https://orcid.org/0000-0002-3671-0384
Figures
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.
Citation: Wood K, Lowrie R, Smith G, Anderson D, Moir J, Attwood L, et al. (2025) 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). PLoS One 20(6): e0326178. https://doi.org/10.1371/journal.pone.0326178
Editor: Rachel Ambagtsheer, Torrens University Australia, AUSTRALIA
Received: December 19, 2024; Accepted: May 26, 2025; Published: June 30, 2025
Copyright: © 2025 Wood et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability: Due to the conditions of our ethical approval granted by the NHS (REC reference 20/SS/0093), the data underlying this study cannot be made publicly available. The ethics application, and corresponding participant consent, allow for anonymised data to be used in future teaching and research and shared with approved researchers or students, but do not permit public sharing of the data. Therefore, in accordance with these constraints, the data cannot be deposited in a public repository. Interested researchers may direct data access requests to Ms. Olga Utkina-MacAskill (olga.utkina-macaskill@glasgow.ac.uk), Executive Assistant at the University of Glasgow, who is independent of the research team and can facilitate inquiries regarding data access.
Funding: This study was funded by The Chief Scientist Office (HIPS/19/27) [RL, DA, AS, FSM received award] and Chiesi Pharmaceuticals (to NHS Greater Glasgow and Clyde) [RL received award]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Sponsor URL: https://www.cso.scot.nhs.uk/.
Competing interests: The authors have declared that no competing interests exist.
Abbreviations: COPD, Chronic Obstructive Pulmonary Disease; DALY, Disability-Adjusted Life Years; GP, General Practitioner; HCP, Health Care Professional; LHW, Liaison Health Worker; MDT, Multi-Disciplinary Team; NHS, National Health Service; NPT, Normalization Process Theory; RCT, Randomised Control Trial; SES, Socio-Economic Status; SIMD, Scottish Index of Multiple Deprivation; TICC PCP, Tailored Intervention at home for patients with moderate-to-severe COPD and Co-Morbidities by Pharmacists and Consultant Physicians
Introduction
Chronic Obstructive Pulmonary Disease (COPD) prevalence is increasing globally [1], presents a major burden to healthcare systems [2] and is one of the top four leading causes of Disability-Adjusted Life Years (DALYs) among people aged over 50 [3]. There is a clear association between socioeconomic status (SES) and COPD prevalence [4,5] with the incidence and prevalence of COPD in the most deprived quintile estimated to be at least double that of the least deprived in Scotland [4,6]. Low SES is associated with increased likelihood of hospitalisation due to COPD [5].
A feasibility study (on which the pilot trial in this paper was based) suggested home-based collaborative Pharmacist and Consultant Respiratory Physician interventions may provide a complementary approach to community care, which could reduce the risk of key COPD-related adverse outcomes (e.g. exacerbations and hospitalisations) [7]. Two UK pilot studies [7,8] and an Australian interdisciplinary intervention for COPD, which included a Pharmacist home-medicines-review [9], reported moderate improvements in key COPD outcomes. However, the studies had limited generalisability – for example, due to small sample size and short follow up [8]. The interventions were not delivered by Pharmacists who had received training to prescribe independently or review and treat respiratory and other co-morbidities. Furthermore, patient and healthcare professional (HCP) perceptions of the interventions were not formally evaluated, although informal patient feedback was positive [7–9]. Patients appreciated the time taken by Pharmacists, found the face-to-face contact valuable and improved their inhaler technique. However, lack of a perceived need for a home medicines review contributed to poor uptake of one intervention [9].
In accordance with stages of testing novel complex interventions and following a successful feasibility study [7], 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) was undertaken in Scotland. The intervention involved home visits by Pharmacist Independent Prescribers working collaboratively with Consultant Respiratory Physicians over a one-year period, with the aim of improving the management of COPD and other comorbidities by providing holistic care. The additional qualifications attained by Pharmacist Independent Prescribers in the UK, allow them to undertake clinical evaluations and prescribe any medicines within their competence. In the context of the TICC PCP intervention, this enabled Pharmacists to independently visit participants in their homes, carry out assessments and prescribe/deprescribe medication in relation to their COPD and other health conditions. This model has been utilised in other targeted groups [10]. The TICC PCP intervention was provided in addition to care as usual. The control group continued to receive care as usual.
Understanding patient perceptions is essential when evaluating a complex intervention [11] as acceptability influences patient adherence and future implementation [12]. Stark social patterning in COPD may interact with the intervention and any potential influence on health inequalities [5,12].
We conducted a process evaluation embedded within the pilot RCT. This study aimed to: (1) explore patient and stakeholder perceptions of the TICC PCP intervention (how it was understood, engagement between patients and Pharmacists and others involved in delivering the intervention, how useful the intervention was) and trial, including the acceptability of trial procedures; and (2) identify likely barriers and facilitators to future implementation of the intervention.
Methods
Ethics
All patients and stakeholders gave informed, written consent at enrolment and the TICC PCP pilot RCT was approved by the South-East Scotland Research Ethics Committee (20/SS/0093) and is registered with the ISRCTN Registry [https://www.isrctn.com/ISRCTN43508703].
