Development of an implementation package for Asthma Medication Optimisation in the Emergency Department (AMEND) - an evidence, theory and person-based approach
1Queen Mary University of London, London, UK
2Barts Health NHS Trust, London, UK
3Bristol Royal Hospital for Children, Bristol, UK
4University of Bristol, Bristol, UK
*Corresponding author; Email: i.skene@nhs.netABSTRACT
Background
Salbutamol is the most commonly prescribed inhaler for adults discharged from the Emergency Department (ED) with uncontrolled asthma. However newer options, e.g. Maintenance and Reliever Therapy (MART), are now recommended due to growing concerns over risks linked to salbutamol over-prescription. Transitioning to new inhalers requires support for both patients and healthcare professionals (HCP). This paper outlines how we developed an implementation package based on evidence, theory and the person-based approach to support asthma medication optimisation in the ED.
Methods
The purpose of this study was to use person-based intervention development methods in a three phase process: (1) understanding behaviour – collating and synthesising evidence from in-depth interviews with the target population (patients and HCPs); secondary deductive analysis using the theoretical domains framework (TDF) to understand barriers and facilitators to prescribing; developing guiding principles and logic model based on underlying theory (2) identifying behavioural content and implementation options - behaviour change techniques were selected and translated into intervention content (3) intervention materials developed and refined with input of stakeholders.
Results
We identified modifiable target behaviours for HCPs to support guideline-based care in the ED. These included identifying eligible patients, communicating rationale, providing patients with inhaler and resources, and communicating changes to primary care.
Key theoretical domains included knowledge, skills, addressing beliefs about consequences, and targeting professional role perceptions. These domains were targeted through a clinical decision aid and training materials for ED HCP, template discharge summary for primary care, and visual and written materials for patients. Minor refinements were made based on stakeholder feedback (six ED doctor think-aloud interviews; two patient workshops with eight and five participants respectively; and 12 survey responses to final draft of video).
Conclusion
We developed an intervention grounded in theory, evidence, and stakeholder feedback aimed at promoting and supporting delivery of guideline recommendation.
Article notes
Competing Interest Statement
IS has given lectures at meetings with honoraria supported by AstraZeneca, is conducting quality improvement activity at their institution supported by AstraZeneca. IS received a PhD studentship from AUKCAR which supported the initial work including the systematic review and data collection for the interviews from patients and healthcare professionals. BB is conducting quality improvement activity at their institution supported by AstraZeneca. KP has given lectures at meetings/webinars, with/without honoraria, supported by Sanofi; has taken part in clinical trials sponsored by AstraZeneca. PEP has attended advisory boards for AstraZeneca, GlaxoSmithKline and Sanofi; has given lectures at meetings/webinars, with/without honoraria, supported by AstraZeneca, Chiesi and GlaxoSmithKline; has attended international conferences with AstraZeneca; has taken part in clinical trials sponsored by AstraZeneca, GlaxoSmithKline, Novartis, Regeneron and Sanofi; is conducting research funded by GlaxoSmithKline for which his institution receives remuneration and quality improvement activity at his institution supported by AstraZeneca.
Funding Statement
The AMEND quality improvement project was funded by AstraZeneca through an Education Grant and AstraZeneca was not involved in the development of the programme educational materials. The views expressed are those of the authors and not necessarily those of AstraZeneca. The AMEND project builds upon IS PhD studentship from AUKCAR which was funded by Asthma+Lung UK as part of the Asthma UK Centre for Applied Research [AUK-AC-2012-01 and AUK-AC-2018-01].
Introduction
Asthma management has traditionally relied upon the use of separate preventer (inhaled corticosteroids – ICS) and reliever (short-acting beta-agonist - SABA) inhalers. However, many people underuse their preventer and overuse their reliever, a pattern associated with increased risk of hospital admission and poor asthma outcomes(1, 2). Emergency Departments (EDs) often see patients during periods of poor asthma control and therefore represent an important opportunity to identify suboptimal management and initiate safer treatment strategies.
