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A Comprehensive Care Management Program to Prevent Chronic Obstructive Pulmonary Disease Hospitalizations: A Randomized, Controlled Trial
Abstract
BACKGROUND: Improving a patient's ability to self-monitor and manage changes in chronic obstructive pulmonary disease (COPD) symptoms may improve outcomes. OBJECTIVE: To determine the efficacy of a comprehensive care management program (CCMP) in reducing the risk for COPD hospitalization. DESIGN: A randomized, controlled trial comparing CCMP with guideline-based usual care. (ClinicalTrials.gov registration number: NCT00395083) SETTING: 20 Veterans Affairs hospital-based outpatient clinics. PARTICIPANTS: Patients hospitalized for COPD in the past year. INTERVENTION: The CCMP included COPD education during 4 individual sessions and 1 group session, an action plan for identification and treatment of exacerbations, and scheduled proactive telephone calls for case management. Patients in both the intervention and usual care groups received a COPD informational booklet; their primary care providers received a copy of COPD guidelines and were advised to manage their patients according to these guidelines. Patients were randomly assigned, stratifying by site based on random, permuted blocks of variable size. MEASUREMENTS: The primary outcome was time to first COPD hospitalization. Staff blinded to study group performed telephone-based assessment of COPD exacerbations and hospitalizations, and all hospitalizations were blindly adjudicated. Secondary outcomes included non-COPD health care use, all-cause mortality, health-related quality of life, patient satisfaction, disease knowledge, and self-efficacy. RESULTS: Of the eligible patients, 209 were randomly assigned to the intervention group and 217 to the usual care group. Citing serious safety concerns, the data monitoring committee terminated the intervention before the trial's planned completion after 426 (44%) of the planned total of 960 patients were enrolled. Mean follow-up was 250 days. When the study was stopped, the 1-year cumulative incidence of COPD-related hospitalization was 27% in the intervention group and 24% in the usual care group (hazard ratio, 1.13 [95% CI, 0.70 to 1.80]; P= 0.62). There were 28 deaths from all causes in the intervention group versus 10 in the usual care group (hazard ratio, 3.00 [CI, 1.46 to 6.17]; P= 0.003). Cause could be assigned in 27 (71%) deaths. Deaths due to COPD accounted for the largest difference: 10 in the intervention group versus 3 in the usual care group (hazard ratio, 3.60 [CI, 0.99 to 13.08]; P= 0.053). LIMITATIONS: Available data could not fully explain the excess mortality in the intervention group. Ability to assess the quality of the educational sessions provided by the case managers was limited. CONCLUSION: A CCMP in patients with severe COPD had not decreased COPD-related hospitalizations when the trial was stopped prematurely. The CCMP was associated with unanticipated excess mortality, results that differ markedly from similar previous trials. A data monitoring committee should be considered in the design of clinical trials involving behavioral interventions.
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“Importantly, the intervention tested produced no harm, which is relevant, given the results of a recent study in which researchers tested a selfmanagement program using a written action plan and stopped it due to increased mortality in the intervention arm (19).”
From Health Coaching and Chronic Obstructive Pulmonary Disease Rehospitalization: A Randomized Study (2016) · cites this paper as [19]
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BackgroundSelf-management interventions in COPD patients with multimorbidity
Vanfleteren, L., & Fabbri, L. (2019) · European Respiratory Journal · doi:10.1183/13993003.01850-2019 · Cited by 10
Home-Based Telemanagement in Advanced COPD: Who Uses it Most? Real-Life Study in Lombardy
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“However, the self-management intervention did not include provision of antibiotics or steroids for self-medication of exacerbations, a practice that in one prior study increased the risk for mortality.(6) Rather, patients were instructed to contact clinicians when they developed respiratory symptoms.”
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“Regarding health-related quality of life, the SF-12 physical and mental domain scores in the intervention group also showed significant improvements, but contradictory results were observed in prior studies using the same quality-of-life instrument following 3-to 12-month follow-up programs [45–47].”
ResultTele-assistance Respiratory Card: Feasibility of Self-Reporting in Patients with Severe COPD
Vitacca, M., Rossin, M., Assoni, G., Baratti, D., Zanardini, M., Ruocco, G., Quinto, T., Bernasconi, A., Scalvini, S., & Colombo, F. (2012) · Telemedicine Journal and e-Health · doi:10.1089/tmj.2012.0089 · Cited by 5
“Unlike the negative study of Fan et al., 4 in which the patient is the main actor of his or her self-management drug action plan, in our protocol patients are invited to perform a strict monitoring of their clinical condition, delegating to nurses and/or doctors prescription of drugs.”