TICC PCP intervention
The intervention was provided by National Health Service (NHS) Pharmacist Independent Prescribers collaborating with Consultant Respiratory Physicians employed by two health boards in Scotland (NHS Greater Glasgow and Clyde and NHS Lothian), in addition to usual care. All participants continued to receive usual care throughout the study – usual care is outlined here. In Scotland, NHS primary and secondary health care is free at the point of use, including prescriptions which are dispensed (filled) in community pharmacies. Patients are registered with one General Practitioner (GP) (Family Physician) where they receive primary health care for non-emergency acute and chronic conditions. GPs co-ordinate comprehensive care and referrals to secondary care based respiratory physicians (including specialist COPD clinics) as needed. Complete clinical records (primary care and hospital consultation notes, prescribing, referrals, laboratory results etc.) are held by GP practices. At recruitment, all participants were under the care of Consultant Respiratory Physicians, after having been referred to local hospital based respiratory clinics. Participants were expected to attend the hospital clinics to receive care and to attend their GP surgery to receive care for COPD and any other health problem.
Independent Prescribers have successfully undertaken an independent prescribing qualification, enabling Pharmacists in the UK to prescribe any medicine. The intervention was tailored to patients’ needs as assessed by the pharmacists. Typically, Pharmacists visited intervention patients repeatedly at home over a one-year period, monthly during the first six months and every second month in the second six months (Pharmacists worked two days per week for the first six months, then one day per week for the next six months). Pharmacists undertook initial holistic assessments of patients’ COPD symptoms and management (including medication), comorbidities and social circumstances (e.g. housing, benefits). Working in conjunction with patients’ Respiratory Consultants and GPs, Pharmacists adjusted or deprescribed existing or prescribed new medications for COPD and comorbidities and referred to other services. Where appropriate, Pharmacists conducted or referred patients for additional tests, to make new diagnoses. Pharmacists updated medical records and informed other HCPs of treatment changes or issues. Intervention (n = 53) and control participants (n = 55) were visited by Researchers to complete study questionnaires and physical measures 3-monthly for 21 months.
Process evaluation
Sampling and recruitment.
Intervention patients were purposively sampled according to SES, sex and intervention site. Participants from the control (care as usual) group were not included in the process evaluation. Using baseline trial data, patients were assigned to quintiles of deprivation using the Scottish Index of Multiple Deprivation (SIMD), an area based measure of SES [13]. Patients from the 1st and 2nd most deprived quintiles were defined as ‘low SES’, those in the 4th and 5th least deprived quintiles as ‘high SES’, while those in the 3rd quintile were defined as ‘mid SES’.
Patients were interviewed between three- and eleven-months post RCT recruitment, thus ensuring experience of pharmacist input. Qualitative researchers (GS, KW) checked patients were well enough to participate prior to contacting them. Patients were then called within a week, reminded what interviews would entail and verbally reconsented before interviews. Four intervention patients (all low SES) declined to participate in an interview: two did not want to complete an interview, one felt unable to speak for long periods, and one did not want to complete a telephone interview. A further patient initially agreed to participate, but scheduling attempts were unsuccessful.
Stakeholders were purposively sampled to include those involved in delivering the intervention and RCT (Pharmacists – two; Respiratory Consultants – two; Researchers – three; and Administrators – one) or whose patients were involved in the trial (one GP, external to study team) and were interviewed along with one additional external Respiratory Consultant identified through team contacts. Interviewing stakeholders external to the study team provided additional insight from those not closely involved in delivering the intervention and trial. Only two of those invited to participate were unable to – one external Respiratory Consultant felt they were not best suited to being interviewed, and one GP did not have the time available.
Data collection
Semi-structured telephone interviews (chosen in part due to the ongoing COVID-19 pandemic) lasting around one hour were completed between December 2021 and November 2022 (KW, GS) to explore patients’ and stakeholders’ perceptions of the intervention using separate interview guides informed by the concepts of Normalization Process Theory (NPT) (S1 File). NPT is used to explore the extent to which practices become routinely embedded in everyday life [14] and has been used extensively to evaluate complex interventions and self-management of chronic conditions [15]. From the perspective of NPT, four kinds of work are involved in a practice becoming embedded: coherence (sense making work); cognitive participation (relational work); collective action (operational work); and reflexive monitoring (appraisal of the practice) [14]. The interview schedules (S1 File) were further developed iteratively based on initial interviews, e.g. to include questions about effects of the COVID-19 pandemic on care.
Both interviewers were female: one an experienced qualitative researcher, the other a medical student without prior qualitative data collection experience, who was guided and supervised by the former. Interviewers did not have prior research experience in relation to COPD. They had no prior relationships with patient participants, but some stakeholders were known to them. Due to breathing difficulties experienced by patients and to facilitate participation, where one hour was felt to be too long for patients to speak, they were offered the option to complete the interview in two parts. Short breaks were also offered where necessary. Family members or carers were occasionally present at the time of the interview. Interviews were digitally audio recorded, transcribed verbatim and then checked (GS and KW). Transcripts were not shared with participants.