Recent national and international guidelines now recommend maintenance and reliever therapy inhaler (MART) – using a low-dose ICS/formoterol inhaler taken both regularly and as needed - instead of SABA (3). This approach ensures patients receive ICS whenever they use a reliever, even when adherence to scheduled preventer therapy is poor, leading to improved asthma control (4). These guidelines represent a significant change in UK clinical practice.
Implementation of MART has focused on primary care (3, 5), yet those with uncontrolled asthma often present directly to the ED. Follow up after hospital attendance is often limited, with a minority of adults receiving a timely medication review, with patients from black and ethnic minority groups least likely to receive any post hospitalisation care (6). Moreover, ED attendance has been associated with increased adherence to recommendations (7) suggesting the ED as a potentially powerful, but underutilised setting for optimising asthma treatment and addressing health inequalities.
Intervention delivery in the ED is challenging due to time pressures, completing priorities, and the acute nature of ED practice. Although ED based interventions show potential to improve longer-term asthma outcomes (8), successful translation of interventions into practice has been limited (9). Updated Medical Research Council (MRC) guidance emphasises the importance of considering implementation processes and context during intervention development to improve uptake and sustainability (9). While asthma guidelines (3) and discharge bundles (10) have been updated, the practical guidance on implementation in ED settings remains limited.
Implementation initiatives are more effective when developed with key stakeholders including patients and healthcare professionals (HCP) (11, 12, 13, 14). The person-based approach (PBA) prioritises understanding users’ perspectives, to ensure interventions are acceptable and feasible (11). Qualitative studies indicate that patients attending the ED with acute asthma are receptive to medication optimisation when clearly explained and supported by information to take home (15), and ED HCP are willing to prescribe improved therapy at discharge when supported by simple processes and training (16).
This evidence indicates readiness to support an ED based implementation package to optimise asthma medication at discharge (15, 16). We hypothesise that optimising asthma mediation at the point of ED discharge could improve asthma outcomes and reduce readmissions. To address this, we developed an implementation package to support asthma medication optimisation in the ED
METHODS
We have followed the guidance for reporting intervention development studies in health research (GUIDED) in this paper (17).
Study Design
This study used a systematic approach to develop an implementation package aimed at asthma medication optimisation in the ED (AMEND). The development process was informed by the Medical Research Council (MRC) framework for complex interventions, but drew specifically on the Behaviour Change Wheel (BCW) and the Person-based approach (PBA) to guide the content and delivery strategy (9, 11, 18). PBA describes iterative methods of planning, optimising, evaluating and implementing behavioural health interventions. It is typically based on mixed methods research where users’ views and experiences are central to ensure the intervention is engaging and persuasive (19). The implementation package was grounded in theory through a secondary analysis of qualitative data using the Theoretical Domains Framework (TDF) (20, 21) and application of the Perceptions and Practicalities Approach (PAPA) (22). The TDF was used to identify theoretical constructs influencing behaviour and has been applied effectively in similar ED based implementation studies (23, 24). PAPA was applied to distinguish between perceptual barriers (e.g. beliefs about asthma control or treatment necessity) and practical barriers (e.g. inhaler availability, ED constraints). This analysis informed the content and delivery strategy of AMEND ensuring that the intervention address both motivational and practical determinants of behaviours, supporting feasible and sustainable implementation.
An AMEND development group was formed to provide iterative feedback from people with asthma, public contributors, HCPs, and a multi-disciplinary expert working group, with expertise in implementation science, behaviour change, complex intervention development, respiratory, emergency and primary care, and qualitative methodologies. Figure 1 summarises the phases and key steps in the development process.
