self-management techniques that can be facilitated by healthcare professionals (HCPs) would have important health as well as economic ramifications.

1.2. Self-management of illness 

Central to the concept of self-management of chronic illness is the role of the patient. A good knowledge of one's condition and treatment options, maintaining regular contact with relevant HCPs, active participation in decision making, and confidence in one's ability to undertake the tasks required to control the condition have been found to be key predictors of health in chronic conditions [11], [12], [13]. Patient self-management can be further enhanced by the HCP through information provision and regular, supportive feedback [12], [14], [15]. However, information provision is often based on clinical treatment guidelines and does not always match the goals of the patient.

Self-management of illness can be understood within the context of self-regulation of illness behaviour [13], [15]. This theory is based on the notion that self-generated thoughts, emotions and behaviour are planned and cyclically adapted to achieve personal goals. The more personal investment on the part of the individual, the more likely the behaviour will be carried out [15]. Related to self-regulation, self-determination theory [16] proposes that motivation to achieve health-related goals will be highest when these goals are derived from personal volition and choice, as opposed to being directed by the clinically relevant health outcomes [16], [17]. Studies have shown that personal volition and autonomy, and perceived competence are positively related to optimal health self-management behaviours, such as smoking cessation [18], medication adherence [19], and blood glucose control [17]. Recently, in Australia, two asthma intervention studies showed the positive impact of a patient-directed goal setting self-management program on asthma control. In these two studies there was a significant decrease in symptom severity scores and significant increase in quality of life scores when compared with control groups [20], [21].

Whilst contemporary research has highlighted the substantial self-treatment component of the condition, there is a paucity of data examining the self-management processes involved in AR. In addition to this, theories of self-management of illness behaviour have only so far been applied to those chronic diseases which require on-going, even daily, adjustments to behaviour in order to effectively manage the illness. Whilst AR can be a chronic condition, patients may experience regular symptoms episodically (for example, during spring time when pollen counts are high). This can be problematic for the patient in that the cyclical processes of behaviour modification required to manage episodes of AR may be interrupted by months of symptom free time. Therefore, it is not certain how principles of self-regulation of illness behaviour and its associated constructs apply with respect to intermittent AR, or how support by HCPs may benefit self-management of this recurrent yet episodic condition.

The aims of the current study were to conduct an intervention for the self-management of intermittent AR, with particular focus on HCP versus patient led goal setting processes. Specifically, we sought to answer two research questions: (1) Is there a difference between AR self-management goals and strategies that are self-selected and AR self-management goals and strategies that are provided by a HCP, on perceived symptom severity and quality of life? and (2) What differences are there in the types of AR-related goals and strategies set by those who self-select their goals and those who are given goals by a HCP which are based on clinical treatment guidelines?

2.1. Study design and intervention 

The study intervention was conducted in community pharmacies in metropolitan Sydney, NSW, Australia. The study was a mixed-method, parallel group design with random allocation of participating pharmacies into either Group A or Group B. The neighbourhoods that these pharmacies were located in were matched on resident income and education status. The pharmacies were members of the Quality Care Pharmacy Program (QCPP) and thus had a patient counseling area and two or more pharmacists on staff.

For each participant the intervention involved a series of three visits: baseline (V1), 1 week from baseline (V2) and 6 weeks from baseline (V3). For all participants, the visits consisted of a brief intervention by a trained pharmacist or pharmacy assistant on the pharmacy premises. The intervention focused on AR education, counselling on identification and avoidance of AR triggers, and setting goals and strategies for improving the participant's AR self-management.

At the initial visit, all participants were given information regarding the study, completed consent forms for participation and demographic information was collected. At all three visits a questionnaire that assessed the participant's experience with AR in terms of symptom severity and the effect of the condition on their quality of life was completed.

As part of the goal setting process for Group A participants (‘participant-set goals’ group) the pharmacist/assistant facilitated the participants to nominate a minimum one or two goals related to their AR that they regarded as personally relevant. They were then assisted to devise strategies in the form of actions they could take in order to achieve these goals. This information was recorded on a card by the participant titled “My Treatment Goals” which they kept for personal reference and brought to subsequent visits. At the completion of Visit 3 the card was returned to the pharmacist.

Conversely, as part of the goal setting process for Group B (‘pharmacist-set goals’ group), participants received a goals card titled “Your Treatment Goals”, on which two principle clinical treatment goals were stated: The first treatment goal was “Eliminate hayfever symptoms”, with room underneath for inserting the particular AR symptoms the patient was personally experiencing; the second treatment goal was “Avoid triggers”, under which were written the likely allergens that the participant described as triggering their AR. The respective strategies for achieving these symptom- and trigger-related goals were to take antihistamine tablets daily and appropriate trigger avoidance activities as outlined by the pharmacist/assistant. Participants in this Group also kept their goals card for personal reference, were required to bring it to their visits and return the card at the completion of Visit 3.