Data analysis
Inductive thematic analysis was used to derive themes and data saturation was achieved [16]. Coding was supported by NVivo 10 software and carried out using codebooks developed from initial coding of interviews. Eight patient interviews were double coded by two researchers (GS, KW). Themes were identified based on prevalence and relevance to research questions. Coding clinics were utilised (GS, KW, FSM) to review, sense check and refine coding and themes (S1 File). Themes were mapped where appropriate to NPT constructs to aid conceptualisation. Participants did not provide feedback on the findings. Themes are illustrated through use of quotations – to protect anonymity, quotes provided by study team and health professionals were attributed to e.g., ‘Stakeholder 1’ or ‘Stakeholder’, without further detail. Perspectives of high and low SES patients were compared.
Results
Interviews were completed with 20 intervention patients and 10 stakeholders (HCPs/study team members) from both study sites (Tables 1 and 2).
Below we report patient perspectives of the intervention followed by stakeholder views (Fig 1, Fig 2). Details of barriers and facilitators to a future trial or implementation of the intervention are then presented.
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.
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.
Patient perception of intervention
Patient understanding and perception of COPD and intervention (Coherence).
Most patients had limited understanding of COPD. Some described delayed, absent or poor-quality information giving about their condition. Deterioration in physical and psychological symptoms related to COPD was common, with limitations experienced in the completion of daily tasks, hobbies and employment (Table 3).
Patient understanding and perception of COPD and intervention – Impact of intervention on understanding of health (Coherence).
Many patients felt better informed about their medications after the intervention, in particular their purpose, mechanism, administration and reduction of side effects. Pharmacists also contributed to an improved understanding of COPD among a few participants (Table 3).
Patient understanding and perception of COPD and intervention – Pharmacist compared to other HCPs (Coherence).
Most patients reported limited previous interaction with Pharmacists, but felt study Pharmacists offered more accessible, regular contact, provided more information and explanation, and spent more time with them than other HCPs (Table 3).
Operationalisation of intervention – Pharmacist actions (Collective Action).
Across a variety of tasks (Table 4) Pharmacists offered information and expertise, reassurance and support, problem solving, bridged gaps in and between care and facilitated access and receipt of care and services for all patients.
Operationalization of intervention – Trust in Pharmacists (Collective action).
Patients expressed trust in Pharmacists based on their perceived professionalism, experience and knowledge – they described trusting Pharmacists “100%” and “wholeheartedly.” One patient did express scepticism relating to Pharmacist advice on COVID-19 vaccination. Trust may have been fostered by patients’ perceptions of the advantages of the care provided by Pharmacists and the relationships they developed with them.
Operationalization of intervention – Relationship with Pharmacists (Collective action).
Pharmacists were perceived as easy to talk to and good listeners. Patients felt free to disclose information, share worries, concerns and grievances. Pharmacists, patients and their families, built beneficial relationships – enabling pharmacists to ‘read’ patients. For two patients, the Pharmacist was like a friend (Table 3).
Evaluation of intervention – Positive impact (Reflexive monitoring).
Most patients had a wholly positive perception of the intervention – one stated participation was “one of the best decisions I have made in my life” (Participant 18, Female, Low SES, Glasgow). They appreciated the privacy and comfort of seeing Pharmacists in their home. This regular, accessible support offered reassurance in the context of long waits between appointments and reduced, particularly face-to-face, contact with other HCPs, such as GPs, due to the COVID-19 pandemic. They also gained access to services they did not know about.
Patients appreciated the holistic care provided by Pharmacists and described changes in outcomes. Several patients felt their breathlessness and exacerbations were better managed and issues picked up earlier, faster access to medications (rescue packs [steroid and/or antibiotic medication to treat flare-up of COPD symptoms, as per management plan], new medications, changes to existing medications) and more efficacious medication use. Three patients felt the intervention had contributed to a reduction in the frequency of hospital admissions, others noting a reduction in infections and exacerbations (frequency and/or severity). Several patients were diagnosed and treated for new health conditions (e.g. high blood pressure, high cholesterol). Improved mobility and ability to complete daily tasks following receipt of mobility aids and home adaptations were described by many patients. Two patients reported lifestyle changes – reduced alcohol consumption and improved weight. Pharmacists had also resolved prescription and appointment issues.
Most patients stated they would appreciate continued access to Pharmacist visits, feeling they had been beneficial and reassuring (Table 3).
Evaluation of intervention – Limited impact on health (Reflexive monitoring).
Some patients while appreciating Pharmacists visits, expressed a perception that the intervention had not greatly impacted their health. For example, they had not experienced major issues with their COPD/health or felt they were adequately managing their health themselves. However, these patients did report medication changes (some ineffective), investigations (one was diagnosed with a new health condition) and had received mobility aids and rescue packs because of Pharmacist input.
Some patients also noted similarities in care or felt the intervention had reinforced what they had already learned, from their respiratory team or GPs, however the consistency of advice across HCPs is reassuring for the intervention.
One patient felt they would not have benefited from the intervention to the same extent without the disruption in their care caused by the COVID-19 pandemic (Table 3).
Evaluation of intervention – Repetitiveness in Pharmacist visits (Reflexive monitoring).
Two patients referred to some repetitiveness in Pharmacist visits, which one felt caused awkwardness (Table 3).
