Process evaluation of a pragmatic, multicentre pilot Randomised Controlled Trial (RCT) in primary care: Tailored intervention for COPD and Co-morbidities by Pharmacists and Consultant Physicians (TICC PCP)

Abstract

Chronic Obstructive Pulmonary Disease (COPD) is a growing global challenge. We undertook a process evaluation embedded within the Tailored Intervention at home for patients with moderate-to-severe COPD and Co-Morbidities by Pharmacists and Consultant Physicians (TICC PCP) pilot randomised controlled trial (RCT), which explored patient/stakeholder perceptions of the intervention, acceptability of trial procedures, and barriers/facilitators to intervention implementation. Semi-structured telephone interviews were conducted with intervention patients (20) and stakeholders (10); data were analysed thematically, conceptualised through Normalisation Process Theory. Patient perspectives compared based on socio-economic status (SES). Patients/stakeholders reported positive perceptions of the intervention/trial procedures. Pharmacists provided support across a range of health/social issues. Challenges related to: recruitment; workload/lone-working; managing patient complexity; and data collection. There were suggestions Pharmacists were able to undertake more actions to support patients from low SES areas. Overall, intervention and trial procedures were acceptable to patients and stakeholders. Findings support progression to full-scale RCT.

Fig 1. Normalisation Process Theory conceptualisation of patient perspectives.

Main themes identified in patient data mapped to four constructs of Normalisation Process Theory (Coherence, Cognitive participation; Collective action; Reflexive monitoring). Includes patient perspectives on the intervention and in italics, patient acceptability of trial procedures.

Fig 2. Normalisation Process Theory conceptualisation of stakeholder perspectives.

Main themes identified in stakeholder data mapped to four constructs of Normalisation Process Theory (Coherence, Cognitive participation; Collective action; Reflexive monitoring). Includes stakeholder perspectives on the intervention and in italics, stakeholder acceptability of trial procedures.