Abstract
Exacerbations are an important cause of morbidity and mortality in COPD. We assessed treatment initiation and health care use at exacerbation in patients receiving a self-management education program including an action plan. COPD patients were randomly assigned to usual care or to a comprehensive self-management program “Living Well with COPD” including a written action plan and case manager support, and were followed-up for 12 months. Patients in the usual care were managed by their respective practitioners. Patients in the self-management program received, as part of a written action plan, a prescription of antibiotics and prednisone for self-initiation in case of aggravation of 2 or more symptoms (dyspnea, sputum volume, sputum purulence) for at least 24 hours, and they had the support of a case-manager for reinforcement and monthly telephone follow-ups. At 12 months, 166 patients presented with at least one exacerbation. Exacerbations (606) were confirmed by aggravation of at least one symptom; 403 (67.6%) presented 2 or more. Antibiotics were used in 61.6% of exacerbations and prednisone in 47.9%. In exacerbations presenting aggravation of 2 or more symptoms, antibiotics and prednisone were used together more often in the action plan than in the usual care group (54.4% vs. 34.8%, p < 0.001). In the action plan, compared to the usual care group, 17.2% vs. 36.3% exacerbations resulted in a hospitalization (p < 0.001). Self-management with the successful use of an action plan for acute exacerbation of COPD holds promise for reducing health care use.
| Abbreviations | ||
| COPD | = | Chronic Obstructive Pulmonary Disease |
| MRC | = | Medical Research Council dyspnea scale |
| FEV1 | = | Forced Expiratory Volume in 1 second |
| FVC | = | Forced Vital Capacity |
INTRODUCTION
It is well known that COPD exacerbations have a considerable negative impact on patients in terms of disease progression (Citation[1], Citation[2]), morbidity (Citation[2]), mortality, and health status (Citation[3],Citation4,Citation5,Citation6). Preventing exacerbations and improving prognosis are key treatment goals (Citation[7], Citation[8]). Delay/failure to visit a professional to initiate antibiotics and corticosteroid treatment leads to deterioration of health status and increased hospitalization risk (Citation[9]). Early recognition and treatment have been recommended as efficient strategies to manage exacerbations (Citation[10]). Self-management programs promote these strategies via the action plan, which focuses on exacerbation prevention and rapid access to treatment.
Studies using multi-component self-management education, including an action plan, have demonstrated reduced emergency department visits and hospitalizations (Citation[11],Citation12,Citation13). However, appropriate use of antibiotics and prednisone to treat exacerbations and their potential effects on health care utilization have not been evaluated. We decided to assess, as part of a self-management program, the use of a written action plan on patients' recognition and response to their exacerbations (through early self-initiation of antibiotics and prednisone), and the subsequent impact of this treatment on healthcare services use (hospitalizations and emergency room visits).
MATERIALS AND METHODS
This is a retrospective analysis of a multicenter randomized clinical trial for which the design and methods have been described elsewhere (Citation[11],Citation14) (trial carried on between 1998–2000 and hence not entered in a public registry). Patients were randomly assigned to usual care or to a self-management intervention and were followed-up for 12 months. Patients in both groups continued to be managed by their respective specialist or general practitioner and maintained their usual access to the provincial universal health programs, featuring free health care services and a drug benefit plan. Patients in the usual care group needed to see their physician to obtain a prescription for the treatment of their COPD exacerbations. Action plans with self-administered prescription for COPD exacerbations were not available as part of regular care at the time of this trial.
Self-management education with an action plan supported by a case manager
All patients in the intervention group received the 7 education modules of the self-management program “Living Well with COPD”, including a written action plan with prescription of antibiotic and prednisone for self-administration in the event of an exacerbation, and supervision by a case manager (Note: since 2005 the program is also available through the website www.livingwellwithcopd.com, password: copd). The self-management program consisted of home teaching 1 hour/week for 7–8 weeks, reviewing different self-management topics such as: basic COPD information; breathing, relaxation and energy conservation techniques; COPD medication and inhalation techniques; and the use of an action plan during exacerbations. The program was supervised by experienced case managers, in collaboration with treating physicians. In addition, during periodically scheduled telephone calls (weekly during the 2-month education period and monthly for the remainder of the study) the case manager reviewed patients' general health conditions and the use of self-management strategies.
The written action plan was designed as a summary of the comprehensive program, with a focus on exacerbations, and included: list of contacts, regular respiratory medication and actions to remain stable (healthy behaviours); symptom recognition and actions to manage exacerbations due to environmental/stress factors or respiratory infections (including a prescription for self-initiation of treatment at home); actions for symptom worsening or dangerous situations.
