https://orcid.org/0000-0003-3468-129X
Figures
Abstract
Introduction
Supported self-management that includes a personalised asthma action plan and regular professional review, reduces unscheduled consultations, and improves asthma outcomes and quality of life. However, despite unequivocal inter/national guideline recommendations, supported self-management is poorly implemented in UK primary care. The IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) implementation strategy (including facilitated provision of patient, professional, and organisational resources) has been developed to address this challenge and is being evaluated in a UK-wide cluster randomised controlled trial (cRCT). The internal pilot aimed to assess the trial recruitment processes, delivery of and general practice engagement with the implementation strategy to inform the progression criteria.
Methods
Using mixed methods, we recruited 12 general practices and monitored trial processes and IMP2ART delivery through team logs and automated data (e.g., use of patient online resources; uptake of practice education modules). Qualitative interviews with general practice staff and IMP2ART facilitators explored feasibility and acceptability of the implementation strategy.
Results
We randomised 12 general practices to the IMP2ART implementation strategy arm (n = 6) or usual asthma care (control, n = 6). One control practice withdrew post-randomisation following concerns about data sharing. Most components were delivered successfully to the implementation group practices so that we met our progression criteria. In all six practices, the facilitated workshop was arranged within 12 weeks of randomisation and the team education module was completed (median 11 accesses/practice), the in-depth module was completed by ‘the healthcare professional responsible for asthma reviews’ (range 3-7 professionals/practice), and the asthma review template was successfully downloaded to the practice system. All six implementation practices received the baseline and first monthly audit and feedback report although there were delays in this process due to national-level governance changes. Practices’ perceptions of IMP2ART were encouraging. In general, they participated in the patient, professional and organisational implementation strategies and reported positive experiences of the trial.
Conclusions
The study provides evidence that the IMP2ART trial is feasible, and the implementation strategy is acceptable with only minor adjustments to trial processes. The IMP2ART strategy is now being tested in a UK-wide cRCT [ref: ISRCTN15448074], evaluating implementation (action plan ownership) and health outcomes (unscheduled care).
Citation: McClatchey K, Bertram D, Barat A, Delaney B, Hammersley V, Korell B, et al. (2026) IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) in UK primary care: An internal pilot for a cluster randomised controlled trial. PLoS One 21(3): e0336745. https://doi.org/10.1371/journal.pone.0336745
Editor: Kathleen Finlayson, Queensland University of Technology, AUSTRALIA
Received: February 21, 2025; Accepted: February 10, 2026; Published: March 20, 2026
Copyright: © 2026 McClatchey 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: Quantitative data underlying the results are presented in the tables within the paper. Qualitative data excerpts underlying the results are included in the text of the paper. We do not have participant consent to share the full interview transcripts.
Funding: IMP2ART was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research (Reference Number RP-PG-1016–20008). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The Asthma UK Centre for Applied Research (reference Asthma UK: AC-2012–01) funded some pre-grant work on the theoretical development of the implementation strategy. BK holds a PhD Fellowship from The Health Improvement Studies Institute. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests: have read the journal’s policy and the authors of this manuscript have the following competing interests: KMcC, AB, BD, VH, VM, JS, LS, MP, DP, SJ, SJCT, HP are all funded via their institutions to work on the NIHR IMP2ART programme as investigators or researchers. DP has advisory board membership with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Viatris, Mundipharma, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals and Thermofisher; consultancy agreements with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Viatris, Mundipharma, Novartis, Pfizer, Teva Pharmaceuticals and Theravance; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Viatris, Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals, Theravance and UK National Health Service; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Viatris, Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Sanofi Genzyme and Teva Pharmaceuticals; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Circassia, Mundipharma, Novartis, Teva Pharmaceuticals and Thermofisher; funding for patient enrolment or completion of research from Novartis; stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 74% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); 5% shareholding in Timestamp which develops adherence monitoring technology; is peer reviewer for grant committees of the UK Efficacy and Mechanism Evaluation programme, and Health Technology Assessment; and was an expert witness for GlaxoSmithKline. This does not alter our adherence to PLOS ONE policies on sharing data and materials.
Introduction
An estimated 5.4 million people have asthma in the United Kingdom (UK) [1]. Each year asthma is responsible for over 6 million primary care consultations, 100,000 hospital admissions [2], and over 1000 deaths (20 a year in children under 14 years) [3]. Recent analysis suggests that lung conditions cost the UK economy £188 billion per year, and that developing and investing in self-management could reduce NHS costs by £128 million per year [4].
For decades [5], national and international guidelines have recommended that people with asthma should be provided with self-management education, reinforced by a personalised asthma action plan and supported by regular review with a healthcare professional [5–8]. Implementation of supported asthma self-management, however, remains poor in routine clinical care. For example, only half (52%) of respondents to a survey conducted by Asthma UK owned an asthma action plan [9] whilst, in our review of clinical records only 6% of people with asthma had a record of being provided with an action plan [10]. In 2014, the UK National Review of Asthma Deaths highlighted that only 23% of those who died from asthma were known to have been provided with an asthma action plan [11]. Further, according to the annual Asthma UK survey, almost 30% of respondents had not attended an annual asthma review [9].
In response to this, the IMP2ART (IMPlementing IMProved Asthma self-management as RouTine) programme has developed a facilitated implementation strategy, to embed supported asthma self-management in UK primary care. Based on multi-layer theoretical underpinning (a synthesis of integrated Promoting Action on Research Implementation in Health Services (iPARIHS) reflecting the pivotal role of facilitation in promoting implementation and the Capability, Opportunity, Motivation – Behaviour (COM-B) framework to promote individual behaviour change) the whole-system strategy operationalises a conceptual framework that addresses the needs of patients, the skills of professionals, and the organisational routines [12]. Facilitated by trained specialist asthma nurses, implementation of IMP2ART aims to promote patient-centred asthma reviews and increase ownership of asthma action plans, which will reduce unscheduled care. We will recruit 144 general practices, randomising them to either receive the IMP2ART implementation strategy or provide usual care [13].
