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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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“Indeed, even in the setting of randomized controlled trials with systematic educational interventions, the majority of COPD patients did not implement self-management strategies as prescribed.(15,40,41) In one trial, only 42% (75 of 150 enrolled patients with AECOPD) were classified as being successful self-managers d…”
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BackgroundMaking collaborative self-management successful in COPD patients with high disease burden
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“standardized care in patients hospitalized with advanced COPD in the prior year, the study was prematurely discontinued due to excessive mortality in the comprehensive care management group.(9) As reported by the investigators, patients in the comprehensive care management program were not successful.”
BackgroundResultThe nurse-coordinated cardiac care bridge transitional care programme: a randomised clinical trial
Jepma, P., Verweij, L., Buurman, B. M., Terbraak, M. S., Daliri, S., Latour, C. H. M., ter Riet, G., Karapinar‐Çarkit, F., Dekker, J. J. H., Klunder, J. L., et al. (2021) · Age and Ageing · doi:10.1093/ageing/afab146 · Cited by 37
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“the intervention group, who received one group session and multiple individual sessions addressing problemsolving techniques and lifestyle changes, followed up by telephone contacts.(13) One explanation for those ambiguous findings might be the high variation across studies evaluating selfmanagement interventions.”
BackgroundProcess evaluation and exploration of telehealth in motor neuron disease in a UK specialist centre
Hobson, E., Baird, W. O., Bradburn, M. J., Cooper, C. L., Mawson, S., Quinn, A., Shaw, P. J., Walsh, T., & McDermott, C. J. (2019) · BMJ Open · doi:10.1136/bmjopen-2018-028526 · Cited by 31
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ResultCollaborative Self-Management and Behavioral Change
Rice, K. L., Bourbeau, J., MacDonald, R. H., & Wilt, T. J. (2014) · Clinics in Chest Medicine · doi:10.1016/j.ccm.2014.02.004 · Cited by 29
“The VA Cooperative trial of CSM (the BREATH trial) (four 90-minute educational sessions, a group reinforcement session, action plans, and follow-up phone calls once a month for 3 months, then every 3 months thereafter) versus usual care had to be prematurely discontinued for safety concerns (increased mortality in the…”
Influentialvan Kruijssen, V., van Staa, A., Dwarswaard, J., Veen, J. C. I. ’., Mennema, B., & Adams, S. (2015) · Respiratory Care · doi:10.4187/respcare.03795 · Cited by 29
“27,28 Only subjects whom health-care providers thought would benefit and would be able to cope were offered self-management diaries.”
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“Improving COPD care quality is assuredly challenging, and in clinical trials, more than one program for COPD readmission reduction was associated with harm (9, 10).”
BackgroundCOPD: Providing the right treatment for the right patient at the right time
Agustí, A. G. N., Ambrosino, N., Blackstock, F. C., Bourbeau, J., Casaburi, R. H., Celli, B. R., Criner, G. J., Crouch, R. H., Negro, R. W. D., Dreher, M., et al. (2022) · Respiratory Medicine · doi:10.1016/j.rmed.2022.107041 · Cited by 32
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A comprehensive care plan that reduces readmissions after acute exacerbations of COPD
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“It was more effective compared to the 2–10-hr individualized and group education programs in previous studies on COPD self-management.(5,8,28) It showed that self-learning was feasible for the patients with COPD in this study.”
MethodJonkman, N. H., Groenwold, R. H. H., Trappenburg, J. C. A., Hoes, A. W., & Schuurmans, M. J. (2017) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2017.01.004 · Cited by 27
“patients with various chronic conditions for a rang e of outcomes[5-8], but several more recently 10 conducted large randomised trials have shown no eff ects[9-13], or even negative effects[14,15].”