Phase 1: Understanding the Problem and Developing Guiding Principles
In line with MRC guidance we reviewed the literature (8) and conducted qualitative studies (15, 16) to explore initial need and understand the problem. We then developed ‘guiding principles’ to specify ‘what’ the design objectives must be, and ‘how’ they may be achieved (25). We used a triangulation method to identify key recurring themes across the data sources or those given high priority by respondents. Initial guiding principles were discussed with the intervention development group before finalisation.
Phase 3 – User testing and Refinement
User testing and refinement of the materials was iterative but is presented as a final step here for ease, see Figure 2. This involved suggesting and agreeing content, assessing useability and identifying potential barriers and facilitators. User testing with stakeholders was conducted separately for people with lived experience of asthma and HCPs. Participants received a shopping voucher as a thank you for their time. Feedback was prioritised using the MoSCoW “Must have”, “should have”, “could have” and “won’t have” method to guide revisions based on their importance(29).
Patient facing materials: Lived experience perspectives were gathered through online workshops. Participants were recruited via outreach to the research teams clinical and professional networks, respiratory patient groups (Asthma + Lung UK, Respiratory Insights) and our PPI group. Eligible participants were adults with a history of attending the ED for asthma related care. Participants were provided with information about the quality improvement project in advance and consent was by participation. Workshops included brief presentations of draft materials followed by facilitated discussion. Field notes and informal participant feedback were collected during the sessions and used to inform refinement of the materials.
HCP facing materials: HCP testing involved “think aloud” interviews with ED HCPs. This method enables participants to verbalise their thoughts while interacting with the materials, offering insights into usability and cognitive processes (11). ED doctors from the trust where the implementation package would be piloted were invited to participate via email. We sought a sample of both resident doctors and consultants to capture a range of perspectives.
Each session began with a scripted introduction. Participants were provided with information about the quality improvement project and gave verbal consent. Participants were informed that participation was voluntary, they could withdraw at any time and that the interview would be audio-recorded for analysis purposes and used to inform the refinement of the materials. Participants then engaged with the materials using two example patient cases while verbalising their thoughts. Open-ended questions at the end of each session elicited feedback on usability, acceptability, and design. Following initial refinement, additional ongoing structured feedback was collected using online survey methods (Microsoft Teams forms), to further refine materials. Participants were provided with information about the purpose of the feedback and how their responses would be used. Participation was voluntary, and consent was by submission of the online form.
Ethics and Consent to Participate
The qualitative research in phase 1 and 2 was conducted in accordance with the Declaration of Helsinki and ethical approval was obtained from Camden and Kings Cross Research Ethics Committee HRA Approval [REC Reference 21/LO/0665]. The study received NHS governance approval from Barts Health NHS Trust. All participants provided written informed consent.
Phase 3, including the user testing and refinement were conducted as part of a quality improvement project, registered at Barts Health NHS Trust, to design the implementation package, deliver and evaluate its acceptability. This did not require separate ethical approval.
All participants in the think aloud interviews provided verbal informed consent. Participants of online workshops and structured survey feedback were informed that their participation was voluntary, that they could withdraw at any time and that all data would be treated confidentially; participation was considered as consent
Patient and public involvement
The AUKCAR and Barts Health NHS Trust ED PPI group advised on the design of the primary qualitative interviews, ensuring the approach and timing was suitable to reach patients in the ED. At each stage of AMEND development the results were presented to AUKCAR PPI members to facilitate interpretation and to refine and help shape the final intervention materials.
RESULTS
Overview
The AMEND implementation package was developed through a structured, multi-phase process to address barriers to optimal asthma management at ED discharge.
Phase 1: Understanding the behaviour
Table 1 presents the guiding principles and confirmed acceptability of an intervention in ED providing specific design considerations were made.
Phase 3 – User testing
Patient facing materials – animation video and written resources to take away
Two online workshops to gain lived experience perspectives were held in March 2024 and September 2024. Thirteen participants with a history of ED presentations for asthma (8 in workshop 1, 5 in workshop 2) participated. The majority had attended the ED in the last year (8/13), and 8/13 reported prior experience of using a MART inhaler. Feedback from the first workshop based on an animation storyboard highlighted In response, the intervention was revised - see Table 3 for changes.
