This is the first randomised controlled trial that investigated the effectiveness of early assisted discharge for COPD exacerbations with supervision at home by community nurses. In addition, this is the first evaluation of early discharge for this disease in the Dutch healthcare system. While patients’ disease-specific health status as expressed in the mean CCQ score after7 days treatment tended to be somewhat better in the usual hospital care group, the difference was small, not clinically relevant and not statistically significant. After 3 months, the difference had disappeared. The same pattern was found in generic health-related quality of life measured with the EQ-5D, although this difference was statistically significant at the end of the supervised treatment. The difference had disappeared at the end of the 3-month follow-up period. There was no difference in treatment failures, readmissions or mortality.
These study results confirm previously published positive results by Davison et al17
and Nicholson et al
but these two studies were either not randomised 17
or included a small number of patients.18
We found no significant difference in CCQ scores, which corresponds with the findings of Davies et al9
and Hernandez et al
who found no differences in disease-specific quality of life measured with the St George's Respiratory Questionnaire. Furthermore, our results are in line with those of earlier studies involving specialised hospital-based nurses.9–12
The readmission rate in our study was 25%, which is comparable to the 30% in previously published studies.9–11
Characteristics like age, smoking history and living situation of patients in our study were similar to those in studies from the UK 9–12
and to that of a survey on hospital-at-home services in British hospitals by Quantrill et al.27
Earlier studies did not measure the impact of hospital-at-home on generic health-related quality of life. We found a significant difference between the two groups, in favour of usual hospital care, at the end of the hospital and home treatment. This difference had disappeared after 3 months. The utility scores are in line with O'Reilly et al
but they found much worse scores at admission than in our study, probably because we did not include patients with more severe exacerbations. Utility and CCQ scores in both groups follow the same pattern. The greater improvement in CCQ and EQ-5D scores of the usual hospital care group at the end of the hospital treatment in comparison with the early discharge group may reflect a true difference in recovery, in which case usual hospital care is the preferred treatment. However, an alternative explanation could be that patients who were discharged early were confronted with their symptoms and limitations earlier and more intensely when they tried to pick up normal life at home. Furthermore, some patients have difficulties viewing hospital care followed by early discharge as one treatment period.29
Expecting to be in a certain state at discharge, and experiencing this is not the case, might be expressed in worse scores on the CCQ and the EQ-5D.
In our trial multiple hospitals participated with different socioeconomic and geographic characteristics, which make it likely that our sample is representative of eligible patients. The percentage of admissions initially considered to be eligible for early discharge at admission was similar to that of previous studies (±37%). Early discharge is possible when the exacerbation is the main problem and comorbidities are (relatively) stable. The percentage of patients living alone suggests that this is not an absolute reason for exclusion, provided that patients have a sufficiently functioning social support system. Still, 25% of screened patients were considered ineligible, because of living in a nursing home, overburden of informal caregiver(s) or living alone with insufficient social support. This suggests that social environment is an important factor when deciding for admission and (early) discharge. Finally, 37% of screened patients were ineligible because of comorbidities.
Considering the very low number of treatment failures in the early discharge group it might be possible to relax the inclusion criteria and randomisation criteria. In our trial, criteria were applied very strictly for safety reasons, but more patients with comorbidities might be eligible in daily practice. Furthermore, the strict review and exclusion of patients at day 1 of admission (eg, those treated with NIV), precluded patients from early discharge even if they had become eligible at day 3 of admission. Therefore, review of eligibility for early discharge should be performed after a few days of hospital treatment. Thirty per cent of patients who consented to participate were not randomised because they showed insufficient recovery and/or were depending on oxygen supply. Unlike in the British hospital-at-home schemes, patients were not sent home with nebulisers or oxygen cylinders, unless these were already part of their treatment. Extension of the treatment possibilities at home may enable early discharge of patient with more severe disease. However, it would also require more expertise of the nursing staff supervising patients at home, which might currently not be present in community-based home care organisations. Future research should focus on determining which treatments can be safely provided at home, which treatments require the supervision of generic or specialised nurses and which criteria should be applied for selecting eligible patients. In addition, a direct comparison between early discharge with generic and early discharge with specialised nursing care would provide more information on which scheme is most safe and effective.
Our study has some limitations. First, in total 139 patients were randomised, where a number of 165 was calculated to be needed to detect a difference of 0.4 in CCQ change scores between the two groups. A post hoc power analysis with these 139 patients and the actual variances in CCQ scores showed that the power to detect a difference in change from baseline of 0.4 between the groups was 73% instead of 80%, which was aimed for. We believe that this slight reduction in power does not have a substantial influence on our final results, because the difference between the groups was only 0.29. It is highly unlikely that this difference would have increased to the clinically relevant difference of 0.4 with an additional 26 patients. In previous randomised studies of early discharge in patients diagnosed with COPD numbers varied between 25 and 222, and only 15–35% of admitted patients was randomised.9–12
Second, our study was not an equivalence trial, which would determine best whether hospital care and early discharge care are equally effective. However, in order to demonstrate equal effectiveness with CCQ score, over 500 patients would have been needed, which is beyond what is attainable in this population. Third, 16% of patients dropped out after randomisation. However, comparison of patients who dropped out with patients who completed the study only revealed more comorbidities for those who dropped out. CCQ scores were not different. Fourth, although our variable selection for the analyses is justifiable, treatment centre could also be considered as an important covariate in the analyses, based on the randomisation design of the study. However, adding treatment centre as additional fixed factor to the analyses did not result in different outcomes in any of the analyses. It was therefore omitted and the analyses remained unchanged. Finally, due to the nature of the intervention, patients and healthcare staff could not be blinded to the allocated group.
In conclusion, we found no significant short-term or long-term differences in outcomes between early discharge and usual hospital care, except for generic health-related quality of life at the end of treatment (T+4 days). Early assisted discharge with home visits by community nurses can reduce length of hospital stay for a selected group of patients admitted with a COPD exacerbation and is an alternative to usual hospital care. The decision to implement early assisted discharge with community nursing does not only depend on the results of the effectiveness analysis. Costs and cost-effectiveness evaluations are of high importance as well. An economic evaluation is currently being performed and results will be published separately.