This paper reports the internal pilot of the IMP2ART cRCT which builds on an extensive programme of implementation strategy development, iterative feasibility testing and refinement [14–17], and aimed to:
- Observe the feasibility of the trial procedures (e.g., general practice recruitment and retention, initial data extraction, randomisation).
- Explore engagement with the IMP2ART implementation strategy (e.g., access to implementation strategy components, acceptability to general practice teams) and fidelity with which the components of the implementation strategy were being adopted/adapted in the context of a trial.
- Assess pre-specified trial progression criteria relating to the feasibility of trial procedures, engagement with the IMP2ART implementation strategy, and ability to recruit for the main trial.
Methods
The reporting of this paper follows guidance for pilot implementation studies [18] and Standards for Reporting Implementation Studies (StaRI) [19].
Design
We designed an internal pilot for the IMP2ART cRCT to assess the feasibility of and engagement with the IMP2ART trial. The trial is registered on The International Standard Randomized Controlled Trial Number database (ISRCTN15448074) and is sponsored by the Academic and Clinical Central Office for Research and Development (ACCORD), the University of Edinburgh and NHS Lothian Health Board. Ethical approval for the study was obtained from NHS Lothian (REC No: 19/EM/0279), NRS and HRA approval (NRS Ref NRS/19/256672), and local governance approvals as required for all sites. The participating practices signed contracts (see below under recruitment and randomisation); all individuals within the practices participating in interviews or other feedback provided written informed consent. Full details of the Hybrid II implementation cRCT (including the internal pilot) are described in the study protocol [13].
Recruitment and randomisation
We aimed to recruit 12 general practices for the internal pilot (of the total 144 for the main trial) across England and Scotland. A sample size of 12 (approximately 8% of the main trial sample), was chosen as being both practical within our resources whilst allowing observation of the processes in sufficient practices representing diversity in our two key stratification variables (practice list size and socio-economic status) and to identify any changes that may be needed to the trial procedures/implementation strategy.
Recruitment re-commenced on 1st January 2021 following a COVID-19 pandemic-related delay. General practices, some of whom had initially expressed interest pre-COVID, were recruited between 5th October 2020 and 17th March 2021. General practices were identified via local Clinical Research Networks, NHS Research Scotland, Optimum Patient Care, or via professional networks. As an implementation trial our inclusion/exclusion criteria were as broad as possible, but to be eligible, practices had to use one of the four electronic health record (EHR) systems commonly used in UK primary care (EMIS, SystmOne, Vision or Microtest) and agree to Optimum Patient Care (OPC: a social enterprise that leads quality improvement initiatives involving routine data extraction from practices https://optimumpatientcare.org) extracting anonymised routine coded data to measure the primary and secondary outcomes for the cRCT. General practices with a list size of >6000 patients were eligible to participate as, for statistical reasons, we wished to avoid cluster sizes <200. Approximately 6% of a UK general practice population have ‘active asthma’ defined as having a diagnostic code for asthma and having been prescribed asthma medication within the previous 12- months [20].
General practices who were interested in taking part in the trial met with a researcher, following which they were asked to sign a service agreement with OPC. We described this step as ‘recruitment’. OPC performed an initial routine data extraction to:
- Demonstrate that there were no insurmountable governance or technical problems,
- Establish that the general practice data would allow assessment of the primary health outcome (unscheduled asthma care),
- Confirm the data could be used in the baseline audit and feedback reports.
If the initial data extraction was unsuccessful, a practice would be ineligible to participate in the trial. Following a successful routine data extraction, the practice signed a localised Organisational Information Document (OID: the contract agreeing to participate in the cRCT) and was then randomised to either the IMP2ART implementation arm or usual asthma care (control) using predetermined stratifiers: practice list size, general practice training status of the practice and area-level socioeconomic conditions. Socioeconomic conditions were measured using the English and Scottish Indices of Multiple Deprivation 2019 (IMD and SIMD), which provide composite measures of social, economic, and environmental disadvantage for small areas (typically 1000–3000 residents). Deprivation and list size were dichotomised by the median. Randomisation was implemented in REDCap (Research Electronic Data Capture) software [21] by the programme manager (VH). Fig 1 displays the recruitment and randomisation process.
Abbreviations: OID = Organisational Information Document; OPC = Optimum Patient Care who extract the routine clinical data.
The IMP2ART implementation strategy.
Randomised general practices remain in the trial for 24 months. Full details of the implementation strategy and its evidence base are available in the trial protocol [13]. Briefly, general practices randomised to the implementation group received the whole-system implementation strategy directed at patients, professionals and the organisation, supported by expert nurse facilitation for 12 months. Components of the implementation strategy included:
- Patient resources (a patient-facing website that hosts a range of information about asthma (e.g., asthma triggers, asthma action plans, asthma reviews), waiting room posters, asthma review invitation letters) [14].
- Professional education (to raise awareness of supported asthma self-management and the importance of team working (an online team module (Module 1), and an individual module (Module 2) for those in the general practice most involved with delivering asthma care) [15].
- Organisational resources (an asthma review template embedded in the practice’s EHR system that guides the delivery of essential components of a patient-centred asthma review [16], and annual and monthly audit and feedback reports [17]).