Evaluation of intervention – Increased and continued contact (Reflexive monitoring).
Two patients would have liked to have seen the Pharmacists more often, for longer or at an earlier stage of their diagnosis. Having a direct method of contact or leaving a message for Pharmacists between visits would have been appreciated by two patients. At the end of the intervention, Pharmacists and Researchers encouraged patients to ensure they had a note of important numbers/contacts or had asked final questions. However, two participants expressed concerns about losing Pharmacist support, with one feeling “thrown to the wayside” (Participant 20, Female, High SES, Lothian) following the end of their visits and would have preferred ongoing support.
SES comparison.
Most patients spoke positively of their experience regardless of SES. However, based on patient reports of actions undertaken, it appeared Pharmacists were able to do more for low SES patients. While most patients mentioned being asked about their mental health, high SES patients were more likely to discuss being referred or self-referring for mental health support such as counselling. Low SES patients were more likely to describe issues and delays around diagnosis which may have contributed to their recounting more instances of Pharmacist assistance. While appreciating the intervention, three low SES patients felt it had not greatly impacted their health (Table 4).
Stakeholder perception of intervention
Stakeholder understanding and perception of COPD care and intervention - Professional background/prior experience of HCPs (Coherence).
Pharmacists had prior COPD knowledge and experience through work in primary care and with community respiratory teams. Researchers were experienced in recruitment, home health assessments and pharmacy-related roles which one stakeholder found helped “enormously.”
Stakeholder understanding and perceptions of COPD care and intervention – Existing health care provision (Cognitive participation).
Access to healthcare services and disruption caused by the COVID-19 pandemic differed within and between geographic areas (e.g. community respiratory teams limited to certain areas). While some patients had continued to receive some form of care during the pandemic, others had little contact with HCPs, increasing a sense of isolation. There was therefore variability in the circumstances and needs of participants in this study (Table 5).
Stakeholder understanding and perceptions of COPD care and intervention - Expectations of role and participating in study (Cognitive participation).
Respiratory Consultants were motivated by previous research involvement and the potential impacts of the intervention, although one Consultant expressed uncertainty about the time commitment involved. One Pharmacist highlighted unanticipated aspects of their role such as referrals for oxygen and long-term antibiotics, discussion of alcohol issues, and the extent of their contact with other HCPs.
Stakeholder understanding and perceptions of COPD care and intervention - Home visits (Cognitive participation).
The study was designed to provide home visits. Indeed, it was clear from stakeholders’ experiences that home visits had enabled the participation of patients unable to attend other locations and in the context of post-pandemic reduced (face-to-face) contact with HCPs (Table 5).
Operationalisation of intervention – Pharmacist tasks and interventions (Collective action).
Pharmacists visited patients at home throughout the intervention and reported undertaking initial assessments, offering patients information and using goal setting techniques, as well as recording interventions, reviewing and making entries in patient’s medical records, and making referrals to other HCPs (Table 4).
Operationalization of intervention – Good working relationships (Collective action).
Good working relationships were experienced between HCPs and study staff who were perceived to be “on board” and supportive – trust was fostered through past work and collaboration.
The Pharmacist role was “not a one-person role” (Stakeholder 6), they were a “middle person between the patient and consultant” (Stakeholder 6). Pharmacists also engaged with GP practices to inform them of medication changes, request tests and appointments and discuss hospital admission. Other HCPs/services involved included: Dieticians; Community Link Workers and Respiratory Teams; Pulmonary Rehabilitation; Occupational Therapy; and Mental Health teams. Previous work experience had also equipped Pharmacists with points of contact within NHS services (Table 5).
Operationalization of intervention – Patients’ health care seeking during trial (Collective action).
Two stakeholders felt some patients viewed Pharmacists as a substitute to their usual care, instead of an addition (Table 5).
Operationalization of intervention – Intervention workload (Collective action).
Pharmacists described significant clinical workload and administrative burdens. The bulk of time-consuming tasks were carried out during initial visits. Beyond this Pharmacists managed changes in patients’ health or life circumstances. Part-time hours and the level of ‘unwellness’ among patients compounded workload challenges.
Due to time pressures, Pharmacists prioritised visiting the most unwell patients and following up others by phone. A Consultant also reported that the intervention generated some additional workload, which could be challenging to incorporate within their usual tasks while ensuring timely responses to Pharmacist requests (Table 5).
Operationalization of intervention – Lone working and lack of workspace (Collective action).
Pharmacists’ contact with Respiratory Consultants or other HCPs while frequent, was not face-to-face. A Pharmacist reflected they did not have a team to discuss challenging consultations with or to gain ideas from. Lack of a dedicated workspace in the local NHS was also a challenge (Table 5).
Evaluation of intervention – Improved patient health and self-management (Reflexive monitoring).
The intervention was perceived to have improved the health and quality of life of patients. Stakeholders described patients’ reduced exacerbations, improved breathing, and diagnosis/management of other health conditions. Long term input was required to improve some aspects of patients’ health (Table 5).
Evaluation of intervention – Improved patient care (Reflexive monitoring).
