National Primary Care Research and Development Centre, University of Manchester
Academic Unit of Psychiatry, University of Leeds, UK
Correspondence: Dr Peter Bower, National Primary Care Research and Development Centre, 5th Floor, Williamson Building, University of Manchester, Manchester M13 9PL, UK. Tel: 0161 275 7638; e-mail: peter.bower{at}man.ac.uk
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ABSTRACT |
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Aims To examine the theoretical underpinnings of stepped care, together with the practicalities of the adoption of this system of care.
Method Narrative literature review.
Results The potential clinical and economic benefits of stepped care are dependent upon underlying assumptions of equivalence in terms of clinical outcomes, efficiency in terms of resource use and costs, and acceptability of minimal interventions to patients and therapists. Illustrative studies of these issues are considered.
Conclusions Although psychological services might benefit from the adoption of the stepped care model, a substantial research agenda needs to be fulfilled before a judgement can be made as to whether stepped care might be an efficient method of delivering psychological services.
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INTRODUCTION |
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STEPPED CARE MODELS |
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The definition of least restrictive may refer to the impact on patients in terms of cost and personal inconvenience (Sobell & Sobell, 2000), but in the context of publicly funded healthcare systems where specialist therapist time is a key limiting factor, least restrictive is often interpreted as referring to the amount of specialist therapist time required (i.e. treatment intensity). In stepped care, more intensive treatments are generally reserved for people who do not benefit from simpler first-line treatments, or for those who can be accurately predicted not to benefit from such treatments (Newman, 2000). In this way, stepped care has the potential for deriving the greatest benefit from available therapeutic resources. However, the focus on low-intensity treatment delivery might actually be counter-productive, without the crucial self-correcting mechanism. Self-correcting means that the results of treatments and decisions about treatment provision are monitored systematically, and changes are made (stepping up) if current treatments are not achieving significant health gain. Rather than regarding withdrawal from therapy as a reflection of a lack of motivation for treatment on the part of the patient, stepped care models see monitoring of progress and outcome as a fundamental responsibility of therapists and the system of care within which they work. A simple two-step model is outlined in Fig. 1.
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Although these features of stepped care may seem to resemble the way in which many clinicians implicitly operate (Breslin et al, 1997; King et al, 2002), stepped care standardises systems and procedures with an explicit aim of improving efficiency (Katon et al, 1997; Scogin et al, 2003). Stepped care models have been described in relation to smoking (Abrams et al, 1996; Smith et al, 2001), back pain (Von Korff & Moore, 2001), alcohol treatment (Breslin et al, 1997; Sobell & Sobell, 2000), migraine (Sculpher et al, 2002), anxiety (Newman, 2000), eating disorders (Wilson et al, 2000), methadone maintenance (King et al, 2002) and depression (Simon et al, 2001; Scogin et al, 2003).
Key elements in stepped care models
What treatments are of relevance to stepped care?
Stepped care requires treatments of differing intensity. This requirement
is amply satisfied in psychological therapies, where a number of less
intensive treatments (or minimal interventions) have been
developed, for example brief therapies
(Scott et al, 1997),
group treatments (Dowrick et al,
2000) and self-help approaches such as bibliotherapy
(Cuijpers, 1997) and
computerised treatments (Proudfoot et
al, 2004).
The main candidate for stepped care is cognitivebehavioural therapy. This therapy has been highlighted by guidelines as the treatment of choice for a number of disorders (Department of Health, 2001). It also has the advantage that there can be a degree of commonality between different steps, all being based on the same theoretical model and therapeutic techniques. There might be advantages to such consistency, although stepping up to an approach that has already failed might be seen as counterproductive (Newman, 2000). However, there is no requirement for stepped care to involve a single therapeutic approach (Davison, 2000; Sobell & Sobell, 2000). Other brief treatments such as problem-solving (Dowrick et al, 2000) are of proven benefit, and a stepped care model might involve stepping up from cognitivebehavioural bibliotherapy to counselling (Ward et al, 2000) or interpersonal therapy (Schulberg et al, 1996). Different treatments may have an effect on different aspects of the patients problem (Newman, 2000).
