Cited by 338Chronic Obstructive Pulmonary Disease (COPD) ResearchAsthma and respiratory diseasesNursing care and research

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A Comprehensive Care Management Program to Prevent Chronic Obstructive Pulmonary Disease Hospitalizations: A Randomized, Controlled Trial

Fan, Vincent S., Gaziano, J. Michael, Lew, Robert, Bourbeau, Jean, Adams, Sandra G., Leatherman, Sarah, Thwin, Soe Soe, Huang, Grant D., Robbins, Richard, Sriram, Peruvemba S., Sharafkhaneh, Amir, Mador, M. Jeffery, Sarosi, George, Panos, Ralph J., Rastogi, Padmashri, Wagner, Todd H., Mazzuca, Steven A., Shannon, Colleen, Colling, Cindy, Liang, Matthew H., Stoller, James K., Fiore, Louis, Niewoehner, Dennis E.·2012·Annals of Internal Medicine

DOI 10.7326/0003-4819-156-10-201205150-00003

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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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Do self-management interventions in COPD patients work and which patients benefit most? An individual patient data meta-analysis
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“The fifth trial even reported higher mortality rates among patients in the self-management group and recruitment was terminated prematurely.(9) Several researchers have postulated hypotheses in an attempt to explain the different outcomes of these five trials.”
Self-citation
Discharge Coordinator Intervention Prevents Hospitalizations in Patients With COPD: A Randomized Controlled Trial
Lainščak, M., Kadivec, S., Košnik, M., Benedik, B., Bratkovic, M., Jakhel, T., Marčun, R., Miklosa, P., Stalc, B., & Farkaš, J. (2013) · Journal of the American Medical Directors Association · doi:10.1016/j.jamda.2013.03.003 · Cited by 76
Continuity of Care to Prevent Readmissions for Patients with Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-Analysis
Yang, F., Xiong, Z.-F., Yang, C.-M., Li, L., Qiao, G., Wang, Y.-C., Zheng, T., He, H.-J., & Hu, H. (2017) · COPD · doi:10.1080/15412555.2016.1256384 · Cited by 64
“Five RCTs evaluated CNI (37,47,57–59).”
BackgroundInfluential
Clinical and cost effectiveness of nurse-led self-management interventions for patients with copd in primary care: A systematic review
Baker, E., & Fatoye, F. (2017) · International Journal of Nursing Studies · doi:10.1016/j.ijnurstu.2017.03.010 · Cited by 76
Can a supported self-management program for COPD upon hospital discharge reduce readmissions? A randomized controlled trial
Singh, S., Rees, K., Gelder, C. M., Morgan, M. D., & Johnson, V. (2016) · International Journal of COPD · doi:10.2147/copd.s91253 · Cited by 68
“However, there have been concerns with these types of interventions, particularly after an acute exacerbation, as recent studies have observed increased mortality rates within the intervention arms.(10,12) Although reasons for this have not been established, it has been postulated that patients may have misplaced conf…”
Result
Toward Integration of mHealth in Primary Care in the Netherlands: A Qualitative Analysis of Stakeholder Perspectives
Bally, E., & Cesuroğlu, T. (2020) · Frontiers in Public Health · doi:10.3389/fpubh.2019.00407 · Cited by 67
Development and Feasibility of a Self-management Intervention for Chronic Obstructive Pulmonary Disease Delivered With Motivational Interviewing Strategies
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Expanding nurse practice in COPD: is it key to providing high quality, effective and safe patient care?
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“More recently, a study evaluating the efficacy in reducing the risk of hospitalisation of comprehensive care management programmes (30% of which were delivered by nurses across six different sites) has raised concerns over the safety of this type of intervention as increased mortality was observed in the treatment gro…”
Background
A Multifaceted Intervention to Improve Compliance With Process Measures for ICU Clinician Communication With ICU Patients and Families*
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Preventing Acute Exacerbations and Hospital Admissions in COPD
Marchetti, N. T., Criner, G. J., & Albert, R. K. (2013) · CHEST Journal · doi:10.1378/chest.12-1801 · Cited by 59
Results of a Medicare Bundled Payments for Care Improvement Initiative for Chronic Obstructive Pulmonary Disease Readmissions
Bhatt, S. P., Wells, J. M., Iyer, A. S., Kirkpatrick, D., Parekh, T. M., Leach, L., Anderson, E. M., Sanders, J. G., Nichols, J. K., Blackburn, C. C., et al. (2017) · Annals of the American Thoracic Society · doi:10.1513/annalsats.201610-775bc · Cited by 61
Assessment of thirty‐day readmission rate, timing, causes and predictors after hospitalization with COVID‐19
Yeo, I., Baek, S., Kim, J. H., Elshakh, H., Voronina, A., Lou, M. S., Vapnik, J., Kaler, R., Dai, X., & Goldbarg, S. H. (2021) · Journal of Internal Medicine · doi:10.1111/joim.13241 · Cited by 60
Helping COPD patients change health behavior in order to improve their quality of life