Actions at exacerbation included using breathing techniques, stress management and energy conservation techniques, avoiding aggravating factors, initiating treatment and contacting the case manager. Treatment initiation included increased use of a short-acting bronchodilator and initiation of prednisone and antibiotic. The instruction given to the patients was to initiate antibiotics and prednisone in the occurrence of at least two major symptoms over 24 hours or more: purulent sputum, increased sputum volume and dyspnea deterioration (exacerbations type-II and type-I as per Anthonisen criteria (Citation[15])). The choice of antibiotics and prednisone dosage for the standing prescription was left to the treating physician. Patients were advised to call their case manager (available during business hours) to discuss treatment initiation, although they could start treatment by themselves.
If symptoms did not improve or got worse despite treatment, patients were instructed to seek immediate assistance (case manager, physician, emergency room). The case manager remained accessible to patients for support and close follow-up at the time of an exacerbation. Since prescriptions were not renewable, the case manager needed to evaluate the exacerbation episode and contact the treating physician before getting a new one.
Assessment of outcomes
Data collection was carried out by independent evaluators blinded to group assignment. All patients underwent periodic evaluation visits at baseline, 4 and 12 months. They also kept a detailed diary of respiratory symptoms, medications and visits to clinics or the hospital. Standardized telephone interviews were conducted every 4 weeks and were designed to record outcomes (medication and health services use) specific to respiratory and non-respiratory causes separately. At the beginning of the interview the evaluator would assess whether in the last 4 weeks the patient had experienced an episode where at least one symptom was aggravated (purulent sputum, increased sputum volume and/or dyspnea deterioration) for at least 24 hours; this was the definition of a COPD exacerbation.
If the presence of at least one exacerbation episode was confirmed, the interviewer would then evaluate (for each episode): exacerbation duration; medication added or changed to treat the exacerbation (bronchodilators, antibiotics, prednisone); delay to start medication from exacerbation onset, duration of intake; and related healthcare services use (unscheduled physician visits, emergency room visits, hospitalizations). If within the 4-week period, the patient presented various exacerbations, they would be coded as different episodes only if respiratory status returned to baseline for at least 72 hours between the end of one episode and the beginning of the next. The evaluator would record separately any other health problems due to non-respiratory causes (e.g., co-morbidities) occurring in the 4-week period, including a brief description of the problem, medication changes and healthcare services used. Since the phone interview was done blinded, there was no mention of the action plan, standing prescription or case manager. An independent adjudication committee reviewed this information to ensure that each exacerbation was due to respiratory causes (COPD exacerbation), and that no outcome related to an exacerbation (e.g use of antibiotics) was assigned to other health problems or vice versa.
Statistical analysis
Results presented in this study relate only to COPD exacerbations and their outcomes in terms of medications and health services used, as recorded during the phone interviews. Exacerbations occurring while patients were hospitalized or treated exclusively at the hospital were excluded, since the decision to initiate treatment was made by a physician. An intent-to-treat analysis was performed. Demographic and baseline clinical characteristics were summarized as a mean ± SD or as a group percentage for categorical and dichotomous variables. Tests of significance were double sided and 95% confidence intervals were used. For statistical calculations we used SAS (Citation[16]) and SISA (Citation[17]), applying chi-square tests for relationships between dichotomous variables and t-test for means comparisons.
RESULTS
Patient characteristics
In the 12-month study period, of the 191 patients enrolled in the study, 166 presented with one or more eligible exacerbations. Baseline characteristics were similar across sociodemographic, clinical and functional variables (), except for smoking history, higher in the usual care group (p = 0.0016) and renal conditions, more predominant in the action plan group (p = 0.02). Most patients were elderly, not highly educated (80% with education ≤ 11th grade), were very limited because of dyspnea, and had moderate to severe COPD.
Table 1 Baseline characteristics of study patients
Exacerbation characteristics
A total of 661 exacerbations were reported among 166 patients. Fifty-five exacerbations were excluded from analysis: 31 without documentation of any of the major symptoms, 14 treated with antibiotics and/or prednisone only at the hospital, and 10 other representing duplicate data collection. Out of the 31 excluded exacerbations without major symptoms reported, 9 (81.9%) in the action plan group and 11 (55%) in the usual care group were treated with antibiotics and/or prednisone. A total of 606 exacerbations met the inclusion criteria: 328 in the usual care and 278 in the action plan group; this difference was not statistically significant. The frequency distribution of exacerbations among patients in the usual care and action plan groups is shown in . Dyspnea was the most common symptom present in exacerbations (95%); the majority of exacerbations presented worsening of 2 or more symptoms. Exacerbations in both groups were not statistically significant in terms of symptoms presentation (see ).