The development and full details of these components can be found in their respective publications [14–17].
All implementation general practices received an initial IMP2ART workshop open to all members of staff (e.g., administrative staff, general practitioners (GPs), nurses, etc.) via Microsoft Teams, during which the IMP2ART facilitator discussed the baseline annual audit and feedback with the practice team and introduced components of the team module. The facilitator (one of the four senior asthma nurses with facilitator expertise who were trained and supported to deliver the IMP2ART implementation strategy) guided the practice to develop their own ‘team plan’ for implementing IMP2ART, discussed how core strategies could be adopted/adapted to suit the general practice clinical care routines, and identified additional strategies that might help individual practices. The workshop was scheduled approximately six weeks post-randomisation, during which several emails were sent to the practice providing implementation strategy resources (the patient resources, access to the team module, and the baseline annual and first monthly audit and feedback reports) in readiness for the workshop. Access to the individual module was provided following the workshop, during which details of staff (name, and email for the log-in, professional role) who wanted to complete the module were collected. Ideally, the asthma review template was uploaded to the practice EHR system prior to the workshop date.
General practices in the control arm of the trial continued with their usual asthma care and did not receive any of the components of the implementation strategy. However, they did receive standard versions of the extensive annual report covering all aspects of asthma care that OPC routinely provides to practices contracted to their quality improvement service. In contrast to the IMP2ART implementation arm annual reports, there was no focus on supported self-management, and the feedback on proportion of patients with an action plan is towards the end of the report.
Data collection and analysis.
The pilot evaluation used data collected from the start of recruitment until the initial implementation strategies had been delivered (approximately 4 months post-randomisation). This included data related to the feasibility of delivering the trial procedures (e.g., general practices recruited and retained, data extraction completed, randomisation, setting up the implementation strategy according to allocation, mailing of the OPC quality improvement questionnaire to a random sample of patients within a random sample of practices to measure asthma action plan ownership). To measure engagement with the IMP2ART implementation strategy in the context of trial participation we collected quantitative data related to: the workshops (e.g., delivery date, number of attendees, online evaluation form for staff), and the patient, professional, and organisational components of the implementation strategy (e.g., Google analytics to record number and duration of visits to the IMP2ART patient website, professional education completions and responses to the online evaluation form, asthma review template uploads, delivery of audit and feedback reports, facilitator contacts with general practices). To explore general practices’ responses to components of the implementation strategy and their experience of the trial, we conducted qualitative interviews with practice staff. In all data collection we offered flexibility in format and aimed for diversity in terms of roles within the team and experience of asthma care, monitoring for new themes to assess saturation. In addition, we interviewed the IMP2ART facilitators to explore their experience of facilitating the delivery of the implementation strategy (see S1 Appendix for the topic guides). Topic guides were developed with the multidisciplinary team (which included patients, clinicians, health psychologists, public health and health service qualitative research expertise) and were piloted with Patient and Public Involvement (PPI) colleagues (individuals with lived experience of asthma) prior to data collection. Quantitative data were analysed using descriptive statistics. We used a Framework Analysis [22] in NVivo 12 (QSR International, Massachusetts, US) of the qualitative data to answer the practical feasibility and acceptability questions for this internal pilot whilst remaining open to unexpected views.
Progression criteria.
Pre-specified progression criteria for the ‘stop/go’ decision were used to determine, in discussion with the Independent Steering Committee and the funder, whether to proceed from the internal pilot to the cRCT. The criteria (detailed in Table 1) reflected ability to recruit, evidence of general practice engagement with the IMP2ART implementation strategy, and patient engagement with the strategy. In parallel to the internal pilot, we report our progress with recruiting practices and ongoing preparations for randomisation in the main trial.
Results
Recruitment and data collection for the pilot took place between October 2020 to September 2021. The results below integrate quantitative and qualitative findings exploring the feasibility of the trial procedures, engagement with the IMP2ART implementation strategy, and fidelity with which the components of the implementation strategy were adopted/adapted.
Feasibility of recruitment and trial processes, and general practice characteristics
From a pool of 100 practices working through the recruitment/randomisation process (see Fig 1 and the Recruitment and Randomisation section), we randomised 12 general practices to participate in the IMP2ART pilot trial. Whilst we were mindful of the need for a diverse sample of practices, the successful conclusion of the recruitment/randomisation process was the key consideration.
All 12 practices were randomised to either the implementation arm (n = 6) or the control arm (n = 6). Seven of the 12 practices (implementation n = 3, control n = 4) were then randomly allocated to quality improvement questionnaire data collection. One practice withdrew post-randomisation to the control arm citing data sharing concerns and insufficient resources to support the questionnaire mailing (see Table 2).
Engagement with the IMP2ART implementation strategy
We conducted interviews (n = 7) with general practice staff (GP n = 3, nurse n = 3, practice manager n = 1) across five practices between July and September 2021. The interview topic guide was used flexibly to accommodate diversity in roles and the time available; the duration ranged from 11 to 39 minutes. In addition, we conducted interviews with three IMP2ART facilitators during August 2021 with interviews ranging from 41 minutes to 1 hour and 19 minutes.
IMP2ART workshops.
An IMP2ART workshop, led by one of the facilitators, was delivered successfully to all six general practices. Table 3 displays the timing of the workshop post-randomisation. On average, a workshop was delivered to a practice within 11.5 weeks of randomisation (range 7–14 weeks). The number of general practice staff who attended the workshops ranged from 7 to 31 per practice. GPs, nurses and administrative staff were represented in all practices; two practices included a pharmacist. The workshops ranged from 35 to 62 minutes in duration. Table 3 displays the number of attendees and workshop duration per practice.
