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

The DOI matches its Crossref record; 42 of the 43 references it cites were found in a registry or an index.

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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Crossref · 10.7326/0003-4819-156-10-201205150-00003

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Citations

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Research works printed but not linked: 2

  1. Effing T, 2007, Cochrane Database Syst Rev, CD002990
  2. Corson K, 2004, Am J Manag Care, 10, 839

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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
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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