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A Randomized Trial of Two Types of Nurse-Assisted Home Care for Patients With COPD^*

^* From the University of Florida Health Science Center/Jacksonville (Dr. Coultas and Ms. Singh), Jacksonville, FL; Department of Mathematics and Statistics (Ms. Frederick and Dr. Wludyka), University of North Florida, Jacksonville, FL; and The Alpha-1 Foundation (Ms. Barnett), Miami, FL.

Correspondence to: David B. Coultas, MD, Department of Internal Medicine, The University of Florida Health Science Center/Jacksonville, Jacksonville, FL 32209; e-mail: david.coultas{at}jax.ufl.edu

	Abstract

TOP Abstract Introduction Materials and Methods Results Discussion References

 
Study objectives: Whereas pulmonary rehabilitation reduces symptoms and improves the quality of life of patients with COPD and is recommended in management guidelines, few patients have access to rehabilitation services. The purpose of this study was to investigate the effectiveness of increasing access to selected components of pulmonary rehabilitation by providing nurse-assisted home care that was composed of patient education, efforts to improve patient self-management skills, and enhanced follow-up.

Design: We conducted a 6-month, randomized, controlled trial.

Setting: Primary care clinics associated with an urban academic health system.

Patients: Patients were 45 years of age with a physician diagnosis of COPD, and had a 20-pack-year smoking history, had experienced at least one respiratory symptom during the past 12 months, and had airflow obstruction (ie, FEV₁/FVC ratio, < 70%; FEV₁, < 80%).

Interventions: Four nurses were trained in the use of the Global Initiative for Chronic Obstructive Lung Disease guidelines, and two of the four nurses received additional training in collaborative management. Patients were randomly assigned to usual care (UC), nurse-assisted medical management (MM), or nurse-assisted collaborative management (CM).

Measurements: The main outcome measures were of generic (Medical Outcome Study 36-item short form [SF-36], illness intrusiveness) and disease-specific (St. George’s respiratory questionnaire [SGRQ]) quality of life and self-reported health-care utilization.

Results: Overall, 151 patients (UC group, 51 patients; MM group, 49 patients; and CM group, 51 patients) completed the study, their average age was 69 years, and 56.9% were women. The average change in the SF-36 general health domain for the MM group vs the UC group was 1.1 (95% confidence interval [CI], –7.9 to 11.2), and for the CM group vs the UC group the average change was 2.5 (95% CI, –7.0 to 12.3). The corresponding changes in SGRQ total domain were –2.9 (95% CI, –9.8 to 4.1) and –2.6 (95% CI, –9.5 to 4.3). There was no change in the number of self-reported emergency department visits or hospitalizations, but the utilization of these services was infrequent.

Conclusion: The findings of our investigation and those from the published literature suggest that interventions to enhance patient education, self-management skills, and follow-up among patients with COPD do not result in clinically meaningful improvements in health status or self-reported health-care utilization. Moreover, future studies of disease management programs for patients with COPD need to evaluate interventions that address associated comorbidities, exercise, and social support.

Key Words: disease management • home care services • hospitalization • pulmonary disease, chronic obstructive • quality of life • randomized controlled trial • rehabilitation

	Introduction

TOP Abstract Introduction Materials and Methods Results Discussion References

 
COPD is a common and growing cause of morbidity and mortality and is associated with a large economic burden worldwide.¹ In response to the public health burden of COPD, several international guidelines have been published on the optimal management of patients with COPD.² However, there are many potential barriers to the implementation of guideline recommendations.³⁴ In particular, whereas pulmonary rehabilitation is recommended in the guidelines because it reduces symptoms and improves the quality of life of patients with COPD,⁵ few patients have access to rehabilitation services.⁶ Therefore, methods are needed to improve access to pulmonary rehabilitation.

Because pulmonary rehabilitation is most often provided at specialized centers and is composed of a number of components, one approach that may improve access is to offer only the essential components that are necessary for improving health outcomes at other locations.⁷ However, little is known about which components of comprehensive pulmonary rehabilitation programs are essential (ie, medical and functional assessment by a multidisciplinary team, patient education, self-management training, psychosocial interventions, exercise, and enhanced follow-up). The purpose of this study was to investigate the effectiveness of increasing access to selected components of pulmonary rehabilitation by providing nurse-assisted home care that was composed of patient education, efforts to improve patient self-management skills, and enhanced follow-up.