Figure 1 Frequency distribution of exacerbations experienced during the 12-month follow-up period; total number of exacerbations 606, 278 in the intervention group and 328 in the usual care group. Fifty-five (55) patients (67.9%) in the usual care group and 53 (62.3%) in the action plan group experienced 3 or more exacerbations during the 12-month follow-up.
Figure 2 Major symptoms present during exacerbations, N = 606. None of the differences were statistically significant.
Treatment of exacerbation and healthcare services use
Antibiotics use was reported in 373 (61.6%) of all exacerbations, while oral corticosteroids were used in 290 (47.9%). In the action plan as compared to the usual care group, patients used antibiotics on average 24.2 and 26.7 days during the 12-month follow-up period, and prednisone over 24.7 and 21 days respectively (differences not significant). As shown in , out of the 403 exacerbations presenting with changes in 2 or more major symptoms, a higher proportion was treated with antibiotics and prednisone in the action plan than in the usual care group (54.4% vs. 34.8%, p < 0.001), difference also seen in the 203 exacerbations with only one symptom (35.3% vs. 17.8%, p = 0.005). Moreover, in the usual care group, a greater percentage of exacerbations presenting worsening of 2 or more symptoms were either treated only with antibiotics or not treated at all (60.0% vs. 38.3%, p < 0.001).
Table 2 Medications used to treat exacerbations
We also observed a trend to earlier initiation of treatment in the action plan group. In exacerbations for which both antibiotics and prednisone were used, 70.2% were treated within three days of symptom onset in the action plan group, compared to 60.2% in the usual care group, although this result did not reach statistical significance (p = 0.12). This tendency was more pronounced in the last exacerbation experienced by each patient in the 12-month follow-up period (80.5% vs. 59.1%, p = 0.068).
In exacerbations treated with both antibiotics and prednisone (229), comparing the action plan to the usual care group, there was a significantly reduced risk of hospitalization (17.2% vs. 36.3%, p < 0.001), emergency room visits (29.9% vs. 54.4%, p < 0.001) and unscheduled physician visits (8.2% vs. 30.9%, p < 0.001).
DISCUSSION
This study adds new findings to those reported in a previously published randomized controlled trial (Citation[11]). The self-management program, including a written action plan and supported by a case manager, led to changes in patient behavior, i.e., more than 50% of patients promptly self-treated their exacerbations with antibiotics and prednisone. This appropriate adoption of self-management was associated with a reduction in hospital admissions and emergency visits.
Other studies (Citation[18],Citation19,Citation20,Citation21) have shown that patients with a written action plan, including a self-administered prescription of antibiotics and prednisone, were more likely to initiate such treatment in the event of an exacerbation than the control where treatment was initiated by their physicians. Some investigators interpreted this as an indication of misuse (Citation[18]). In our study, the action plan group used antibiotics and prednisone more frequently, but the total usage in number of days over the year was not different between groups, meaning that the usual care group had longer treatments. Patients often have little or no understanding of their symptoms, of warning signs that herald exacerbations, and of which specific actions should be taken to mitigate their severity.
In the usual care group, where patients did not have self-management education, we can presume that patients were less likely to recognize the onset of an exacerbation. Recent studies have shown that an action plan provides patients with a better understanding of the importance of early intervention and of how to implement appropriate exacerbation treatment (Citation[22]). Furthermore, even if patients in the usual care group knew how to recognize exacerbations and the actions to be taken, they were left with the sole option of obtaining a prescription by contacting their physician or by going to the emergency department.
A Cochrane review from 2005 (Citation[23]) demonstrated that action plans help COPD patients to recognise and respond to their exacerbations through self-initiation of medication; however, it failed to show benefits on health services use. Lack of statistical power and variability of published results were a serious limitation in the majority of included studies (Citation[20],Citation21,Citation22). One recent study showing negative results on the use of an action plan for COPD was non-randomized (Citation[18]), and as such had an increased potential for bias. On the other hand, a randomized clinical trial published in 2007 showed a reduction of visits to general practitioners in patients with a written action plan and reserve supplies of antibiotics and prednisone compared to those in usual care (Citation[19]).
Our study is the first to demonstrate not only that patients can master specific skills to properly use antibiotics and prednisone in the event of an exacerbation, but that this strategy could potentially reduce health services use. We showed a reduction in hospital admission and emergency visits in exacerbations treated with both antibiotics and prednisone in the action plan group compared to the usual care group, as well as a tendency to seek help faster. This is in line with the results of a recent cohort study on exacerbations (Citation[9]), showing that the delay in seeing a professional to initiate antibiotics and prednisone was associated with an increased hospitalization risk.
