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Abstract
Objectives To compare patient outcomes of three regimes of follow-up care for rheumatoid arthritis (RA) outpatients with low disease activity.
Methods RA outpatients (n=287) with Disease Activity Score (DAS28-CRP)<3.2 and Health Assessment Questionnaire<2.5 from two Danish rheumatology clinics were randomised to 2-year follow-up by either: (1) planned rheumatologist consultations, (2) shared care without planned consultations or (3) planned nursing consultations. The primary outcome was change in disease activity. DAS28-CRP, Health Assessment Questionnaire, visual analogue scale (VAS)-pain, fatigue, global health, confidence and satisfaction, quality-of-life by the Short Form 12 and self-efficacy measured by the RA Self-Efficacy questionnaire and the Arthritis Self-Efficacy Scale, were recorded annually and safety measures were recorded. x-Rays of hands and feet were taken at baseline and at 2-year follow-up. Mixed effect models were used to explore differences between the three groups over time.
Results At 2-year follow-up, the group allocated to nursing consultations had lower disease activity than the group that underwent rheumatologist consultations (DAS28-CRP −0.3, p=0.049). The nursing group increased their self-efficacy (Arthritis Self-Efficacy Scale 18.8, p=0.001), confidence (10.7, p=0.001) and satisfaction (10.8, p<0.001) compared with the rheumatologist group. The shared care group reported a transient lower satisfaction compared with the rheumatologist group after 1 year (−8.8, p=0.004). No statistically significant differences were seen in other outcome variables.
Conclusions It is safe to implement shared care and nursing consultations as alternatives to rheumatologist consultations for RA outpatients with low disease activity without deterioration in disease control. Nursing consultations can enhance patients’ self-efficacy, confidence and satisfaction.
- Rheumatoid Arthritis
- Outcomes research
- Health services research
- Disease Activity
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Introduction
Rheumatoid arthritis (RA) is a chronic progressive disease which requires lifelong monitoring with continual adjustments to pharmacological treatment.1 Most patients go through unpredictable periods where they suffer from swollen and tender joints, progressive joint destruction, fatigue, psychological distress and varying problems in performing everyday tasks.2–5 The treatment goal is to achieve remission or sustained low disease activity.1
Traditionally, patients with stable RA have been managed by planned routine consultations by rheumatologists every 3–12 months.1 ,6 ,7 An internal audit in 2006 (K Hørslev-Petersen, unpublished data, 2006) revealed that 45% of the routine consultations by a rheumatologist were undertaken without documented patient need at King Christian X's Hospital for rheumatic diseases in Graasten, Denmark. Patients and rheumatologists thus seemed to spend time on planned consultations at times when patients felt well and did not experience problems related to their RA. Projection of future demands suggests that there will be a shortage of specialist physicians, including rheumatologists.8
This led us to question how we could use the available resources in more effective ways without reducing disease control. British and Dutch studies had shown that nursing consultations and different versions of shared care were not inferior to traditional rheumatologist follow-up in controlling disease activity in patients with RA.9–13 Based on these findings, the 2-year AMBulant behandling af etableret Reumatoid Artrit/Outpatient treatment of established RA-study (AMBRA) was planned as a collaboration between the rheumatology department at Vejle Hospital and King Christian X's Hospital for Rheumatic Diseases in Graasten, Denmark, to be conducted between 2008 and 2011.
The aim of the AMBRA was to compare patient outcomes in alternative regimes of follow-up care with traditional follow-up with rheumatologists for outpatients with sustained low active RA.
Our hypothesis was that we could implement a shared care model with no planned consultations and planned consultations by experienced rheumatology nurses without reducing clinical outcome and quality of life, but that the participants’ self-efficacy,9 ,14 confidence and satisfaction with care might differ depending on the type of follow-up care.
Results from the first year of the study and a qualitative study of the participants’ experiences with the different types of follow-up care have already been published.15 ,16 Results regarding the cost of implementing the different types of follow-up care, including the number of consultations in each group and cost effectiveness will be reported in a later paper.