	Materials and Methods

TOP Abstract Introduction Materials and Methods Results Discussion References

 
Study Design, Subjects, and Setting
This was a randomized, controlled trial of patients with COPD cared for by primary care physicians from 17 primary care clinic sites, which are part of an urban academic health center. All of the patients who were 45 years of age with a COPD-related diagnosis code (from the International Classification of Diseases, Ninth Revision codes 491, 492, 496) during the period from September 2000 to August 2001 (n = 2,120) were selected from an electronic claims database and were sent a letter informing them of the study with an invitation to participate. Interested persons were asked to answer brief screening questions to determine their eligibility. The University of Florida Health Science Center/Jacksonville Institutional Review Board approved the project.

Case Definition
To be eligible for the study, patients had to fulfill three criteria based on smoking history, respiratory symptoms, and spirometric testing results. Eligible persons had to be a current or former smoker with at least a 20-pack-year smoking history and at least one respiratory symptom (eg, cough, shortness of breath, or wheeze) during the past 12 months. Persons who fulfilled the smoking and respiratory symptom criteria also had to demonstrate airflow obstruction (ie, FEV₁/FVC ratio, < 70%; and FEV₁, < 80% predicted). Spirometry was performed in the subject’s home by the study coordinator (B.B.), following American Thoracic Society standards⁸ using a MicroLoop (Micro Medical Ltd; Kent, UK).

Intervention
Prior to randomization and intervention group assignment, the study coordinator obtained informed consent and collected the baseline data. Patients were randomly assigned to one of three intervention groups (usual care [UC], nurse-assisted medical management [MM], or nurse-assisted collaborative management [CM]) using a computer-generated random list. The study coordinator provided patients in the UC group with two educational booklets from the American Lung Association that were relevant to COPD⁹¹⁰ and advised them to follow the recommendations of their physician, which may have also included recommendations from a pulmonary physician if one was consulted.

The MM and CM interventions were provided by a total of four nurses (two per group) who were randomly assigned to an intervention group and trained separately (by D.C.). Both groups of nurses received approximately 8 h of training in standardized MM using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines.⁷ The training was composed of two 4-h sessions that included 3.5 h of lecture and 4.5 h of problem-based learning using six case scenarios. The case scenarios were designed to reinforce lecture material concerning the diagnosis of COPD, the assessment of COPD severity, patient self-management, smoking cessation, follow-up, and formation of an action plan for exacerbations. Overall, the goal of the MM intervention by the nurses was to enhance patient knowledge about COPD, their symptoms, and optimal MM.⁷

In addition to the 8 h of training in MM, the nurses assigned to the CM intervention received approximately 8 additional hours of training in "collaborative care," which is patient-centered and intended to facilitate the adoption of healthy behaviors, including lifestyle and self-management skills.¹¹ The CM intervention was designed to enhance the MM intervention. The materials and topics used for this component of the intervention were adapted from the American College of Physicians¹² and Rollnick et al.¹³ The training focused on the specific skills of establishing rapport, setting an agenda, assessing readiness to change, tailoring information and feedback, and reducing resistance. Training in these skills was composed of 1.5 h of lectures on the principles of collaborative management, and 6.5 h of interactive sessions with observation, discussion, and feedback using three different formats, including five case scenarios, critique of three videotaped interviews, and two role plays.

Nurses in both groups maintained a written log of contact duration and topics addressed with their patients (Table 1 ). The categories of topics addressed included review of symptoms and medications; education about COPD, symptoms, and medications; smoking cessation; a written action plan for worsening symptoms; and completion of a letter to their primary care physician describing the patient’s status and, if indicated, suggestions for modifying management to be consistent with GOLD guidelines. The initial contact by the nurses was conducted in the patient’s home, and subsequent contact was intended to occur at least once a month by telephone.

Because psychosocial factors may have a major impact on health outcomes, several characteristics of the patients were measured including self-efficacy,¹⁴ social support,¹⁵ BSI-18 score,¹⁶ and the CES-D score.¹⁷ Self-efficacy was assessed using a 34-item scale that was specifically developed for patients with COPD¹⁴ and that measures their confidence in managing or avoiding breathing difficulty in the following five domains: negative affect (eg, feeling down or depressed); intense emotional arousal (eg, became angry); physical exertion (eg, going up stairs too fast); weather/environment (eg, humidity); and behavioral risks (eg, overeating). The 20-item Medical Outcomes Study social support survey¹⁵ assesses patient reports of the availability of someone to provide support in the following four domains: tangible (eg, takes patient to doctor); affectionate (eg, shows love and affection); positive social interaction (eg, has a good time with); and emotional/informational (eg, listens). The BSI-18¹⁶ is an 18-item questionnaire that assesses overall distress and is composed of the following three domains: depression; anxiety; and somatic symptoms. The CES-D questionnaire¹⁷ is a 20-item instrument that is used to assess the frequency of depressive symptoms.