All participants were also provided with a brochure on AR symptoms, a pen and 1 week's free supply (i.e. 7 tablets) of an oral antihistamine. At the conclusion of Visit 2 they were supplied with a further 4 weeks supply of the same antihistamine and at the completion of the study at Visit 3, all participants received debriefing information regarding the study aims.

2.2. Pharmacist recruitment and training 

A convenience sample of pharmacists and/or pharmacy assistants were recruited from a University of Sydney database of pharmacies that had previously participated in asthma self-management research conducted by the Faculty of Pharmacy. All pharmacists and assistants were trained in the pathophysiology of AR, appropriate pharmacotherapy for the condition and in the concepts of patient self-management. As part of the training all general contraindications and critical issues pertinent to the use of each class of medications in AR were reiterated, using the Pharmaceutical Society of Australia's standards of practice for over the counter/non-prescription medications. Subsequently, the participants were separated into their respective study arms to complete the training session. Group A pharmacists were trained to guide patients to nominate their own goals for AR management and to outline strategies to attain these goals. Pharmacists did this by discussing with the patient those aspects of AR control which were currently problematic for the patient, regardless of their clinical significance. Pharmacists then prompted the patient to construct a clear, unambiguous goal relating to each aspect of the problem areas as nominated by the patient. Strategy development was similarly developed: the pharmacist prompted the patient to articulate what he/she could do to actually achieve the goal and these details were also written down on the Goals Card. A key component of the pharmacist training was the notion that these goals and strategies were derived from patient needs and resources, rather than imposed or directed by the pharmacist. Group B pharmacists were trained to provide the clinical goals for treatment of the participants and instruct them on appropriate strategies to achieve these goals.

2.3. Participant recruitment 

Each pharmacist/assistant was requested to recruit between 5 and 10 people to participate in the study. All people who entered the pharmacy were invited to join the study if they were currently experiencing symptoms of intermittent AR and were either requesting the brand of oral antihistamine used in the study or indicated that they had no preference for a specific antihistamine. Additional inclusion criteria were that participants were aged over 18 years of age, had a previous history of intermittent AR, presented in the pharmacy with symptoms of AR and were able to return for all follow-up visits. Participants were excluded on the following criteria: they presented with additional symptoms not likely caused by AR; inability to read, write or understand English; had previous allergy to antihistamines; pregnancy; terminal illness; or were previously involved in self-management research conducted by the University or any other AR study. Patients with no clear diagnosis of AR or symptoms not completely consistent with AR were excluded from the study, and pharmacists were encouraged to follow the standards of practice in referring these patients to appropriate avenues.

2.4. Measures 

Baseline demographics were collected from all participants at the initial visit, including name, age, gender, occupation, contact details and medical practitioner contact details. Also collected at this visit were details relating to their AR history, such as age of onset, symptoms they experienced, perceived causes, related conditions and treatments used in the past.

The Mini Rhinoconjunctivitis Quality of Life Questionnaire (Mini RQLQ©) was used as a measure of quality of life [22]. This is a validated questionnaire consisting of 14 questions answered on a 6-point Likert scale, which was completed by the patient at all three visits. Scores are calculated for the questionnaire's five sub-categories – impairment to daily activities, practical problems, nose symptoms, eye symptoms and other symptoms – as well as overall (total score).

Perceived symptom severity was assessed by participants at each of their visits by providing a score, out of 10 (where 10=as bad as symptoms could possibly be, and 0=no symptoms).

Goals and strategies for both groups were recorded on the goals card as well as copied verbatim in the pharmacist/assistant's data collection forms.

2.5. Data analysis 

All quantitative data were entered into the SPSS version 12.0.1 package for analysis. Group comparisons (age, AR-related symptom severity and quality of life) at baseline were assessed for significance using Student's t-tests. Changes within the groups and between groups over time were analysed using General Linear Model (GLM) with repeated measures analysis of variance.

The written goals and strategies were treated as qualitative data existing as a pre-structured case, presented in a clearly defined sampling plan (i.e. the goals card) [23]. All goals and strategies of Groups A and B participants were transcribed from the pharmacy data collection forms and cross-checked against participant goals cards. A thematic cross-case analysis of these data were then performed to compare the goals and strategies of each group. A variable-oriented approach was taken, which involved coding the goals and strategies into themes and tallying the number of responses occurring within the themes [23]. This process was completed by one researcher, then the interpretation and assigning of themes was discussed and cross-checked with two others in order to minimise potential researcher bias. The frequencies of goals and strategies occurring in these themes from the different groups were then tabulated in order to observe any similarities and differences (Fig. 1, Table 6).

