| Plan the development process |
Supported self-management for asthma, which includes patient education, regular review, and personalised asthma action plan provision, has been recommended by guidelines for 30 years (British Thoracic Society et al., 1990). Evidence from 27 systematic reviews (270 RCTs), concluded that supported self-management reduces hospitalisations, accident and emergency attendances, unscheduled consultations, and improves markers of asthma control and quality-of-life (Pinnock et al., 2017). However, action plan provision is poorly implemented (only 52% of those surveyed) (Asthma UK, 2020), and in the National Review of Asthma Deaths, 77% of those who died did not have an asthma action plan (Royal College of Physicians, 2014). Whilst patient education, professional training, and organisational support are all essential to support self-management, they are rarely effective in isolation (Taylor et al., 2014). Therefore, within the IMP2ART programme, we aimed to develop patient resources within a whole-systems implementation strategy (https://www.ed.ac.uk/usher/imp2art).
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| Involve stakeholders, including those who will deliver, use and benefit from the intervention |
We enlisted the expertise of the AUKCAR Patient and Public Involvement group (‘PPI colleagues’). This included those with lived experience supported by researchers with expertise in facilitating PPI groups. We formed a Professional Advisory Group (PAG) of GPs and nurses from the Primary Care Respiratory Society (PCRS). Both PPI and PAG meetings took place at regular intervals over the course of the development.
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| Bring together a team and establish decision-making processes |
The IMP2ART team consists of primary care academics, general practitioners, health psychologists, nurses, PPI and PAG colleagues. We discussed widely at weekly team meetings with all views welcomed. Senior members of the IMP2ART team took final decisions on patient resource content to meet majority preferences, ensure adherence to guideline recommendations, and promote supported asthma self-management implementation.
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| Review published research evidence |
Patient resources were to be aligned with BTS/SIGN (2019), NICE (2021), and GINA (2022) global guidelines on the management of asthma. All the guidelines recommend supported self-management and agree that this should include advice on adherence to maintenance treatment, recognising deterioration, action to be taken, and routine reviews. Where there were discrepancies (such as GINA’s increased emphasis on first-line use of combined ‘Maintenance and Reliever Therapy’ which is not recommended by UK guidelines), on the advice of the PAG, we followed UK guidelines. General practice staff recognise that patients want information about managing their asthma, but consider that a limited range of resources made it difficult to find action plans and information tailored to individual patients. They also note that encouraging patients to attend for routine asthma reviews is challenging (Morrow et al., 2017). For patients, self-management education (with an action plan) has particular value early after diagnosis when coping strategies are beginning to form, and after an attack when existing management has clearly failed (Daines et al., 2020).
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| Draw on existing theories |
The COM-B (capability, opportunity, motivation, behaviour) framework for understanding behaviour (Michie et al., 2011) and the Behavior Change Technique Taxonomy (Michie et al., 2013) were used in the development of all IMP2ART resources, and all resources were designed to incorporate relevant behaviour change techniques.
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| Articulate programme theory |
A full programme theory including a logic model for the IMP2ART programme has been developed (Steed et al., 2023). Evaluation of the programme theory for the patient resources will be explored in a process evaluation of the IMP2ART cluster-RCT.
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| Undertake primary data collection |
Following the design of the patient resources (detailed in the ‘design and refine the intervention section’), we tested feasibility of the resources and sought users’ perceptions.
17 interviews were conducted (with adults and children/young people) following the initial design of the IMP2ART developed patient resources. An online survey with 95 individuals was conducted to ensure we captured well-used information sources for the IMP2ART patient information website and included information where gaps where identified.
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| Understand context |
Primary care is made up of varying demographics (e.g. ages, ethnic groups, socioeconomic groups) and varying geography (e.g. rural, urban). For general practices in England, the Quality and Outcomes Framework determines performance-related payments (NHS Confederation, 2003). General practices use different systems, therefore we designed aspects of the IMP2ART patient resources (e.g. invitation letters) so they could be adapted by the practice.
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| Pay attention to future implementation of the intervention in the real world |
IMP2ART is a programme of implementation research. The resources were developed explicitly for implementation in routine clinical practice within the context of a UK-wide cluster randomised implementation trial (https://www.isrctn.com/ISRCTN15448074). The patient resources were designed to be simple and accessible for ease of use in primary care. The process evaluation will consider future use of the intervention, ‘scale up’ and sustainability in real-world contexts.
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| Design and refine the intervention |
Linked to behaviour change techniques (Michie et al., 2013), and considering health literacy, the IMP 2ART team with PPI and professional colleagues designed the following patient-facing resources:
a website containing information about asthma and a variety of asthma action plans. templates for letters that general practices can use to invite patients for their annual review, remind patients about missed appointments, and invite patients to a review following unscheduled care (all highlighting the importance of asthma action plans). Posters that general practices can use to encourage patients to ask about an action plan if they do not have one.
Following the primary data collection (interviews with adults and children/young people, and the online survey) we refined the patient resources. The resources were also reviewed and updated following the outbreak of the COVID-19 pandemic to meet additional patient information needs (McClatchey et al., 2021).
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| End the development phase |
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