Should GPs be fined for rises in avoidable emergency admissions to hospital? No
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Assessment of Self-Management Treatment Needs Among COPD Helpline Callers
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“Despite this important gap in information, prior research has shown that providing COPD patients solely with education and action plans is insufficient to reduce hospitalization risk and improve quality of life (17).”
BackgroundRemote Patient Monitoring in the Management of Chronic Obstructive Pulmonary Disease
Chalupsky, M., Craddock, K., Schivo, M., & Kuhn, B. T. (2022) · Journal of Investigative Medicine · doi:10.1136/jim-2022-002430 · Cited by 7
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Intrinsic factors influence self-management participation in COPD: effects on self-efficacy
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Kimball, B. K., Tutalo, R. A., Minami, T., & Eaton, C. B. (2021) · JACCP JOURNAL OF THE AMERICAN COLLEGE OF CLINICAL PHARMACY · doi:10.1002/jac5.1428 · Cited by 4
“On the contrary, a study by Fan et al., evaluated the efficacy of a comprehensive care management program (CCMP) on reducing COPD hospitalization risk, found an unexpected excess in mortality among patients with severe COPD assigned to the CCMP intervention.”
ResultInfluentialDevelopments in respiratory self-management interventions over the last two decades
Effing, T. (2023) · Chronic Respiratory Disease · doi:10.1177/14799731231221819 · Cited by 4
“28 Available data could not fully explain the excess mortality 28 but the fact that COPD-speci fi c action plans were used in a severe COPD population with frequently existing comorbidities may have played a part.”
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“Furthermore, as with every chronic disease, COPD health outcomes and care costs are determined not only by the healthcare system and its available offerings, but also by the behaviors of patients.(17) In the context of this complexity, the task force felt that it was critical to ground CHA's program design in an under…”
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Orjuela, N. G., Eslava-Schmalbach, J. H., & Ospina, N. V. C. (2018) · Biomédica · doi:10.7705/biomedica.v38i0.3991 · Cited by 4
The ‘wicked problem’ of telerehabilitation: Considerations for planning the way forward
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“For example, Fan et al. [27] conducted a study of 426 patients who had been hospitalized for an acute exacerbation of COPD within the previous year.”
Self-Management: Personalized Action Plans for COPD Exacerbations
Effing, T., & Lenferink, A. (2020) · Respiratory medicine · doi:10.1007/978-3-030-44889-9_11 · Cited by 4
Point: Should Storefront Clinics Provide Case Finding and Chronic Care for COPD? Yes
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“It is potentially a pertinent point that these investigators included closer (monthly) telephone follow-up than Fan et al.(18) and Effing et al.”
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Pang, R., Shannon, B., Collyer, T. A., Srikanth, V. K., & Andrew, N. E. (2025) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd014713.pub2 · Cited by 3
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Coad, F. (2013) · InnovAiT Education and inspiration for general practice · doi:10.1177/1755738012467334 · Cited by 3
Solanes, I., Bolíbar, I., Pou, M. A., Peiró, M., Valverde, P., Fraga, M., Medrano, C., Bigorra, T., Freixas, M., Casals, I. L., et al. (2017) · Atención Primaria · doi:10.1016/j.aprim.2017.01.014 · Cited by 3
“GOLD Estadio I 16 (13,3) 8 (10,7) 0,006 12 (11,5) 18 (19,1) 0,009 NS NS Estadio II 63 (52,5) 31 (41,3) 57 (54,8) 36 (38,3) Estadio III 35 (29,2) 20 (26,7) 31 (29,8) 26 (27,7) Estadio IV 6 (5,0) 16 (21,3) 4 (3,8) 14 (14,9)”
Effectiveness of Healthcare Coordination in Patients with Chronic Respiratory Diseases
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“[7] was terminated before its planned completion date, due to the excess mortality estimated within the participants allocated to TPE, compared to guideline-concordant usual care.”
ResultLi, Y., Feng, J., Li, Y.-C., Jia, W., & Qian, H. (2018) · Medical Science Monitor · doi:10.12659/msm.908463 · Cited by 3
“A recently published clinical study, which included patients with AECOPD, showed that the use of multidisciplinary integrated PR programs did not show clinical effectiveness, and the study was terminated due to increased patient mortality [13].”
BackgroundAbraham, J., Meng, A., Caravelli, N., Traeger, L., NGUYEN, M., Arora, V. M., & Press, V. G. (2025) · JMIR Human Factors · doi:10.2196/77953 · Cited by 2
“Despite this disproportionate effect, very few studies examining the implementation and effectiveness of COPD DTOC interventions have explicitly included Black populations [41].”
