PHARM-LC: What role can Community Pharmacy play in supporting people with long Covid? Protocol for a mixed methods study

Background

The patient-preferred term for symptoms that persist for 12 or more weeks following a COVID-19 infection, is known as Long Covid¹. Reports indicate that Long Covid now affects around 1.9 million adults in the UK, some with persistent symptoms lasting for over one year². Long Covid is reported in 44% of people 28 days after a COVID-19 diagnosis; with 200 million people thought to be affected globally³. ‘Post COVID-19 syndrome’ is an overarching term for a complex, multisystem illness following COVID-19 infection, regardless of its severity, irrespective of recovery time or perceived recovery¹. The World Health Organization (WHO), National Institute for Health and Care Excellence (NICE) and Systematized Nomenclature of Medicine Clinical Terms (SNOMED) International (https://www.snomed.org/)⁴ have all adopted the term ‘post COVID-19 condition’ for classification. However, through the exchange of lived experiences, patient groups within the UK identified ‘Long Covid’ as their preferred term⁵ – we will continue to use this term in our research.

People at higher risk of Long Covid include females, people aged 35–69 years, those working in health and social care, people living in more deprived communities, and people with another health condition or disability⁶. Symptoms of Long Covid have a great impact on daily life and can be physical, cognitive, and/or psychological^7–9. Office for National Statistics (ONS) data indicates that fatigue is the most common symptom (by 71% of those with self-reported Long Covid), along with difficulty concentrating (52%), shortness of breath (48%) and muscle ache (47%)⁶. Long Covid is a burdensome and debilitating condition, data from 10 UK population-based longitudinal studies suggests that 13.7% of people living with Long Covid experience symptoms that limit their day-to-day function¹⁰; with the latest ONS data suggesting 79% (1.5 million) experience symptoms that adversely affect daily activities, and19% (380,000) report that daily activities have been "limited a lot"⁶. Organ damage is also reported to persist in three-in-five of those with Long Covid, 12 months after initial infection – which may have long term implications¹¹.

People living with prolonged symptoms following acute COVID-19 infection experience significant uncertainty about managing their immediate symptoms, sense of recovery and longer-term health; this is reinforced by social stigma and a lack of public awareness about Long Covid, which can contribute to worry and distress^12,13. People with ongoing symptoms following COVID-19 are not always believed or may have their symptoms dismissed as ‘mild’, which invalidates their sense of illness and may be perceived as ‘gas-lighting’¹⁴. These experiences may drive a reluctance among people with Long Covid to seek help¹⁵. Thus, being believed and not having symptoms dismissed as anxiety were crucial to facilitate further help-seeking¹⁶.

Primary Care within the UK is under immense pressure due to a myriad of factors such as funding, limited resources and GP job satisfaction, and patient satisfaction¹⁷. In an attempt to combat access issues primary care practices have been integrating remote consultations into practice since the onset of the COVID-19 pandemic¹⁸ with these consultations showing an improvement in access to care and enabling staff working in General Practice to manage workloads more effectively^18–20. However, remote consultations are not always applicable for those that are at a greater risk of Long Covid such as residents in more deprived areas, or/and those are living with a disability^21,22. Indeed, there were initial attempts to provide online resources and establish clinics for those living with Long Covid, these have since proved to be challenging to sustain due to high demand, with access being limited and subject to residential areas along with difficulties in underrating uptake and engagement with online resources^23–28. Recent evidence also suggests that people living with Long Covid may not seek help from primary care due to these difficulties in access; instead relying on guided self-management¹⁰. People living with Long Covid commonly access support groups, particularly online, to share experiences and inform self-management strategies; however, engagement with these groups is often driven by a perceived lack of understanding and empathy from others, including healthcare professionals¹².

Community pharmacies operate in over 11,700 locations in the UK and provide ongoing, opportunistic support to people with a range of health problems^29–31, as well as their key supporting role when it came to the COVID-19 vaccine roll out and supporting patients during the pandemic^32,33. They are an integral part of NHS primary care services and offer people a link to local health and social care^12,15, especially for those that have long term conditions, and for those that live in more deprived areas, due to their proximity (people are closer to a pharmacy than a general practice)^{15,16,31,34–36}. Furthermore, due to the accessibility of these community³² pharmacies and that people are able to walk-in to get advice, signposting and recommendations; they may represent a convenient and plausible public health setting to offer support to people with Long Covid^30,32,37,38. The Royal Pharmaceutical Society (RPS) further acknowledge the role pharmacists have in supporting people with Long Covid; the Society recommends pharmacists should be engaged in research on Long Covid and have time protected to keep up to date with the latest evidence and learning resources on Long Covid^39,40.