Methods
Study design
After enrolment, the participants completed two 3-h multidisciplinary sessions (run by rheumatologists, physiotherapists, occupational therapists and nurses). The course aimed to enhance the participants’ self-efficacy, including knowing when and how to seek help. They were taught to contact health professionals if they experienced swollen joints for more than three consecutive days.15
By the end of the course, the participants were randomly allocated to one of the three regimes for follow-up care. Randomisation was performed using a computer-generated random number sequence. A secretary randomised the participants in blocks of nine—three for each group.
A clinical steering group planned and implemented the details of the standardised elements of the study. A support-group was established comprising two patient research partners, representatives from the hospital management teams, General Practitioners (GPs), the Regional Quality Department and the University of Southern Denmark.
The study was planned as an open, randomised, controlled trial with three arms. All participants had an annual hospital review by a senior rheumatologist and a 40 joint examination (hands, wrists, elbows, shoulders, knees, ankles and feet) performed by a blinded investigator.
The rheumatologist group (control group)
Participants in this group continued with follow-up as usual with planned 20–30 min consultations every 3–12 months with a senior rheumatologist or a junior physician supervised by senior rheumatologists. The frequency of the consultations was based on the rheumatologist's judgment. The aim of the treatment was to maintain Disease Activity Score DAS28-CRP<3.2,17 ,18 using disease modifying antirheumatic drugs.19 In the case of a flare-up, the participants could get an additional appointment between planned consultations. The monitoring of side effects was undertaken by the rheumatologists.
The shared care group
Participants in this group were offered no planned consultations, apart from the annual hospital reviews. These participants could address problems to their GP or to the clinically experienced rheumatology outpatient nurses at the hospital via a nurse-led telephone helpline. The GPs took over the responsibility for monitoring the blood tests according to written guidelines defined by the rheumatology departments. GPs were free to contact the rheumatology department and use the nurse-led telephone line for advice or specialist review.
The nursing group
Participants in this group were allocated to planned 30-min consultations every 3 months with a clinically experienced rheumatology outpatient nurse. The nurses were trained to perform joint assessments and evaluate the blood tests and the Health Assessment Questionnaire (HAQ). These participants could also address problems through the nurse-led telephone helpline. If the DAS28-CRP exceeded 3.2 points, the patient should be seen by a rheumatologist within 5 working days. The nurses consulted a rheumatologist if blood tests exceeded agreed limitations, or if they had questions. The nurses could make referrals to the GP, an occupational therapist, a physiotherapist or a podiatrist in primary care. A procedure for the consultations was developed by the four nurses involved in the study from both hospitals. Apart from monitoring the patients’ medication and clinical assessment the procedure included self-management issues and that patients were to take responsibility for their disease.
Participants
Consecutive outpatients diagnosed with RA—according to the American College of Rheumatology list criteria20—for at least 18 months and attending an outpatient consultation at one of the participating departments were evaluated by their rheumatologist to participate in the study in accordance with the admission criteria (table 1). The rheumatologist completed the initial clinical examination.
Inclusion and exclusion criteria for enrolment in the 2-year AMBRA-study
Outcome measures
The primary outcome measure was disease activity, measured by the DAS28-CRP. Minimal important difference for deterioration in the DAS28-CRP is 0.62 and a change of 1.2 points is considered to be clinically important.17
All the participants completed a set of questionnaires at baseline and at 1-year and 2-year follow-up. The questionnaires were posted to the patients’ homes and were to be returned by prepaid post. A summary of the included outcome measures at the different time points is given in table 2.
Summary of outcome measures at the different time points of the study
The questionnaires included sociodemographic and clinical data, self-efficacy to reflect the participants’ belief in their own ability to manage disease related problems,14 ,15 satisfaction and confidence in the care received.27
All the participants had x-rays taken of the joints in their hands and feet at baseline and at 2-year follow-up in order to evaluate whether erosions had developed or progressed. x-Rays were read by experienced external radiologists blind to group allocation.