How to assess the benefits of pulmonary rehabilitation
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“Antibiotics have a wide clinical application rate (31).”
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“, 2011) COPD self-management education 12 (Bird et al., 2010; Bourbeau et al., 2003; Bucknall et al., 2012; Casas et al., 2006; Efraimsson et al., 2008; Fan et al., 2012; Leung et al., 2004; Moullec et al., 2012; Newcomer et al., 2004; Poole et al., 2001; Rice et al., 2010; Trappenburg et al., 2011) Smoking cessation…”
BackgroundMethodResultInfluentialImplications of DRG Classification in a Bundled Payment Initiative for COPD.
Parekh, T. M., Bhatt, S. P., Westfall, A. O., Wells, J. M., Kirkpatrick, D., Iyer, A. S., Mugavero, M. J., Willig, J. H., & Dransfield, M. T. (2017) · PubMed · Cited by 2
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O’Reilly, S. P. (2013) · Current Emergency and Hospital Medicine Reports · doi:10.1007/s40138-013-0028-0 · Cited by 2
“At the time the trial was stopped, no difference in hospitalization for COPD was noted [63].”
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COPD Exacerbations: An Evidence-Based Review
Robbins, R. (2012) · DOAJ (DOAJ: Directory of Open Access Journals) · Cited by 2
Could digital health applications improve the health of COPD patients?
Jacobs, M. R., & Criner, G. J. (2016) · Expert Review of Respiratory Medicine · doi:10.1586/17476348.2016.1157476 · Cited by 2
“In at least one study, enhanced COPD education not only failed to achieve the goal of reduced hospitalizations and emergency room visits, but actually resulted in just the opposite effects [7].”
BackgroundCan we reduce the risk of readmission for a patient with an exacerbation of COPD?
Ayache, M. B., Boyaji, S., & Pile, J. C. (2014) · Cleveland Clinic Journal of Medicine · doi:10.3949/ccjm.81a.13139 · Cited by 2
Interventions to reduce rehospitalizations following COPD exacerbations: a systematic review
Prieto-Centurion, V., Markos, M. A., Ramey, N. I., Gussin, H. A., Nyenhuis, S. M., Joo, M. J., Prasad, B., Bracken, N. E., DiDomenico, R. J., Godwin, P. O., et al. (2014) · Cited by 2
Integrating the care of the complex COPD patient
Donner, C. F., Carrozzi, L., Maio, S., Baldacci, S., Pistelli, F., Viegi, G., Purro, A., Torchio, R., Clini, E. M., Amaducci, S., et al. (2017) · Monaldi Archives for Chest Disease · doi:10.4081/monaldi.2017.786 · Cited by 2
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“No randomised early palliative care intervention studies are available for this particular population, although it has been shown that it is feasible to provide palliative care interventions in this population [11-15] A study conducted in the UK found that patients with COPD are much less likely to die at home and to…”
BackgroundAmbrosino, N., Casaburi, R. H., Chetta, A. A., Clini, E. M., Donner, C. F., Dreher, M., Goldstein, R. S., Jubran, A., Nici, L. L., Owen, C. A., et al. (2015) · Multidisciplinary Respiratory Medicine · doi:10.1186/s40248-015-0026-z · Cited by 2
Self-Management in Pulmonary Rehabilitation
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Self-medication as Part of Self-management Plans for Patients With COPD
Steurer-Stey, C. A. (2019) · JAMA · doi:10.1001/jama.2019.2048 · Cited by 2
Self-medication as Part of Self-management Plans for Patients With COPD—Reply
Aboumatar, H. J., & Wise, R. A. (2019) · JAMA · doi:10.1001/jama.2019.2076 · Cited by 2
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“Not only has it been difficult to identify effective strategies for preventing readmission, but prior delivery system innovations that have used nurse care managers have, in some instances, led to paradoxically worse clinical outcomes (5, 6).”
BackgroundCOPD Action Plans: Gaps in Development Methods, Content, and Format
Yusup, I., Tang, R., Kouri, A., Sin, D. D., Marciniuk, D., & Gupta, S. (2026) · International Journal of COPD · doi:10.2147/copd.s571223 · Cited by 1
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“In addition, a study involving 20 Veterans Affairs (VA) hospitalbased patients led to concerns of increased mortality with the use of a comprehensive care management program, which resulted in early termination.(11) The following is a review of management options available for COPD with a focus on current evidence of…”
BackgroundDistributed Cognition for Improving Cancer Care Coordination
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Integrated disease management: good news but more work to do
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“16 The majority of patients in this study had severe COPD (60% were on domiciliary oxygen and 40% had two admissions in the previous year) and there was no reduction in COPD hospitalisations while an excess of deaths occurred in the intervention arm.”