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Fig. 1. Thematic analysis of participant goals. Results are expressed as a percentage of the total recorded goals per group (Group A=58 goals, Group B=162 goals). Nose symptoms include: Runny nose, Itchy nose, sneezing, nasal congestion and other nasal symptoms. Eye symptoms include: Itchy eyes, watery eyes, eye irritation and other eye symptoms. Sleep symptoms include: Fatigue, Sleep disturbance and somnolence. Other symptoms include: Headache, skin symptoms, blocked ears, itchy throat, wheezing, less infection and other symptoms (non-specific).

3.1. Pharmacist characteristics 

Eight pharmacists and one pharmacy assistant (each from different pharmacies) agreed to participate in the study and were allocated equally to the Group A or the Group B arm of the study based on the geographical location of their pharmacy.

3.2. Participant characteristics 

A total of 56 people agreed to participate in the study; 27 in Group A and 29 in Group B. At the end of the study 26 participants from Group A and 21 from Group B completed all three visits, representing 96% and 72% completion rates, respectively. Three participants from Group B left the study due to a severe reaction to the medication. Four others completed Visits 1 and 2 but did not return for the 6 week follow-up (Visit 3) and the remaining participant from Group B did not return after Visit 1. The Group A participant who did not complete the study did not return for the 6 week follow-up (Visit 3). The mean age of Group A participants was 37.2 (±17.7) years, which was significantly lower than that of Group B, which was 56.6 (±17.9) years (p<0.001). Both groups had similar proportions of males and females (p>0.05), with two-thirds of patients being female (Group A 36% male, 64% female; Group B 33% male, 67% female).

In regards to AR history, the majority of participants (77.8%) reported the onset of symptoms to have occurred from their teenage years (>12 years old) or later. Perceived causes of symptoms most frequently reported were weather (30%), grass/pollen (25%), dust (17%), dust mites (5%), change in temperature (5%) and colds (5%). At baseline, the most commonly described AR symptoms were runny nose (25%), sneezing (16%), blocked nose (10%), itchy eyes (10%), watery eyes (8%), headache (5%) and itchy nose (5%). The commonly used AR treatments prior to the study were antihistamines (48%), intra-nasal corticosteroids (20%) and nasal decongestants (15%). The most commonly associated conditions reported were sinusitis (36%), asthma (33%) and eczema (23%).

3.3. Quantitative data analysis 

3.3.1. Participant rated symptom severity 

At baseline there was no difference between mean perceived AR symptom severity scores in Group A and Group B participants (p>0.05) (Table 1). A comparison of perceived symptom severity scores between Visit 1/Visit 2/Visit 3 showed that for both groups there was a significant decrease in symptom severity scores over the study period (F2,40=57.35; p<0.001; partial η=0.74). There was also a significant interaction effect of time by group (F2,40=4.22; p<0.05; partial η=0.17), with mean perceived symptom severity scores of Group B (‘pharmacist-set’ goals) being significantly lower than Group A (‘participant-set’ goals) from Visit 1 to Visit 2 (F(1,46)=8.00, p<0.05, partial η=0.15).

Table 1. Mean scores and standard deviations (SD) for patient rated symptom severity

		Visits
		1	2	3
	A (n=23)	6.47 (1.42)	5.54 (1.69)	3.96 (1.68)
	B (n=20)	6.43 (1.83)	4.15 (1.18)	2.72 (1.80)

3.3.2. Quality of life measures 

At baseline there was no difference in the Total Mini RQLQ© scores between Group A and Group B participants (p>0.05) or in the Subscale Mini RQLQ© scores between Group A and Group B participants (p>0.05) (Table 2). Comparison of the Total Mini RQLQ© scores between Group A and Group B between Visits 1, 2 and 3 indicated that there was a significant decrease in scores in both groups (F(2,35)=27.43, p<0.001; partial η=0.61) (Table 4). However, neither group improved more than the other (F(2,35)=1.03, p>0.05).