As an extra safety measure all participants completed a short questionnaire including the HAQ every 3 months,21 whether or not they had experienced specific side effects during the past 3 months and the RA Disease Activity Index.28
Data from these questionnaires were entered into a database as soon as they were received by the hospital. An alert was shown if the results exceeded certain limits compared with the baseline score: if the HAQ-score increased by more than 20% or by more than 0.25 points,21 if the RA Disease Activity Index-score increased by more than 1.4 points34 or if the patient reported side effects. In case of an alert, the rheumatology nurses contacted the participants in the shared care group, and also if the questionnaire was not returned after sending a written reminder. If one or more of these problems happened twice in a row, the nurse contacted a rheumatologist.
Power calculation
Assuming a drop-out of 10%, power calculations suggested that 98 participants should be included in each group (294 in total), to have a power of 90% to reject the null-hypotheses. We assumed that no difference could be observed in the number of patients with a DAS28-CRP>3.2, who at the same time, had a significant increase in DAS28-CRP>0.62 from baseline at the 2-year follow-up, between the rheumatologist group and the shared care group or the nursing group.
Statistical methods
STATA V.10.1 (Stata Corp, College Station, Texas, USA) was used to perform the statistical analyses according to intention-to-treat. Mixed effect models31 were used to examine the repeated measurements of the outcome measures. We tested whether time, group and the interactions between group and time were significant predictors for the different response variables. Both the individual patient and hospital were regarded as clusters in the analyses. Model assumptions were checked by residual plots. Differences between groups in changes in DAS28-CRP and baseline characteristics were explored in multiple regression analyses. Differences between completers and non-completers and whether progressions on x-rays were seen or not were explored in logistic regression analyses. Patient safety measures were analysed in regression analyses for numeric outcome variables, logistic regression analyses for binary outcome variables or χ² tests for categorical data. The significance level was set at 95%. Missing values were considered to be completely random. Two of the authors performed the statistical analyses independently before the results were compared and finalised.
Results
Participants
In total, 287 adult outpatients with RA were enrolled from 1 January 2008 through to February 2010; 203 (18.8%) out of 1080 outpatients with RA from Hospital 1 (King Christian X's hospital for rheumatic diseases in Graasten) and 84 (17.2%) outpatients out of a possible 487 from Hospital 2 (Vejle hospital) (figure 1). Out of 877 patients who did not meet the inclusion criteria, 246 patients declined to participate from Hospital 1 (living far away; family situation; wished to continue with the same physician; wished to maintain regular visits; a feeling of being unable to complete the questionnaires, or because they did not want to be allocated to the shared care group). Those who did not meet the inclusion criteria were significantly older, and the proportion of women was significantly higher than the group of enrolled patients.15 The same applied to the 246 who declined to participate (median age 68 years and 75% female) compared with the enrolled participants (66 years and 70% respectively). Although we planned to include 294 participants, only a few eligible patients were left for possible inclusion in the two hospitals’ patient populations. The actual drop-out rate for the first year was 5.6% compared with the estimated 10%. This allowed for early completion of inclusion by the end of February 2009. Patients who dropped out were invited to the annual follow-up visits (figure 1).
Flow chart for the number of patients enrolled, allocated to each group, drop-outs and reasons for drop-out and the number analysed at 1-year and 2-year follow-up. Note: The patients who dropped out were invited to participate in the annual follow-up visits according to the intention-to-treat analysis.
Baseline characteristics for all participants and by study group are shown in table 3. There were no statistically significant differences between the groups.
Baseline characteristics
Raw data from the response variables at baseline, 12-months and 24-months follow-up are reported in an online supplementary file (S1).
No significant difference was seen in the number of patients with DAS28-CRP>3.2 and an increase in DAS28-CRP>0.62 from baseline to 1-year or 2-year follow-up (rheumatologist group 24 and 17, shared care group 20 and 16 and nursing group 15 and 11 patients at 12 and 24 months, respectively). No significant difference in the number of patients with progression on x-rays of hands and feet from 0–2 years was detected between the shared care group and the rheumatologist group (OR 0.58, p=0.280) or between the nursing group and the rheumatologist group (OR 1.07, p=0.884) controlling for erosions at baseline and anti-cyclic citrullinated peptide antibody (anti-CCP) positivity.