Pharmacists delivered additional, holistic care to patients and were able to spend more time with them. Pharmacists organised investigations, treatments and referrals which may not otherwise have occurred. There was a perception that patients were receiving safer care and Pharmacist input was valued by other HCPs (Table 5).
Evaluation of intervention – Workload of other HCPs (Reflexive monitoring).
A Consultant felt “quite redundant” seeing some intervention patients. Pharmacists had carried out many necessary treatment and monitoring tasks e.g. referral for bone density tests. Despite saving Consultants’ time, around an hour of Consultant time per week was required to support Pharmacists (Table 5).
Evaluation of intervention – Home visits (Reflexive monitoring).
Home visits were seen to provide better insight and a fuller understanding of patients who were perceived to be more open in their own home, with relatives providing supplemental information. New issues were identified and acted upon quickly, which may not have been picked up in other healthcare settings (Table 5).
Evaluation of intervention – Study role rewarding (Reflexive monitoring).
The Pharmacist role was viewed as rewarding, involving relationship building with patients, providing support, implementing changes, and observing improvements. Positive feedback had also been received from patients (Table 5).
Evaluation of intervention – Perceived advantage of Pharmacists in this role (Reflexive monitoring).
Pharmacists “unique skill set” (Stakeholder 7) and wider expertise was viewed favourably compared to the more specialised COPD/respiratory knowledge of Respiratory Nurses and Physiotherapists. Their ability to prescribe, change and deprescribe medications for multiple health conditions and improve patient understanding was viewed positively. Pharmacists in general were viewed as “methodical” (Stakeholder 1) and “highly skilled” (Stakeholder 4) (Table 5).
Intervention challenges – Perceptions of health and care of patients (Reflexive monitoring).
The needs of patients were perceived as complex. Some were house- or bed-bound, many had difficulties managing at home and were experiencing isolation and loneliness. Pharmacists were challenged by the changeable nature of patients’ health, encountering circumstances which required them to work to the top of their licence. This included decisions around medications, hospital admissions and mental health issues. COVID disruption may have limited training in one site. Despite training and prior respiratory experience, Pharmacists reported encountering respiratory and other clinical scenarios for which they felt further training would have been beneficial and reassuring. A small number of patients were felt to be less receptive to Pharmacists’ input, while less could be done for some who felt they were already adequately managed without the need for additional intervention.
Intervention challenges – Preparing patients for the end of Pharmacist visits (Reflexive monitoring).
When the intervention period ended, patients continued to receive usual care. Patients were encouraged to ensure they had asked Pharmacists final questions and kept notes of contacts. However, concerns were expressed regarding the potential deterioration in patients’ health beyond the end of Pharmacists’ visits (Table 5).
Patient and stakeholder acceptability of trial procedures
Patient acceptability – Understanding of study information and intervention (Coherence).
Study information was generally understood. However, some patients noted areas of uncertainty, e.g., exactly what Pharmacists would do.
Patient acceptability – Perception of study invitation and support from others to participate (Cognitive participation).
Most patients reacted positively to the study invitation, facilitated for some by a prior conversation with their Respiratory Consultant. Conversations with a study Researcher and a patient’s partner overcame initial reservations of two patients; the families of other patients were supportive of their participation. Patients were motivated to participate in the hopes of benefiting from Pharmacist input, or to help others with COPD and also their Respiratory Consultant.
“It was [Respiratory Consultant] that actually asked me if I would mind taking part in it…when we were on the phone…and I says that I wouldn’t mind that, so he passed my name and then…got in contact with me.” Participant 16, Female, Low SES, Glasgow.
Patient acceptability – Data collection and researcher home visits (Collective action).
Data collection procedures were generally acceptable, possibly facilitated by the positive interactions and relationship several patients reported with study Researchers. However, trial questionnaires were noted to be long and repetitive, while some questions were not felt to be relevant to a few patients.
“It’s a repetitive procedure in that they have to see if there’s any change in answer to the questions that they give you…So that’s why it has to be repetitive. But I can understand that. There’s no problem with that.” Participant 10, Male, High SES, Glasgow.
Patient acceptability – Participation in future trial (Reflexive monitoring).
Most patients were willing to participate in a future trial. A small number qualified this decision, depending on trial requirements (time, travel) and their own health, i.e., if experiencing issues that required support.
“…it’s as if I don’t want to waste anybody’s time. Whereas if I’ve got issues at the time…but then again, you don’t know when you’re going to have the issues. That’s the point. So, you can’t actually say that.” Participant 16, Female, Low SES, Glasgow.
Stakeholder acceptability – Trial patient and staff recruitment (Cognitive participation).
Postal invitations were sent to lists of eligible patients who had moderate or severe COPD and were on a Respiratory Consultant’s outpatient clinic list. Follow-up telephone calls were planned and found to be necessary due to a limited response to postal invitations. Respiratory Consultant endorsement was perceived to have encouraged and motivated some patients’ participation.
“… it was a lot easier, because the Consultant had already said, we’re doing a study, somebody might be in touch with you. So, it was almost like, you know, there was a foot in the door.” Stakeholder 2.
