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Can a hospital-initiated program result in reduced acute care use and better quality of life for patients hospitalized for chronic obstructive pulmonary disease (COPD)?
In this single-site randomized clinical trial that included 240 patients with COPD, a 3-month program that combined transition and long-term management support, compared with usual care, resulted in a greater number of COPD-related hospitalizations and emergency department visits (1.40 vs 0.72 per participant); this comparison was statistically significant. There was no significant change in health-related quality of life (2.81 vs −2.69 in the 100-point St George’s Respiratory Questionnaire) at 6 months.
This type of program may result in more acute care use among patients with COPD, but requires further research to determine the reason for this unexpected finding.
Patients hospitalized for chronic obstructive pulmonary disease (COPD) exacerbations have high rehospitalization rates and reduced quality of life.
To evaluate whether a hospital-initiated program that combined transition and long-term self-management support for patients hospitalized due to COPD and their family caregivers can improve outcomes.
Design, Setting, and Participants
Single-site randomized clinical trial conducted in Baltimore, Maryland, with 240 participants. Participants were patients hospitalized due to COPD, randomized to intervention or usual care, and followed up for 6 months after hospital discharge. Enrollment occurred from March 2015 to May 2016; follow-up ended in December 2016.
The intervention (n = 120) involved a comprehensive 3-month program to help patients and their family caregivers with long-term self-management of COPD. It was delivered by nurses with special training on supporting patients with COPD using standardized tools. Usual care (n = 120) included transition support for 30 days after discharge to ensure adherence to discharge plan and connection to outpatient care.
Main Outcomes and Measures
The primary outcome was number of COPD-related acute care events (hospitalizations and emergency department visits) per participant at 6 months. The co-primary outcome was change in participants’ health-related quality of life measured by the St George’s Respiratory Questionnaire (SGRQ) at 6 months after discharge (score, 0 [best] to 100 [worst]; 4-point difference is clinically meaningful).
Among 240 patients who were randomized (mean [SD] age, 64.9 [9.8] years; 61.7% women), 203 (85%) completed the study. The mean (SD) baseline SGRQ score was 62.3 (18.8) in the intervention group and 63.6 (17.4) in the usual care group. The mean number of COPD-related acute care events per participant at 6 months was 1.40 (95% CI, 1.01-1.79) in the intervention group vs 0.72 (95% CI, 0.45-0.97) in the usual care group (difference, 0.68 [95% CI, 0.22-1.15]; P = .004). The mean change in participants’ SGRQ total score at 6 months was 2.81 in the intervention group and −2.69 in the usual care group (adjusted difference, 5.18 [95% CI, −2.15 to 12.51]; P = .11). During the study period, there were 15 deaths (intervention: 8; usual care: 7) and 339 hospitalizations (intervention: 202; usual care: 137).
Conclusions and Relevance
In a single-site randomized clinical trial of patients hospitalized due to COPD, a 3-month program that combined transition and long-term self-management support resulted in significantly greater COPD-related hospitalizations and emergency department visits, without improvement in quality of life. Further research is needed to determine reasons for this unanticipated finding.
ClinicalTrials.gov Identifier: NCT02036294
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Corresponding Author: Hanan Aboumatar, MD, MPH, Armstrong Institute for Patient Safety and Quality, Johns Hopkins School of Medicine, 750 E Pratt St, 15th Floor, Baltimore, MD 21202 (email@example.com).
Accepted for Publication: July 23, 2019.
Author Contributions: Dr Aboumatar had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Aboumatar, Naqibuddin, Chung, Chaudhry, Bone, Gurses, Knowlton, Pronovost, Rand, Roter, Sylvester, Wolff, Hibbard, Wise.
Acquisition, analysis, or interpretation of data: Aboumatar, Naqibuddin, Chung, Kim, Saunders, Pronovost, Putcha, Rand, Thompson, Wise.
Drafting of the manuscript: Aboumatar, Naqibuddin, Chung, Chaudhry, Thompson, Hibbard, Wise.