- the need to simplify messaging in the patient facing animation,
- avoidance of medical jargon
- stronger communication of the importance of ICS and the risks of SABA overuse
- additional resources to reinforce messages post-discharge.
The second workshop reviewed the revised materials, using the storyboard visuals for the animation video. Participants confirmed acceptability with minor amendments to wording and visuals. No further substantial changes were suggested.
The full animation video was subsequently shared via email with a wider group for structured feedback. Twelve participants responded, including patients (n=4), PPI contributors (n=2), HCPs (emergency medicine doctor n=1, respiratory doctor n=4, nurses or allied health professionals n=2). Seven reported a history of asthma, and all had English as their first language. Survey feedback confirmed that the animation was clear, relevant, and acceptable to both patients and healthcare professionals, with no new major concerns raised.
“Really like it - concise, clear and gets the message across” - Patient feedback via feedback form
DISCUSSION
This paper describes the systematic development of AMEND, a theory informed implementation package designed to optimise asthma medication management - specifically initiation of MART- for adults presenting to the ED with uncontrolled asthma. AMEND supports the delivery of the updated NICE/BTS/SIGN Asthma guidelines (3) and targets ED discharge as a critical opportunity to promote supported self-management in a setting where health inequalities are often magnified. Developed using a multi-method approach, combining behavioural theory, qualitative research, and stakeholder engagement, AMEND adopts a whole systems perspective to identify modifiable behaviours, and practical constraints relevant to ED care (18, 34, 35). The resulting package supports non-respiratory specialists to initiate guideline concordant therapy, at ED discharge via a brief training package and clinical decision aid, aligned with national and international guidance (3, 36). Transparent reporting of this process provides a pragmatic model for intervention development in acute care settings.
Existing literature on asthma care in the ED has predominantly focused on patient education, with limited attention to changing long-term preventer therapy at the point of ED discharge (8). Patients generally prefer doctors to recommend a change in treatment and provide a rationale, and qualitative studies have suggested patients trust and would defer to such recommendation (15) (37).
Patients and healthcare professionals recognised the value of optimising preventer therapy at ED discharge, but reported barriers including time pressures, role boundaries, and uncertainty regarding prescribing guidelines (15, 16). Although decision support interventions can improve patient outcomes (38), clinician facing tools in electronic health records often suffer from poor uptake due to integration and engagement issues (39). These findings suggest that effectiveness alone is insufficient, tools must be designed for usability and acceptability in high-pressure ED settings. AMEND was designed as a simple, low burden flow diagram with embedded links for further information, aligning with existing practices, rather than requiring changes to electronic systems. Supporting HCP confidence in recommending medication changes was central to the intervention (16), with resources facilitating consistent, evidence-based messaging, and proportionate written and digital information to support self-management after discharge.
Visual and patient facing resources were included to reinforce teachable moment during ED visits, facilitating behaviour change, such as medication optimisation (40, 41). ED attendance has been associated with patients following treatment advice (7) highlighting this as a key opportunity to influence long-term outcomes. Brief visual interventions, such as bedside animations, have improved treatment control perceptions and reducing medication harm (42), while pictures of inhalers and mechanisms aid patients with language barriers or literacy barriers (43). AMEND incorporates both an animation video and written information sheets with embedded links to reinforce key messages and support self-management addressing the common problem of poor recall of information following ED visits.
Organisational factors and sustainability were also considered. The package was designed to integrate with existing ED workflows, requiring minimal additional resources, with senior HCP support highlighted as key (44).These design choices increased the likelihood of sustained use and potential replication in other ED settings.