However, this approach was not always possible, for example due to staff recruitment delays and COVID impacts. Building relationships with secondary care staff was perceived as important in identifying further patients. Most patients contacted were receptive towards participating in the trial. Reasons for non-participation included: not wishing to be involved in research; previous research participation; being too unwell or not unwell enough; and negative family input.
Stakeholder acceptability – Data collection and input, complicated by IT infrastructure (Collective action).
Researchers spent considerable travel and time completing data collection. Study questionnaires were long, with some repetitiveness and questions requiring explanation. Patients could become fed-up or struggled with respiratory symptoms – as a result, questionnaires were occasionally not completed during a single visit. Completing some follow-up questionnaires by phone was preferred by some patients.
“…you go and see somebody that can hardly breathe, or they’re coughing, a lot of them cough, a lot. So, they maybe have a coughing fit that takes them a good five, ten minutes to recover.” Stakeholder.
Physical health measures were also collected. However, patients were at times too unwell to complete them, while some also refused to be weighed. Measures from medical records were instead utilised however, these were often outdated.
“There’s times when I’ve not done [physical measures]. If somebody is so, like mentally unwell, physically unwell, I’m not going to move them…especially if I’m on my own…So I always just document it, you know, not appropriate to move the patient today, or we’d use the last readings we’ve had.” Stakeholder.
IT access issues working across two sites also caused significant problems at baseline, resulting in a more challenging process for data input which only one person could work on at a time. Data input was time consuming, and use of multiple databases contributed to duplication.
“…just inputting this information…into the spreadsheets…I think is just taking a lot longer…than they initially thought, because there’s a lot more information that we needed to find that’s not on the questionnaire that we have to go hunting for…I think it’s taken nearly six months to get that all in.” Stakeholder 3.
However, direct contact with GP practice staff extracting data from patient records was beneficial.
While good safety measures were in place for lone working, intervention and trial staff were often unaware who else would be present in patients’ homes.
Table 6 summarises the key strengths and challenges identified in the pilot RCT from patient and stakeholder perspectives, and their implications for planning a future trial.
Barriers and facilitators to expansion, future larger scale trial and wider implementation
A range of further potential barriers and facilitators to a future, larger scale trial or implementation of the intervention were identified by stakeholders (Table 7). These related to: recruitment, geographic differences in service provision, clinical risk/training, cost effectiveness/funding, IT infrastructure, intervention flexibility, additional staff and resources, and Multi-Disciplinary Teams (MDTs).
Discussion
The TICC-PCP intervention was well received by patients and stakeholders. Patients appreciated regular, accessible contact with a HCP who was able to assess their COPD and comorbidities, act to resolve problems and support them with their COPD, wider health and needs. Many patients described improvements to their COPD management, medications and mobility and most reported positive perceptions, regardless of SES. Stakeholders felt the intervention had a positive impact on many patients, providing them with additional, holistic care which led to improvements in their COPD/health and potentially reducing the workload of other HCPs. Some patients were bypassing GPs, suggesting there is also the potential for this intervention to reduce pressures on GPs. However, some challenges were encountered in the delivery of the trial and intervention, and there were several suggestions regarding how to mitigate these (Table 6).
This positive response resonates with other home or outreach Pharmacist interventions or medicine reviews [8,10]. The feasibility trial preceding the current pilot RCT, found that intervention participants experienced a lower rate of exacerbation, had fewer respiratory hospitalisations and shorter admissions to hospital [7]. A similar intervention among people experiencing homelessness trialled in a pilot RCT, delayed median time to emergency department visit and hospitalisation and also appeared to improve quality of life [10]. Some of the patients participating in this process evaluation reported an improvement in their breathlessness and exacerbation management. A few also felt there had been a reduction in their frequency of being admitted to hospital.
Previous research [9] had identified a lack of a perceived need for medicines review could be a barrier to implementation. In contrast, most TICC PCP participants were motivated to work with the Pharmacist. Patients in our study had moderate-to-severe COPD rather than mild COPD, which may have contributed to higher levels of motivation and need for support. Our findings also resonate with the positive views of patients and stakeholders in a prescribing Pharmacist outreach intervention among people experiencing homelessness [17].
A feasibility study of home outreach by Liaison Health Workers (LHW) for patients with COPD and psychological comorbidity, similarly reported patients appreciating the holistic, personalised approach to their care [18]. However, in contrast to the LHWs’ patients who did not want continued support, most TICC PCP patients would have preferred continued Pharmacist support beyond the trial end [18]. Interventions and pulmonary rehabilitation courses for patients with COPD have faced barriers to recruitment and attendance due to the ability of patients to travel to intervention locations due to distance, inadequate transport and patients’ health and mobility [19–21]. The home-based nature of the TICC PCP intervention was felt to have facilitated patient participation.
While no RCTs have specifically assessed home-based Pharmacist interventions for patients with COPD, a systematic review [22] identified twelve RCTs of home visit interventions by Pharmacists aimed at people with other health conditions, “at risk of medication-related problems”. Most interventions were focused solely on advice and medication support; two included some form of lifestyle advice. The review found no evidence these types of intervention influenced hospitalisation, medication adherence, knowledge, or quality of life. However, none of the studies explored interventions delivered by Pharmacist Independent Prescribers, collaborative Pharmacist-Consultant Respiratory Physician interventions or whether perspectives varied among subgroups of the population such as those of a low SES. A further study found that a home-based Pharmacist intervention targeting medically underserved populations, such as older adults with dementia, in Taiwan could significantly improve disease status, medical knowledge, self-care skills and mitigate drug related problems [23].
