A pilot randomised controlled trial of the Tailored Intervention for people with moderate-to-severe Chronic Obstructive Pulmonary Disease and Co-morbidities delivered by Pharmacists and Consultant respiratory Physicians (TICC-PCP)

Abstract

To achieve progression criteria for a definitive phase three randomised controlled trial (RCT). Prospective phase two multicentre parallel-group RCT. Participants recruited from secondary care respiratory clinics in two health boards in Scotland, United Kingdom. 110 adults with moderate-severe COPD and co-morbidities. Tailored Intervention for COPD and Co-morbidities by Pharmacists and Consultant Physicians (TICC-PCP): home visits (for a year) by generalist prescribing pharmacists collaborating with consultant respiratory physicians. Pharmacists assessed, prescribed, de-prescribed, and referred participants to health and social care services as appropriate, in addition to Usual Care (UC). Recruit ≥100 participants; deliver TICC-PCP to ≥70% intervention-arm participants; collect ≥90% in-person data; retain ≥80% participants until 21-months. Secondary outcomes include clinical and health service utilisation. Recruitment, data collection, retention and participant retention targets were achieved over 21 months. TICC-PCP delivery: the median number of contacts, nine per participant in one year, matched the a-priori target although fewer than expected (13 (27%)) received the planned schedule of contacts (monthly for six months then every other month for six months). Secondary outcomes included increased prescribing of bone strengthening medicines, de-prescribing of medicines associated with increasing falls risk; delayed time to emergency health care contacts, fewer exacerbations; improved health related quality of life and longer duration of hospitalisation. A definitive phase three RCT of TICC-PCP may improve outcomes for people with moderate-severe COPD and co-morbidities. Trial registration: The trial is registered with the UK Clinical Trials Registry (https://doi.org/10.1186/ISRCTN43508703). Registration date: 3/1/2020.