Across five practices, 17 general practice staff members filled out an online evaluation form following the workshops (in the sixth practice the staff did not have time to complete the evaluation form before rushing to their afternoon clinics). Respondees represented a range of roles within the practices (Advanced nurse practitioner 3, Pharmacist 1, Data Quality Assurance Manager 1, GP 5, Health Care Assistant 2, Patient Care Advisor, 1, Practice Nurse 1, Receptionist 3). 16 (94.1%) stated that they had accessed and viewed the team module prior to the workshop. 14 respondents (82.4%) either agreed or strongly agreed that the workshop improved their understanding of supported self-management for asthma and also helped them to understand their role in supported self-management of asthma. 16 (94.1%) either agreed or strongly agreed that the workshop content was organised and easy to follow. There was one suggestion for improvement to the workshop, which was to include a demonstration of the review template and other resources. When asked if there was anything staff would do differently having completed the workshop, six mentioned asthma action plans (e.g., discussing them with patients, printing them, or sending them to patients using the EHR), two staff mentioned becoming more knowledgeable or aware and up to date with processes in the general practice, two mentioned promoting attendance at asthma reviews, and two receptionist members of staff said they would ask patients more questions about their asthma care.
Results from the qualitative interviews found that general practice staff were positive about the workshops, as they provided a useful revision, and inspired healthcare professionals to make positive changes to the delivery of asthma care and to improve strategies in their practice.
‘‘It [workshop] was good to have – to kind of reinvigorate my understanding of asthma basically…and to try and inspire my colleagues to engage with the IMP2ART module and also the templates.’’ (Practice 3, general practitioner)
One participant felt it was beneficial to their practice that all staff members were invited to the workshop, as it started conversations and prompted ideas of how organisational changes could be made to the provision of asthma care.
‘‘I think it [workshop] was very important just because it gave everyone then a bit of understanding of what should be happening and how things should work....So it kind of got the whole staff talking about it, which was good.’’ (Practice 5, practice and research nurse)
Patient resources.
All six general practices were emailed the patient resources prior to the workshop. The email included a link to the IMP2ART ‘Living with Asthma’ website which included patient-facing pages, the waiting room posters, and suggested patient invitation letters [14]. Over the internal pilot period (when no main trial practices had been randomised), the patient-facing website received 444 unique page views, with an average of 1 minute and 8 seconds spent on each page.
The qualitative interviews found that the patient resources were mostly viewed as useful by general practice staff. For example, a number of participants valued the patient resources on the ‘Living with Asthma’ website.
“I think being able to direct the patients to the website is really, really helpful as well so that they can go through that themselves and I’ve kind of gone through it and looked through what they will be accessing and what they can see. I think that’s really, really helpful for them” (Practice 2, general practitioner)
However, some participants highlighted that there is already a breadth of online asthma information directed towards patients, and that they were likely to continue to signpost patients towards more familiar resources such as Asthma UK [now Asthma + Lung UK].
‘‘Asthma UK’s is nice and easy to remember. I think, you know, in my head I’ve seen Asthma UK for so long as my reference option. So, I think I’m almost on kind of autopilot when I recommend it to patients really’’ (Practice 3, general practitioner)
There was a range of adoption of the IMP2ART waiting room posters. At the time of the pilot study, the UK was still under COVID-19 restrictions, and for this reason some practices either did not have posters in waiting areas, or rarely had patients in their waiting room. However, they were well received, and some practices suggested alternative strategies for displaying information.
“We don’t because we haven’t got that many posters at the moment but we are thinking about putting it on our website” (Practice 1, practice manager)
‘‘We got all the IMP2ART stuff out, we’ve got posters in our waiting room, we’ve got an electronic board in the waiting room, on our Facebook page, on websites we’ve got that all rolled out’’ (Practice 4, general practitioner partner)
There were mixed findings in terms of the invitation letters. Some practices had adapted the IMP2ART developed invitation letters for use in their practice; others were either unaware of them or did not send invitation letters in their practice.
“…in terms of the invitation letters and the messages. So we had some in place already but what I did is I took those and I sort of integrated them into our own ones as well. I thought the ones that were helpful in terms of just sort of providing things like almost kind of like the gold standard we’re aiming for so I’d need to have this level of information. So that was quite helpful to compare across” (Practice 4, general practitioner partner)
Professional education modules.
Team module (Module 1): All six general practices were enrolled for the team module prior to their IMP2ART workshop. Each practice received one login for multiple use, which anyone in the practice team could access. All six practices completed the module (100%), spending between 10 minutes and 58 minutes over the course of between 1 and 49 visits.
A total of 21 members of staff across four practices completed an online evaluation form for the team module. 17 (81.0%) either agreed or strongly agreed that the module had improved their understanding of supported self-management in asthma. All agreed that the content of the course was organised and easy to follow. 17 (81.0%) either agreed or strongly agreed that the module helped them to understand their role in supported self-management of asthma. In response to an optional question asking staff if there is anything that they would do differently following viewing the team module, four mentioned they would identify high-risk patients, three said that they would encourage/highlight supported self-management more, two mentioned they would use the IMP2ART review template, two mentioned asthma reviews and processes to invite patients for these. Only two said there would be no change in their practice. Additionally, qualitative interview findings were generally positive.