Health outcomes in the intervention groups were assessed at baseline and after the 6-month intervention by two different trained interviewers who were not involved in the interventions and were blinded to group assignments. The four outcome measures included three quality-of-life questionnaires and self-reported health-care utilization. The SGRQ¹⁸ is a 76-item, disease-specific questionnaire that is composed of an overall total score and three subscores for symptoms, activity, and impact. Two generic instruments were used, the SF-36¹⁹ and the illness intrusiveness scale.²⁰ The 36-item SF-36 instrument is composed of eight domains including physical functioning, role-physical, pain, general health, vitality, social functioning, role-emotional, and mental health. The illness intrusiveness questionnaire is a 13-item instrument that measures patients’ perceptions about how much the illness and/or treatment interferes with 13 domains of their life (ie, health, diet, work, active recreation, passive recreation, financial situation, relationship with significant other, sex life, family relations, other social relations, self-expression/self-improvement, religious expression, and community and civic involvement). Self-reported health-care utilization for the 6 months prior to the interview was determined separately for physician office visits, emergency department visits, and hospitalizations for lung disease and other conditions.

Statistical Analysis
The main measures of intervention effect (ie, change in health outcomes) were average changes from baseline in the SF-36 questionnaire, the illness intrusiveness questionnaire, the SGRQ, and self-reported health-care utilization after the 6-month intervention period. Baseline differences among the intervention groups in the potential determinants of health outcomes were first assessed with univariate analyses, and multivariate procedures were used to adjust for unequal distributions of baseline characteristics. High levels of distress were defined as a score of 10 for men and 13 for women using the BSI-18.¹⁶ The severity of airflow obstruction was categorized using the GOLD criteria⁷ (FEV₁ percent predicted), with stage I at 80% predicted, stage IIa at 50% predicted and < 80% predicted, stage IIb at 30% predicted and < 50% predicted, and stage III at < 30% predicted. All of the analyses were conducted using a statistical software package (SAS, version 9.1.2; SAS Institute; Cary, NC).

The clinical significance of average differences was assessed using published cutoff values for the SF-36²¹ and the SGRQ.²² For the SF-36 and SGRQ, the minimally important clinical improvements are + 10 and – 4, respectively. The study was originally designed with 100 patients per group to provide an 84% power to detect a mean (± SD) difference of 7 ± 17 points (p < 0.05) between the UC and intervention groups in the SGRQ total domain scores.

	Results

TOP Abstract Introduction Materials and Methods Results Discussion References

 
Patient Enrollment and Baseline Characteristics
During the period September 2000 through August 2001, 2,120 patients with a COPD-related diagnosis were identified from an administrative database, and during the period September 2001 through June 2003, 10.2% of patients (n = 217) were enrolled in this study (Fig 1 ). The reasons for the failure to enroll in the study were the inability to contact the patient (43.3%), a refusal to participate (23.3%), or the patient was not eligible (15.0%) or was deceased (8.2%). On average, patients who were not enrolled were younger (67 years vs 69 years, respectively), and a higher proportion was black (23% vs 13%, respectively) or other race (6.1% vs 0.7%, respectively).

View larger version (21K): [in this window] [in a new window] [Download PPT slide]   Figure 1.. Flowchart of patient enrollment and participation in randomized trial of two types of nurse-assisted home care.

The mean age of the 151 persons who completed the study was 69.0 ± 8.2 years, a slight majority were women (56.9%), and > 80% were white (Table 2 ). Although the distribution of most of the baseline characteristics of the three groups was similar (Tables 2 and 3 ), only the distribution of gender and the tangible domain of social support were significantly different among the intervention groups.

Although there were no clinically or statistically significant differences between domains of the SF-36 or the SGRQ comparing the CM group with UC group (Table 4), on average the CM group reported a statistically significant improvement in their perceived illness intrusiveness (Table 4). There were no clinical or statistical differences between the CM and MM groups in any of the health-related quality-of-life measures (Table 4).

