The transition from hospital to home is a high-risk period for patients. One out of 5 patients suffers an adverse event shortly after discharge, with about one-third of events deemed preventable. Chronic obstructive pulmonary disease (COPD) is a leading cause of hospitalizations. Few interventional studies have focused on improving the hospital-to-home transition for patients with COPD. These patients have specific needs that are not the focus of general transitional care programs. For example, patients with COPD report needing information about COPD and how to manage it. About half lack the skills for proper inhaler use, and many do not know how to manage “breathlessness episodes” and detect early signs of acute exacerbations.
In the Better Respiratory Education and Treatment Help Empower (BREATHE) study, we proposed developing and evaluating a comprehensive patient- and family-centered transitional care program for patients who have COPD and their family caregivers. Specifically, we aimed to do the following: 1. Develop and pilot test a hospital-initiated, patient- and family-centered, 3-month transitional care intervention to empower and build the capacity of patients with COPD and their family caregivers and to improve their disease self-management, problem-solving, and coping skills. 2. Conduct a single-blinded randomized controlled trial (RCT) among 240 patients with COPD admitted to 1 academic medical center to test the effects of intervention compared with usual care on health-related quality of life (HRQOL), survival, and use of emergency department (ED) and hospital services. 3. Evaluate intervention impact on patient experience, activation, self-efficacy, and self-care behaviors. 4. Evaluate intervention process and impact on family-caregiver self-efficacy, stress, and coping skills.
In the study's initial phase, we co-developed the BREATHE transitional care program with patients who have COPD, family caregivers, and stakeholders. The BREATHE program was designed to facilitate the transition-to-home process and build the capacity of patients with COPD and their family caregivers to manage COPD at home. Given the complex needs of these patients, the program offers tailored services to both patients and family caregivers starting early during the hospital stay and continuing for 3 months postdischarge. The program includes tailored transition support to ensure that patients and family caregivers are prepared for discharge, individualized COPD self-management support, and facilitated access to community programs and treatment services. The program is delivered by COPD nurse transition guides on hospital transition teams who received special training on how to support patients with COPD and their families and used standardized tools to deliver the program. We tested the program in a single-blinded RCT at 1 academic community hospital in Baltimore, Maryland. Patients older than 40 years who were hospitalized because of a COPD exacerbation were enrolled and randomized in a 1:1 ratio to receive either the BREATHE program intervention or usual care using a computer algorithm. Patients in the usual care arm received support from a general transition guide for 1 month postdischarge. Patients randomized to receive the BREATHE program intervention were offered the opportunity to invite a family caregiver, if available, to enroll with them in the study. Data collectors and outcomes assessors were blinded to the participants' arm allocation. We measured program effect on acute care utilization and HRQOL compared with usual transitional care services. The primary outcomes were the combined number of COPD-related hospitalizations and ED visits per participant at 6 months postdischarge and the change in HRQOL as measured by the St. George's Respiratory Questionnaire (SGRQ) over the 6-month study period. The SGRQ is a validated instrument for measuring HRQOL among patients with respiratory disease. Higher scores on this instrument signify worse QOL. A difference of 4 points on the SGRQ is considered clinically significant. Other outcome measures include all-cause hospitalizations and ED visits, patient activation, self-efficacy, and self-care behaviors. We performed unadjusted analyses of the treatment effect between the 2 study arms under intention to treat (ITT). We conducted regression analyses using models with link functions based on the distribution of the outcomes, adjusting for hospital unit and relevant baseline characteristics.
We enrolled 240 patients and 31 family caregivers into this study. All the patient participants were included in an ITT analysis. During the 6-month postdischarge period, there were 7 deaths (5.8%) in the usual care arm and 8 deaths (6.7%) in the intervention arm ( > 0.99). Data were available to calculate the change in SGRQ scores for 88 and 91 participants in the BREATHE study and usual care arms, respectively, at 6 months postdischarge (80% of all participants alive). The mean difference in SGRQ total score from baseline to 6 months was 2.81 and −2.69 among participants in the BREATHE and usual care arms, respectively. The adjusted difference between study arms at 6 months postdischarge was 5.18 (95% CI, −2.15 to 12.51; = 0.11). Hospitalization and ED visits for COPD were significantly higher among participants in the BREATHE arm. Visits outcomes were assessed for all participants who were alive at 6 months postdischarge (usual care, n = 113; intervention, n = 112). At 6 months (study primary endpoint), there was a mean of 0.72 (SD = 1.38) COPD-related acute care visits (hospitalizations and ED visits) per participant in the usual care arm and a mean of 1.40 (SD = 2.08) visits per participant in the intervention arm ( = 0.004; Cohen = 0.39). The adjusted incidence rate ratio of events for the intervention compared with the usual care arm was 1.59 (95% CI, 1.32-1.92; < 0.001). The mean number of COPD-related hospitalizations per participant was 1.13 (SD = 1.90) in the intervention arm compared with 0.61 (SD = 1.04) in the usual care arm at 6 months postdischarge ( = 0.011; Cohen = 0.34). The IRR of COPD-related hospitalizations for BREATHE compared with the usual care arm was 1.41 (95% CI, 1.28-1.56; < 0.001). This paradoxical and significant increase in COPD-related acute care events among participants randomized to the intervention arm was limited to patients with high activation status and was more pronounced among men than women. Of note, the intervention was well received by participants (87% of participants would “definitely recommend” the BREATHE program to family members or friends who have COPD). No harms were attributed to the study intervention.
The provision of the BREATHE program, a disease-specific, patient- and family-centered transitional care program for patients who have COPD and their family caregivers was not effective in improving HRQOL and resulted in an unanticipated increase in acute care use compared with the usual transition support provided to these patients during discharge from the hospital to home. Further research is needed to explain the paradoxical findings in this study.
This study was conducted at 1 academic medical center serving an urban, inner-city population with a large percentage of low-income patients. Study results may not be generalizable to all patients with COPD.