In terms of learning for a future large-scale trial (Table 6) it was clear that not all patients required the same level of support. A systematic review and qualitative synthesis have suggested that the complexity and unpredictability of COPD requires services to be flexible and promote continuity [24]. While the TICC PCP intervention was tailored to patient needs, including numbers of visits and actions, further flexibility may assist in the management of Pharmacist and MDT workload and matching the needs of patients. Recruitment of additional staff (e.g. Pharmacy Technicians) may also contribute to alleviating workload pressures. While Pharmacists in this study were autonomous clinicians, trained to prescribe and deprescribe or change any medicine, aligning or incorporating this intervention with MDTs could support Pharmacists dealing with new/complex issues and clinical risk. Recruitment of Pharmacists with respiratory experience may be advantageous, nevertheless provision of training related to respiratory conditions and other issues that may be encountered e.g. mental health, could increase the confidence of Pharmacists in dealing with a complex, frail patient population.
The results of this study should also be considered in the context of the continued consequences of the COVID-19 pandemic. Access to health care and treatments such as pulmonary rehabilitation were more difficult, while face-to-face interaction with HCPs was vastly reduced [25,26]. A sense of isolation from support (health services, family and friends), combined with longer-term changes in health care access may have contributed to the positive patient perspective of this intervention. The pandemic may have increased inequalities in COPD and other chronic respiratory diseases [27], which could contribute to the suggestion that low SES patients self-reported more Pharmacist actions.
Strengths and limitations
The participation of patients from two settings and with a range of socioeconomic environments and a range of stakeholders are strengths, allowing the inclusion of a variety of viewpoints and insights into the procedures and processes involved. Purposive sampling of patient interviewees ensured a balanced sample in terms of sex, geographical location and SES, which enabled a comparison of perspectives. A further strength was the use of NPT which allowed findings to be more explanatory than descriptive as it is a well-established theory used to understand the implementation of complex interventions and self-management of chronic conditions.
A limitation of this study is the small sample size of participants from one country, which restricts generalisability. As control participants were not interviewed, we have been unable to present their perceptions of participating in the trial. A further limitation relates to the reliance on individual recall of events and Pharmacist interventions. Several patients were unable to remember certain aspects of the trial, details of interventions and changes made by Pharmacists or other HCPs. The timing of interviews varied and those interviewed at an earlier stage may not have appreciated any longer-term impacts of Pharmacist actions, while those interviewed later in the intervention may have forgotten some early actions. Some patients may also have conflated the Pharmacist intervention visits with repeated Researcher visits. Finally, as interviews were carried out by telephone, additional insights from body language, facial expressions and patients’ home environments were not collected.
Implications for future research
Our findings suggest this intervention was viewed positively by patients and stakeholders and demonstrates Pharmacist prescribers were able to undertake a broad range of activities to help patients with COPD and comorbidities. The intervention may be particularly useful for patients from a low SES and consideration could be given to targeting this subpopulation, although further examination of this issue is required. We have identified likely barriers and facilitators to future implementation of the intervention as a form of routine service delivery and made suggestions for mitigation. Overall, the intervention was very positively received. Trial procedures were acceptable and seem to have good implementation potential. If the pilot trial meets the pre-determined progression criteria, then progress to a full scale RCT is merited.
Supporting information
S1 File. Interview schedules and coding trees.
https://doi.org/10.1371/journal.pone.0326178.s001
(DOCX)
S2 File. Consolidated criteria for reporting qualitative studies (COREQ): 32-item checklist.
https://doi.org/10.1371/journal.pone.0326178.s002
(DOCX)
Acknowledgments
The authors would like to acknowledge the support and assistance of Miss Bethany Stanley of the Robertson Centre for Biostatistics, University of Glasgow with baseline patient characteristics data.
References
- 1. GBD Chronic Respiratory Disease Collaborators. Prevalence and attributable health burden of chronic respiratory diseases, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Respir Med. 2020;8(6):585–96. pmid:32526187
- 2.
The Scottish Government. COPD Best Practice Guide The Scottish Government; 2017.
- 3. Vos T, Lim SS, Abbafati C, Abbas KM, Abbasi M, Abbasifard M, et al. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020;396(10258):1204–22. pmid:33069326
- 4. Snell N, Strachan D, Hubbard R, Gibson J, Gruffydd-Jones K, Jarrold I. S32 Epidemiology of chronic obstructive pulmonary disease (COPD) in the uk: findings from the british lung foundation’s ‘respiratory health of the nation’ project. Thorax. 2016;71(Suppl 3):A20.1-A20.
- 5. Gershon AS, Dolmage TE, Stephenson A, Jackson B. Chronic obstructive pulmonary disease and socioeconomic status: a systematic review. COPD. 2012;9(3):216–26. pmid:22497534
- 6. Levin KA, Anderson D, Crighton E. Prevalence of COPD by age, sex, socioeconomic position and smoking status; a cross-sectional study. HE. 2020;120(5/6):275–88.