Although the prevalence of physician visits for lung disease and other conditions during the previous 6 months (ie, for one or more visits) increased or were unchanged in all groups from baseline to follow-up, the patterns of emergency department visits and hospitalizations were less consistent (data not shown). On average, for any measures of self-reported health-care utilization there were no statistically significant differences between the UC group and either the MM or CM group (Table 4).

	Discussion

TOP Abstract Introduction Materials and Methods Results Discussion References

 
In this randomized trial, we found that among patients with COPD, neither type of nurse-assisted home care was effective in improving health-related quality of life or health-care utilization beyond UC and providing informational literature. The one exception was that patients in the CM group reported less illness intrusiveness compared with the UC group, but the clinical relevance of this finding is uncertain. Overall, our findings are generalizable to nonhospitalized patients with COPD who are cared for in primary care.

Factors that need to be considered in the interpretation of our findings include insufficient power and potential biases. Because study enrollment was limited by several factors (Fig 1), the actual power to detect a minimally important change of four points in the SGRQ²² was low (22%). Whereas our failure to detect statistically significant differences in the SF-36 and SGRQ was limited by sample sizes, the direction and magnitude of treatment effects did not consistently approach values that are considered to be clinically important.²¹²² Moreover, because of the low occurrence of emergency department utilization and hospitalizations, the power to detect differences between the groups for these outcomes was even lower.

The major sources of bias include the failure of randomization, measurement bias, and unequal dropout from the groups. Although this was a randomized trial, a few baseline characteristics were not equally distributed among the three groups (Tables 2 and 3). However, using multivariate analysis to adjust for these baseline differences, we found no differences in the outcomes between the treatment groups. To limit interviewer bias, each interviewer who obtained the baseline and 6-month outcome data was blinded to the patient’s treatment group. Although self-reported health-care utilization may be subject to recall bias, it has been shown to be an acceptable method of measurement and may actually result in an underestimation of utilization with more frequent use.²³ The occurrence of dropouts was equally distributed among the three groups (Fig 1), thus minimizing the potential bias from unequal attrition.

Overall, our findings are consistent with the limited literature on nonpharmacologic interventions in COPD.⁵²⁴ In a systematic review of nine self-management education trials for patients with COPD, Monninkhof et al²⁴ found little or no effect on health-related quality of life or health-care utilization. Sin et al⁵ conducted a metaanalysis of disease management programs for patients with COPD that included eight studies (four were also included in the review by Monninkhof et al²⁴), and only three included the SGRQ as an outcome measure. The pooled summary estimate for mean change in the SGRQ total domain was only –2.5 (95% confidence interval, –4.8 to –0.1), which did not achieve the minimal, clinically important difference of –4.0²² and is nearly identical to the changes in our trial (Table 4). Among four interventions targeting hospitalized patients, only one has demonstrated a reduction of hospitalizations.⁵ This metaanalysis was additionally limited by the heterogeneity of the study populations and the small number of investigations, which included hospitalized patients (four studies) and outpatients (four studies).

In summary, the results of our investigation and findings from the published literature suggest that the addition of patient education, efforts to improve patient self-management skills, and enhanced follow-up to UC for patients with COPD do not provide clinically meaningful improvements in patients’ health status or health-care utilization. The lack of effectiveness of these interventions suggests that peer interactions and exercise, which were not part of our interventions but are components of pulmonary rehabilitation programs, may be necessary for improving health status. Furthermore, patients with COPD have multiple comorbidities (eg, cardiovascular disease and distress) [Table 2], which were not specifically addressed in our intervention and may adversely affect health status. These results suggest that future studies of disease management programs for patients with COPD need to expand interventions beyond patient education, self-management skills, and enhanced follow-up, and need to evaluate interventions that address associated comorbidities, exercise, and social support.

	Acknowledgements

 
We thank nurses Valerie Abella, Debbie Aragon, Denise Davis, and Ellen Tarulli.

	Footnotes

 
Abbreviations: BSI = Brief Symptom Inventory; CES-D = Centers for Epidemiologic Studies-Depression; CM = collaborative management; GOLD = Global Initiative for Chronic Obstructive Lung Disease; MM = medical management; SF-36 = Medical Outcome Study 36-item short form; SGRQ = St. George’s respiratory questionnaire; UC = usual care

This study was supported by a grant from Robert Wood Johnson Foundation.

Received for publication November 9, 2004. Accepted for publication February 21, 2005.

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