Critical revision of the manuscript for important intellectual content: Aboumatar, Naqibuddin, Chung, Chaudhry, Kim, Saunders, Bone, Gurses, Knowlton, Pronovost, Putcha, Rand, Roter, Sylvester, Thompson, Wolff, Wise.
Statistical analysis: Aboumatar, Chung, Thompson.
Obtained funding: Aboumatar, Gurses, Rand.
Administrative, technical, or material support: Aboumatar, Naqibuddin, Chung, Chaudhry, Kim, Saunders, Bone, Gurses, Roter, Sylvester, Wise.
Supervision: Aboumatar, Naqibuddin, Pronovost, Hibbard.
Conflict of Interest Disclosures: Drs Aboumatar, Saunders, Gurses, and Wolff; Ms Chung; Ms Chaudhry; and Mr Kim reported receiving grants from the Patient-Centered Outcomes Research Institute (PCORI). Dr Putcha reported receiving grants from the National Heart, Lung, and Blood Institute. Dr Hibbard reported receiving personal fees from Insignia Health and having equity ownership in Insignia Health, as well as receiving royalties on the Patient Activation Measure paid by Insignia Health through the University of Oregon. Dr Wise reported receiving grants and personal fees from AstraZeneca/Medimmune, Boehringer Ingelheim, and GlaxoSmithKline; personal fees from AbbVie, Contrafect, Kiniksa, Novartis, Pulmonx, Roche, Spiration, Sunovion, Syneos, Merck, Circassia, Pneuma, Verona, Bonti, Denali, and Aradigm; grants from Pearl Therapeutics and Sanofi; and nonfinancial support from Propeller Health. No other disclosures were reported.
Funding/Support: Funding was provided by PCORI (Award IHS 1304-7118).
Role of the Funder/Sponsor: PCORI had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: The opinions in this publication are solely the responsibility of the authors and do not necessarily represent the views of PCORI, its board of governors, or methodology committee.
Meeting Presentation: This study was presented at the American Public Health 2018 Annual Meeting; November 12, 2018; San Diego, California.
Data Sharing Statement: See Supplement 4.
Additional Contributions: We acknowledge the important contributions of Edna Shattuck, RN, RRT, a study co-investigator and patient partner who died before publication of study results, and all the members of the BREATHE Patient Family Partners Group. They were compensated for their role in the study. We are also grateful for the support from the Johns Hopkins Homecare Group (Hajara Adebowale, RN, BSN; Donna Kurtz, RN; Leslie Piet, RN, MA, CCM, CHPN; Laura Syron, RN, MSN, MPH; and Mary Myers, MS, RN) and the Johns Hopkins Biostatistics Center. Ms Adebowale, Ms Kurtz, and Ms Piet performed the role of the chronic obstructive pulmonary disease nurse on study and were paid for this work. Ms Syron and Ms Myers were not compensated. The Johns Hopkins Biostatistics Center received compensation. We thank the members of the BREATHE Study data safety and monitoring board: David Levine, MD (Johns Hopkins University); Albert Wu, MD (Johns Hopkins University); Sanjay V. Desai, MD (Johns Hopkins University); and John Linnell (patient advocate on the board). Drs Levine, Wu, and Desai received no compensation for their role in the study; Mr Linnell received an honorarium. We also acknowledge the support and contributions of Kai Shea, MSW, LCSW-C (Johns Hopkins Bayview Social Work Department); Jamie Sullivan, MPH (COPD Foundation); Eric E. Howell, MD (Johns Hopkins Hospitalist service); Emmanuel Garcia-Morales, PhD (Johns Hopkins Armstrong Institute); and Joseph Neiman, MD (Johns Hopkins Armstrong Institute). Ms Shea was not compensated. Ms Sullivan and Drs Howell, Garcia-Morales, and Neiman were compensated for their role in the study.
Additional Information: This article is a corrected version of an article that has been retracted (Aboumatar H, Naqibuddin M, Chung S, et al. Effect of a program combining transitional care and long-term self-management support on outcomes of hospitalized patients with chronic obstructive pulmonary disease: a randomized clinical trial. JAMA. 2018;320(22):2335-2343 doi:10.1001/jama.2018.17933).
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