Article Text

The effectiveness and cost effectiveness of a national lay-led self care support programme for patients with long-term conditions: a pragmatic randomised controlled trial
1. Anne Kennedy1,
2. David Reeves1,
3. Peter Bower1,
4. Victoria Lee1,
5. Elizabeth Middleton1,
6. Gerry Richardson2,
7. Caroline Gardner1,
8. Claire Gately1,
9. Anne Rogers1
1. 1National Primary Care Research and Development Centre, University of Manchester, Manchester, UK
2. 2Centre for Health Economics, University of York, York, UK
1. Correspondence to:  Dr A Kennedy  National Primary Care Research and Development Centre, 5th Floor, Williamson Building, University of Manchester, Manchester M13 9PL, UK; anne.p.kennedy{at}manchester.ac.uk

## Abstract

Objective: Supporting patients’ self care could have a major effect on the management of long-term conditions, which has led to worldwide interest in effective self care interventions. In England, self care support is being developed through the “Expert Patients Programme”, which provides lay-led generic courses to improve patients’ self care skills. However, the clinical and cost effectiveness of such courses remains unclear.

Methods: Two-arm pragmatic randomised controlled trial design with waiting list control in community settings in England. 629 patients with a wide range of self-defined long-term conditions were studied. The lay-led self care support group involved 6-weekly sessions to teach self care skills. Primary outcomes were self-efficacy, reported energy and routine health services utilisation at 6 months. A cost-effectiveness analysis was also conducted.

## RESULTS

In total, 629 patients were recruited between April 2003 and March 2005 (fig 2). We have discussed some of the reasons for not taking part in REPORT elsewhere.25,31 Reasons included problems with access (no local course available, course times unsuitable, lack of provision for those with disabilities); poor current health state; a feeling that they were already effective self-managers; dislike of the group approach; or insufficient motivation to commit to a 6-week course. A total of 521 (83%) patients returned 6-month assessments (although completion of individual scales varied slightly). There were no marked differences in baseline characteristics (table 1). Approximately one third of patients reported preferences to enter the EPP immediately, half were indifferent, and the remainder reported preferences for the wait list control.

Table 1

Baseline demographic and health characteristics

Figure 2

Consolidated Standards of Reporting Trials diagram showing patient flow through the Research into Expert Patients—Outcomes in a Randomised Trial.

There was differential attrition, with 79.2% of 6-month assessments returned by the intervention group and 86.4% by the controls (difference 7.2%, 95% CI 1.3% to 13%). Stepwise logistic regression analysis was used to estimate the probability of return on the basis of patient characteristics. Return was significantly more likely from patients who were older, had the condition longer, owned their own home or had certain types of condition (musculoskeletal, circulatory, respiratory). The inverse of these probabilities was assigned as weights.

On primary outcomes (table 2), the intervention patients reported considerably higher scores for overall self-efficacy and energy, but reported no differences in healthcare utilisation. On secondary outcomes, intervention patients reported considerably fewer social role limitations, better psychological well-being, lower health distress, more exercise and relaxation, and greater partnership with clinicians. There were no differences between groups on general health, pain, diet, use of complementary products or information seeking.

Table 2

Outcomes at 6-month follow-up

To explore whether the intervention effect, when significant, varied between conditions, patients were classified into eight conditions (table 1) and the interaction between condition and trial group added to the primary analysis. The trial was not powered to detect interactions, so a criterion of p<0.15 was used to warrant further investigation.29 There were no significant differences between subgroups on any primary outcomes, and only one secondary outcome met the criterion (partnership with clinicians, p = 0.13).

None of the results relating to the primary outcome were influenced substantively by the sensitivity analyses. In the secondary outcomes, the sensitivity analysis with seasonality and time between recruitment and follow-up as additional covariates, the intervention group scored significantly higher on general health than the controls (p = 0.037). In the sensitivity analysis with Strategic Health Authority as an additional covariate, the increase in exercise in the intervention group was no longer statistically significant (p = 0.068).

