In this study, we developed and implemented a clinical pathway for the management of COPD exacerbations, and compared the outcomes (LOS, complication rate, readmission rate and mortality) of patients managed with the COPD clinical pathway with patients previously managed using the standard care guidelines.
As a baseline for comparison, we used historical controls from patients that were most recently managed using standard care guidelines one year prior to implementation of the clinical pathway. This control group was comparable to the patients that were prospectively recruited in the clinical pathway group: both groups had similar access to drugs, pulmonary rehabilitation, and smoking cessation clinic sessions; and their demographic profiles were similar. We did not find significant differences in the age, gender, and ethnicity between the groups.
The median BMI of the study population was 24.4 (20.9–27.2) which is classified as overweight following the Malaysian obesity guidelines (MOH 2004). Sixty one percent of the patients were overweight and obese, while 25.1% had normal BMI and 14.4% were underweight. Rampal et al. 2007 showed that the overall national prevalence of obesity in Malaysia was 11.7% [14
], however, we noted that they classified the cut-off point of obesity as BMI
. We classified obesity as a BMI
as recommended by the Malaysian clinical guidelines in management of obesity 2004[15
A total of 171(88.6%) subjects were ex-smokers and 22(11.4%) were still actively smoking. There were more active smokers (17%) in the non-CP group compared to CP group (5.3%). This may have contributed to the differences in LOS between the groups. It is unfortunate that we failed to match this factor between the groups. The CP group had their smoking history taken with the knowledge that they were participating in a clinical trial. There is a possibility that they may have under reported their years of smoking. The historical controls from case notes had smoking history taken and verified over a few entries. This may have been more reflective of an accurate number of pack years and smoking status. However there was no significant association between smoking history and length of stay in the two groups. The study also found no significant association between smoking history and complication. When we removed the 22 current smokers and reanalyzed the data, the length of stay between the CP and non-CP group was still significant (p
In terms of severity of COPD, majority of the patients admitted for COPD exacerbation had moderate to severe stage of disease. This is in keeping with the role of UKMMC as a tertiary referral centre. Another possible reason is most COPD patients approach their doctor at a later stage of the disease.
As COPD patients are generally elderly, comorbidities are expected to be higher. More than 50% of COPD patients in this study had at least one comorbid disease. The most common comorbid disease was hypertension. A large study by Mannino et al. (2008) reported that lung function impairment was associated with more comorbid disease [16
]. The risk of hospitalization and mortality were increased with comorbid disease, in which the mortality was worse in patients with impaired lung function [16
]. Prevalence of diabetes was found to be increased in COPD where 15% of the patients with COPD admitted to the hospital had diabetes mellitus [16
]. This result was almost similar to the prevalence of diabetes in our COPD population (19.2%). Antonelli et al. (1997) found that selected comorbids including chronic renal failure and myocardial infarction or ischemia were able to predict mortality in patients with advanced COPD [17
This study confirmed our hypothesis that usage of CP in the management of acute exacerbation of COPD decreased the hospital length of stay (LOS). We found a significant reduction in LOS of the CP group as compared to the non-CP group. The overall median LOS of COPD patients was 6
days and ranged between 2 to 13
days. The median LOS in non-CP group was 7
days whilst the LOS in CP group was 5
days. A Study by Celis et al. (2004), which utilized the COPD CP, also showed a significant reduction of mean hospital stay of 13.21
days in the control group and 10.24
days in the CP group [18
]. A similar study by Santamaria showed shortening of 0.89
days (13.2%) of hospital stay in the pathway group; however, this was not statistically significant [9
]. This was a prospective unblinded study in a single unit and the non-CP group had more co-morbidities. This could have contributed to the LOS being not significant. A retrospective study by Celis et al. (2004) also did demonstrate a significant decrease in LOS [18
], possibly due to the retrospective nature of the study.
For other respiratory disease CPs, Bailey et al. (1998) showed that the use of CP in asthma also caused reduction in the LOS [19
]. This reduction in LOS was also noted after implementation of pneumonia clinical pathway [20
There is insufficient data to indicate the optimal duration of hospitalization in patients with COPD exacerbation. A study on necessary length of hospital stay for COPD done by Mushlin et al. (1991) found that 6.9
days was considered averaged LOS [22
]. Our overall (both non-CP and CP groups) mean LOS was 6.56
days. We developed a 5-day COPD CP based on the recommended average use of antibiotic (3 to 7
days) from GOLD guidelines. Our CP was similar to COPD CP from the Grey Bruce Health Network in this aspect (approximately 5
days target). This study showed that CP can help in reducing length of stay and indirectly reducing cost of care.
The non-CP group had significantly more complications than the CP group (38 vs. 13). This is consistent with the study by Santamaria et al. (2004) which also showed fewer complications in the CP group [9
]. Acute respiratory failure (14 cases) was the most common complication seen which is similar to the study by Santamaria et al. (2004) [9
]. COPD patients are prone to develop type II respiratory failure with CO2 retention which would lead to mechanical ventilation support.
The number of readmissions was similar in both groups. We found no significant difference in the number of unplanned readmissions between the two groups. The main reason for readmission in this study was shortness of breath. The CP group also had longer readmission interval after discharge. Our findings were consistent with the study by Santamaria et al. [9
]. The earliest unplanned readmission was four days in the CP group and one day in the non-CP group. There is an on-going study by the EUROPEAN Quality of Care Pathways Study on COPD (EQCP-COPD) looking at readmission rates as a primary outcome.
There was no significant association in mortality between the non-CP and CP groups. Our finding was similar to Santamaria et al. study [9
]. There were two deaths in the CP group. Both patients were in stage IV COPD. One was a 70-year old male ex-smoker who had hypertension and ischaemic heart disease. The second subject was an 81-year old male who had no comorbidities. Both deaths were associated with COPD exacerbation.
We encountered minimal initial resistance to the clinical pathway. However, this was not a major issue. This lack of acceptance resulted in some deviation from the clinical pathway. Several batches of medical officers and house officers were rotated into the medical unit during the duration of this study. Information on the COPD clinical pathway may not be well disseminated. Our briefing sessions should have been more regular to improve the compliance and adherence to the CP. In our study it was not possible to screen admission during long weekends or public holidays. We designated a single investigator to review and prompt the doctors. This problem can be improved by appointing case managers in each ward. Due to the retrospective nature of case control section of this study, there were a number of incomplete data documentation and recording.
This study on COPD clinical pathway in Malaysia showed a decrease in LOS and complications. We are currently evaluating the effectiveness of the CP using this current data from a cost analysis point of view. This will be published upon completion of analysis. We continue to improve our COPD clinical pathway by studying the variances. We will use these to tailor the current CP to reflect our resources available to us.