Innovations and Contributions
The development of AMEND also reinforces previous ED research (23, 45, 46, 47, 48, 49, 50, 51) in finding that the TDF is useful for identifying important domains for change behaviour interventions. In the ED context, knowledge, environmental context and resources and professional role (47, 48, 50, 51). AMEND demonstrates that behavioural frameworks can guide intervention design even in complex high intensity settings. AMEND is among the first implementation packages to apply behavioural frameworks systematically to support prescribing behaviours in the ED. Using a PBA approach, allowed us to accommodate diverse stakeholder perspectives (11) resulting in a multifaceted, acceptable package. The development process was transparent and systematic, linking behavioural theory to intervention content through a logic model and guiding principles, highlighting both the value of optimisation for this population and the potential for replication in other acute care contexts.
Practical Implications - Impact on Healthcare Practice
The AMEND implementation package has been designed for easy integration into routine ED practices, to support safe and effective initiation of guideline-concordant preventer therapy, such as MART, during acute presentations, thereby supporting faster implementation of guidelines in clinical practice. The decision aid can be embedded into local prescribing guidelines, accessible via the intranet and used during clinical decision making without disrupting time sensitive care. It also functions as a training tool, supporting prescriber confidence in initiating MART regimes in non-specialist settings and utilising a teachable and reachable moment for groups such as young adults who often tolerate symptoms without seeking preventative help (52). While new NICE/BTS/SIGN guidelines are an important starting point to increase knowledge and awareness, alone they are unlikely to change behaviour of the clinical teams in EDs. Evidence internationally suggests that the new MART regime is being poorly implemented in the outpatient setting, with many patients still being given a SABA reliever inhaler (53). Multiple complex behaviours are required across the system to implement such guidelines and support adults optimally. AMEND has potential to be an important facilitator of these.
For patients, the tailored materials offer clear, actionable explanations and discharge instructions that support medication adherence beyond the ED visit. As such, AMEND has the potential to reduce repeat attendances, and promote safer asthma care in emergency settings.
There is potential to expand this implementation package to a wider group of asthma patients presenting to unscheduled care with their asthma including GPs, urgent treatment centres and on discharge from hospitals wards; the benefits in these contexts should be tested. The implementation package has been designed with considerations for a diverse demographic base, but further tailoring with considerations for cultural competence, language and health literacy may still be required.
Strengths and Limitations
Key strengths include the rigorous development informed by theory, evidenced and multidisciplinary input, including patient and public involvement. Limitations included a phased roll out during updates to national guidance which may impact on the HCP beliefs and behaviours and impact the emphases of key messages within the training materials.
Initiating a new medication regime and discontinuing an existing one are not equivalent behaviours. While the AMEND implementation package was designed to support initiation of MART and optimise adherence, it did not explicitly target the discontinuation of salbutamol overuse. Nevertheless, given the interconnected nature of prescribing and adherence behaviours, we hope the resources developed might also contribute indirectly to reductions in inappropriate salbutamol use. Future work should consider strategies that more explicitly address discontinuation behaviours alongside initiation.
Future work should assess implementation, clinical outcomes and equitable impact across demographic groups, with potential refinement of delivery modes and engagement of broader professional groups (i.e. nursing and pharmacy professionals who play a key role in discharge and education).
Conclusion
AMEND provides a theory informed, pragmatic implementation package to support the optimisation of asthma medication at ED discharge. It addresses known barriers to change, aligns with guideline recommendations, and offers transferable learning to implementing complex interventions in high pressure, acute care settings. A future evaluation is proposed to assess both implementation and clinical outcomes.