Existing research acknowledges the prevalence and the lived experiences of those that have Long Covid, as well as the barriers to seeking care and support^6,10–13. Research also provides insight into current primary care practices for those with Long Covid which highlights a key gap in research where the role of community pharmacy in supporting those with Long covid can be explored. This research aims to address this gap by exploring how community pharmacy teams can support those with Long Covid effectively through a series of work packages (a group of related tasks within a research project), workshops, engagement, and opportunities for training.

Aim

To explore the role of community pharmacy in supporting the management of people living with Long Covid.

Objectives

A two-phase multi-method study using semi-structured interviews and co-design

Ethical approval

The study received ethical approval from Keele University Research Ethics Committee (REC) on 01/05/2024 (REC number: 2024-0791 950) and will adhere to the ethical principles set out in the Declaration of Helsinki⁴¹. this included the study protocol, written informed consent forms and other relevant documents e.g. advertisements. Based on recruitment, consenting and data collection activities i.e., not recruiting NHS patients, recruiting staff based on professional role (not NHS service). As such, Health Research Authority (HRA) approvals will not be required. All documents have been approved for use by the ethics committee.

Consent forms include statements that confirm the participant consents to be involved in the study but also that their anonymised data, and words provided in interviews could be use in publications.

Patient and Public Involvement and Engagement (PPIE)

People with lived experience of Long Covid (experts by experience) were actively involved in developing this grant. We consulted a range of people with lived experience of Long Covid including members of Long Covid Support peer support group (Margaret O’Hara – Long Covid Support [LCS]), Greater Manchester Long Covid Support Group (previously Manchester Clinical Commissioning Group), and members of a patient stakeholder group that supported the PERISCOPE study (CI- Maidment)³³. Jones and Briggs are co-investigators with lived experience of Long Covid. Both have contributed to the development of the proposal, funding application, and drafting of the protocol. They will continue to play integral roles in this research, including data collection and analysis.

A Patient Advisory Group (PAG) will be convened of about 10 individuals with lived experience of Long Covid. Diversity among members will be actively encouraged with members identified through LCS and ethnic minority community networks established in other research. A PPIE project officer will be responsible for supporting PPI members throughout the study, coordinating meetings and processing reimbursements (PPI members will be reimbursed as per NIIHR guidelines based on activity type). Higginbottom (AH) will also identify training needs and contribute to developing meeting agendas to ensure activities incorporate the national standards for PPIE.

The PAG will meet up to 4 times during the study (either in-person or virtually via secure video-conferencing platform), providing input at different stages; including commenting on public-facing documents for the ethics application, recruitment methods, data collection, preliminary findings, co-design of training materials, and dissemination. The research team will produce summary notes from meetings and conversations with PAG members to ensure key contributions are recorded and actioned. An excel spreadsheet will be developed to record PAG suggestions and research team actions i.e., “they said: we did”. Summary reports and key actions will be reported back to PPI members.

A Clinical Advisory Group (CAG) has been established and clinicians (see acknowledgements for a full list of CAG members) with experience within pharmacy and wider primary car and/or Long Covid will be invited to 4 meetings throughout the study. The CAG will support the team with recruitment, advise on data analysis and dissemination among other roles. Summary notes will be produced from each meeting to ensure key contributions are recorded and actioned.

Conceptual and theoretical framing

The research adopts a broadly interpretivist approach, the notion that reality is subjective and social constructed⁴² and therefore seeks to understand perceptions and subjective experiences of others in relation to Long Covid. In this study context, experiences of people with Long Covid and community pharmacy staff will be explored to understand health and healthcare experiences, needs, expectations and preferences. Relevant psychological and sociological theories will be identified during the research process to inform data collection, sensitise the process of analysis, and allow development of a conceptual understanding that goes beyond individual-level data.

Settings

People with self-reported Long Covid in the UK and community pharmacy staff working in the UK. Staff will be recruited based on their professional role.

Data collection methods, sampling strategy and recruitment

Qualitative methods using semi-structured interviews

Sample size estimates are derived from previous qualitative research conducted by the team and informed by contemporary methodological debates about the concept of saturation^44,45.