BackgroundThe Alice Springs Hospital Readmission Prevention Project (ASHRAPP): a randomised control trial
Diplock, G., Ward, J. S., Stewart, S., Scuffham, P., Stewart, P., Reeve, C. A., Davidson, L., & Maguire, G. P. (2017) · BMC Health Services Research · doi:10.1186/s12913-017-2077-7 · Cited by 29
Chronic Obstructive Pulmonary Disease Readmissions and Other Measures of Hospital Quality
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“Although few studies showed that efforts to reduce COPD readmissions were associated with increased mortality, others showed that intensive outpatient management of COPD exacerbations could reduce readmissions without increasing mortality (27, 28).”
BackgroundSupported self-management for COPD: making progress, but there are still challenges
Pinnock, H., Steed, L., & Jordan, R. E. (2016) · European Respiratory Journal · doi:10.1183/13993003.00576-2016 · Cited by 24
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“More recently, however, a randomized controlled trial (RCT) of patients with COPD hospitalized in the year before study entry and conducted at 20 Veterans Affairs outpatient clinics (27) compared a comprehensive care management program with guideline-based usual care.”
BackgroundIntegrated Care in Chronic Obstructive Pulmonary Disease and Rehabilitation
Nici, L. L., & ZuWallack, R. (2018) · COPD Journal of Chronic Obstructive Pulmonary Disease · doi:10.1080/15412555.2018.1501671 · Cited by 24
“Self-management has been commonly used to help manage COPD exacerbations, stressing the early recognition and appropriate management of these events; adding to the confusion, these interventions are often termed, “disease management” or “comprehensive care management” (24,25).”
BackgroundRamachandran, J., Hossain, M., Hrycek, C., Tse, E., Muller, K., Woodman, R. J., Kaambwa, B., & Wigg, A. J. (2018) · The Medical Journal of Australia · doi:10.5694/mja17.01164 · Cited by 23
COPD care programme can reduce readmissions and in-patient bed days
Ko, F. W. S., Leung, M.-Y., Pun, M.-C., Ngai, J. C. N., Tung, A., Ng, S. S., Cheung, R., Chan, T., Chan, P.-Y., & Hui, D. S. C. (2013) · Respiratory Medicine · doi:10.1016/j.rmed.2014.09.019 · Cited by 23
“In addition, this programme involving patients with severe COPD had not decreased COPD-related hospitalizations [12].”
BackgroundInfluentialAn international randomized study of a home-based self-management program for severe COPD: the COMET
Texereau, J., Casán, P., Tognella, S., Haidl, P., Bourbeau, J., & Kessler, R. (2016) · International Journal of COPD · doi:10.2147/copd.s107151 · Cited by 23
“This group of COPD patients with advanced disease might be at risk of increased comorbidities and mortality as recently shown in a large Veterans Administration trial.(6) COMET will allow us to assess the safety profile of a self-management program in patients with advanced COPD.”
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“excess mortality in self-help plan groups [70] and no effect of nurse-controlled interventions [71].”
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BackgroundChronic Obstructive Pulmonary Disease
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“Avoiding hospitalization is appropriate in selected patients and can lead to a reduced risk for rehospitalization and a trend toward a reduced mortality rate, although a recent study cast doubt after it was ended early for an increased risk of mortality in those patients treated at home.(84,85) These “hospital at home…”
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“However, studies on internet-based telehealth interventions in patients with COPD have reported mixed results as well [14-17].”
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“Compared to other studies of intensive disease management, our patient population also differed in terms of the severity of their airflow obstruction: the mean FEV 1 of low-risk COPD patients in our registry was 1.9 L, compared to 1.0–1.2 L in the studies conducted by Bourbeau et al 4 and Fan et al. 7 Intensive chroni…”
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Can self-management programmes change healthcare utilisation in COPD?
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“Fan and colleagues [26] recently implemented a self-management intervention in COPD patients with the intention of minimizing hospital visits.”
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“with COPD (23,25,27,29,32), and with multiple chronic conditions (22–24,30,31).”
