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Original Research: COPD |

Predischarge Bundle for Patients With Acute Exacerbations of COPD to Reduce Readmissions and ED VisitsCOPD Bundle to Prevent Readmissions and ED Visits: A Randomized Controlled Trial FREE TO VIEW

Jeffrey H. Jennings, MD; Krishna Thavarajah, MD; Michael P. Mendez, MD, FCCP; Michael Eichenhorn, MD, FCCP; Paul Kvale, MD, FCCP; Lenar Yessayan, MD
Author and Funding Information

From the Division of Pulmonary and Critical Care Medicine, Henry Ford Health System, Detroit, MI.

CORRESPONDENCE TO: Jeffrey H. Jennings, MD, Division of Pulmonary and Critical Care Medicine, Henry Ford Health System, K-17, 2799 W Grand Blvd, Detroit, MI 48202; e-mail: jjennin2@hfhs.org


FOR EDITORIAL COMMENT SEE PAGE 1199

FUNDING/SUPPORT: This study was supported by the Breech Chair for Health Care Quality Improvement [Grant J90002].

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2015;147(5):1227-1234. doi:10.1378/chest.14-1123
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BACKGROUND:  Hospital readmissions for acute exacerbations of COPD (AECOPDs) pose burdens to the health-care system and patients. A current gap in knowledge is whether a predischarge screening and educational tool administered to patients with COPD reduces readmissions and ED visits.

METHODS:  A single-center, randomized trial of admitted patients with AECOPDs was conducted at Henry Ford Hospital between February 2010 and April 2013. One hundred seventy-two patients were randomized to either the control (standard care) or the bundle group in which patients received smoking cessation counseling, screening for gastroesophageal reflux disease and depression or anxiety, standardized inhaler education, and a 48-h postdischarge telephone call. The primary end point was the difference in the composite risk of hospitalizations or ED visits for AECOPD between the two groups in the 30 days following discharge. A secondary end point was 90-day readmission rate.

RESULTS:  Of the 172 patients, 18 of 79 in the control group (22.78%) and 18 of 93 in the bundle group (19.35%) were readmitted within 30 days. The risk of ED visits or hospitalizations within 30 days was not different between the groups (risk difference, −3.43%; 95% CI, −15.68% to 8.82%; P = .58). Overall, the time to readmission in 30 and 90 days was similar between groups (log-rank test P = .71 and .88, respectively).

CONCLUSIONS:  A predischarge bundle intervention in AECOPD is not sufficient to reduce the 30-day risk of hospitalizations or ED visits. More resources may be needed to generate a measurable effect on readmission rates.

TRIAL REGISTRY:  ClinicalTrials.gov; No.: NCT02135744; URL: www.clinicaltrials.gov

Figures in this Article

Acute exacerbations of COPD (AECOPDs) account for a large proportion of health-care expenditures owing to the number of hospitalizations and ED visits.1,2 The 30-day all-cause readmission rate for patients with COPD exacerbations was 20.5% in 2008, with a mean adjusted cost per admission of $11,100.3 Hospital readmissions for COPD add to the health-care cost burden and have been identified as the fourth most costly, potentially preventable readmission.4 Thus, innovative methods to reduce readmissions comprise an important goal for health-care institutions.

One strategy for reducing readmissions is to identify risk factors that lead to readmission and to provide interventions prior to discharge from the hospital. Various predischarge interventions have been shown to reduce hospital admission rates and costs for general medical patients.57 Favorable results have also been demonstrated when the predischarge intervention is applied to specific diseases. Congestive heart failure has been extensively studied in this setting. When a comprehensive discharge plan combined with postdischarge support is applied toward patients admitted for an exacerbation of congestive heart failure, a significant reduction in readmission rates and a trend toward improved health outcomes, such as survival and quality of life, are seen.811

Previous studies evaluated strategies to reduce readmission rates in patients with COPD. Most have focused on postdischarge interventions, such as home interventions or self-management educational programs,1214 and variable results have been observed.15 A current gap in knowledge is whether a comprehensive predischarge plan for patients with COPD reduces readmissions and ED visits. Koehler et al16 found that the 30-day readmission and ED visit rates were reduced with the use of a targeted care bundle. In their study, however, only four patients with COPD were included, and the total study population was small (41 patients). To our knowledge, no other studies have examined a predischarge bundle targeting patients admitted to the hospital with a COPD exacerbation. We hypothesized that applying a bundle of screening and educational interventions related to risks of AECOPDs to hospitalized patients with a COPD exacerbation would decrease the rate of 30-day readmissions or ED visits.