- 7. Hunt V, Anderson D, Lowrie R, Montgomery Sardar C, Ballantyne S, Bryson G, et al. A non-randomised controlled pilot study of clinical pharmacist collaborative intervention for community dwelling patients with COPD. NPJ Prim Care Respir Med. 2018;28(1):38. pmid:30305634
- 8. Alton S, Farndon L. The impact of community pharmacy-led medicines management support for people with COPD. Br J Community Nurs. 2018;23(6):266–71. pmid:29869904
- 9. Liang J, Abramson MJ, Russell G, Holland AE, Zwar NA, Bonevski B, et al. Interdisciplinary COPD intervention in primary care: a cluster randomised controlled trial. Eur Respir J. 2019;53(4):1801530. pmid:30792342
- 10. Lowrie R, McPherson A, Mair FS, Stock K, Maguire D, Paudyal V, et al. Holistic health and social care outreach for people experiencing homelessness with recent non-fatal overdose in Glasgow, Scotland: the Pharmacist and third sector Homeless charity worker Outreach Engagement Non-medical Independent prescriber Rx (PHOENIx) pilot randomised controlled trial. bmjph. 2024;2(1):e000219.
- 11. Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017;17(1):88. pmid:28126032
- 12. Diepeveen S, Ling T, Suhrcke M, Roland M, Marteau TM. Public acceptability of government intervention to change health-related behaviours: a systematic review and narrative synthesis. BMC Public Health. 2013;13:756. pmid:23947336
- 13. The Scottish Government Housing and Social Justice Directorate. Scottish Index of Multiple Deprivation 2020. 2020 [cited 2024 05/02/2024. ]. https://www.gov.scot/collections/scottish-index-of-multiple-deprivation-2020/
- 14. May C, Finch T. Implementing, Embedding, and Integrating Practices: An Outline of Normalization Process Theory. Sociology. 2009;43(3):535–54.
- 15. Murray E, Treweek S, Pope C, MacFarlane A, Ballini L, Dowrick C, et al. Normalisation process theory: a framework for developing, evaluating and implementing complex interventions. BMC Med. 2010;8:63. pmid:20961442
- 16. Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology. 2006;3(2):77–101.
- 17.
Johnsen S, Cuthill F, Blenkinsopp J. Qualitative Evaluation of Clincial Pharmacist Prescribing Input into the Care of People Experencing Homelessness. 2019.
- 18. Langer S, Chew-Graham CA, Drinkwater J, Afzal C, Keane K, Hunter C, et al. A motivational intervention for patients with COPD in primary care: qualitative evaluation of a new practitioner role. BMC Fam Pract. 2014;15:164. pmid:25284048
- 19. Huang B, De Vore D, Chirinos C, Wolf J, Low D, Willard-Grace R, et al. Strategies for recruitment and retention of underrepresented populations with chronic obstructive pulmonary disease for a clinical trial. BMC Med Res Methodol. 2019;19(1):39. pmid:30791871
- 20. Keating A, Lee AL, Holland AE. Lack of perceived benefit and inadequate transport influence uptake and completion of pulmonary rehabilitation in people with chronic obstructive pulmonary disease: a qualitative study. J Physiother. 2011;57(3):183–90. pmid:21843834
- 21. Keating A, Lee A, Holland AE. What prevents people with chronic obstructive pulmonary disease from attending pulmonary rehabilitation? A systematic review. Chron Respir Dis. 2011;8(2):89–99. pmid:21596892
- 22. Abbott RA, Moore DA, Rogers M, Bethel A, Stein K, Coon JT. Effectiveness of pharmacist home visits for individuals at risk of medication-related problems: a systematic review and meta-analysis of randomised controlled trials. BMC Health Serv Res. 2020;20(1):39. pmid:31941489
- 23. Liang Y-H, Wang K-H, Huang H-M, Shia B-C, Chan S-Y, Ho C-W, et al. Reducing Medication Problems among Minority Individuals with Low Socioeconomic Status through Pharmacist Home Visits. Int J Environ Res Public Health. 2022;19(7):4234. pmid:35409914
- 24. Giacomini M, DeJean D, Simeonov D, Smith A. Experiences of living and dying with COPD: a systematic review and synthesis of the qualitative empirical literature. Ont Health Technol Assess Ser. 2012;12(13):1–47. pmid:23074423
- 25. Press VG, Gershon AS, Sciurba FC, Blagev DP. Concerns About Coronavirus Disease-Related Collateral Damage for Patients With COPD. Chest. 2020;158(3):866–8. pmid:32473947
- 26. Madawala S, Quach A, Lim JY, Varatharaj S, Perera B, Osadnik C, et al. Healthcare experience of adults with COPD during the COVID-19 pandemic: A rapid review of international literature. BMJ Open Respir Res. 2023;10(1):e001514. pmid:36858459
- 27. Gardiner L, Singh S. Inequality in Pulmonary Rehabilitation - The challenges magnified by the COVID-19 pandemic. Chron Respir Dis. 2022;19:14799731221104098. pmid:35687527