The issue of medication should also not be ignored. Generally, access to medication is not constrained in the same way as access to psychological therapy, because it does not generally require access to a specialist therapist. However, modern models of collaborative care do involve significant support from case managers to improve compliance with medication (Badamgarav et al, 2003), and thus the principles of stepped care can be applied in this context (Katon et al, 1999; Araya et al, 2003; Unutzer et al, 2003).
How many steps should be involved?
The number of steps will be bounded by two factors. First, there are only a
finite number of interventions available that differ qualitatively in terms of
intensity. Second, since stepped care seeks to reduce the average amount of
therapeutic input per patient, an upper limit is provided by the amount of
therapist input that is routinely provided in traditional services. In the UK
National Health Service, this might be 816 sessions (50 min long) of
face-to-face therapy, often cognitivebehavioural
(Lovell & Richards, 2000;
Department of Health, 2001).
Given this ceiling, there are probably four qualitatively different steps:
pure self-help (no therapist input beyond assessment); guided self-help and
group therapy (therapist input around 12 h per patient); brief
individual therapy (therapist input around 6 h per patient); and longer-term
individual therapy (therapist input around 16 h per patient). Different steps
might use different professionals, with pure self-help at the initial step,
followed by guided self-help from a practice nurse
(Richards et al,
2002) or primary care mental health worker
(Bower, 2002), then individual
therapy from a clinical psychologist or mental health nurse.
Much informal mental healthcare is undertaken by patients in the community without the intervention of mental health services (Rogers et al, 1999), and the first level of any stepped care system might involve facilitating natural recovery outside statutory services (Sobell & Sobell, 2000). However, the relationship between such community-level initiatives and statutory services is likely to be complex (Abrams et al, 1996).
How are decisions to be made about stepping up?
Stepping up requires a decision about patient progress based
on judgements about significant health gain or
improvement, but the exact definition will be dependent on the
type of disorder, its natural history and the effectiveness of available
treatments (Breslin et al,
1997,
1999;
Sobell & Sobell, 2000).
This might involve the use of clinically significant and reliable
change (Jacobson & Truax,
1991) or individualised expected outcomes based on
patient pre-treatment variables (Lutz,
2003). In some disorders, different criteria might be relevant.
For example, in depression, because residual symptoms are associated with
later relapse, treatment until full remission has been recommended
(Scogin et al,
2003).
Decisions may be based on data collected within treatment (Breslin et al, 1997). The use of simple assessment and decision rules (e.g. a threshold score on the Beck Depression Inventory completed by a patient) has the advantage that this approach is cheap and easily standardised (Scogin et al, 2003). More complex assessments by experienced clinicians might have advantages but would add significantly to costs, and it is important that the benefits of stepped care are not swallowed up by the professional time required to implement the system. Furthermore, professional decision-making may on occasion be less valid than judgements made on the basis of guidelines and decision rules (Breslin et al, 1997). There is also a trade-off between false positives (i.e. inappropriate stepping up) and false negatives (failure to step up when appropriate), and the complexity of decision-making should therefore be sensitive to the costs of treatment at different steps (Sobell & Sobell, 2000).
The role of the patient requires consideration, as choice of treatment might be an important component of patient-centred services, but might also have important implications for efficiency within stepped care. The whole issue of the acceptability of stepped care to patients is dealt with in more detail below.
Which patients or disorders are appropriate for stepped care models?