Setting and Participants

We conducted a single-center, two-group, randomized trial of patients with AECOPDs admitted to Henry Ford Hospital between February 2010 and April 2013. Inclusion criteria were a diagnosis of COPD with the presence of an acute exacerbation, age > 40 years, and current or ex-smoker with a history equivalent to at least 20 pack-years.

The diagnosis of COPD was made based on spirometric testing in the prior year that demonstrated airflow obstruction (FEV1/FVC < 70% and FEV1 < 80%) based on GOLD (Global Initiative for Chronic Obstructive Lung Disease) criteria.17 If spirometric data were not available, a previously validated questionnaire18 was used in the diagnosis of COPD for purposes of study inclusion. The presence of airflow obstruction was then confirmed by spirometry prior to discharge.

The diagnosis of AECOPD was made by the primary team but was confirmed by the research team prior to assessing eligibility for inclusion. AECOPD was defined as an acute event characterized by a worsening of the patient’s respiratory symptoms beyond normal day-to-day variations, leading to a change in medication.19 If there was a question about a true diagnosis of AECOPD, a pulmonologist on the research team (J. H. J. or K. T.) evaluated the patient.

Patients were excluded if there was a medical history of asthma, interstitial lung disease, bronchiectasis, presence of airway hardware (eg, tracheal stents, tracheotomy), lung cancer, any other cancer with an associated life expectancy of < 1 year, any cancer where the patient was receiving active chemotherapy or radiation treatment, active substance abuse, or neuromuscular disorders affecting the respiratory system. Additional exclusion criteria were language barriers, residence in a nursing home, ICU stay during the current admission, and significant delirium or dementia. The protocol (#6174) was approved by the Henry Ford Hospital Institutional Review Board, and all patients provided informed consent prior to randomization.

Study Design

A computer-generated list was used to randomize patients in a 1:1 ratio, stratified by age and sex, to either the bundle or the control group. A research nurse screened potential patients. After meeting entry criteria, patients were approached within 72 h of admission for informed consent. Upon study entry, patients in both groups underwent spirometry 1 to 2 days prior to the anticipated day of discharge. In addition, both groups received systemic steroids, antibiotics, and inhaler therapy at the primary team’s discretion. All patients received education from nursing staff regarding inhaler use as part of the routine discharge process.

Bundle Group:

Patients assigned to the bundle group received a 60-min visit by a member of the research team 24 h prior to the anticipated discharge day. During this visit, a core set of AECOPD risks were addressed (Table 1). Active smokers received smoking cessation counseling and, with patient agreement, were enrolled in the Henry Ford Health System Smoking Cessation Program. The decision to prescribe a pharmacologic treatment for smoking cessation was deferred to the primary team. Patients with gastroesophageal reflux disease (GERD) symptoms, as assessed by the GERD questionnaire,20 were advised on dietary and lifestyle modifications. The decision to initiate pharmacologic treatment was deferred to the primary team. The Hospital Anxiety and Depression Scale21 was also administered. The primary team was notified if a patient was identified as having anxiety or depressive symptoms, and referral to outpatient behavioral health services or pharmacologic treatment was deferred to the primary team. The research nurse also used patient education techniques on the proper use of inhalers.

Table Graphic Jump Location
TABLE 1 ]  Acute Exacerbation of COPD Bundle

GERD = gastroesophageal reflux disease; GOLD = Global Initiative for Chronic Obstructive Lung Disease.

Forty-eight hours after discharge, patients in the bundle group were contacted by telephone to reinforce the items in the bundle. All enrolled participants were evaluated and treated per standards of care, as directed by the inpatient primary care team.

The primary end point was the difference in the composite risk of hospitalizations or ED visits for AECOPDs between the two groups in the 30 days following discharge. A secondary end point was the 90-day rate of readmission. Readmissions were counted in both groups by querying the Henry Ford Health System electronic medical record.