Almagro, P., & Castro (2013) · International Journal of COPD · doi:10.2147/copd.s34211 · Cited by 60
“50,51 54 A Cochrane review concluded that pulmonary rehabilitation initiated during hospitalization for COPD exacerbation or shortly after discharge significantly reduced the likelihood of rehospitalization (odds ratio = 0.22; 95% confidence interval [CI] = 0.08–0.58), with a number needed to treat…”
Influential
Changes in telemonitored physiological variables and symptoms prior to exacerbations of chronic obstructive pulmonary disease
Burton, C. D., Pinnock, H., & McKinstry, B. (2014) · Journal of Telemedicine and Telecare · doi:10.1177/1357633x14562733 · Cited by 59
“This difficulty may be the reason for the positive results in some more intensive programmes,(17) compared to negative(18) or adverse outcomes in others.(19) Telemonitoring enables monitoring of physiological outcomes and both patients and their clinicians express considerable confidence in the pulse oximetry.”
Result
Care of patients with a diagnosis of chronic obstructive pulmonary disease: a cluster randomised controlled trial
Zwar, N. A., Hermiz, O. S., Comino, E. J., Middleton, S., Vagholkar, S., Xuan, W., Wilson, S. F., & Marks, G. B. (2012) · The Medical Journal of Australia · doi:10.5694/mja12.10813 · Cited by 58
Improvement in COPD management by access to asthma/COPD clinics in primary care: Data from the observational PATHOS study
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“30,38 In addition, it isn’t yet clear why such interventions fail when they do, or whether social determinants of health are more important than diagnostic considerations in some clinical settings.”
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Lenferink, A., van der Palen, J. A. M., van der Valk, P. D. L. P. M., Cafarella, P., van Veen, A., Quinn, S. J., Groothuis‐Oudshoorn, C. G. M., Burt, M. G., Young, M., Frith, P. A., et al. (2019) · European Respiratory Journal · doi:10.1183/13993003.02134-2018 · Cited by 57
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Non‐pharmacological treatments for COPD
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Do Chronic Obstructive Pulmonary Diseases (COPD) Self-Management Interventions Consider Health Literacy and Patient Activation? A Systematic Review
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A self-management approach using self-initiated action plans for symptoms with ongoing nurse support in patients with Chronic Obstructive Pulmonary Disease (COPD) and comorbidities: The COPE-III study protocol
Lenferink, A., Frith, P. A., van der Valk, P., Buckman, J., Sladek, R., Cafarella, P., van der Palen, J. A. M., & Effing, T. (2013) · Contemporary Clinical Trials · doi:10.1016/j.cct.2013.06.003 · Cited by 55
“[51] a COPD specific action plan was included in a comprehensive care management program (CCMP) based in US Veteran hospitals.”
Background
Supported self-management for patients with COPD who have recently been discharged from hospital: a systematic review and meta-analysis
Majothi, S., Jolly, K., Heneghan, N., Price, M., Riley, R., Turner, A., Bayliss, S., Moore, D., Singh, S. J., Adab, P., et al. (2015) · International Journal of COPD · doi:10.2147/copd.s74162 · Cited by 63
Gestión de casos y cronicidad compleja: conceptos, modelos, evidencias e incertidumbres
Morales‐Asencio, J. M. (2013) · Enfermería Clínica · doi:10.1016/j.enfcli.2013.10.002 · Cited by 51
Health literacy in asthma and chronic obstructive pulmonary disease (COPD) care: a narrative review and future directions
Poureslami, I. M., FitzGerald, J. M., Tregobov, N., Goldstein, R. S., Lougheed, M. D., & Gupta, S. (2022) · Respiratory Research · doi:10.1186/s12931-022-02290-5 · Cited by 56
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Harrison, S., Janaudis-Ferreira, T., Brooks, D., Desveaux, L., & Goldstein, R. (2015) · Chest · doi:10.1378/chest.14-1658 · Cited by 64
Impact of a COPD comprehensive case management program on hospital length of stay and readmission rates
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Case Management for Patients with Complex Multimorbidity: Development and Validation of a Coordinated Intervention between Primary and Hospital Care
Tortajada, S., Giménez-Campos, M. S., Villar-López, J., Faubel-Cava, R., Donat-Castelló, L., Valdivieso-Martínez, B., Soriano-Melchor, E., Bahamontes-Mulió, A., & García-Gómez, J. (2017) · International Journal of Integrated Care · doi:10.5334/ijic.2493 · Cited by 40
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Maddocks, M. M., Kon, S. S. C., Singh, S. J., & Man, W. D. (2014) · Respirology · doi:10.1111/resp.12454 · Cited by 48
Patient Anxiety and Depression Moderate the Effects of Increased Self-management Knowledge on Physical Activity: A Secondary Analysis of a Randomised Controlled Trial on Health-Mentoring in COPD