Stepped care models may be most appropriate for disorders in which adverse
consequences would not result from starting patients on too low a step, or
where the perception of treatment failure at lower levels does
not greatly affect later outcome. For example, in the treatment of eating
disorders, stepped care might be far more appropriate for bulimia and binge
eating than for anorexia nervosa (Wilson
et al, 2000). A recent model for depression
(Scogin et al, 2003)
suggests that stepped care psychological therapy might be particularly
relevant for minor depression, as opposed to major depression: the latter
might be better managed through complex collaborative models of care
(Gilbody et al,
2003). There is a general perception that minimal interventions
are best restricted to less severe disorders, although the evidence for this
is not definitive (Lovell & Richards,
2000). However, it is important that decisions about the use of
minimal interventions as a first-line treatment are made on the basis of good
research evidence, as there may be cases in which early intensive treatment is
actually more clinically effective and cost-effective than a minimal
intervention.
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CLINICAL AND ECONOMIC EVALUATION OF STEPPED CARE MODELS |
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Equivalence assumption
There is evidence that minimal interventions can, like their more
therapist-intensive versions, be more effective than usual care
or no treatment conditions
(Cuijpers, 1997; Dowrick et al, 2000;
Lovell & Richards, 2000;
Bower et al, 2001; Kaltenthaler et al,
2002). However, such comparisons are not the most relevant to the
equivalence assumption. First, they do not compare minimal interventions with
traditional, more intensive versions. Furthermore, they may also validate the
efficiency assumption. For example, if a simple bibliotherapy treatment is
superior to no treatment, providing bibliotherapy to patients
would still need an overall increase in the amount of resources required
or cutbacks in other parts of the service even if the
bibliotherapy were relatively cheap. Whether that is worthwhile is a question
of allocative efficiency (Donaldson et
al, 2002). Only when a treatment costs less and provides
equal effectiveness is it described as technically efficient, which is the key
criterion for stepped care treatments. Therefore, published demonstrations of
the benefits of stepped care treatments v. usual care
may not be definitive in the current context.
The key demonstration required to support stepped care models is the comparison of minimal interventions with traditional psychological therapy. A number of studies have reported that minimal interventions do not differ in effectiveness from more intensive, therapist-delivered treatments (Lovell & Richards, 2000). However, the finding that there is no difference in the clinical effectiveness of two treatments does not prove that they are equivalent. Most psychological therapy trials are designed and powered to examine whether there are differences in effectiveness, whereas proving equivalence requires specific analytical procedures (Rogers et al, 1996; Ebbutt & Frith, 1998) and routinely requires a larger sample size (Hargreaves et al, 1999; Durand & King, 2003). A trial with a small sample size might conclude that two treatments did not differ significantly in a statistical sense, even though the outcomes differed in a clinically significant way.
This problem can be illustrated with respect to a recent systematic review of computerised cognitivebehavioural therapy. Six trials compared it with the therapist-led form of this therapy, and the review reported that five of them showed computerised therapy to be as good as the therapist-led treatment (Kaltenthaler et al, 2002). However, the sample sizes per group in these studies ranged from 6 to 38, which means that the finding of no statistically significant difference between the two forms of delivery of cognitivebehavioural therapy is likely to occur even in the presence of important treatment effects. This can be illustrated most easily by summarising the data in terms of standardised effect sizes, rather than statistical significance (available from the author upon request). In four trials reporting no statistically significant differences between treatments, 32 comparisons were made between computerised and therapist-led cognitivebehavioural therapy, and 9 (28%) of these differences were either medium or large according to current conventions (Lipsey, 1990). This highlights the fact that small trials may report no significant difference between treatments that do in fact differ in clinically significant ways.
However, it should be noted that traditional equivalence trials examine equivalence at the level of the individual patient, whereas it is also possible to view this issue from the perspective of a population. For example, a modestly effective treatment that could be used with a large number of patients might provide more population health benefit than a more effective treatment that could only be provided to a small proportion of the population. An alternative trial design, the so-called outcome maximisation design (Sutton, 1997), seeks to determine how much overall clinical benefit can be derived from a given therapeutic resource. Such a design may be appropriate for testing whether traditional, intensive psychological therapies, which might be more clinically effective with individual patients, are also delivering greater benefits at the level of the population.
