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Effectiveness of innovations in nurse led chronic disease management f
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     1 Centre for Health Sciences, Barts and The London, Queen Mary's School of Medicine and Dentistry, London E1 2AT, 2 Public Health and Primary Care Unit, St Bartholomew School of Nursing and Midwifery, City University, London EC1A 7QN, 3 Department of Nursing Science, Maastricht University, PO Box 616, 6220 MD Maastricht, Netherlands, 4 Department of Adult Nursing, City University, St Bartholomew School of Nursing and Midwifery, London E1 2EA, 5 Academic Unit of Respiratory Medicine, Barts and The London, Queen Mary's School of Medicine and Dentistry, St Bartholomew's Hospital, London EC1A 7BE

    Correspondence to: S J C Taylor s.j.c.taylor@qmul.ac.uk

    Objective To determine the effectiveness of innovations in management of chronic disease involving nurses for patients with chronic obstructive pulmonary disease (COPD).

    Design Systematic review of randomised controlled trials.

    Data sources 24 electronic databases searched for English or Dutch language studies published between January 1980 and January 2005.

    Review methods Included studies described inpatient, outpatient, and community based interventions for chronic disease management that were led, coordinated, or delivered by nurses. Hospital at home and early discharge schemes for acute exacerbations of COPD were excluded.

    Results We identified nine relevant randomised controlled trials, most of which had some potential methodological flaws. All the interventions seemed to be variations on a case management model. The interventions described could be divided into brief (one month) and longer term (around a year) or more intensive interventions. Only two studies examined the effect of brief interventions, these found little evidence of any benefit. Meta-analysis of the long term interventions failed to detect any influence on mortality at 9-12 months' follow-up (Peto odds ratio 0.85, 95% confidence interval 0.58 to 1.26). There was evidence that the long term interventions had not improved patients' health related quality of life, psychological wellbeing, disability, or pulmonary function. The evidence on whether long term interventions reduced readmissions to hospital was equivocal, but the only study exclusively directed at patients on long term oxygen therapy reported a reduction in readmission. We identified several outcomes where little or no evidence was available; these included patients' satisfaction, self management skills, adherence with treatment recommendations, the likelihood of smoking cessation, and the effect of the interventions on carers.

    Conclusion There is little evidence to date to support the widespread implementation of nurse led management interventions for COPD, but the data are too sparse to exclude any clinically relevant benefit or harm arising from such interventions.

    Chronic obstructive pulmonary disease (COPD) affects an estimated 600 million people worldwide1 and in Europe it is the fifth leading cause of death.2–3 Each year the NHS spends more than £800m ($1415m, 1161m) on the disease,4 and exacerbations of COPD are a principal cause of the pressure on acute hospital beds in winter.5 Recognition of the public health burden of COPD has provided the impetus to develop new models of care. In the United Kingdom innovations in clinical service for COPD are being driven by a host of initiatives to redesign roles and processes in primary care and at the primary and secondary care interface, including changes to community and primary care nursing6 7 and general practitioners' contracts8 and schemes to support self management, such as the expert patient programme,9 together with the national service frameworks.10

    The literature around these service innovations describes two types of interventions: hospital at home or early discharge schemes for acute exacerbations and interventions aimed at improving the management of COPD as a chronic disease. Such interventions may be multidisciplinary but commonly they are led, coordinated, and delivered (at least in part) by nurses. Ram and colleagues recently reviewed the role of early discharge schemes and hospital at home schemes for acute exacerbations of COPD11 and suggested that they are safe and should be adopted. But what is the evidence to support schemes to improve the chronic disease management of COPD?

    As part of a larger project12 that attempted to synthesise all the available evidence (including qualitative, quantitative, economic, and "grey"13 literature) on the effectiveness of all the different clinical service innovations for COPD provided or led by nurses, we conducted a systematic review of randomised controlled trials of chronic disease management interventions for COPD.

    Methods

    Types of trials

    To be considered for inclusion, studies had to evaluate clinical service interventions or packages of care aimed at improving the management of patients with COPD in the community. Eligible studies included inpatient, outpatient, or community based interventions that were either nurse led, nurse coordinated, or largely delivered by nurses. (Whenever necessary we contacted authors to establish the nature of the intervention.) We excluded drug trials, hospital at home or early discharge schemes for patients with acute exacerbations, educational interventions directed solely at other healthcare providers, and studies in which a substantial proportion of patients did not have COPD.

    Types of outcomes

    Principal outcomes of interest included survival, use of healthcare resources, activities of daily life, patients' health related quality of life (HRQOL), and carers' quality of life. We also examined all other reported outcomes.

    Identification and selection of trials

    We performed a systematic literature review of English and Dutch language papers using a predefined protocol. (We included Dutch papers because of the tradition of research on community nursing in the Netherlands.) We searched 16 electronic English language databases for the period January 1980 to January 2005 and eight Dutch citation databases and hand searched the conference proceedings of seven respiratory associations (see bmj.com, appendix 1). We also wrote to researchers and practitioners to identify unpublished trials.

    Two reviewers working independently screened every citation retrieved in the searches and obtained the full text of all potentially eligible studies. BC undertook data extraction, using forms developed for the study, and quality assessment, which was checked by ST. HV extracted data from the Dutch language papers. Disagreements were resolved by discussion among the steering group.