Statistics

Statistical analysis was performed using SAS version 9.3 software (SAS Institute Inc). Categorical data were reported as percentages and continuous data as mean ± SD. Between-group comparisons for categorical variables were made using either χ2 or Fisher exact tests when the expected frequencies were less than five. For continuous variable comparisons, a two-sided t test or Kruskal-Wallis test was conducted when data were not normally distributed. Internal data query revealed that 30-day readmission rates for patients with COPD at Henry Ford Hospital were 20% in the year prior to initiation of this study. To detect a 10% absolute risk reduction between the two groups with a two-sided, 5% significance level and a power of 80%, a sample size of 215 patients was needed for each group. To recruit this number of patients, a 24-month inclusion period was anticipated. To account for a potentially longer enrollment period, an interim analysis for efficacy or futility was planned at 3 years. The 30- and 90-day event-free survival rates from readmission were calculated using the Kaplan-Meier product limit estimator, and survival curves were compared using the log-rank test. Hazard ratios of comparison were calculated using the Cox proportional hazards model. P < .05 indicates statistical significance.

A total of 1,225 patients were screened for inclusion into the study (Fig 1). Of these, 1,054 were excluded for the following reasons: admitting diagnosis determined not to be an AECOPD (n = 304), discharged prior to bundle (n = 4), language barrier (n = 9), nursing home resident (n = 10), ICU admission or transfer (n = 14), age < 40 years (n = 18), presence of a tracheostomy (n = 23), lack of medical insurance (n = 34), cancer (n = 52), altered mental status or dementia (n = 122), declined to participate (n = 123), substance abuse (n = 160), and smoking history < 20 pack-years (n = 165). One hundred seventy-two patients fulfilled the inclusion criteria, signed informed consent, and were enrolled in the study. The baseline characteristics of patients in both groups are shown in Table 2. The population was well balanced with respect to all recorded characteristics.

Table Graphic Jump Location
TABLE 2 ]  Baseline Group Characteristics

Data are presented as No. (%), mean ± SD, or mean (interquartile range).

The trial was stopped early after an interim analysis at 3 years did not demonstrate that further accrual could achieve the desired 10% difference in the primary composite end point of ED visit or rehospitalization between the two groups. Of the 172 patients, 18 of 79 in the control group (22.78%) and 18 of 93 in the bundle group (19.35%) were readmitted within 30 days. The risk of ED visits or hospitalizations within 30 days was not different between the groups (risk difference, −3.43%; 95% CI, −15.68% to 8.82%; P = .58). Overall, the time to readmission in 30 days was similar between groups (log-rank test P = .71). Of those readmitted, the median time to readmission was earlier in the bundle group than in the control group (10.5 [interquartile range, 3-15] vs 18.0 [interquartile range 11-28] days, respectively; P = .01). The time to readmission within 90 days was similar between the two groups (log-rank test P = .88).

Predictor variables for 30- and 90-day readmissions in the bundle group were analyzed using the Cox proportional hazards model (Table 3). Among traditional risk factors associated with COPD exacerbations (active smoking, history of GERD, depression, anxiety, and number of COPD exacerbations in the previous year), only COPD exacerbations in the previous year emerged as a significant predictor for 30-day readmission for AECOPD (hazard ratio, 1.42; 95% CI, 1.17-1.72; P < .001).

Table Graphic Jump Location
TABLE 3 ]  Thirty- and Ninety-Day Univariate HRs for COPD Readmissions, Bundle Group

HR = hazard ratio. See Table 1 legend for expansion of other abbreviation.

a 

Statistically significant at P < .05.

Up to 65% of the patients hospitalized for AECOPDs have an increased risk for readmission to the hospital in the year following admission.1,2 An important goal in reducing readmissions is to identify risk factors for exacerbation or recurrence of the initial cause for hospitalization and to intervene prior to discharge. In this study, we examined the effects of a predischarge patient education and screening tool on the rate of ED visits or hospital readmissions for COPD exacerbations. The screening tool was used as an intervention because identified risk factors were acted on through education and notification of the primary team for follow-up. We found no overall difference in readmission rates between patients receiving the bundle and those receiving the standard care. The lack of difference persisted after controlling for postdischarge outpatient visits. In addition, a time-based interim analysis suggested that completion of the study to the predesignated sample size would not likely have shown a difference between these groups. In agreement with prior studies,1,19 we found that the number of exacerbations predicted subsequent COPD admissions. Of note, even in the intervention group, the number of exacerbations was the only significant predictor of 30- and 90-day readmission rates.