“Oh, it’s very useful, I learnt more… all this asthma that we have to be you know, mindful of these and all these things. But it’s just a reminder or refreshing my knowledge” (Practice 1, practice manager)
Individual module (Module 2): In total, 101 general practice staff across the six practices asked to be enrolled for the team module. Of these, 29 completed at least 80% of the module (12 nurses, 10 GPs, 2 pharmacists, 2 health care assistants, 1 student, 2 not stated), with three or more clinical staff per practice completing the whole module (including some ‘additional resources’ sections). The average completion time was 66 minutes across an average of two visits (range 1–5). The minimum completion time was 12 minutes, though the participant had responded with appropriate text to all the questions. See Table 3 for further details for each practice. A total of 13 staff across five practices completed an online evaluation form after completing the individual module. All agreed that the module improved their understanding of supported asthma self-management, describing the content as organised and easy to follow, and applicable to their clinical practice. When asked what they would do differently having completed the module, answers included asthma action plans (e.g., co-create a personalised plan for every patient) (n = 8), motivational interviewing techniques (n = 4), and reviewing patients post attacks (n = 1).
There was very positive feedback about the individual module during the qualitative interviews.
“I just love that education module two, it’s brilliant.” (Practice 3, general practitioner)
It was considered that Module 2 increased awareness of supporting asthma self-management and refreshed clinician knowledge of asthma. One GP observed that it restored her confidence in asthma management which had become the expertise of the practice’s ‘skilled’ asthma nurses.
‘‘It was quite interesting, especially for me because I’d only ever done training on asthma before through like websites and through Asthma UK… and what should be in the reviews because I was new to practice nursing… it helped my knowledge with asthma, and what should happen and about the treatment plans’’ (Practice 5, practice and research nurse)
‘‘So, basically it taught and revised my knowledge of the asthma plan, and the importance of completing a plan... because it’s something that I haven’t done probably, in all honesty, since I was a GP trainee, which is about 10 or 12 years ago. So, that second module about where to find the plan, how to print the plan, how to complete the plan, has given me the confidence to print some out, which I now have in my little book in my desk, so I can just whip one out” (Practice 3, general practitioner)
Organisational strategies.
Audit and feedback reports: All implementation group practices received both their annual baseline and first monthly report prior to their workshop, so these were discussed at the facilitated workshop. Control group practices received the standard annual report from OPC not customised to IMP2ART trial and with no facilitated discussion. Technical changes required to comply with new governance requirements resulted in delays in sending the monthly reports to all but one practice across the pilot period. Table 3 displays the number of expected monthly reports for the practice and the number of monthly reports that were actually delivered. The qualitative interviews found that most participants had not studied the audit and feedback reports.
“I’ve not seen the latest one, no I haven’t, although I did pick it up briefly but I haven’t been through it yet. It’s on my to do list” (Practice 4, general practitioner partner)
Participants who had viewed the reports were positive about them. One participant discussed the value of audit and feedback reports in helping to ensure that patients are appropriately reviewed following unscheduled care.
‘‘If we miss the hospital letter, your report stated who is missing and you know that you haven’t been reviewed, and then that is very helpful for our clinician’’ (Practice 1, practice manager)
Healthcare professionals suggested that training on the audit and feedback reports would help with understanding how the data are generated and also the content of the reports.
‘‘I think it would almost be helpful just to have a little bit more of an explanation in terms of where the numbers are pulled from… what codes or what did that researcher look for in the notes because even if they are actually being missed or is it that we’re not coding this properly… it’s about being quite helpful for clinicians understanding the report” (Practice 4, general practitioner partner)
The IMP2ART facilitators also felt that further training on audit and feedback reports would be useful. One facilitator discussed a lack of confidence in the reports as a result of several issues including inaccuracies and delays.
‘‘Maybe one of the areas that if I were doing it again with new people [both facilitators and practice staff] would be to think about how we can provide some sort of training and support to more quickly and better understand the audit and feedback reports and how to make best use of them’’ (IMP2ART facilitator 1)
IMP2ART asthma review template: Five out of the six practices had the IMP2ART asthma review template uploaded to the practice EHR system prior to their workshop. In the remaining practice, the template was uploaded eight days after the workshop. The qualitative interviews found that the asthma review template was well received by clinicians, it was seen as comprehensive and possibly superior to existing review templates.
“It’s so comprehensive, it’s got everything that you might want” (Practice 3, general practitioner
‘‘So we’re actually using, obviously as we’re meant to, [the IMP2ART] template now. And I actually think it’s better than our original, it still ticks all the boxes, but I just think it’s quite straightforward and it’s quite, it’s relatively easy to use as well’’ (Practice 5, practice nurse)
The IMP2ART facilitators also discussed the positive feedback they received from clinicians about the IMP2ART asthma review template describing it as “really popular.”
Facilitation.
Throughout the pilot period, facilitators logged 21 emails and 6 meetings (in addition to the workshops) across the six general practices. Practice staff discussed their IMP2ART facilitation experience in the qualitative interviews, and were positive about the role played by the IMP2ART facilitators.
‘‘She [facilitator] was really excellent, she was very knowledgeable, very practical, she struck me as experienced and understanding what we do – you know, how life is in primary care’’ (Practice 3, general practitioner)
‘‘Unless somebody’s facilitating, you sometimes you can kind of, like, not see the wood for the trees, or you don’t kind of consider the question in a slightly different way that they put it to you. So that then influences your management plans, or your action plans might be different because you hadn’t considered other perspectives when you’re making that plan’’ (Practice 5, advanced nurse practitioner)
There were some challenges around the facilitation, which had been switched to remote delivery because of COVID-19 restrictions. For example, IMP2ART facilitators had to learn to navigate the online meeting software (Microsoft Teams) as well as delivering the content of the workshops.