Efficiency assumption
Equivalent clinical outcomes in traditional and minimal interventions have
been taken to imply that the latter are more efficient because of the lower
amount of therapist input required. For example, studies in alcohol treatment
have quoted data relating to therapist hours per abstinent
patient (Wilson et al,
2000). This may be valid from the perspective of a psychological
therapy services manager. However, other stakeholders may require a more
comprehensive analysis of costs, such as direct treatment costs in other
sectors (e.g. primary care visits and medication, use of social services and
voluntary sector providers) and patient costs (such as purchasing manuals or
using private therapy). Limiting the analysis of costs to those associated
with the psychological therapy service alone ignores the potential for
cost-shifting to other sectors. Demonstrations of increased efficiency in
stepped care models may be illusory if significant cost-shifting occurs. There
is some evidence that patients receiving minimal interventions are more likely
to seek additional interventions than those receiving traditional treatments
(Treasure et al,
1996; Thiels et al,
1998).
Acceptability assumption
Patient attitudes to psychological therapy are generally very positive
(Priest et al, 1996),
but it cannot be assumed that these positive attitudes will generalise to
minimal interventions. Patients may feel that the provision of minimal
interventions is inappropriate (Scogin
et al, 2003), especially for more severe disorders
(Landreville et al,
2001). Trials of minimal interventions in primary care rarely
report overall uptake rates to the offer of such treatment
(Bower et al, 2001).
One non-randomised study found that one-fifth of patients motivated to return
a screening questionnaire to a computerised self-help clinic refused
computer-aided treatment when it was offered
(Marks et al, 2003).
In another study, scarcely more than half of patients offered self-help while
on a waiting list for cognitivebehavioural therapy took up the offer
(Whitfield et al,
2001).
The issue of patient acceptability raises the possibility of tension between the desire to gain the greatest amount of clinical benefit from available resources, and the need to provide services that are patient-centred and meet current policy concerns with providing choice to patients. Clearly, the goal is to allow patients to have a role in treatment decision-making, and there are published trials in which psychological therapy and pharmacotherapy treatments were both available within a stepped care model, and patients could choose between them in collaboration with their clinicians (Unutzer et al, 2003). Equally, within a stepped care system such as that outlined in Fig. 1, patients may be provided with a choice of interventions within steps (for example, guided self-help, computerised cognitivebehavioural therapy or group therapy at step 1), even if choices between steps are more constrained. However, the efficiency benefits of stepped care may be determined in part by constraints on choice: for example, offering minimal interventions such as bibliotherapy at the first step may have little effect if patients are allowed to choose more intensive treatment, and if most have an expectation of (and preference for) the latter type of treatment.
A second important issue is the acceptability of stepped care to professionals. Trials may be conducted by advocates of minimal intervention, and it cannot be assumed that all professionals will feel comfortable with the philosophical assumptions that underpin stepped care models or the changes to working methods that may be required (Cushman & Gilford, 2000).
Equivalence, efficiency and acceptability assumptions in published stepped care trials
There are few studies of a complete stepped care model. Two relevant
studies of stepped care for eating disorders have been conducted in the UK
(Treasure et al,
1996; Palmer et al,
2002), and one is considered here in detail to highlight important
issues relating to the equivalence, efficiency and acceptability assumptions.
This trial compared standard 16-session cognitivebehavioural therapy
for bulimia nervosa with a stepped care model, in which the first step was the
use of a self-help manual for 8 weeks
(Treasure et al,
1996). After this period patients were assessed, and those who no
longer met ICD10 criteria for bulimia were not offered further therapy,
whereas those who did were offered eight sessions of
cognitivebehavioural therapy. Sample size at baseline was 55 per group.
In the stepped care arm, 16 out of 41 patients (39%) were deemed to be
recovered at 8 weeks and were not offered further therapy. Of the remaining
patients, 9 were offered treatment but did not take it up. There was an 11%
difference in withdrawal rates in favour of the stepped care group. In terms
of outcomes, end-of-treatment abstinence rates in both groups were 30%, and at
18 months remission was 40% in the stepped care group and 41% in the
traditional treatment group. Outside the trial, 38% of patients in the stepped
care group sought extra treatment, compared with 17% of the traditional
treatment group.