List of abbreviations
- ACP
- Advanced Care Practitioner
- AMEND
- Asthma Medication Optimisation in the Emergency Department
- APEASE
- Acceptability, Practicability, Effectiveness, Affordability, Side-effects and Equity
- AUKCAR
- Asthma UK Centre for Applied Research
- BCW
- Behaviour change wheel
- BCT
- Behaviour change technique
- BTS
- British Thoracic Society
- CSM
- Common-sense model
- DPI Dry
- Powered Inhaler
- ED
- Emergency Department
- FY
- Foundation Year
- GINA
- Global Initiative for Asthma
- GP
- General Practitioner
- HCP
- Health care professional
- HRA
- Health Research Authority
- ICS
- Inhaled corticosteroids
- MART
- Maintenance and Reliever Therapy
- MRC
- Medical Research Council
- NCF
- Necessity Concerns Framework
- NHS
- National Health Service
- NICE
- National Institute for Health and Care Excellence
- PAPA
- Perceptions and practicalities approach
- PBA
- Person Based Approach
- PPI
- Patient and Public Involvement
- REC
- Research Ethics Committee
- SABA
- Short acting beta-agonist
- ST
- Speciality Trainee
- TDF
- Theoretical Domains Framework
- TTA
- To Take Away
- UK
- United Kingdom
Untitled section
Additional file 1: TIDier description of AMEND intervention
DECLARATIONS
Human Ethics and Consent to Participate
Ethical approval for the qualitative research in phase 1 and 2 was obtained from Camden and Kings Cross Research Ethics Committee HRA Approval [REC Reference 21/LO/0665]. The study received NHS governance approval from Barts Health NHS Trust. All participants provided written informed consent.
Phase 3, including the user testing and refinement were conducted as part of a quality improvement project which was registered at Barts Health to design the implementation package, implement and evaluate the acceptability. This did not require separate ethical approval.
Stakeholders were informed that participation was voluntary, that they could withdraw at any time and that all data would be treated confidentially. Verbal informed consent was obtained from all participants in the think aloud interviews prior to participation. For online workshops and structured feedback via Microsoft Forms, participation was voluntary and consent was by participation.
Declaration of competing interests
IS has given lectures at meetings with honoraria supported by AstraZeneca, is conducting quality improvement activity at their institution supported by AstraZeneca. IS received a PhD studentship from AUKCAR which supported the initial work including the systematic review and data collection for the interviews from patients and healthcare professionals.
BB is conducting quality improvement activity at their institution supported by AstraZeneca. KP has given lectures at meetings/webinars, with/without honoraria, supported by Sanofi; has taken part in clinical trials sponsored by AstraZeneca.
PEP has attended advisory boards for AstraZeneca, GlaxoSmithKline and Sanofi; has given lectures at meetings/webinars, with/without honoraria, supported by AstraZeneca, Chiesi and GlaxoSmithKline; has attended international conferences with AstraZeneca; has taken part in clinical trials sponsored by AstraZeneca, GlaxoSmithKline, Novartis, Regeneron and Sanofi; is conducting research funded by GlaxoSmithKline for which his institution receives remuneration and quality improvement activity at his institution supported by AstraZeneca.
Funding
The AMEND quality improvement project was funded by AstraZeneca through an Education Grant and AstraZeneca was not involved in the development of the programme educational materials. The views expressed are those of the authors and not necessarily those of AstraZeneca. The AMEND project builds upon IS’s PhD studentship from AUKCAR, which was funded by Asthma+Lung UK as part of the Asthma UK Centre for Applied Research [AUK-AC-2012-01 and AUK-AC-2018-01].
Contributors
The development of this implementation package was conceptualised by IS with support from PP and LS. It followed on from IS’s PhD project, who was supervised by LS, PP, KP & CG. IS, BB, JB, ADS, PP and LS drafted and refined the implementation package materials with feedback from all authors. IS conducted the data analyses with support from PP and LS and with feedback from all authors. IS drafted the initial manuscript, with PP and LS substantively contributing to revisions. All authors critically reviewed the manuscript, contributing important intellectual content and approved the final manuscript. PP and LS share joint senior authorship.
Consent for publication
Not applicable
Availability of data and materials
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
The materials in the AMEND implementation package are available from the corresponding author on reasonable request
Patient and public involvement
Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Intervention development methodology section for further details.
Data Availability
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. The materials in the AMEND implementation package are available from the corresponding author on reasonable request