Clinical and psychological outcome from a randomized controlled trial of patient-initiated direct-access hospital follow-up for rheumatoid arthritis extended to 4 years

J. R. Kirwan, K. Mitchell, S. Hewlett, M. Hehir, J. Pollock1, D. Memel2 and B. Bennett3

Academic Rheumatology, University of Bristol Division of Medicine, Bristol Royal Infirmary, Bristol,
1 Faculty of Health and Social Care, University of the West of England, Glenside Campus, Bristol,
2 Air Balloon Surgery, Bristol, and
3 Directorate of Medicine, Bristol Royal Infirmary, Bristol, UK


    Abstract
 Top
 Abstract
 Introduction
 Method
 Results
 Discussion
 References
 
Background. Patients with rheumatoid arthritis (RA) are traditionally seen regularly as out-patients, irrespective of whether it is appropriate or timely to see them. A randomized controlled trial has shown that over 2 yr, seeing patients only when they or their general practitioner (GP) request a review saves time and resources and is more convenient. This study aimed to assess clinical and psychological outcomes when the trial was extended to 4 yr.

Method. A total of 209 patients were randomized into either ‘routine review’ (control) or ‘no routine follow-up’ but access to rapid review on request (direct access). Clinical and psychological status and patient satisfaction and confidence were reviewed after 24 and 48 months.

Results. Mean age at entry was 56 yr and mean disease duration 11 yr, and 134 patients remained in the study after 48 months. There were no differences between the groups, nor between those who completed the study and those who did not. There were no major differences in clinical or psychological status between the groups at 24 or 48 months. However, self-efficacy for function was stronger at 48 months for direct access patients (mean 64.0 vs 52.0, P=0.005), as was self-efficacy for other symptoms (mean 67.8 vs 59.3, P=0.009). Satisfaction at 48 months was increased in direct access compared with control (mean 8.7 vs 7.6, P=0.01) as was confidence in the system (8.9 vs 7.6, P<0.01).

Conclusion. It is effective for patients with rheumatoid arthritis to have no regular follow-up, provided they have access to rapid review when they or their GP request it. Patients using a self-referral system of care had higher self-efficacy and greater satisfaction and confidence than those using the traditional system.

KEY WORDS: Self-efficacy, Out-patient appointments.


    Introduction
 Top
 Abstract
 Introduction
 Method
 Results
 Discussion
 References
 
Rheumatoid arthritis (RA) is a chronic, variable disease requiring a continuing long-term programme of follow-up care [1]. While patterns of hospital review vary, patients are traditionally seen in an out-patient department on a regular basis (every 3–6 months). Follow-up review of RA patients accounts for up to 75% of rheumatologists' workload [2]. Therefore, these clinics are heavily booked in advance and inflexible, making it difficult to accommodate requests for urgent appointments for disease deterioration. Furthermore, routine appointments may be occurring irrespective of whether they are appropriate or timely. Thus patients are often seen when they are relatively well and require no medical intervention but cannot be seen quickly when they do need intervention. This leads to frustration and disappointment for both patients and health care professionals.

We therefore undertook a 2-yr randomized controlled trial of traditional out-patient care compared with a system of patient- or GP-initiated direct access to specialist services [3]. This found that patients' health was well maintained, their satisfaction and confidence improved and the cost of health care delivery substantially reduced. While this relatively short-term study showed a favourable outcome, the question of long-term effectiveness and benefit remains to be addressed. As one of the outcome measures of our initial study, patients in the direct access group were offered the opportunity to continue in that pattern of care, and all opted to do so. As a result the initial randomization was maintained and we are now able to present results after 4 yr of follow-up.


    Method
 Top
 Abstract
 Introduction
 Method
 Results
 Discussion
 References
 
Three hundred and two consecutive patients attending the United Bristol Healthcare NHS Trust rheumatology out-patient department with established RA according to international criteria [4] were invited to take part, the study having received approval from the local research ethics committee. After receiving information on both arms of the study, patients who gave consent were randomized to either direct access and shared care with their GP (no routine hospital review but rapid access on request, direct access group, DAG) or traditional hospital care (regular planned review, control group, CG). GPs of DAG patients were provided with management guidelines based on previous publications [5, 6]. (Responsibility for monitoring specific anti-rheumatoid drugs is routinely held by GPs in this locality.)

