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)
Lowrie R., Anderson D., Sheikh A., Moir J., McPherson A., Stanley B., Cameron G., Attwood L., Noble D., Rankine E., Anderson J., Greenlaw N., Hughes F., McIntosh E., Achiaw SO., Tait LA., Wood K., Scobie H., Mair FS.
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.