Data on all major categories of health services utilisation are provided in table 3, with conventional measures of significance and effect size statistics for comparative purposes. There was a difference in QALYs of 0.02 (95% CI 0.007 to 0.034, adjusted for baseline characteristics) in favour of the intervention group, and a reduced cost of £27 ($53; €41) (95% CI £368 ($721; €557) to £422 ($827; €639)). Thus the intervention group were associated with a better QALY profile as well as a small reduction in costs. Although there is considerable uncertainty around the estimates of costs and QALYs, if decision-makers are willing to pay £20 000 ($391 91 and €30 282) per QALY,32 there is a 70% probability that the intervention is cost effective. Full details of the economic analysis will be presented elsewhere, including appropriate sensitivity analyses.

Table 3

Mean resource use over the 6-month period*

## DISCUSSION

The lay-led self care support programme was responsible for significant increases in self-efficacy and energy, but did not affect routine health-services utilisation. Patients in the intervention groups reported increased health-related quality of life, and the programme was cost effective at conventional levels of a decision makers’ willingness to pay.

### Internal validity issues

Internal validity was increased through procedures to ensure concealment of allocation.33 Attrition was relatively low given the national sample and the consequent restriction to postal follow-up. Delivery of the intervention was outside the control of the REPORT team, and the intervention was being tested within REPORT at the same time as it was being implemented routinely, and it is possible that initial delivery was suboptimal, although central quality assurance procedures were in place.

Pragmatic trials such as REPORT use large sample sizes and limited controls on patient entry, and these methods have been criticised.34 The heterogenous sample means that variation in prognosis and capacity to benefit within groups is high; care must be taken in applying the results to individual patients and particular patient groups. Although the subgroup analysis did not find that effects were moderated by health condition, such analyses were post hoc and underpowered, and classification of patient problems was based on self-report only. The results of REPORT may have greater implications for overall health service policy concerning long-term conditions than for individual clinical decisions. It should be noted that variability in the quality of delivery of the course and in the types of patients entering the trial would generally make it more difficult to show a statistically significant effect.

Patients were randomised to the intervention or a wait list control, and there was potential for patient preferences to affect outcomes through “resentful demoralisation” of the control group. However, measures at baseline showed that initial preferences were mixed, and qualitative data suggested that a proportion of patients were ambivalent about the intervention.25 Furthermore, a recent systematic review showed a lack of clear evidence that preferences and resentful demoralisation are significant predictors of outcome in trials.26

### External validity issues

REPORT was designed to maximise external validity, by recruiting a patient population similar to that accessing EPP. However this approach was only partly successful. Patients volunteered through various sources, and as with many self care studies,10 it proved impossible to estimate the proportion of eligible patients who declined. To ensure that REPORT did not compromise routine provision, only a proportion of patients who entered the programme routinely were approached.25

Data on the participants in REPORT were compared with data from the Health Survey for England, a representative annual cross-sectional survey which identified nearly 7000 adults with at least one long-standing condition.35 The trial sample involved a higher proportion of women (70% compared with 56% in the Health Survey), and they were generally less active (20% in paid employment vs 48%) and reported greater numbers of long-term conditions (2.6 vs 1.8). There were smaller differences in the proportion living alone (28% vs 23%), and the proportions of ethnic minorities (5% vs 6%) and owner occupiers (68% vs 72%) were similar.

• The burden of long-term conditions is significant, and there is interest in the potential for increasing the role of patient self care in the management of these conditions.

• Effective self care may improve outcomes and reduce health service utilisation.

• In England, significant resources have been invested in the development of a lay-led self care group support programme for patients, but the clinical and cost effectiveness of that programme delivered in routine National Health Service contexts is unclear.

• The trial shows that a lay-led self care group support programme improves patient self-efficacy and self-reported energy.

• Although the programme does not have a significant effect on routine health service utilisation over 6 months, overall it is associated with improvements in health related quality of life at no increased cost, and is likely to be cost effective.

• The programme may be a useful addition to current provision for long-term conditions.