People with Long Covid

Up to 20 people with self-reported Long Covid will be recruited via social media (to include, but not limited to, Facebook^R, X^R), personal and professional networks. We will also use a snowball method⁴⁶ of recruitment.

Community pharmacy staff

Up to 20 community pharmacy staff (e.g. Pharmacist, Pharmacy Technician, Pharmacy Assistant) will be recruited to participate in this part of the study. An equal representation of different roles will be approached to partake in the study.

Community pharmacy staff will be recruited via personal and professional networks (for example, Centre for Pharmacy Postgraduate Education (CPPE), and social media (to include, but not limited to, Facebook^R, X^R). We will also use a snowball method of recruitment.

A mixed recruitment strategy will be adopted to support inclusion and maximise diversity of the sample for both people with Long Covid and community pharmacy staff – UK-wide recruitment is planned (Table 2). A purposive approach to sampling will be guided by a set of inclusion criteria (listed below). Recruitment will be regularly monitored to assess sample diversity against key demographic characteristics (e.g., ethnicity); this will help the research team to identify gaps in recruitment and potentially missing perspectives. Snowball sampling will also be used, with participants encouraged to share information about the research with people in their own networks.

Inclusion and exclusion criteria

As well as previously discussed recruitment strategies (e.g., social media, professional and personal networks) physical materials (posters) will be displayed on noticeboards based in community hubs and religious centres. People living with Long Covid (Table 1) will be identified based on self-reported symptoms. No NHS research sites, or patient identification centres (PICs) will be used in this research.

Advertisements will sign-post potential participants to the study website (PHARM-LC - Keele University) for further information and provide contact details (telephone, email) for the research team. Prospective participants will be directed to contact the research team to express their interest in the study and to request further information. On request, a member of the research team will send a copy of the relevant participant information sheet (PIS) to the individual and follow-up to confirm participation (by email or post). If the individual does not reply after three follow-up attempts, no further follow-up will be made.

To schedule an interview, a member of the research team will contact (telephone or email) the individual to confirm eligibility. If eligible, an interview will be scheduled according to participant preferences (see 3.1.5 for interview format options) and consent will be obtained prior to data collection (see 3.1.4). Participants will be offered a shopping voucher after completing an interview. A ‘thank you’ letter/email will be provided with the voucher and details of the website where research findings will be published.

The research team have designed processes to reduce the potential for “imposter participants” (individuals expressing interest in research participant who falsely claim to meet the eligibility criteria) to disrupt data collection on this study. There has been an increase in reporting of this phenomenon⁴⁷. Hence, in the first instance the research team will attempt to conduct recruitment via established and legitimate communities and groups (as described above), but this may not always be possible. Thus, pre-interview eligibility checks will be closely monitored and audio recordings from interviews will be reviewed to check for similarities and signs of false claims, prior to sending recordings for transcription or providing payment for participation.

Most interviews will be conducted by a member of the research team with a background in qualitative methods. Remaining interviews will be conducted by co-investigators with lived experience of Long Covid (Briggs, Jones) – qualitative interview training and support will be provided. All interviewers will have a Good Clinical Practice (GCP) certificate. Interviews will take place either face-to-face, in a convenient location for the participant (e.g. at one of the collaborating universities, the participant’s home, private room/space in the community), by telephone or online via MS Teams (or equivalent). The researcher will conduct telephone and online interviews in a private room or office, where confidentiality can be assured. Interviews with people living with Long Covid are expected to last up to 60 minutes, interviews with pharmacy staff are expected to last up to 60 minutes. Interviews will be recorded and transcribed for analysis, consent will be obtained prior to the interview to record and be transcribed by an external company (The Transcription Company), who have a confidentiality agreement with Keele University.

Discussion during interviews will be facilitated by the researcher using a topic guide (separate topic guides will be specifically designed for people living with Long Covid or community pharmacy staff). The topic guides have been developed based on existing research and with input from people with lived experience of Long Covid and community pharmacy practice. The topic guide covers experiences of living with and/or managing Long Covid, access to healthcare services, engagement with and acceptability of community pharmacy providing advice and support about Long Covid. Interviews with pharmacy staff will explore experiences of delivering services to people with Long Covid, training needs, and training and service delivery preferences.

Data analysis

Interview transcripts will be pseudonymised prior to analysis; participant names will be replaced with a unique study code (e.g., PLC001 people with Long Covid, CPS001 community pharmacy staff) and data that may identify the individual (place names, healthcare provider names) will be removed.