There are a number of potential limitations of this study. Risk factors, once identified, were simply reported to the primary team. The intervention used for identified risk factors was left up to the judgment of the team. Although the effect on readmissions might have been increased had the intervention extended to more-aggressive follow-up, the aim of this study was to determine whether a less resource-intensive approach would be of benefit. The study also did not examine patient compliance for the specific risk factors addressed, which could have provided further insight into the effectiveness of the specific interventions. Additionally, the inclusion and exclusion criteria limited the applicability of the results. We specifically chose a design to exclude patient populations unlikely to benefit from an educational intervention. If the study had shown positive results, future designs would use less restrictive exclusion criteria. Finally, postdischarge interventions, such as pulmonary rehabilitation, that have been shown to decrease exacerbations were not applied because this was beyond the scope of a simple education-based intervention that was not resource intensive.22,23

In the current study, patients were considered for inclusion if they had a smoking history of at least 20 pack-years, which could have potentially excluded patients with COPD who would otherwise have qualified for enrollment. Although some studies have used a lower cutoff for inclusion,24 we chose a 20-pack-year cutoff to maximize the specificity for a diagnosis of COPD.

The intervention comprised a focused screening bundle administered by a research nurse 1 to 2 days prior to the anticipated date of discharge. The additional time spent with the patient was limited to about 1 h. Although this approach is attractive in that considerably fewer resources are required, the effectiveness of such an approach is unknown. Previous studies showing a reduction in readmission rates have included multidisciplinary discharge planning programs, integrated care programs, or other resource-intensive approaches. Although these approaches were sometimes effective, the additional resources required may have been the necessary component that led to their success. For example, Koehler et al16 found a reduction in 30-day readmission or ED visit rates with a care bundle that integrated an educational program extending up to 1 week postdischarge. A study by Casas et al25 was limited to inpatient interventions, but the program used a comprehensive patient education program along with an individually tailored plan. Others similarly found a reduction in readmissions but used resource-intensive approaches.7,14,15,26 Nonetheless, not all programs were effective in reducing readmissions, even with varying levels of resource utilization.27

Although an intervention using limited resources might be expected to weaken the effect on readmissions, we hypothesized that a bundle targeting specific risk factors for a COPD exacerbation would offset this. Therefore, the bundle was composed of items previously shown to be associated with COPD exacerbations. Smoking is the most common risk factor for COPD, and smoking cessation has been deemed “the single most effective and cost-effective way to reduce exposure to COPD risk factors.”17 Nearly one-half of the patients in the bundle group were active smokers, thus making smoking cessation an attractive target. In addition, the presence of GERD has been shown to be associated with an increased rate of COPD exacerbations28 and, therefore, was included in the bundle tool. Depression is an important psychiatric disorder for patients with COPD, with a prevalence as high as 57% in some studies.8,9,2932 More recently, depression has been associated with an increased risk for AECOPDs.3337 The presence of depressive symptoms during a hospitalization for a COPD exacerbation increases the risk for readmission within the subsequent year.35 Thus, in light of these findings, depression was included in the bundle. Proper inhaler technique is critical for COPD control and may alter exacerbation rates.38 This component in the bundle was a subset of patient education and required the most time from the research nurse.

Despite the association of these factors with COPD exacerbations, readmission rates were not reduced in the bundle group. However, even if targeting depression, GERD, smoking cessation, and inhaler education was effective, it is unknown whether these interventions would exert their effect on ED visits and readmission rates within 90 days. Pharmacologic therapy for depression exerts no clinically significant effects for at least 2 weeks. Smokers have frequent relapses, and the success rate of smoking cessation remains low. Despite associations with GERD and COPD exacerbations, it is unknown whether treatment alters exacerbation rates.