‘‘Still very much a bit like a fish out of water and mainly because of the technology, because I’m used to doing an awful lot of face-to-face facilitating and training. And I’m not fantastically good with technology. And Microsoft Teams is not the technology that I’m fantastically familiar with. So I still struggle’’ (IMP2ART facilitator 2)
Time management also posed a challenge to facilitation of the IMP2ART strategies, with IMP2ART facilitators and practice staff struggling to find a suitable meeting time when all key staff members were able to attend (practices should receive the workshop and up to 10h of contact time with the facilitator across 12 months). Practices found it difficult to “block out” time during their working day to meet with facilitators; facilitators described “a lot of to-ing and fro-ing to get people in the room” as they tried to be flexible whilst working around their other commitments. Learnings from the pilot proved useful in streamlining the communication between IMP2ART facilitators and the pilot study practices.
Trial progression criteria
The findings of this internal pilot demonstrated that we had met the progression criteria (see Table 1) and the main trial commenced randomisation in August 2021.
Changes for the main trial
We paused randomisation for five months so that we could assess the learnings from the pilot and make any necessary changes before commencing randomisation for the main trial. No substantial changes were made to the implementation strategy or trial procedures, but some minor adjustments were made to the processes. Following the withdrawal of a control general practice, we defined a procedure in which the programme manager (VH) would be notified if a general practice was (or maybe) considering withdrawing so they could contact the practice promptly to address any concerns. In terms of the implementation strategy, we refined the set-up processes so that OPC met with the practice approximately two weeks prior to the workshop to upload the asthma review template and install the Practice and Patient Level Report Generator software tool (used to identify high-risk patients from the audit and feedback reports). We added SMS asthma review invitation templates to the patient resources, and also made very minor changes to a table in the monthly audit and feedback email to match the visuals of the attached report and added ‘Please feel free to circulate this email to members of staff in your practice’ to enhance engagement with the reports.
Finally, we made minor changes to the facilitation processes including reducing the number of slides used in the workshops so that facilitators have more time to highlight the resources available to the practice (e.g., the audit and feedback reports) and to discuss the practice’s team plan including identifying a champion in the practice to help drive progress. Remote workshops remained a necessity in the aftermath of the pandemic which had the advantage of improving access for part-time staff or in multi-centre practices. We provided support for the sessions not only to manage technical issues, but also to relieve the facilitator of administrative and/or research related tasks.
Discussion
The IMP2ART internal pilot to a cluster randomised controlled trial assessed the feasibility of trial processes and engagement with the implementation strategy and demonstrated that we had met the progression criteria. We successfully recruited our target of 12 general practices to participate in the pilot, though the unique immediate post-pandemic context limits extrapolation to recruitment in a future trial.
The delivery of the implementation strategy to the six implementation practices was generally successful, and the strategy was typically well received. Minor adjustments were made to trial procedures with no substantial changes made to the implementation strategy. Previous feasibility studies had iteratively tested and refined the multiple components of the implementation strategy [14–17], then in a ‘pre-pilot’ we had combined the components in a unified strategy for delivery in four practices. At this stage we realised that using the team education module (Module 1) in the pre-pilot facilitation workshop was constraining the discussion. We therefore took a more ‘practice-centred’ approach, focussing the discussion on the individual practice interests/needs and capturing key priorities in a ‘practice plan’ which was followed up by the facilitator over the next 12-months [12] In addition, we had adapted the resources to a post-Covid context – including remote delivery of the workshop. The pilot trial was the first time these changes had been put into practice and the experience for the practices and the facilitators was a key focus for our pilot assessment.
A delay between recruitment (which required contracting with OPC for data extraction and their quality improvement service) and randomisation was intentional to ensure that we did not randomise a general practice that was unable to provide the routine data that provided the primary outcome (unscheduled care) as well as underpinning the audit and feedback strategy. The COVID-19 pandemic exacerbated this delay. Several of the practices had originally expressed interest early in 2020 before the pandemic forced us to postpone starting the trial. We re-established contact in Autumn 2020 when it seemed likely that we would be able to recommence in January 2021 but this added to the prolonged recruitment/randomisation timeline (see Fig 1).
Unfortunately, one general practice withdrew post-randomisation citing governance and resource issues with supporting delivery of the quality improvement questionnaire. The practice was allocated to the control arm of the trial, therefore withdrawal was not related to the demands of the implementation strategy, so does not raise concerns about the potential of IMP2ART to be scaled up in routine primary care in the UK (if successful).
There were delays in the delivery of the audit and feedback over the pilot period, with only one practice receiving the full complement of monthly audit and feedback reports. This was due to technical changes being required to comply with the latest NHS data-sharing opt-out over the summer of 2021 [23]. This specific issue has now been resolved, but supporting facilitators and practices to interpret their audit reports remains a challenge [17]. The 5-month follow-up reported in this paper captured the critical early trial interventions and allowed us to move on to recruiting for the main trial, but as an internal pilot the practices remained in the trial for two years and we continued to monitor their progress with follow-up and data extraction processes.
Strengths and limitations
Minimal changes were needed due to the extensive development [24–29] and pre-piloting of the IMP2ART strategies and resources [14–17] which included input from patient and public involvement, a professional advisory group, current general practice staff and those currently living with and being treated for asthma in the UK. This broad context helped mitigate any lack of generalisability in practices recruited to the pilot trial and/or the views we were able to capture.
A limitation of the study was that no practices in Scotland were able to be recruited in time for the pilot (due to data extraction delays). However, the practices in the pilot were relatively diverse in terms of their geography in England, their list size, and deprivation status, which makes the findings more generalisable. All practices were teaching practices, reflecting the extensive involvement of primary care in training GP registrars, undergraduates, foundations doctors, nurses and other professionals but limiting applicability to non-training practices.
