A Randomized Clinical Trial
Findings 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 fewer COPD-related hospitalizations and emergency department visits (0.72 vs 1.40 per participant) and better change in health-related quality of life (−1.53 vs +5.44 in the 100-point St George’s Respiratory Questionnaire) at 6 months. Both comparisons were statistically significant.
Meaning This type of program may offer benefit to patients with COPD, but requires further evaluation in other settings.
Importance Patients hospitalized for chronic obstructive pulmonary disease (COPD) exacerbations have high rehospitalization rates and reduced quality of life.
Objective To evaluate a hospital-initiated program that combined transition and long-term self-management support for patients hospitalized due to COPD and their family caregivers.
Design, Setting, and Participants This single-site randomized clinical trial was 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.
Interventions The intervention (n = 120) was a comprehensive 3-month program to help patients and their family caregivers with long-term self-management of COPD. It was delivered by COPD nurses (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).
Results Among 240 patients who were randomized (mean [SD] age, 64.9 [9.8] years; females, 61.7%), 203 (85%) completed the study. The mean (SD) baseline SGRQ score was 63.1 (19.9) in the intervention group and 62.6 (19.3) in the usual care group. The mean number of COPD-related acute care events per participant at 6 months was 0.72 (95% CI, 0.45-0.97) in the intervention group vs 1.40 (95% CI, 1.01-1.79) in the usual care group (difference, 0.68 [95% CI, 0.22 to 1.15]; P = .004). The mean change in participants’ SGRQ total score at 6 months was −1.53 in the intervention and +5.44 in the usual care group (adjusted difference, −6.69 [95% CI, −12.97 to −0.40]; P = .04). During the study period, there were 15 deaths (intervention: 7; usual care: 8) and 337 hospitalizations (intervention: 135; usual care: 202).
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 fewer COPD-related hospitalizations and emergency department visits and better health-related quality of life at 6 months after discharge. Further research is needed to evaluate this intervention in other settings.