    Assessment of methodological quality of trials

    We used the Delphi list14 and the Jadad criteria15 to assess methodological quality. We used the results of our data extraction together with the outcomes of the quality assessment to allocate an evidence score to each individual study using the levels of evidence from the Oxford Centre for Evidence-based Medicine.16

    Synthesis

    We grouped the findings of each study by type or duration of intervention and synthesised each outcome variable separately with an overall score for level of evidence for each outcome. When feasible and appropriate we conducted meta-analyses and calculated Peto odds ratios or Cohen's d standardised differences using Comprehensive Meta Analysis software (Biostat, NJ, 1999). Potentially important outcomes that had not been evaluated in any of the studies were identified by wider consultation, in particular with consumers, and by the review's advisory groups.

    Results

    Search for trials

    After screening of titles and s we identified 175 potentially relevant articles, of which we included nine randomised controlled trials describing interventions for the management of chronic disease (fig 1).17–25 We also identified one systematic review26 that included four of the trials we identified. We identified five potentially relevant studies whose results were unavailable because the studies were ongoing or being written up (see bmj.com, appendix 2). We excluded two potential trials because one did not present any data comparing the intervention and control groups27 and in the other the results of the statistical analyses did not seem to be adjusted for the cluster randomised design.28

    Fig 1 Process of study selection

    Methodological quality

    Most of the trials had potential methodological limitations, and only two studies reported on both random sequence generation and allocation concealment (see bmj.com, appendix 3). Five trials either did not report a clear calculation of sample size or failed to achieve the intended sample size. We assessed the level of evidence for each of the individual trials to be either 2b ("low quality randomised controlled trial") or 1b– (individual randomised controlled trial with a wide confidence interval; we have also used this where no confidence interval was supplied).16

    Description of the studies

    Table 1 describes the characteristics of the included studies. Most studies included patients with moderate or severe COPD (British Thoracic Society definitions29); one study included only patients receiving long term oxygen therapy.21 The interventions could be divided into brief interventions after a hospital admission (two studies,22 23 both around one month in duration) and more intensive24 or long term studies (around a year duration17–21 25) with follow-up at one year. The interventions studied had many similarities and all seemed to be variations on a "case management" approach (involving "the active management of high risk people with complex needs with case managers, usually nurses, taking responsibility for caseloads working in an integrated system"30). All the interventions included home visits by a nurse, except for one that was clinic based25 and two studies that were unclear on this point.19 22 Three interventions included telephone follow-up.21 22 24 Promotion of self care or self management30 was a major component of most of the home visits. This typically involved educating patients about medication and giving advice on stopping smoking, fitness, and the early identification of acute exacerbations. Some interventions included regular spirometry or pulse oximetry.19–21 Only the two most recent studies mentioned providing a supply of drugs or a prescription to be kept at home and filled in the event of an acute exacerbation,24 25 and these were also the only studies to mention the introduction of self treatment plans for patients. Two of the studies promoted exercise or physical activity,20 24 and one included a fitness programme led by a physiotherapist.25

    Table 1 Characteristics of trials included in the review

    Synthesis of findings

    Table 2 shows the effects of the brief and long term interventions on the outcomes examined. The results of statistical meta-analysis are shown where possible, but most outcome data were presented in various ways across the studies and it either was not possible to perform a meta-analysis or would have been potentially misleading because only two of the small number of studies reporting an outcome could have been included. Information on brief interventions is limited because there were only two randomised controlled trials. Meta-analysis of the trials of the long term or intensive interventions failed to detect any influence on mortality at 9-12 months' follow-up (Peto odds ratio 0.85 favouring intervention, 95% confidence interval 0.58 to 1.26; fig 2). We found a similar result when we carried out sensitivity analyses excluding the trial involving only patients on long term oxygen therapy.

    Table 2 Effects of interventions for management of COPD by nurses in community with estimated level of evidence score

    Fig 2 Effects of nurse led management interventions for COPD on mortality from trials of long term or intensive interventions (Peto odds ratios)

    Neither of the randomised controlled trials of brief interventions found evidence of a reduction in readmissions to hospital. The box summarises the outcomes where the evidence is equivocal. Evidence for a reduction in all cause readmissions at around 12 months' follow-up with the long term or more intensive interventions was equivocal. Bourbeau et al (40% reduction in readmissions for acute exacerbations, 57% reduction in other admissions, confidence intervals not given, both P = 0.01)24 and Farrero et al (mean number of admissions per intervention patient 0.5 (SD 0.9) v 1.3 (SD 1.7) per control patient)21 reported a significant reduction in hospital admissions with their interventions, but three other studies reporting this outcome found no significant effect on hospital admissions.17 19 20 Only two studies reported on respiratory readmissions at 12 months, again the results differed.17 24 The evidence around days spent in hospital and visits to the general practitioner or family physician was also equivocal, but there was some evidence for fewer visits to an emergency department (table 2).

    Meta-analysis of the three studies23–25 reporting health related quality of life measured by the total St George's respiratory questionnaire score at between three and six months' follow-up found no detectable effect (Cohen's d standardised difference (expressed in units of SD) 0.06, –0.14 to 0.26, fixed effects model, test for heterogeneity P = 0.61). Overall the evidence suggested that long term interventions do not improve patients' health related quality of life at 12 months' follow-up and may not improve patients' psychological wellbeing, impairment and disability, or pulmonary function. For many outcomes there was only reasonable quality evidence from a single trial, and the evidence was even weaker, or entirely absent, for several other outcomes (summarised in the box). In particular, there was an absence of evidence around the effect of these interventions on carers.

    Discussion

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