Access to specialist review
DAG patients or their GPs could request review through a nurse-run telephone helpline, whereby general advice or assistance was also given. Fortnightly ring-fenced rheumatology clinics gave a maximum wait of 10 working days for review. A clinical assessment by a rheumatologist was undertaken at 24 months in all direct access patients as part of the outcome assessment, but this may also have contributed to the medical care of some patients. Control patients had traditional rheumatologist review ordered routinely every 3–4 months or at a different interval if clinically indicated. Requests for medical review of control patients ahead of schedule were dealt with according to normal practice with GP requests assessed by a rheumatologist (usually not the study rheumatologist) who decided on the timing of the review. In the rare event of an emergency (e.g. septic arthritis) all patients would be dealt with immediately. At hospital reviews all patients were managed according to need and further follow-up given as clinically indicated. DAG patients might occasionally be given a specific follow-up appointment, but would then revert to patient-initiated review.

Outcome measures: clinical and psychological
To assess the overall state of RA, plasma viscosity (PV), C-reactive protein (CRP), haemoglobin (Hb), hand radiographs [7], grip strength, range of movement at knee and elbow, and articular index [8] were measured at 0, 24 and 48 months. Clinical and psychological status was measured at 0, 24, 36 and 48 months: pain and disease activity (10-cm visual analogue scales, VAS), disability (Health Assessment Questionnaire, HAQ) [9, 10], days lost from work, helplessness (Arthritis Helplessness Index, AHI) [11], anxiety and depression (Hospital Anxiety and Depression Scale, HAD) [12] and self-efficacy [13].

Satisfaction measures
Satisfaction with and confidence in the system of care were recorded using 10-cm VASs at 0, 24 and 48 months. For satisfaction, patients were asked, ‘How satisfied are you with the system of care provided for your arthritis?’ and the scale was anchored at one end by ‘Not at all satisfied’ and at the other by ‘Completely satisfied’. For confidence, patients were asked, ‘How confident are you that if you have problems this system of care will be able to support you?’ and the scale was anchored at one end by ‘Not at all confident’ and at the other by ‘Completely confident’.

Sample size and statistics
The original minimum sample size was based on the ability to detect as statistically significant (P<0.05) a 12% change in pain using a 100-mm VAS at 95% power and was estimated to be 186 patients [15]. Changes in variables between the two groups of patients at 24 and 48 months were compared using Student's t-tests or the Mann–Whitney U-test (non-parametric data) without modification of P values.


    Results
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 Abstract
 Introduction
 Method
 Results
 Discussion
 References
 
Of 302 subjects invited to participate, 209 agreed to do so and were randomized. Of these, 182 were able to contribute to the initial analysis at 24 months [3]. The present paper reports results from the 134 patients who completed data collection at 0, 24 and 48 months. Nineteen patients died and 29 others were not included in the analysis for various reasons as shown in Fig. 1Go. Twelve patients in the direct access group declined to continue filling in questionnaires or come up for assessment (eight in the first 2 yr, four in the second 2 yr), while 24 did so in the control group (14 in the first 2 yr, 10 in the second 2 yr). Other reasons were approximately the same in each group.



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FIG. 1. Patient flow through the study and reasons for non-completion.

 
Mean age at entry was 55.9 yr in the direct access group and 57.1 yr in the controls. Although grip strength in the right and left hand was slightly greater in the direct access group than the control group (P<0.05), there were no clinically important differences at entry in clinical or psychological status between the two groups, nor between those who completed the study and those who did not, although those who did not complete 48 months of the study tended to have a longer disease duration, longer early morning stiffness and a lower self-efficacy for function and other (Table 1Go). The articular index was measured, but for unrelated reasons the method used was updated halfway through the study [14] and so changes between the groups over the 4 yr cannot be compared. The previously reported data [3] showed no significant difference between the groups over the first 2 yr and the two groups were similar after 4 yr for tender joint count (DAG mean 5.4%, 95% CI 4.1–6.7; CG mean 6.9, 95% CI 5.1–8.7) and swollen joint count (DAG mean 4.8, 95% CI 4.0–5.6; CG mean 6.0, 95% CI 4.8–7.2). For all measures of disease the range of severity was large. For example, overall disease activity on a 10-cm scale ranged from 0 to 9.8. The HAQ score (mean 1.57, 95% CI 1.36–1.78) ranged from 0 to 2.9.


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TABLE 1. Characteristics of patients at entry

 
The baseline values for the measured variables are shown in Table 1Go and changes in the scores between 0–24, 24–48 and 0–48 months are shown in Table 2Go. There were few statistically significant differences. Patient satisfaction with their system of out-patient care was high at the time of randomization (CG 8.4, DAG 8.2), but declined in the control group over 4 yr to 7.6. In contrast, satisfaction in the direct access group increased further to 8.7 (P<0.01). Patient confidence scores were also high at the time of entry to the study (CG 8.2, DAG 8.4), declined in the control group by 0.6 to 7.6, but increased in the direct access group by 0.5 to 8.9 (P<0.01).


