Interim findings from a pragmatic, multicentre pilot randomised controlled trial (RCT) of optimisation of prescribing by primary care pharmacists in patients with chronic obstructive pulmonary disease (COPD) and associated co-morbidities

Problem

Therapeutic management of people at home with moderate-severe COPD and comorbidities is time consuming and suboptimal. There is room for improvement in clinical outcomes, cost effectiveness, quality of life and a need to reduce numbers of acute and primary care medical contacts. NHS employee General Practice-based Pharmacists prescribe medicines but whether they collaboratively improve care for people with COPD and co-morbidities, is under-researched.

Approach

We are undertaking a multicentre pilot RCT of a home-based intervention comprising of a collaborative pharmacist independent prescriber supported by a consultant physician for patients with moderate-to-severe COPD and associated co-morbidities. Our aim is to inform a subsequent definitive RCT. Participants were recruited from respiratory clinics in Glasgow and Lothian between July 2021 - February 2022. Comprehensive baseline data were collected during home visits by researchers, supplemented by clinical records including: demographics; home circumstances; lifestyle; medicines; comorbidities; frailty; EuroQol 5D5L; breathlessness assessments; Patient Experience with Treatment; resource use; primary and secondary and social care resource use. After baseline data collection, participants were randomly allocated (1:1) to either pharmacist intervention (home visits including patient assessment, prescribing and referral to health and social care when appropriate, monthly for 6 months then every 2 months for 6 months) plus Usual Care (UC) or UC. Pharmacists had full read and write access to all primary and acute NHS clinical records. Independent researchers continue to follow up participants at home 3 monthly until trial closedown in the third quarter of 2023. The RCT includes accompanying qualitative process and economic evaluations.

Findings

We successfully recruited 110 participants: 55 Intervention and 55 UC. 59% female; mean age 67 years. Baseline number of diagnoses (mean): 2.8 respiratory; 7.6 other physical health; 1.1 mental health with a mean of 11.3 medicines/patient. In the previous year, mean: healthcare contacts=27; costing £5607. 20% reported quality of life states “worse than death”; 4% reported “perfect health”. 52/55 received pharmacist intervention e.g. referral for DEXA scans; X-rays. Pharmacists prescribed for respiratory; infections; gastrointestinal; pain; nutrition/anaemia; skin; nervous system; and genitourinary problems. 55/55 received usual care. After 12 months, 22 participants died; 6 withdrawn. 18/24 month follow up is underway.

Consequences

We met our pre-specified recruitment and retention targets and the intervention was delivered as planned. Qualitative data indicate that the intervention was valued by patients and carers. We are collecting final follow-up data from our pilot RCT and interim results will be available for July 2023 to allow planning for the definitive trial.