Our baseline readmission rate for both the control and the bundle groups was in line with the national average; the 30-day readmission rate among patients with COPD is 22.6%, accounting for 4% of all 30-day readmissions.39 In the current study, control and bundle patients had a 30-day readmission rate of 22.78% and 19.35%, respectively. Of note, early postdischarge follow-up within 30 days was associated with decreased readmissions at 90 days. It is possible that this follow-up provides an opportunity to intervene on risk factors that lead to readmission. An additional observation was that of patients readmitted, the median time to readmission was earlier in the bundle group than in the control group. One interpretation of this finding is that patients who received the bundle were more cognizant of their symptoms and may have contacted their general practitioner at an earlier point compared with patients in the control group.

In summary, a simple tool designed to identify and target AECOPD risk factors was ineffective at reducing 30- or 90-day readmissions. Success at reducing these readmissions, if effective at all, may, therefore, require a more comprehensive, resource-intensive, and costly approach.

Author contributions: J. H. J. is the guarantor of the manuscript and takes responsibility for the integrity of the data and the accuracy of the data analysis. J. H. J. is the principal investigator of the study. J. H. J., K. T., M. P. M., M. E., and L. Y. contributed to the study concept and design, data acquisition and analysis, data interpretation, drafting of the manuscript, and approval of the final manuscript and P. K. contributed to the data interpretation, drafting of the manuscript, and approval of the final manuscript.

Financial/nonfinancial disclosures: The authors have reported to CHEST the following conflicts of interest: Dr Thavarajah received an honorarium from InterMune for talks given regarding idiopathic pulmonary fibrosis awareness and disease education. Drs Jennings, Mendez, Eichenhorn, Kvale, and Yessayan have reported that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.

Role of sponsors: The sponsor had no role in the design of the study, the collection and analysis of the data, or the preparation of the manuscript.

AECOPD

acute exacerbation of COPD

GERD

gastroesophageal reflux disease

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Tables

Table Graphic Jump Location
TABLE 1 ]  Acute Exacerbation of COPD Bundle

GERD = gastroesophageal reflux disease; GOLD = Global Initiative for Chronic Obstructive Lung Disease.

Table Graphic Jump Location
TABLE 2 ]  Baseline Group Characteristics

Data are presented as No. (%), mean ± SD, or mean (interquartile range).

Table Graphic Jump Location
TABLE 3 ]  Thirty- and Ninety-Day Univariate HRs for COPD Readmissions, Bundle Group

HR = hazard ratio. See Table 1 legend for expansion of other abbreviation.

a 

Statistically significant at P < .05.

References

Almagro P, Barreiro B, Ochoa de Echaguen A, et al. Risk factors for hospital readmission in patients with chronic obstructive pulmonary disease. Respiration. 2006;73(3):311-317. [CrossRef] [PubMed]
 
Roberts CM, Lowe D, Bucknall CE, Ryland I, Kelly Y, Pearson MG. Clinical audit indicators of outcome following admission to hospital with acute exacerbation of chronic obstructive pulmonary disease. Thorax. 2002;57(2):137-141. [CrossRef] [PubMed]
 
Elixhauser A, Au DH, Podulka J. HCUP Statistical Brief 121: Readmissions for Chronic Obstructive Pulmonary Disease, 2008. Rockville, MD: Agency for Healthcare Research and Quality; 2011.
 
Medicare Payment Advisory Committee. Report to the Congress: Promoting Greater Efficiency in Medicare. Washington, DC: MEDPAC; 2007.
 
Coleman EA, Parry C, Chalmers S, Min SJ. The care transitions intervention: results of a randomized controlled trial. Arch Intern Med. 2006;166(17):1822-1828. [CrossRef] [PubMed]
 
Naylor MD, Brooten D, Campbell R, et al. Comprehensive discharge planning and home follow-up of hospitalized elders: a randomized clinical trial. JAMA. 1999;281(7):613-620. [CrossRef] [PubMed]
 
Jack BW, Chetty VK, Anthony D, et al. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med. 2009;150(3):178-187. [CrossRef] [PubMed]
 
Kasper EK, Gerstenblith G, Hefter G, et al. A randomized trial of the efficacy of multidisciplinary care in heart failure outpatients at high risk of hospital readmission. J Am Coll Cardiol. 2002;39(3):471-480. [CrossRef] [PubMed]
 
McAlister FA, Lawson FM, Teo KK, Armstrong PW. A systematic review of randomized trials of disease management programs in heart failure. Am J Med. 2001;110(5):378-384. [CrossRef] [PubMed]
 
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