Table 2. Mean scores and SD of Mini RQLQ© total scores [22]

		Visits
		1	2	3
	A (n=24)	2.67 (1.15)	1.87 (0.97)	1.43 (1.13)
	B (n=20–27)	2.85 (0.74)	1.65 (1.01)	1.02 (0.68)

Comparison of the Mini RQLQ® Subscale scores between Visits 1, 2 and 3 (Table 3) revealed that all subscale scores were significantly decreased over the study period (Table 4). Given this observed significant multivariate effect, further repeated measures analyses were performed for Visit 1/Visit 2 and Visit 2/Visit 3 (Table 4). This revealed a similar pattern of improvements over all time periods in both Groups with the exception of the Activities Subscale Visit 2/Visit 3 (p>0.05) and the Nose Symptoms Subscale at Visit 1/Visit 2 (p>0.05) (Table 4).

Table 3. Mean scores and standard deviations (SD) for Mini RQLQ© Subscale scores [22]

	Visit	QoL Subscale	Group A Mean (SD)	Group B Mean (SD)
	1	Activities	2.07 (1.31)	2.56 (0.88)
		Practical problems	3.36 (1.25)	3.71 (1.46)
		Nose symptoms	2.69 (1.62)	2.20 (2.02)
		Eye symptoms	2.48 (1.53)	2.38 (2.13)
		Other symptoms	2.28 (1.55)	2.48 (1.07)
	2	Activities	1.40 (1.04)	1.63 (1.23)
		Practical problems	2.34 (1.18)	2.29 (1.53)
		Nose symptoms	2.18 (1.08)	2.13 (1.62)
		Eye symptoms	1.76 (1.04)	0.98 (1.26)
		Other symptoms	1.84 (1.28)	1.59 (1.36)
	3	Activities	1.25 (1.08)	1.29 (0.98)
		Practical problems	1.61 (1.36)	1.32 (1.08)
		Nose symptoms	1.81 (1.03)	1.13 (1.19)
		Eye symptoms	1.35 (1.37)	0.43 (0.54)
		Other symptoms	1.39 (1.31)	0.83 (0.95)

Table 4. Repeated measures scores for Mini RQLQ© [22]

	Mini RQLQ® scores	Measure	d.f.	F	p-Value	η2
	Total†	V1/V2/V3	2,35	27.43	0.01	0.61
		V1/V2	1,44	51.78	0.01	0.54
		V2/V3	1,39	8.23	0.01	0.17
	Activities†	V1/V2/V3	2,42	14.53	0.01	0.41
		V1/V2	1,50	30.92	0.0	0.38
		V2/V3	1,44	2.00	0.16	0.04
	Practical problems†	V1/V2/V3	2,38	31.85	0.01	0.63
		V1/V2	1,47	41.41	0.01	0.47
		V2/V3	1,41	11.03	0.01	0.21
	Nose symptoms†	V1/V2/V3	2,41	5.96	0.01	0.23
		V1/V2	1,48	1.26	0.27	0.03
		V2/V3	1,43	11.30	0.01	0.21
	Eye symptoms* (Group A/Group B)	V1/V2			0.01/0.01
		V2/V3			0.01/0.01
		V1/V3			0.07/0.05
	Other symptoms†	V1/V2/V3	2,41	16.38	0.01	0.44
		V1/V2	1,48	21.07	0.01	0.31
		V2/V3	1,43	7.85	0.02	0.15

* Wilcoxon Signed Ranks Test. † General Linear Model (GLM) repeated measures multivariate analysis of variance.

As the data relating to the Eye Symptoms Subscale was found to have a non-normal distribution, a Wilcoxon Signed Ranks test was undertaken. Results indicated improvements between Visit 1 and Visit 2, and Visit 1 and Visit 3 for both Groups. However, whilst a significant improvement in these subscale scores between Visit 2 and Visit 3 was found for Group B (‘pharmacist-set’ goals), there was no improvement for Group A (‘participant-set’ goals) for this time period (Table 4).

3.4. Qualitative data analysis 

3.4.1. Goals and strategies 

Comparison of the total number of AR goals and strategies demonstrated that participants in Group B (‘pharmacist-set’ goals) recorded almost three times as many symptom- and trigger-related goals and twice as many trigger-avoidance strategies than Group A (‘participant-set’ goals) (Table 5). Results of the thematic analysis of participant goals are summarised in Fig. 1 and participant strategies in Table 6.

Table 5. Total number of goals and strategies recorded for Groups A and B

	Group (N)	Goals set	Strategies outlined
	A (26)	58	46
	B (29)	162	94

Table 6. Strategies recorded for Groups A and B

		Group A	Group B
	Avoid associated activities	1	6
	Maintain allergen-free home	1	6
	Avoid indoor allergens	1	3
	Avoid outdoor allergens	3	12
	Avoid temperature fluctuations	1	4
	Avoid specific allergens	1	5
	Protective clothing	2	13
	General measures	6	0
	Other	1	6
	Identify triggers	1	0
	Additional product use	2	8
	Take antihistamine	26	31

Total number of strategies: Group A=46, Group B=94.