DAS28-CRP at 1-year follow-up was a significant predictor for drop-out of the study (OR 0.63, p=0.019).
The results from the random effects models are reported in table 4 for all the outcome measures. No significant difference in disease activity (DAS28-CRP) was seen between the groups in general or over time for all participants. At 2-year follow-up, the nursing group had lower disease activity than the rheumatologist group (−0.3, p=0.049), increased their self-efficacy (Arthritis Self-Efficacy Scale 18.8, p=0.001), confidence (10.7, p=0.001) satisfaction (10.8, p<0.001) compared with the rheumatologist group. Self-efficacy measured by the RA Self-Efficacy questionnaire increased significantly in the nursing group compared with the rheumatologist group at year 1 (3.7, p=0.05), but the difference was insignificant at year 2. The shared care group reported lower satisfaction compared with the rheumatologist group after 1 year (−8.8, p=0.004), but the difference was insignificant at year 2. No statistically significant differences were seen in any of the other outcome variables.
Results from the random intercept analyses: estimated coefficients for the primary and secondary outcome measures with observation time, study-group and interaction between observation time and study-group
Patient safety issues
Data about compliance with blood tests at planned intervals, the number of out-of-range blood tests and whether appropriate reaction to out-of-range blood tests was taken are reported in table 5.
Patient safety measures
A significantly lower number of patients in the shared care group had their blood tests taken at the planned intervals than in the rheumatologist group (χ² 0.19, p=0.039). The OR for having their blood tests taken at the right time for 90% of the time was significantly lower in the shared care group compared with the rheumatologist group (OR=0.49, p=0.049), but there were no significant differences in OR for having out-of-range blood tests (OR 0.70, p=0.272) or in the number of alerts between the shared care and the rheumatologist’ groups. The nursing group did not differ significantly from the medical group in any of these measures. No significant differences were seen between the groups in any of the other safety measures.
Discussion
The results show that the follow-up care regime for outpatients with RA can be changed from a traditional rheumatologist's setting to tight follow-up with nursing consultations or shared care without a decline in disease control. Our results are in line with findings from other studies.9 ,29 ,32 No significant difference appeared in disease activity between the shared care group and the 'rheumatologist’ group. Unexpectedly, the nursing group displayed significantly lower disease activity at 2-year follow-up compared with the rheumatologists’ group, but the difference did not exceed the minimum important difference17 and there was no significant difference between the groups in the number of patients with DAS28-CRP>3.2 or with DAS28-CRP>3.2 and an increase >0.62 from baseline to 2-year follow-up. The nursing group had shorter intervals between planned consultations (3 months) than the rheumatologists’ group (3–12 months), and the tighter control in the nursing group and the use of a specific nursing procedure may explain some of the differences in self-efficacy and disease activity score.
No significant differences were seen between the groups in any of the other clinical response variables or in quality of life.
The participants’ confidence and satisfaction with their follow-up care increased in the nursing group and decreased in the shared care group compared with the rheumatologist group despite high levels at baseline already. Satisfaction in the shared care group increased from 1-year to 2-year follow-up, but the difference from the baseline score was not significant. This could be explained by findings from the qualitative study that participants in the shared care group felt insecure in the beginning, but gained confidence and a feeling of security over time.16 Along with the fact that there were three GPs who did not want to participate, this may explain the higher drop out in the first year in the shared care group. In the Bristol study,9 ,27 where shared care and traditional follow-up were compared, the shared care group did not change in satisfaction and only decreased slightly in confidence, whereas the rheumatologist group declined in both outcome measures from 0–2 years. These differences may be due to contextual differences, such as the longer waiting time to see a rheumatologist in the UK, compared with Denmark.
