Implantación Toolbo

Authors:

M. Ferwerda, S. van Beugen, H. van Middendorp, H. Visser, H.E.Vonkeman, M.C.W.

Creemers, P.C.L.M. van Riel, W. Kievit and A.W.M. Evers

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Abstract

Objectives

To stimulate the implementation of effective treatment strategies for improving health- related quality of life (HRQoL) of patients with rheumatoid arthritis (RA), cost-benefit ratios are required to inform stake-holders. A cost-effectiveness study from a societal perspective was conducted alongside a randomized controlled trial on a tailored and therapist-guided internet-based cognitive behavioural intervention (ICBT) for patients with elevated levels of distress, as an addition to usual care alone.

Method

Data were collected at baseline/pre-intervention, 6 months/post-intervention, and three- monthly thereafter during one year follow-up. Effects were measured in quality-adjusted life years (QALYs) and costs from a societal perspective including healthcare sector costs

(including healthcare use, medication, and intervention costs), patient travel costs for healthcare use, and costs associated with loss of labor.

Results

The intervention improved quality of life compared to usual care alone (Δ QALYs= 0.059), but also led to higher costs (Δ= € 4.211,44), which reduced substantially when medication costs were left out of the equation (Δ= € 1.862,72). Most (93%) of the simulated ICERS were in the north-east quadrant, suggesting a high probability that the intervention is effective in improving HRQoL, but at a greater monetary cost for society compared to usual care alone.

Conclusions

A tailored and guided ICBT intervention as an addition to usual care for patients with RA with heightened distress was effective in gaining quality of life. Consequently,

implementation of the ICBT into standard healthcare for patients with RA is recommended, yet further study into cost reductions in this population is warranted.

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Introduction

Within the field of rheumatoid arthritis (RA), the psychological impact of the disease has become increasingly apparent. Patients report decreased health-related quality of life (HRQoL) as a result of living with physical factors such as pain and psychological factors such as negative mood (e.g.,(1-3) As these factors are associated with the disease trajectory, health care utilization, and workplace disability of patients (4-8) these factors lead to significant societal health expenses (9-12).

About one third of patients with RA has been shown to experience a significantly reduced HRQoL (1, 3). For this subgroup, cognitive-behavioural treatment can aid in improving HRQoL (13-15). In a recent randomized controlled trial, we showed a therapist- guided internet-based cognitive behavioural treatment (ICBT) tailored to the specific problems of the individual patient with RA with elevated levels of distress to lead to improvements in especially psychological functioning (e.g., depressed mood) (16). The findings of our study are in line with studies on face-to-face cognitive behavioural treatments (17), which the therapy closely resembles. And add to preliminary evidence that ICBT can be as effective as face-to-face treatments for a range of somatic conditions and symptoms (18- 20).

Benefits of internet-based treatments, such as increased flexibility in terms of time and place of following therapy, are suggested to make these treatments feasible for widespread implementation (21, 22) . Evidence on cost-effectiveness of internet-based therapy is still scarce. Preliminary evidence has suggested that internet-based interventions could be a cost-effective way to improve mental health, specifically if guidance by a

psychological therapist is offered (23). Within the domain of RA, one study on a self-

management intervention for patients with RA-related distress found a reduction of distress and pain, and improved self-efficacy, but no effects on health care utilization (24), which is important in the evaluation of costs. However, no studies on the cost-effectiveness of ICBT in

165 RA have been conducted up to now. Stakeholders are in need of this kind of information to balance treatment choices and policy decisions. For example, a recent study within the field of rheumatology reports on how rheumatologists balance multiple aspects of a treatment choice, including efficacy, patient preferences, and costs (25).

The current paper reports on a pre-planned cost-effectiveness study from a societal perspective on a tailored and therapist-guided ICBT for patients with RA with elevated levels of distress as an adjunct to care as usual, which was conducted alongside a randomized controlled trial of which the results have been reported elsewhere (16). We predicted the ICBT to be a cost-effective intervention as addition to care as usual.

Method

Design

An economic evaluation from a societal perspective was conducted of a tailored therapist- guided ICBT as an adjunct to care as usual (CAU), alongside a randomized controlled trial (RCT). Patients with elevated levels of distress were either randomized to standard

rheumatological care as usually conducted in the Netherlands or additionally to the ICBT. Further details of the RCT can be found in a previous publication on the effects of the ICBT on psychological functioning, physical functioning, and impact of RA on daily life (16). This paper focuses only on aspects relevant to the economic evaluation. All patients provided written informed consent to participation in the study. The regional medical ethical

committee approved the study (NL24343.091.08), which was registered in the national trial registry (NTR2100).

166 Adult patients with a rheumatologist-certified diagnosis of rheumatoid arthritis (26)

receiving out-patient standard rheumatological care at one academic and three non-

academic hospitals were invited to participate. Only patients with elevated levels of distress as defined by heightened scores of negative mood (≥ 21 for negative mood on the Impact of Rheumatic Diseases on General Health and Lifestyle (IRGL) (27) and/ or anxiety (a score of ≥5 for anxiety on the IRGL) were included. Exclusion criteria were (1) insufficient command of the Dutch language, (2) severe physical or psychiatric comorbidity (i.e., requiring acute and /or intensive medical attention. When this was not the case, patients indicated which condition more highly impacted patient’s HRQoL), (3) pregnancy, (4) current treatment by a cognitive-behavioural therapist or comparable practitioner, and (5) no access to a computer and internet.

Care as usual and ICBT

Usual care was offered in both the intervention and control group. Hospitals in the Netherlands follow the recommendations of the Dutch Society for Rheumatology for rheumatological care. Usual care for RA patients generally consists of 3- to 6-month shared care check-ups by a rheumatology nurse and the rheumatologist to monitor disease activity and treatment. Additionally, physical therapy and occupational therapy are potentially provided, depending on patient and disease characteristics.

The intervention group received ICBT as an addition to usual care. Aspects of tailoring to treatment goals and individual strategies and therapist contact were important treatment ingredients. Treatment commenced with one or two face-to-face intake sessions consisting of the formulation of individual goals based on the main problems of the patient. Based on these goals, specific treatment modules were chosen embedded within the ICBT website, with the therapist guiding the choice of assignments within each of these modules based on specific risk and resilience factors of the patient. Therapists and patients remained

167 in weekly or bi-weekly contact within the secured message service within the ICBT website, based on personal patient preferences. Treatment modules focused on coping with 1) pain and functional disability, 2) fatigue, 3) social functioning, and 4) negative mood. Due to the individual tailoring, treatment length varied between 9 and 65 weeks (M=26.07, SD=12.22). All six therapists had a Masters degree in psychology and two additionally had post- academic training in cognitive behavioural therapy. Supervision was provided by a senior clinical psychologist with post-academic training in cognitive behavioural treatment. Patients received one telephone-administered session by a research assistant on how the intervention-website was set-up, which lasted about half an hour. Further information on the ICBT intervention can be found in our earlier publication (16).