Early Integrated Palliative Home Care and Standard Care for End-Stage COPD (EPIC): A Phase II Pilot RCT Testing Feasibility, Acceptability, and Effectiveness

Abstract

ContextAlthough early integrated palliative home care (PHC) is believed to be beneficial for patients with chronic obstructive pulmonary disease (COPD), trials testing this hypothesis are rare and show inconclusive results. ObjectivesTo test feasibility, acceptability, and preliminary effectiveness of early integrated PHC for end-stage COPD. MethodsTesting a six-month early integrated PHC pilot randomized controlled trial given by palliative home care nurses (PHCNs) for end-stage COPD with five components: 1) preinclusion COPD support training for PHCNs; 2) monthly PHC visits; 3) leaflets on coping mechanisms; 4) a protocol on symptom management and support, a care plan and an action plan; and 5) integration of PHC and usual care through reporting and communication mechanisms. Patient-reported outcomes were assessed six times weekly. Participants and health care professionals involved were interviewed. ResultsOf 70 eligible patients, 39 (56%) participated (20:19 intervention vs control group) and 64% completed the trial. A patient received on average 3.4 PHC visits, mainly for disease insight, symptom management, and care planning. Nurses distributed all reports but hardly connected with health professionals except general practitioners (GPs); eight of 10 interviewed patients referred to the psychosocial support, breathing exercises, and care decisions as helpful. Some GPs criticized PHC being given too early, but pulmonologists and PHCNs did not. Effectiveness analysis showed no overall intervention effect for the outcomes, but between baseline and week 24, fewer hospitalizations in the control group (P = 0.03) and a trend of higher perceived quality of care in the intervention group (P = 0.06) were found. A clinically relevant difference was observed at week 24 for health-related quality of life in favor of the control group. ConclusionOur intervention on early integrated PHC for end-stage COPD is feasible and accepted but did not yield the anticipated preliminary effectiveness. Before moving to a Phase III trial, enhanced coordination of care, more GP involvement, more intensive training for PHCNs in COPD support, and revision of the trial design, for example, of targeted outcomes in line with individual patient goals and care preferences should be done.