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“Similarly, dexamethasone increases αvβ3 expression in cells; however, using these drugs has severe dose-dependent toxicity (Saag et al., 1994; Huscher et al., 2009; Davis et al., 2011; Fan et al., 2012).”
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van Zelst, C. M., Kasteleyn, M., van Noort, E. V., Molken, M. R.-V., Braunstahl, G., Chavannes, N., In, & Veen, J. I. (2021) · Respiratory Research · doi:10.1186/s12931-021-01685-0 · Cited by 16
Early Identification of Exacerbations in Patients with Chronic Obstructive Pulmonary Disease (COPD)
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“Although some studies have found self-management to be a successful strategy for reducing hospital admissions in patients with COPD by improving management of AEs,(56,57) others describe results as largely equivocal(58,59) one large, randomized, controlled trial actually showed increased mortality in those patients un…”
ResultScheerens, C., Chambaere, K., Pardon, K., Derom, E., Belle, S. V., Joos, G., Pype, P. F., & Deliëns, L. (2018) · PLoS ONE · doi:10.1371/journal.pone.0203326 · Cited by 18
Effects of a Digital Self-care Intervention in Adults with COPD: A Pilot Study
Bugajski, A., Frazier, S. K., Cousin, L., Rechenberg, K., Brown, J. D., Lengerich, A. J., Moser, D. K., & Lennie, T. A. (2019) · Western Journal of Nursing Research · doi:10.1177/0193945919892282 · Cited by 21
Risk factors for early readmission after acute exacerbation of chronic obstructive pulmonary disease
Jo, Y. S., Rhee, C. K., Kim, K., Yoo, K. H., & Park, Y.-B. (2020) · Therapeutic Advances in Respiratory Disease · doi:10.1177/1753466620961688 · Cited by 18
“,[14] reported termination of clinical trial due to unanticipated excess mortality in an intervention group received COPD care program including education.”
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McDonald, C. F., & Khor, Y. H. (2013) · Internal Medicine Journal · doi:10.1111/imj.12219 · Cited by 19
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“In the study with increased mortality, patients were educated and provided with a COPD action plan, but the patients in the intervention/ action plan group continued to delay treatment for the same amount of time as the usual care group, which was on average 7 days.(62) Although the specific reason for increased morta…”
Buhr, R. G., JACKSON, N. J., Kominski, G. F., Dubinett, S. M., Mangione, C. M., & Ong, M. K. (2020) · Journal of General Internal Medicine · doi:10.1007/s11606-020-05958-0 · Cited by 18
Mortality of patients with COPD participating in chronic disease management programmes: a happy end?
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“In an effort to develop and introduce programs to reduce COPD hospitalizations, the VHA sponsored a multicenter RCT examining the efficacy of a multidisciplinary comprehensive care management plan comprised patient and primary care provider education, the development of an action plan for exacerbation management, and…”
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Successful patient self-management of COPD requires hands-on guidance
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“This may be partly explained by the use of COPD-specific action plans for patients with COPD and comorbidities (21).”
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“It is certainly possible that global efforts to keep patients out of the hospital might, in some instances, place patients at risk by delaying necessary acute care.(2) It is also possible that unmeasured variables, particularly access to hospice and palliative care services that might facilitate “good” deaths, could b…”
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A Scoping Review of Telehealth-Assisted Case Management for Chronic Illnesses
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“[34]) and said that she had made changes to the way she used the plan.”
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Self-management for COPD?: Why does it generate negative connotations?
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Telehealth Monitoring With Nurse Clinician Oversight—Reply
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The Qigong Wuqinxi for chronic obstructive pulmonary disease
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“Health benefits from such rehabilitation project were counterbalanced by an unexpected and still unexplained higher mortality in patients with COPD participating in a comprehensive care plan.([6]) Wuqinxi (WQX) developed from the Chinese philosophy and Traditional Chinese Medicine theory.”
Background
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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