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

Abstract

IMPORTANCEPatients 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. INTERVENTIONSThe 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 MEASURESThe 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 RELEVANCEIn 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.

Quality & safety in the literature: May 2020

“…Aboumatar and colleagues3 suggested a similar rationale for the backfire effect in their study. In post-hoc subgroup analyses performed after discovery of the coding error, it was noted that the increase in COPD-related acute care events was identified in patients with high activation status (the patient’s knowledge, skill, and confidence in managing one’s own health).…”

“…Aboumatar and colleagues3 sought to understand the impact of combining a transitional care programme with self-management support on COPD-related acute care events (hospitalisations and emergency department (ED) visits) and health-related quality of life (HRQL) among patients hospitalised with COPD. Specifically the intervention included the following three components:…”

Improving continuity of care of patients with respiratory disease at hospital discharge

“…Interventions to improve care at hospital discharge The literature regarding interventions to improve the continuity of care for patients with respiratory disease is dominated by studies of COPD, and the evidence for improved outcomes in this group is mixed. Aboumatar et al [38] recently undertook a randomised controlled trial of a 3-month hospitalinitiated intervention for patients recruited at hospitalisation due to COPD that comprised three components: 1) individualised self-management support (e.g. support to take medications correctly, recognise exacerbation symptoms and enact an action plan), 2) facilitated access to treatment services in the community and 3) transitional support aiming to ensure patients and their caregivers understood the post-discharge plan.…”

Interventional lifestyle and self-management trials: A double-edged sword. Is it time to mandate formal data and safety monitoring?

“…While unexpected there are now several trials in chronic respiratory disease to have reported adverse outcome for 'lifestyle or self-management' interventions. [4][5][6][7] It is difficult to appreciate a potential causal mechanism in these various trials, especially when adverse signals were temporally separate from the interventional period. 4,6 However, with several published reports potential safety concerns cannot be ignored.…”

“…Imbalances in disease severity may also help explain worse outcomes in intervention groups, with significantly worse functional impairment, 4 respiratory failure and cardiac co-morbidity, 7 and lung function 6 reported, respectively. None of these trials stratified their randomisation on any markers of disease severity.…”