Effect of a Hospital-Initiated Program Combining Transitional Care and Long-term Self-management Support on Outcomes of Patients Hospitalized With Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial

Abstract

Importance: Patients hospitalized for chronic obstructive pulmonary disease (COPD) exacerbations have high rehospitalization rates and reduced quality of life.

Objective: 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.

Interventions: 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).

Results: 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.

Trial registration: ClinicalTrials.gov Identifier: NCT02036294.

Figure 1.. Recruitment, Randomization, and Retention of Participants

^aPatients may have more than 1 reason for not being eligible for the study. ^bData on hospitalizations, emergency department visits, and deaths were collected via medical record and vital statistics record review, and were analyzed for all study participants except for 1 participant in the intervention group who withdrew from the study shortly after hospital discharge due to moving out of state.

Figure 2.. Time to First Chronic Obstructive Pulmonary Disease–Related Acute Care Event (Hospitalization or Emergency Department Visit) or Death

The median time to first event for the intervention group is 122 days (95% CI, 78-180) compared with greater than 180 days for the usual care group (exact value is not computed because it is beyond the 6-month observation period). Cox proportional hazards model adjusted for hospital unit, age, oxygen use, and prior hospitalization.

Figure 3.. Cumulative Number of Chronic Obstructive Pulmonary Disease (COPD)–Related and All-Cause Events per Participant by Event Type and Study Group at 1, 3, and 6 Months After Discharge

The boxes in the graphs show the median and interquartile range (IQR) of the data, with the bottom and top indicating the 25th and 75th percentiles, respectively; the upper whisker extends from the top of the box to the largest value no further than 1.5 times the IQR. The bottom whiskers extend from the bottom of the boxes to the smallest value no further than 1.5 times the IQR; outliers outside the whiskers range are also presented (dots). The circles and triangles indicate the mean number of events for usual care and the intervention, respectively. The black lines across the boxes indicate the median. Boxplots at each time point are staggered to avoid superimposition. Boxplots do not show when the 75th percentile of all data is zero. Whiskers do not show when all data points except for outliers are at zero. ^aEmergency department visits that led to a hospitalization are not included in the emergency department visit counts.