The trial does highlight some of the problems in providing a rigorous evidence base for stepped care. First, it should be noted that none of the main results listed (relating to withdrawal from the trial, other treatment or clinical outcome) were reported as being statistically significant, although the differences reported in withdrawal rates and treatment outside the trial may be important clinically and economically. This highlights the problems of demonstrating equivalence when the sample size is relatively modest. The trial did provide some evidence of similar outcomes in the less intensive treatment arm, and implementation would allow more patients to be treated from the same therapeutic resources. However, this evidence of efficiency was restricted to the psychological therapy service, and there were no data on where the extra treatment was sought and where the costs fell (e.g. on the wider healthcare system or the patient). Also, the costs of the stepping up assessment were not taken into account. No specific data were presented on the acceptability of the model, although the rates of withdrawal suggest that the manual was generally acceptable to patients.
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FUTURE RESEARCH AGENDA |
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Given the concerns discussed above about current evidence on the equivalence and efficiency assumptions, the initial research agenda needs to focus on rigorous evaluations of these assumptions in the comparison of a selection of current minimal interventions (such as bibliotherapy and computerised treatments) with traditional psychological therapy. Such studies would provide evidence concerning the components of the stepped care model, but not about the model as a whole. Observational evaluations of a functioning stepped care model could be used to examine issues such as patient throughput within the various steps, issues relating to decision-making about stepping up and possible negative effects of treatment failure at lower steps and loss of continuity caused by changes in providers. As noted above, economic benefits might be dependent on patients restricting their help-seeking to the minimal interventions provided, and qualitative research to understand patient decision-making would be useful (Pilgrim et al, 1997; Breslin et al, 1999).
The final stage in the research agenda would be a controlled trial evaluation to compare an entire stepped care model with a traditional model of service delivery. This might require a large-scale cluster randomised trial (Gilbody & Whitty, 2002), and would seek to quantify the overall public health benefit of traditional and stepped care models.
However, the time required to complete such an ambitious research agenda may significantly delay service development. A more efficient alternative might be the use of modelling, which refers to the use of mathematical simulations to assess outcomes and costs associated with different health technologies and patient populations (Chilcott et al, 2003). Modelling could identify the potential for stepped care to be both clinically effective and cost-effective based on current data; in addition, models might be useful to extend results from existing randomised controlled trials and in the design of future trials (Chilcott et al, 2003).
First, modelling could be used to extend current trial data by examining longer-term outcomes (e.g. relapse and recurrence), different comparators, the effect of context (e.g. US data in the UK setting) and the effects of minimal interventions within a broader system of care (Brennan & Akehurst, 2000). For example, modelling could be used to determine the optimal number of steps in a stepped care model (Fig. 1), by identifying the number that provided the best potential trade-off between efficiency and complexity. Cost-effectiveness within a model could be examined from a wider societal perspective than is the case with existing research. Data on the effects of different interventions in the hierarchy of stepped care could be combined to examine pathways through the model of a hypothetical cohort of people with depression (Valenstein et al, 2001). The effect of the patient acceptability assumption could be modelled by examining the effect of assuming that different proportions of patients refuse to enter the lower levels of the hierarchy and enter more intensive steps.
Second, modelling could assist in informing the design of future trials and indicating their likely value. Models could help to specify an appropriate equivalence limit for future comparisons of minimal interventions and traditional therapy, suggest the optimal length of follow-up of outcomes (Chilcott et al, 2003) and highlight the key parameters that determine the likely cost-effectiveness of stepped care, and thus assist in the prioritisation of future trials (Torgerson & Byford, 2002).
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CONCLUDING REMARKS |
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Clinical Implications and Limitations |
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LIMITATIONS
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Received for publication November 13, 2003. Revision received September 9, 2004. Accepted for publication September 10, 2004.