Our study had several strengths. First, the trial selected patients who were at risk of exacerbations and hospital admissions, the COPD population we anticipated could benefit from this intervention. Second, the intervention involved not only lecture based teaching but also a healthcare system organization that supports patient self-care, well defined roles and long-term follow-up by a case manager. Finally, the evaluation of symptom presentation during exacerbations was very strict in both groups, requiring patients to fill a diary card to respond to monthly evaluation interviews, to minimize under-reporting of exacerbations, and properly assign medication use and outcomes.
The study clearly has some limitations. All patients received action plans as part of a self-management program and therefore the specific intervention of the action plan in the event of an exacerbation was not tested separately. The action plan cannot be defined as a separate entity from “self-management”, since its proper use requires mastering the majority of self-management skills taught in such a program. To date, there is lack of evidence to support the use of an action plan without a broader self-management program (Citation[23]). On the other hand, a self-management education program without an action plan would fail to provide patients with an essential tool to promptly manage the most critical episodes of their COPD trajectory, exacerbations. However, the application of a program as intensive as the one used in this study might seem unpractical in some environments. Hence, the objective of future research should be to explore whether an action plan, supported by a less intensive self-management program, might lead to similar benefits.
Another limitation was the lack of information, regarding failure of some patients in the intervention group, to successfully use antibiotics and prednisone in the event of an exacerbation. The timeframe of 12 months may have been insufficient to reach behaviour change, especially in those who only had one exacerbation. As with any other skill, patients will likely experience a learning curve, and need to practice using their action plans. Patients tended to use their standing prescription more promptly on their last exacerbation. This suggests the importance of self-management education within an integrated care delivery system, including the support of a case manager, who can help the patient to implement new behaviours by reviewing past experiences (negative or positive) and reinforcing self-efficacy. Symptom severity could also have influenced patients' decisions to initiate treatment and explain some of the inconsistencies found in the application of the action plan directives.
For example, patients in the action plan group were not always using their antibiotics and prednisone in the event of an exacerbation. This was observed in a smaller number of exacerbations in the intervention as compared to the usual care group. We could hypothesize that in some cases patients felt that symptoms were not severe enough to initiate treatment; it would be supported by the low admission and emergency visit rates observed for these exacerbations. On the other hand, more patients in the action plan group took antibiotics and prednisone when reporting only one symptom, despite not being instructed to do so by the action plan. We cannot conclude whether this was inappropriate or if the severe worsening of a single symptom led patients/case managers to initiate treatment. However, this remains to be shown in a definitive trial.
In summary, despite some limitations, our study provides evidence that a self-management education program, that includes a written action plan, is an effective strategy to help patients recognize COPD exacerbation symptoms and initiate treatment promptly. A self-management approach, including the use of a written action plan for early treatment of exacerbations, holds promise for positive benefits on COPD care delivery, i.e., reduction in emergency department visits and hospital admissions. A definitive trial, where the action plan plays the central role, is still required.
FINANCIAL SUPPORT
Work was performed at the Montréal Chest Institute of the McGill University Health Centre, Montréal, Québec, Canada. Funding was received as an unrestricted grant from Boehringer Ingelheim Canada, Burlington, Ontario, in partnership with the Fonds de la recherche en santé du Québec (FRSQ), Montréal, Québec.
Declaration of interest
Jean Bourbeau has received fees for speaking to conferences, and for serving as expert on advisory boards for AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline and Pfizer; Jean Bourbeau's MUHC Research Institute received research grants from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline and Pfizer. The rest of the authors (Maria Sedeno, Dina Hamd, Diane Nault) report no conflict of interest. The authors alone are responsible for the content and writing of this paper. The authors alone are responsible for the content and writing of the paper.