We feared that the GPs would not take action if blood tests exceeded the agreed limits, as the rheumatologists at the hospitals were used to monitoring the blood tests on all patients before the study was initiated. Despite the differences in compliance, there was no difference in the number of out-of-range blood test results or whether appropriate action was taken, and there was no difference in the number of alerts between the shared care and the rheumatologist group. Inspection of the journals for patients who died did not lead us to suspect negligence of any kind.
The study had some limitations. Due to lack of funding, we were not able to include, as initially planned, a second reading and scoring of the x-rays based on the Sharp/van der Heijde Score.33 We acknowledge that the precision regarding the development or progression of erosions could have been further refined. Multiple comparisons were used, but the results confirm our hypotheses and are consistent with findings from focus-group interviews with patients from the three groups.16 The sample size was a little less than the power calculation required (287 instead of 294). Although 16 dropped out of the study in the 1st year and another 12 in the 2nd year, only four did not show up for the final visit, apart from the seven who died. Thus, the study still had sufficient power to fulfil the initial power calculations. It was not possible to blind the treatment arm for either clinicians or patients. This may potentially constitute a bias.
Conclusion
This study showed that it is safe to implement shared care or allow experienced rheumatology nurses perform tight follow-up care for patients with low-active RA. Including nurses in the follow-up care offers the potential to increase patients’ self-efficacy beliefs and their confidence and satisfaction with their follow-up care. Future studies are needed to examine the results from nursing management with less frequent follow-up and of patients with more active disease.
Acknowledgments
We would like to thank all the patients who painstakingly completed all the questionnaires in the study. Thank you to Lorna Campbell for editorial assistance and to DANBIO for hosting our data during the study. Thank you to the AMBulant behandling af Reumatoid Artrit/Outpatient support group, (patient research partners (Anne Kylling Jensen and Bodil Pickardt), GPs (Bent Kristensen and Ernst Hansen), departmental managers (Lis Smedegaard Andersen, Bente Rasmussen, Gitte Birk Sørensen, Ejler Ejlersen and Kirsten Bisgaard), clinicians (Tove Lorenzen, Kate Brandt, Käthe Jensen, Pia Rhode Rasmussen, Ellen Toftegaard, Lone Holm Hansen), research secretary Kirsten Frøhlich, the Research Unit of Nursing at the University of Southern Denmark (Lis Wagner) and the Department of Quality in the Region of Southern Denmark (Ulla Møller-Ølgaard and Peter Qvist)).
References
Supplementary materials
Supplementary Data
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Files in this Data Supplement:
- Data supplement 1 - Online supplement
Footnotes
Handling editor Tore K Kvien
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Contributors JP has participated in the conception and design of the study, the analysis and interpretation of data, drafted the manuscript and has approved the final submitted version. JS has participated in the conception and design of the study, the analysis and interpretation of data, provided important intellectual content of the manuscript and has approved the final submitted version. KH-P and HCH have participated in the conception and design of the study, the acquisition of data and interpretation of the results, have provided important intellectual content of the manuscript and have approved the final submitted version. RP has participated in the acquisition of the data, important intellectual content of the manuscript and has approved the final submitted version.
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Funding This work was supported by the Region of Southern Denmark; Sygehus Sønderjylland (Hospital of Southern Jutland); Hans Christensen's Memorial Foundation; Gigtforeningen (The Danish Rheumatism Association), King Christian X's Hospital for Rheumatic Diseases in Graasten, Denmark, and Kvalitets-og Efteruddannelsesudvalget for almen praksis (KEU) (The Quality and Continuing Education board for General Practice).
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Competing interests None.
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Ethics approval The study was conducted in compliance with the Helsinki Declaration of 2004. The local scientific ethics committee considered that formal approval was not required as no pharmacological interventions were involved. The study was registered with the Danish Data Protection Agency (Reference No. 2007-41-1268). Verbal and signed written consent was obtained from each participant before enrolment.
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Provenance and peer review Not commissioned; externally peer reviewed.