4.1. Discussion 

To our knowledge, this is the first study that applies principles of self-regulation of illness behaviour in a commonly occurring and chronic, yet episodic condition. It was unclear whether or not self-management interventions would be of use in an intermittent condition with a large self-management component, as is the case in intermittent AR. This study indicates that there are advantages in this approach, as both study Groups improved after receiving interventions that fostered self-management techniques. Importantly, however, the results of this study suggest that, under certain conditions, HCP directed goals and strategies may be of more benefit than goals and strategies derived from personal choice.

The pharmacist/assistant-led approach (Group B), focussing on clinically relevant goals (symptom control and avoidance of triggers), contributed to greater improvements in perceived symptom severity compared to the pharmacist/assistant facilitating participant-nominated goals (Group A). The difference between the interventions taken in the two groups was that in Group B treatment goals were set by the pharmacist/assistant and tailored to the individual patient's symptoms and triggers, and they were partnered with appropriate strategies. In contrast, in Group A, patients were assisted in devising their own goals and strategies as relating to their perceived symptoms.

Results from studies incorporating the goal setting principles of self-determination in other disease states have supported the theory [24]. However, these theories have been modelled in disease states that are more chronic and disabling than intermittent AR, for example, diabetes and heart failure [17], [24], [25]. Therefore, self-regulation/self-determination theories of self-management of illness may be more applicable to more chronic, disabling conditions.

Qualitative analysis of the goal setting practices of Group A, as compared to Group B, showed that Group B (‘pharmacist-set’ goals) participants nominated far more symptom- and trigger- related goals and strategies compared to Group A (‘participant-set’ goals) participants. Research shows that a larger repertoire of goals and strategies is related to better self-management practices [26]. Furthermore, the strategies devised by Group A participants were couched in very general terms, resulting in poor formulation of specific activities needed to be undertaken to carry out the strategy.

Greater input of a pharmacist/assistant led to better identification of triggers and more specific strategies in Group B, suggesting that patients may benefit the most when they are provided, by the HCP, with organised and structured treatment goals and strategies which are tailored to their particular symptoms. In this way patient autonomy is activated but support is given to the cognitive process of self-management. Thus personal investment on the part of the patient may only be useful when the patient has the means to transform this into action. Other studies incorporating goal setting have focused on the need to record concrete and attainable goals. The reasoning is that specific planning of actions is needed to enhance goal-directed behaviour [21], [27], [28]. Applying this principle to the current study provides a possible explanation for the greater improvements in Group B participants, as they received more help in the planning of more specific and detailed strategies (i.e. process skills) required to achieve their goals.

These results should be interpreted with attention to the study's limitations. A convenience sample of pharmacists, who had previously participated in intervention studies, was used. Their motivation and interest in the enhancement of patient self-management may be greater than the general population of pharmacists/assistants. Both groups of participants received interventions to enhance self-management, and this may account for the lack of significant differences between the Groups on the quality of life measure. The overall improvements in self-reported symptom severity and quality of life found in both Groups is likely due to a combination of factors including taking medication, and the fact that the intervention resulted in both Groups receiving more contact time with the pharmacist/assistant than they would usually when experiencing an episode of intermittent AR. There was a significant age difference between groups at baseline and this may have contributed to the difference between groups in changes in symptom severity. Changes in the nose due to aging include structural, hormonal, mucosal, olfactory, and neural effects. Age differences therefore may have compromised improvements in measures of AR symptoms and/or quality of life.

To shed some light on these issues, further development of the study intervention could be applied to controlled trials with a larger sample size, including participants who have persistent as well as intermittent AR, and a measure of success in goal attainment. Intervention arms varying goal specificity and HCP input would help to clarify the relative importance of these two factors in the self-management process. An additional outcome measure – perceived competence (or self-efficacy) – should also be included, given the demonstrated role of this attribute in patient self-management [19].

4.2. Conclusion 

A self-management intervention for intermittent AR was developed and resulted in improvements in symptom severity and quality of life for the study participants. The results suggest that goal setting which reflects the clinical treatment aims for intermittent AR, coupled with HCP input into the goal setting provides more structure and hence better development of patients’ process skills.

4.3. Practice implications 

A brief intervention, which provides structured techniques tailored to patient symptoms, can enhance patient self-management of intermittent allergic rhinitis and improve symptom severity.