REFERENCES
- Donaldson G C, Seemungal T A, Bhowmik A, Wedzicha J A. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax 2002; 57: 847–852
- Garcia-Aymerich J, Monso E, Marrades R M, Escarrabill J, Felez M A, Sunyer J, et al. Risk factors for hospitalization for a chronic obstructive pulmonary disease exacerbation. EFRAM study. Am J Respir Crit Care Med 2001; 164: 1002–1007
- Miravitlles M, Ferrer M, Pont A, Zalacain R, Alvarez-Sala J L, Masa F, et al. Effect of exacerbations on quality of life in patients with chronic obstructive pulmonary disease: a 2 year follow up study. Thorax 2004; 59: 387–395
- Seemungal T A, Donaldson G C, Paul E A, Bestall J C, Jeffries D J, Wedzicha J A. Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 1998; 157: 1418–1422
- Seemungal T A, Donaldson G C, Bhowmik A, Jeffries D J, Wedzicha J A. Time course and recovery of exacerbations in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2000; 161: 1608–1613
- Spencer S, Jones P W. Time course of recovery of health status following an infective exacerbation of chronic bronchitis. Thorax 2003; 58: 589–593
- Celli B R, Mac Nee W. Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper. Eur Respir J 2004; 23: 932–946
- O'Donnell D E, Aaron S, Bourbeau J, Hernandez P, Marciniuk D, Balter M, Ford G, Gervais A, Goldstein R, Hodde R, Maltais F, Road J. Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease—2003. Can Respir J. 2003; 10(Suppl A)11A–65A
- Wilkinson T M, Donaldson G C, Hurst J R, Seemungal T A, Wedzicha J A. Early therapy improves outcomes of exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2004; 169: 1298–1303
- Nici L, Donner C, Wouters E, Zuwallack R, Ambrosino N, Bourbeau J, Carone M, Celli B, Engelen M, Fahy B, Garvey C, Goldstein R, Gosselink R, Lareau S, Mac Intyre N, Maltais F, Morgan M, O'Donnell D, Prefault C, Reardon J, Rochester C, Schols A, Singh S, Troosters T. American Thoracic Society/European Respiratory Society statement on pulmonary rehabilitation. Am J Respir Crit Care Med 2006; 173: 1390–1413
- Bourbeau J, Julien M, Maltais F, Rouleau M, Beaupre A, Begin R, Renzi P, Nault D, Borycki E, Schwartzman K, Singh R, Collet J P. Reduction of hospital utilization in patients with chronic obstructive pulmonary disease: a disease-specific self-management intervention. Arch Intern Med 2003; 163: 585–591
- Casas A, Troosters T, Garcia-Aymerich J, Roca J, Hernandez C, Alonso A, del Pozo F, de Toledo P, Anto J M, Rodriguez-Roisin R, Decramer M. Integrated care prevents hospitalisations for exacerbations in COPD patients. Eur Respir J 2006; 28: 123–130
- Gadoury M A, Schwartzman K, Rouleau M, Maltais F, Julien M, Beaupre A, Renzi P, Begin R, Nault D, Bourbeau J. Self-management reduces both short- and long-term hospitalisation in COPD. Eur Respir J 2005; 26: 853–857
- Bourbeau J, Collet J P, Schwartzman K, Ducruet T, Nault D, Bradley C. Economic benefits of self-management education in COPD. Chest 2006; 130: 1704–1711
- Anthonisen N R, Manfreda J, Warren C P, Hershfield E S, Harding G K, Nelson N A. Antibiotic therapy in exacerbations of chronic obstructive pulmonary disease. Ann Intern Med 1987; 106: 196–204
- Zhou Z-H, Perkins A, Hui S L. Comparisons of software packages for generalized linear multilevel models. Am Statistic 1999; 53: 282–290
- Uitenbroek D G. SISA-Binomial. Electronic Citation. 1997, http://home.clara.net/sisa/binomial.htm
- Beaulieu-Genest L, Chretien D, Maltais F, Pelletier K, Parent J G, Lacasse Y. Self-administered prescriptions of oral steroids and antibiotics in chronic obstructive pulmonary disease: are we doing more harm than good?. Chron Respir Dis 2007; 4: 143–147
- Sridhar M, Taylor R, Dawson S, Roberts N J, Partridge M R. A nurse led intermediate care package in patients who have been hospitalised with an acute exacerbation of chronic obstructive pulmonary disease. Thorax 2008; 63: 194–200
- Watson P B, Town G I, Holbrook N, Dwan C, Toop L J, Drennan C J. Evaluation of a self-management plan for chronic obstructive pulmonary disease. Eur Respir J 1997; 10: 1267–1271
- Wood-Baker R, McGlone S, Venn A, Walters E H. Written action plans in chronic obstructive pulmonary disease increase appropriate treatment for acute exacerbations. Respirology 2006; 11: 619–626
- McGeoch G R, Willsman K J, Dowson C A, Town G I, Frampton C M, McCartin F J, et al. Self-management plans in the primary care of patients with chronic obstructive pulmonary disease. Respirology 2006; 11: 611–618
- Turnock A C, Walters E H, Walters J A, Wood-Baker R. Action plans for chronic obstructive pulmonary disease. 2005, Electronic Citation Cochrane Database Syst Rev (4), CD005074