All these issues raise questions about external validity. As noted above, REPORT was conducted in parallel with the national implementation of the EPP self care initiative, and the Department of Health collected data on patients who took part in the lay-led self care support programme as part of the wider initiative, but did not participate in the trial. Comparison of populations in and outside the trial showed broad similarities in characteristics.36 The EPP faces significant challenges in reaching out to a broader population of patients with chronic disease in the community, and it is unclear whether the results of REPORT will generalise to that population should the EPP be successful in increasing participation. However, it is likely that the results of the trial can be generalised to the population currently accessing the intervention.

Other studies of the CDSMP have not always provided relevant data for effect size calculations, but two reported a somewhat different pattern of results, with comparatively smaller effects on self-efficacy and psychological well-being in Hispanic and Chinese populations, larger effects on self-rated health and health service utilisation, and similar effects on social role limitations, pain, and partnership with the doctor.13,14 Clearly there are differences in patient populations and health service contexts that could account for these variations. Such variations do highlight the need for primary studies of imported interventions, because results in one population cannot be generalised. However, the current results broadly replicate previous studies.11,13–15 They also extend them with a comprehensive assessment of patient quality of life and economic outcomes.

### Interpretation of the outcomes

In terms of the model in fig 1, the intervention shows the largest relative effect on self-efficacy, and the effect decreases further down the causal pathway. The pattern of results accords with the model in fig 1, where the effects are mediated through self-efficacy. The self-efficacy concept has a significant theoretical and empirical basis,21 but it is not a conventional health outcome and was originally seen as a mediator of other outcomes rather than an outcome per se. The REPORT team is conducting a discrete choice experiment37 to investigate the value placed on self-efficacy by patients compared with other outcomes of the intervention.

Energy was the primary measure of health status because it was an outcome which could be potentially modified by the intervention across all patients. Although other dimensions were available, these were less relevant to all types of patient (for example, pain in patients with diabetes). However, the circumscribed nature of the health status measure must be considered when interpreting the results.

The lack of effect on utilisation may reflect the short nature of the follow-up, which may not have provided enough time for patterns of usage to change, or the fact that the intervention was not linked explicitly with wider care provision. Inpatient use was reduced (which supports a previous study of the CDSMP11) although the difference was not statistically significant. However, the overall reduction in utilisation meant that the costs of provision of the programme were offset, and there was a small net reduction in costs. The formal cost-effectiveness analysis showed that the programme is likely to be cost effective when compared with a wait list control.

Several research questions remain. The exact mechanisms by which the intervention achieves its effects are unclear, and may be due to the structured nature of the intervention or more non-specific mechanisms such as the group experience. The group approach may not be acceptable to a proportion of patients, and the benefits of the intervention need to be compared with other approaches, such as individual interventions, on line delivery or the training of health professionals in the facilitation of self management.

### Conclusion

In conclusion, the results indicate that provision of a lay-led self care support programme to patients with long-term conditions results in significant increases in self-efficacy and energy, and is likely to be cost effective. The programme may be a useful addition to current provision for long-term conditions.

### Policy implications

• The Expert Patients Programme is a major Department of Health policy initiative designed to introduce effective self care into the National Health Service, and has been given a high priority.

• Self care is suggested as being a way to improve patient outcomes and quality of life, and reduce demand on the health service, thus ensuring that the future provision of health care is affordable.

• This study provides empirical data relating to these assumptions. The programme does not have a significant effect on routine health service utilisation over 6 months, but it is associated with improvements in outcomes and health-related quality of life at no increased cost, and is likely to be cost effective.

• The programme may be a useful addition to current provision for long-term conditions.

## Acknowledgments

We thank Fran Morris, Claire Chandler and Sophie Jerrim for their hard work in the administration of the trial; the patients who kindly agreed to participate and complete the written assessments; the staff within the Expert Patients Programme and the Primary Care Trusts who helped recruit patients; and Ayesha Dost and Geoff Royston at the Strategy Directorate of the Department of Health. NPCRDC is a department of the University of Manchester but is funded by the Department of Health. The views expressed in this paper are the views of the authors and not the funding body.

## Footnotes

• Funding: The REPORT study was funded by the Department of Health. The funding body was not involved in the design, analysis and reporting of the REPORT trial beyond commissioning reviews of the protocol, and checking the accuracy of certain facts and material included in the final draft.

• Competing interests: None.