BackgroundComparing community models of COPD care
Flood-Page, P. T. (2016) · British Journal of Healthcare Management · doi:10.12968/bjhc.2016.22.7.355 · Cited by 1
Quelle est la place de l’éducation thérapeutique dans la prévention des exacerbations ?
Surpas, P. (2017) · Revue des Maladies Respiratoires · doi:10.1016/j.rmr.2017.03.012 · Cited by 1
El modelo de atención a crónicos en la EPOC
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Quality & safety in the literature: May 2020
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Farragher, J. F., Zhang, J., Harrison, T. G., Ravani, P., Elliott, M. J., & Hemmelgarn, B. R. (2021) · Canadian Journal of Kidney Health and Disease · doi:10.1177/20543581211001224 · Cited by 1
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“Indeed, realist approaches could have helped address unexpected outcomes in one US-based Veterans’ Administration multi-centric RCT where a COPD chronic management program led to more deaths in the intervention arm [6].”
BackgroundStelianides, S., & Grosbois, J. (2018) · EMC - Tratado de Medicina · doi:10.1016/s1636-5410(18)89314-x · Cited by 1
“[19] Fan VS, Gaziano JM, Lew R, Bourbeau J, Adams SG, Leatherman S, et al.”
BackgroundWhere's the beef? Progress on reducing readmissions
Williams, M. V. (2014) · Journal of Hospital Medicine · doi:10.1002/jhm.2165
“Another RCT at 20 sites evaluated a comprehensive care management program to prevent hospitalizations among 960 VA patients with COPD.(25) It had to be stopped early due to elevated all-cause mortality in the intervention group, and there was no difference in hospitalization rates.”
BackgroundBostock-Cox, B. (2013) · Independent Nurse · doi:10.12968/indn.2013.3.6.98886
The Role of Pulmonology in the National Health System Chronicity Strategy
Soler-Cataluña, J., Toril, F. S., & Benito, M. C. (2015) · Archivos de Bronconeumología · doi:10.1016/j.arbr.2015.04.014
Krishnan, J. A., Gussin, H. A., Prieto-Centurion, V., Sullivan, J. L., Zaidi, F., & Thomashow, B. M. (2015)
Can patients with COPD self-manage?
Rabe, K. F., Ward, B., & Albrechts, C. (2012)
Metadata
- Authors
- Fan, V. S., Gaziano, J. M., Lew, R., Bourbeau, J., Adams, S. G., Leatherman, S., Thwin, S. S., Huang, G. D., Robbins, R., Sriram, P. S., Sharafkhaneh, A., Mador, M. J., Sarosi, G., Panos, R. J., Rastogi, P., Wagner, T. H., Mazzuca, S. A., Shannon, C., Colling, C., Liang, M. H., Stoller, J. K., Fiore, L., & Niewoehner, D. E.
- Affiliations
- Brigham and Women's Hospital (US)
- ORCID
- Venue
- Annals of Internal Medicine
- Publisher
- American College of Physicians
- Published
- 2012-05-15
- Volume
- 156
- Issue
- 10
- Pages
- 673-683
- ISSN
- 0003-4819 (ISSN-L)
- 1539-3704
- OpenAlex
- W2036326371
- Cited by
- 338
- References
- 43
- Citations by year
- 2026: 5 · 2025: 6 · 2024: 7 · 2023: 7 · 2022: 16 · 2021: 15 · 2020: 19 · 2019: 22 · 2018: 26 · 2017: 40 · 2016: 36 · 2015: 35 · 2014: 49 · 2013: 38 · 2012: 17
- FWCI
- 35.79
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Annals of Internal Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Chronic Obstructive Pulmonary Disease (COPD) Research
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Asthma and respiratory diseases
- Health Sciences › Nursing › Research and Theory › Nursing care and research
- Keywords
- chronic obstructive pulmonary disease, care management programs, patient education, self-management, veterans, COPD guidelines, all-cause mortality, health-related quality of life, patient satisfaction, disease knowledge, self-efficacy, health care utilization, trial termination
- MeSH terms
- Aged, Anti-Inflammatory Agents, Anti-Bacterial Agents, Cause of Death, Depression, Female, Follow-Up Studies, Hospitalization, Humans, Male, Middle Aged, Patient Education as Topic, Prednisone, Quality of Life, Self Care, Telephone, Proportional Hazards Models, Patient Satisfaction, Case Management, Pulmonary Disease, Chronic Obstructive
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