There are also some limitations with regard to the data on engagement with the implementation strategy that we were able to collect. For example, using Google Analytics we are unable to establish which specific practices engaged with the patient-facing website, but we rejected the option of practice-specific logins to avoid creating a ‘password barrier’ preventing easy use. Further, with regard to exploring the engagement with the professional education, Module 1 provided a team login (because it was designed as a team building resource), so we are unable to establish whether each visit was from a unique staff member – or indeed groups of staff members. Additionally, it should be noted that all clinical staff could request to be enrolled on the individual module (Module 2) – typically collected as a list during the workshop – even if they are not involved with asthma care delivery. This will have influenced the relatively low completion rates for the module though it was encouraging that at least one key clinician in all six implementation practices undertook the complete module.
Finally, from our pilot data we are restricted in the comments we can make on patient engagement, partly because of the short timescale, but also because the measures are either second-hand (views of practice staff on patient engagement) or imprecise (overall use of the website). Whilst this reflects the professional/practice target of the IMP2ART implementation strategies (and thus our outcomes) the main trial includes a ‘quality improvement questionnaire’ mailed to a random sample of patients from a random sample of practices which will allow some investigation of the impact on patients in participating practices [13,30].
Conclusion
The internal pilot suggested that the IMP2ART programme was likely to be successful in recruitment and implementation delivery. The components of the implementation strategy are theoretically informed [12] and evidence-based (patient information [31], professional education [27], use of templates [29] and audit and feedback [32]) and our findings that these initiatives were generally acceptable and feasible in the context of supported self-management of asthma is encouraging. Additionally, general practice engagement in the pilot suggests that IMP2ART has the potential to be an effective strategy to improve the delivery of supported asthma self-management in UK primary care. Having met the progression criteria, the IMP2ART strategy is now being tested in a UK-wide cRCT, evaluating implementation (action plan ownership) and health outcomes (unscheduled care).
Supporting information
S1 Appendix. IMP2ART pilot interview topic guides.
a) Healthcare Professionals and Administrators employed in IMP2ART implementation practices. b) Interview Topic Guide to be used with facilitators working with IMP2ART implementation practices.
https://doi.org/10.1371/journal.pone.0336745.s001
(DOCX)
Acknowledgments
The authors acknowledge all members of the IMP2ART programme group for their contributions including: Brian McKinstry, Aziz Sheikh (University of Edinburgh); Sandra Eldridge, Chris Griffiths (Queen Mary University of London); Deborah Fitzsimmons (Swansea University); Naomi Fulop (University College, London) Ann-Louise Caress (University of Huddersfield). We valued the expertise of Education for Health (who developed the education modules) and Optimum Patient Care (who developed the templates and audit and feedback components of the implementation strategy). We are grateful to members of the IMP2ART Primary Care Respiratory Society Professional Advisory Group, coordinated by Dr Steve Holmes, and to the IMP2ART Patient and Public Involvement Group, co-ordinated by Dr Tracy Jackson and led by Elisabeth Ehrlich and Noelle Morgan. We thank the primary care general practices that participated in this study. We acknowledge the helpful advice of the Independent Programme Steering Committee chaired by Professor Robbie Foy.
References
- 1. Asthma + Lung UK. What is Asthma? 2021. [cited 2026 Feb]. Available from: https://www.asthmaandlung.org.uk/conditions/asthma/what-asthma
- 2. Mukherjee M, Stoddart A, Gupta RP, Nwaru BI, Farr A, Heaven M, et al. The epidemiology, healthcare and societal burden and costs of asthma in the UK and its member nations: analyses of standalone and linked national databases. BMC Med. 2016;14(1):113. pmid:27568881
- 3. British Lung Foundation. The Battle for Breath. 2016. [cited 2026 Feb]. Available from: https://www.asthmaandlung.org.uk/battle-breath-report
- 4. Asthma + Lung UK. Investing in breath: reducing the economic cost of lung conditions through increased research and innovation. [cited 2026 Feb]. Available from: https://www.asthmaandlung.org.uk/investinginbreath-reducingeconomiccostoflungconditions-autumn-2023
- 5. British Thoracic Society, Research Unit of the Royal College of Physicians of London, King’s Fund Centre, National Asthma Campaign. Guidelines for management of asthma in adults: I-chronic persistent asthma. BMJ. 1990;301:651–3.
- 6. British Thoracic Society/Scottish Intercollegiate Guideline Network. British Guideline on the Management of Asthma. 2019. [cited 2026 Feb]. Available from: https://www.sign.ac.uk/media/1773/sign158-updated.pdf
- 7. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention. 2025. [cited 2026 Feb]. Available from: https://ginasthma.org/reports
- 8. National Institute for Health and Care Excellence. Asthma: diagnosis, monitoring and chronic asthma management, NICE NG80. 2017. [cited 2026 Feb]. Available from: https://www.nice.org.uk/guidance/ng80
- 9. Asthma UK. Asthma Care in Crisis. Annual Asthma Survey. 2020. [cited 2026 Feb]. Available from https://www.asthmaandlung.org.uk/sites/default/files/2023-03/aas-2020_2a-1.pdf
- 10. Newby C, Wright N, Eldridge S, Morrow S, Vince-Lawer E, Appiagyei F, et al. Estimating exacerbation rates from routine UK primary care data: an exploratory validation from the IMP2ART programme. Eur Respir J. 2017;50(suppl 61):PA1603.