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TABLE 2. Changes in scores for 134 patients with data at all time points

 
Pain scores (the primary outcome measure) were increased by 1.6 in the control group and 1.38 in the direct access group. The significant difference previously reported at 2 yr was not maintained at 4 yr. The possibility of not detecting a 20% or more greater increase in pain in the direct access group compared with the control group in this study was calculated as 2%.


    Discussion
 Top
 Abstract
 Introduction
 Method
 Results
 Discussion
 References
 
This extension to 48 months of our initial 24-month randomized controlled trial of patient-initiated direct access to specialist care for rheumatoid arthritis has demonstrated that patients' health status is maintained at least as well as under routine hospital care. Furthermore, patient satisfaction with and confidence in the service has continued to improve.

The control patients (who may have felt they were gaining no direct benefit from the study) were more likely to discontinue data collection (24 patients) compared with the direct access group (12 patients), who were given control over their own out-patient attendances. Overall, by 48 months there was a moderate drop-out of patients, nevertheless the two groups remained well balanced for measures of disease status and demographic variables at entry. Therefore there were no clinically relevant differences at entry between those who completed the study and those who did not.

The mean health status of the two groups shows patients with modest levels of disease activity and disability. This reflects the patient population, but for all measures of disease the range of severity was large. Changes in mean health status within the two groups over 48 months were relatively small, as would be expected from previous studies [16, 17]. The mean changes in pain and disability, which were not statistically significant, favoured the direct access patients. It may be that there were differences in outcome between the groups, but that the study was too small to detect them. A power calculation showed that for pain (the main outcome measure) there was a 2% chance of missing a deterioration of 20% in the direct access patients. Thus it is unlikely that patients would be symptomatically disadvantaged by undertaking direct access follow-up. Furthermore, the nature of the system suggests that overall pain during the study may possibly have been reduced because of more timely intervention. This is being investigated by more frequent pain monitoring during a further follow-up of the study, currently underway.

The lead rheumatologist in the study could not be blinded to the group assignment of the patients, which may be considered a weakness in the study design. However, had different clinicians managed the two groups this would have introduced another variable (personal approach to patient management). Employing a single approach to management enables the effect of service deliveries/access to be assessed.

These results further challenge the traditional view that chronically ill patients (in this instance with rheumatoid arthritis) require frequent routine hospital review. They provide evidence that clinical effectiveness and patient satisfaction and confidence can be maintained for at least 4 yr with the patient initiating access to specialist services. In this study, there may also have been some additional clinical benefit from the hospital review at 24 months. We did not record which interventions were undertaken at that time. Also, while in our earlier report [3] over the first 24 months we measured the economic impact of direct access care and showed that it required substantially less clinical resource, we did not measure the use of resources during the following 24 months. Furthermore, it would be useful to know what happened to patients when they were seen at hospital consultations throughout the study and whether these activities differed between the two groups. We are now investigating in detail the use of resources, whether direct access to services results in patients receiving more timely care and whether the content of consultations differs between traditional routine follow-up visits and direct access visits.

While these further studies will fill in the detail of how the services differ, the results presented here, taken together with our previous report [3], strongly suggest that wider introduction of patient-initiated direct access to specialist care would be beneficial to both patients themselves and to the organization of health care delivery. Some unresolved issues remain. We have previously reported that of 302 subjects invited to participate in the direct access system, only 209 (69.2%) did so [3]. Patients who declined to take part were older (68 yr compared with 58 yr), had greater disease duration (14 yr compared with 11 yr) and were more affected by their arthritis (HAQ score 2.0 compared with 1.4). It may be that the decliners were anxious about making a major change in a well-established care system or were uncertain about initiating consultant review themselves, although no data are available on this. It would therefore be advisable to investigate how any large-scale implementation of a direct access scheme might affect patients more broadly, including patient perceptions of the service, personal control, empowerment, decision-making, perceived roles of professionals, and patient relationships with health professionals.


    Acknowledgments
 
The study was funded by an NHS Research and Development grant. The authors would like to thank S. Browning (study secretary), S. Tipler (rheumatology specialist nurse, who managed the patient telephone line), A. Brook and her fellow NHS secretaries, clinic staff W. Harrison and T. Feeney, and all the patients who took part.


    Notes
 
Correspondence to: J. Kirwan, Academic Rheumatology, University of Bristol Division of Medicine, Bristol Royal Infirmary, Bristol BS2 8HW, UK. E-mail: john.kirwan{at}Bristol.ac.uk Back


    References
 Top
 Abstract
 Introduction
 Method
 Results
 Discussion
 References
 

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Submitted 28 March 2002; Accepted 19 September 2002