Interview data will be analysed using a thematic framework approach⁴⁸. The two datasets ([i] people with Long Covid; [ii] community pharmacy staff) will be analysed separately at first, then combined to establish a framework of cross-cutting themes. Data will be coded using a data-driven approach with codes then used to develop and refine themes of the framework. Analysis will be guided by the concept of saturation, applied at a theme level^45,47–49. Themes which do not fit the framework will be reviewed and retained for reporting separately. The qualitative researchers will lead data analysis and discuss preliminary findings with the multidisciplinary research team (primary care, pharmacy, social science, experts by experience), to enhance rigour. PAG and CAG members will review preliminary findings. Interview topic guides will be updated, iteratively, to support exploration and enhance development of key themes.

Findings will inform Phase 2 of the project, which seeks to develop the online training and information resources.

Stakeholder workshops to co-design training

Two workshops are planned to support the co-design of training. Workshops will take place face-to face at Keele University or in a central location convenient for most participants, or online via MS Teams (or equivalent) if participants prefer. A hybrid approach will be made available to accommodate mixed preferences should this be required. Stakeholders will include up to 20 individuals with representation from topic experts, people with lived experience of Long Covid, primary care practitioners, community pharmacy staff, and research team members. Stakeholders will be identified from the pool of qualitative participants (Phase 1), the PAG, CAG, and existing networks.

The first workshop will guide stakeholders through the process of designing the scope of the training (e.g., writing learning outcomes, agreeing content and format of delivery structure, creating practice-based learning activities to meet different adult learning styles, producing outlines/templates for additional resources). Findings from Phase 1 qualitative interviews will be used during this workshop, together with national priorities, agendas, guidance, and legislation relevant to Long Covid, to prompt discussion and inform the initial scope. This workshop will be facilitated by CPPE and include a variety of interactive activities to promote active participation, respect, power and knowledge sharing, reciprocity, and relationship development^53,54. The research team and collaborators will record and review discussions from the first workshop to develop prototype designs, which will then be reviewed in the second workshop.

The second workshop will focus on reviewing prototype content and capturing feedback on content, clinical accuracy, and educational appropriateness to support further refinement. Mapping tables will be used to ensure that the content and user requirements highlighted for inclusion in the module incorporate the identified behaviour change theories^51,52, and align with the digital vision for the NHS and relevant health and public health stakeholders. Revisions will then be made as required to finalise the training resources. Stakeholders attending the workshops will be reimbursed for their time at £25 per hour (in line with NIHR involvement rates)⁵⁴ and reasonable travel expenses, where transport has been required.

Piloting training with end-users

The research team will pilot the training with community pharmacy staff, prior to making the online training widely available. The pilot will involve a full run-through of the online training course, pre- and post-training assessment, a review of any additional training resources, and participation in a focus group. Table 3 details the inclusion and exclusion criteria for the piloting of end users.

Settings

This part of the study involves recruitment of community pharmacy staff working in the UK. Staff will be recruited based on their professional role through existing networks.

Data collection methods, sampling strategy and recruitment

A purposive sample of up to 10 community pharmacy staff (e.g. pharmacists, technicians, pharmacy assistants) will take part in a pilot of the online training. All will be invited to take part in a subsequent focus group to discuss the online training. Participants will be recruited through existing professional networks (e.g., The Midlands Community Pharmacy Practice Network), the pool of participants who took part in Stage 1 interviews but did not participate in one of the co-design stakeholder engagement workshops (due to potential for bias), and snowballing.

Inclusion and exclusion criteria

A digital recruitment poster will be circulated by email and social media via professional networks and mailing lists. The poster will invite prospective participants to contact a member of the research team to express their interest in the research (assumed consent to further contact) and request further information. On receipt of this contact, a member of the research team will check eligibility and share the PIS. The researcher will follow-up with the prospective participant to confirm interest in participating and to schedule a suitable time to conduct the pilot and focus group. After sending the PIS, three follow-up contacts will be attempted; if the individual does not respond then no further contact will be made.

Data analysis

Analysis of pre- and post-training questionnaires will be kept at a descriptive level due to small numbers involved. These findings are intended to provide a signal around impact on learning and suitability of content – findings will also help inform questions during focus group discussion.

Analysis of focus group data will follow a data-driven thematic approach⁵⁵, led by a qualitative researcher in the team. Themes will be discussed and agreed with the research team.