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RETRACTED: Effect of a Program Combining Transitional Care and Long-term Self-management Support on Outcomes of Hospitalized Patients With Chronic Obstructive Pulmonary Disease
Aboumatar, H. J., Naqibuddin, M., Chung, S., Chaudhry, H. R., Kim, S. W., Saunders, J., Bone, L., Gürses, A. P., Knowlton, A. R., Pronovost, P. J., et al. (2018) · JAMA · doi:10.1001/jama.2018.17933 · Cited by 48
“An earlier study using a COPD action plan with selfinitiated treatment was stopped prematurely for concerns of increased mortality.(26) There are several features that may have increased program effectiveness.”
Method
Retracted
A Telemedicine-Based Intervention Reduces the Frequency and Severity of COPD Exacerbation Symptoms: A Randomized, Controlled Trial
CORDOVA, F. C., CICCOLELLA, D. E., Grabianowski, C. L., Gaughan, J. P., Brennan, K. J., Goldstein, F. J., Jacobs, M. R., & Criner, G. J. (2015) · Telemedicine Journal and e-Health · doi:10.1089/tmj.2015.0035 · Cited by 47
“However, when a multicenter cooperative trial involving 20 Veterans Administration hospitals attempted a similar study, the study was stopped prematurely due to excessive mortality in the comprehensive case management group.(22) The reason for this difference is unclear, but the study did show that the time from the o…”
Self-Management in Chronic Obstructive Pulmonary Disease. Time for a Paradigm Shift?
Nici, L. L., Bontly, T. D., ZuWallack, R., & Gross, N. J. (2014) · Annals of the American Thoracic Society · doi:10.1513/annalsats.201306-150fr · Cited by 47
Assessing the effect of culturally specific audiovisual educational interventions on attaining self-management skills for chronic obstructive pulmonary disease in Mandarin- and Cantonese-speaking patients: a randomized controlled trial
Poureslami, I., Kwan, S., Lam, S., Khan, N., & FitzGerald, J. (2016) · International Journal of COPD · doi:10.2147/copd.s105408 · Cited by 40
“In contrast, the heightened sense of “being able to achieve goals” found in participants who watched either clinician video (Group 1) or both videos (Group 3) may have been a consequence of the emphasis given on steps to achieve self-management goals in the clinician video, which possibly contributed to a greater sens…”
Effectiveness of Interventions Targeting Treatable Traits for the Management of Obstructive Airway Diseases: A Systematic Review and Meta-Analysis
Sarwar, M. R., McDonald, V. M., Abramson, M. J., McLoughlin, R. F., Geethadevi, G. M., & George, J. (2022) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2022.05.012 · Cited by 44
The effect of clinical interventions on hospital readmissions: a meta-review of published meta-analyses
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“Indeed, a recent RCT comparing HRR of patients with chronic obstructive pulmonary disease, who had usual care and a comprehensive management program combining education, an action plan for identification and treatment of exacerbations and scheduled telephone calls, found that the intervention was associated with an un…”
Background
Important, misunderstood, and challenging: a qualitative study of nurses’ and allied health professionals’ perceptions of implementing self-management for patients with COPD
Young, H. M. L., Apps, L. D., Harrison, S., Johnson, V., Hudson, N., & Singh, S. J. (2015) · International Journal of COPD · doi:10.2147/copd.s78670 · Cited by 42
Care-seeking and delay of care during COPD exacerbations
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Impact of an integrated disease management program in reducing exacerbations in patients with severe asthma and COPD
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“implemented disease education by case managers combined with an action plan, and reported excess mortality in the intervention group [7].”
Background
Cost-effectiveness of integrated COPD care: the RECODE cluster randomised trial
Boland, M. R. S., Kruis, A. L., Tsiachristas, A., Assendelft, W. J., Gussekloo, J., Blom, C. M. G., Chavannes, N. H., & Mölken, M. R. (2015) · BMJ Open · doi:10.1136/bmjopen-2014-007284 · Cited by 44
Effects of Pulmonary Rehabilitation on Exacerbation Number and Severity in People With COPD
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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: Fan, Vincent S.
Lew, Robert
Bourbeau, Jean
Leatherman, Sarah
Huang, Grant D.
Sriram, Peruvemba S.
Sharafkhaneh, Amir
Mador, M. Jeffery
Sarosi, George
Panos, Ralph J.
Wagner, Todd H.
Liang, Matthew H.
Stoller, James K.
Fiore, Louis
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
DOI: 10.7326/0003-4819-156-10-201205150-00003
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
Licence: www.acpjournals.org/journal/aim/text-and-data-mining (tdm)
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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A Comprehensive Care Management Program to Prevent Chronic Obstructive Pulmonary Disease Hospitalizations: A Randomized, Controlled Trial

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