- 11. Levy M, Andrews R, Buckingham R, Evans H, Francis C, Houston R, et al. Why asthma still kills: the National Review of Asthma Deaths (NRAD). [cited 2026 Feb]. Available from: https://www.rcplondon.ac.uk/projects/outputs/why-asthma-still-kills
- 12. Steed L, Sheringham J, McClatchey K, Hammersley V, Marsh V, Morgan N, et al. IMP2ART: development of a multi-level programme theory integrating the COM-B model and the iPARIHS framework, to enhance implementation of supported self-management of asthma in primary care. Implement Sci Commun. 2023;4(1):136. pmid:37957778
- 13. McClatchey K, Hammersley V, Steed L, Sheringham J, Marsh V, Barat A, et al. IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) in primary care: study protocol for a cluster randomised controlled implementation trial. Trials. 2023;24(1):252. pmid:37013577
- 14. Barat A, Czyzykowska K, McClatchey K, Jackson T, Steed L, Sheringham J, et al. Developing theoretically underpinned primary care resources for patients with asthma: an exemplar from the IMP2ART trial. Prim Health Care Res Dev. 2024;25:e35. pmid:39300749
- 15. McClatchey K, Marsh V, Steed L, Holmes S, Taylor SJC, Wiener-Ogilvie S, et al. Developing a theoretically informed education programme within the context of a complex implementation strategy in UK primary care: an exemplar from the IMP2ART trial. Trials. 2022;23(1):350. pmid:35461269
- 16. McClatchey K, Sheldon A, Steed L, Sheringham J, Appiagyei F, Price D, et al. Development of a patient-centred electronic review template to support self-management in primary care: a mixed-methods study. BJGP Open. 2023;7(2). pmid:36868789
- 17. McClatchey K, Sheldon A, Steed L, Sheringham J, Holmes S, Preston M, et al. Development of theoretically informed audit and feedback: An exemplar from a complex implementation strategy to improve asthma self-management in UK primary care. J Eval Clin Pract. 2024;30(1):86–100. pmid:37438918
- 18. Pearson N, Naylor P-J, Ashe MC, Fernandez M, Yoong SL, Wolfenden L. Guidance for conducting feasibility and pilot studies for implementation trials. Pilot Feasibility Stud. 2020;6(1):167. pmid:33292770
- 19. Pinnock H, Barwick M, Carpenter CR, Eldridge S, Grandes G, Griffiths CJ, et al. Standards for Reporting Implementation Studies (StaRI) Statement. BMJ. 2017;356:i6795. pmid:28264797
- 20. NHS Digital. Quality and Outcomes Framework (QOF). [cited 2026 Feb]. 2023. Available from: https://digital.nhs.uk/data-and-information/data-tools-and-services/data-services/general-practice-data-hub/quality-outcomes-framework-qof
- 21. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81. pmid:18929686
- 22.
Ritchie J, Spencer L. Chapter_9. Qualitative data analysis for applied policy research. In: Bryman A, Burgess R, editors. Analysing Qualitative Data. London: Routledge; 1994. pp 173–94.
- 23. NHS. Opt out of sharing your health records. [cited 2026 Feb]. Available from: https://www.nhs.uk/using-the-nhs/about-the-nhs/opt-out-of-sharing-your-health-records/
- 24. Daines L, Morrow S, Wiener-Ogilvie S, Scott C, Steed L, Taylor SJ, et al. Understanding how patients establish strategies for living with asthma: a qualitative study in UK primary care as part of IMP2ART. Br J Gen Pract. 2020;70(694):e303–11. pmid:32205333
- 25. Hamour O, Smyth E, Pinnock H. Completing asthma action plans by screen-sharing in video-consultations: practical insights from a feasibility assessment. NPJ Prim Care Respir Med. 2020;30(1):48. pmid:33087713
- 26. Kinley E, Skene I, Steed E, Pinnock H, McClatchey K. Delivery of supported self-management in remote asthma reviews: A systematic rapid realist review. Health Expect. 2022;25(4):1200–14. pmid:35411670
- 27. McCleary N, Andrews A, Buelo A, Captieux M, Morrow S, Wiener-Ogilvie S, et al. IMP2ART systematic review of education for healthcare professionals implementing supported self-management for asthma. NPJ Prim Care Respir Med. 2018;28(1):42. pmid:30401831
- 28. Morrow S, Daines L, Wiener-Ogilvie S, Steed L, McKee L, Caress A-L, et al. Exploring the perspectives of clinical professionals and support staff on implementing supported self-management for asthma in UK general practice: an IMP2ART qualitative study. NPJ Prim Care Respir Med. 2017;27(1):45. pmid:28720751
- 29. Morrissey M, Shepherd E, Kinley E, McClatchey K, Pinnock H. Effectiveness and perceptions of using templates in long-term condition reviews: a systematic synthesis of quantitative and qualitative studies. Br J Gen Pract. 2021;71(710):e652–9. pmid:33690148
- 30. Sheringham J, Steed L, McClatchey K, Delaney B, Barat A, Hammersley V, et al. Understanding the processes underpinning implementing improved asthma self-management as routine (IMP2ART) in primary care: study protocol for a process evaluation within a cluster randomised controlled implementation trial. Trials. 2024;25:359.
- 31. Miles C, Arden-Close E, Thomas M, Bruton A, Yardley L, Hankins M, et al. Barriers and facilitators of effective self-management in asthma: systematic review and thematic synthesis of patient and healthcare professional views. NPJ Prim Care Respir Med. 2017;27(1):57. pmid:28993623
- 32. Ivers N, Jamtvedt G, Flottorp S, Young JM, Odgaard-Jensen J, French SD, et al. Audit and feedback: effects on professional practice and healthcare outcomes. Cochrane Database Syst Rev. 2012;2012(6):CD000259. pmid:22696318