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

Abstract

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.

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 usual care 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 usual care group is 126 days (95% CI, 81-180) compared with greater than 180 days for the intervention 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 whisker extends from the bottom of the box 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 line across the box indicates 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.