Stage 1: Collating and analysing evidence
Rapid review
The full rapid review is available elsewhere (11). Rapid review is a form of synthesis which supports the review of existing evidence in a timely manner (12). It aimed to explore clinicians’ and patients’ views and experiences of penicillin allergy testing services.
Outcomes
The review identified only two studies which reported patients’ views of PAT. All patients thought that PAT would provide valuable medical information. The majority of patients reported limited knowledge of penicillin allergy and PAT services. Clinicians reported several barriers to referring patients for PAT. These included difficulties establishing the allergy history, lack of knowledge on referral processes and organisational pressures making allergy testing a low priority. A number of clinicians and patients reported being reluctant to prescribe or consume penicillin after a negative PAT result.
Qualitative interviews
Full details of the qualitative work are available elsewhere (13). Two qualitative studies were undertaken by MW; one interviewing 31 patients with a penicillin allergy record (16 with previous experience of PAT) and the second interviewing 19 general practitioners. The aim was to identify patients’ and clinicians’ views on the barriers and facilitators for PAT and antibiotic use after a negative test. Semi-structured interviews were conducted over the phone by an experienced qualitative researcher (PhD qualified) with substantial previous experience of conducting qualitative research. Patients were identified from a general adult hospital allergy clinic and from general practices in the same geographical area. Clinicians were identified in general practices and by the local microbiology services.
Outcomes
An inductive thematic analysis approach was used to analyse data. The majority of patients who were motivated to get tested had experienced a negative consequence of having a penicillin allergy label (such as limited availability of antibiotics they could use). Patients reported concerns about the possibility of having an allergic reaction during PAT; the degree of the severity of their previous reactions affected how apprehensive they were about the test. Moreover, when the test was perceived as more invasive, e.g. the OCT compared to the ST, patients reported being more concerned about PAT. Patients were also concerned about how much they would be monitored during the test and highlighted the importance of feeling informed, safe and observed by qualified professionals. Some patients reported being unsure about a negative test result and feeling anxious about taking penicillin if prescribed, as they doubted whether the test result was accurate.
Clinicians reported that they often felt that penicillin allergy records were incorrect however reported uncertainty about how to identify patients with true penicillin allergy and were reluctant to amend medical records without objective evidence. Penicillin allergy status was not seen to be a major problem in general practice due to the availability of alternative antibiotics and clinicians struggled to identify the risks of incorrect allergy records. Clinicians were seen to differ in their consultation styles when speaking to patients about their antibiotic prescribing decisions and allergy status. They reported lack of experience of PAT services and the need for more information on referral criteria. Regarding the process of changing a patients’ record after a negative test result, clinicians reported being happy to update medical records on directions from secondary care but were unsure who was responsible for making sure that patients understood allergy test results.
Expert Discussions
As part of this first stage we consulted our wider clinical research team using monthly tele-conferences and emails to gain their feedback on several aspects of the intervention development, such as the interpretation of evidence collated in the rapid review and the qualitative studies, the development of early iterations of the intervention materials, and the development of the initial intervention plan and components. The clinical research team included a consultant immunologist, a consultant microbiologist, a consultant anaesthetist, a general practitioner and professors with expertise in applied health research.
Stage 2: Intervention planning and development
Creating guiding principles
In line with the person-based approach (7) brief guiding principles were created to be consulted through the whole intervention development process. This ensured that the intervention met the original objectives. Based on the findings of the rapid review, qualitative interviews and expert discussion, the characteristics and behavioural needs of the target users were identified. Guiding principles were then created to outline the intervention objectives and the key design features which addressed them.
Outcomes
Table 1 presents the ALABAMA guiding principles. These focused on increasing confidence to refer and attend for PAT and increasing motivation to prescribe/consume penicillin following a negative PAT result. Guiding principles also included increasing clinician confidence in discussing penicillin allergy with patients and improving communication between primary and secondary care about penicillin allergy status. Lastly the intervention needed to present the PAAP as reliable and trusted and provide accessible and easy to use materials for clinicians and patients.
Behavioural analysis
The aim of the behavioural analysis was to use behaviour change theory (14) to describe the content of the ALABAMA intervention package and map the evidence from the rapid review, qualitative studies and expert consultations.
The first step of the behavioural analysis process was to identify target behaviours, their barriers and facilitators, and how intervention components would support desired behaviour change based on evidence collated in stage 1. Intervention components were mapped to the TDF framework(15) and the Behaviour Change Wheel (BCW)(14) referring to the Behaviour Change Techniques Taxonomy (BCTv1)(16). This produced a list of TDF barriers, target constructs (what needs to change for the behaviour to occur), intervention functions (ways an intervention can change behaviour) and behaviour change techniques used for each of the barriers/facilitators.
Outcomes
The full behavioural analysis is presented in additional files (see Additional File 1). Firstly, we identified barriers and facilitators to referral of low risk patients to PAT and patient attendance to PAT. The analysis highlighted that both clinicians’ and patients’ knowledge and perceptions of penicillin allergy and test procedures could be modified; information needed to be supported by scientific evidence for clinicians and patients to be reassured that the test was safe. We designed a resource for clinicians entitled “Penicillin Allergy Testing: Information for general practice” which contained information on penicillin allergy and PAAP procedures. As part of the ALABAMA trial, this will be supported by site training and working instructions which provide practical guidance on screening patients and referral to PAT (relevant BCTs for clinicians were ‘information about antecedents’ and ‘information about health consequences’). For patients we developed two patient booklets, one to be provided prior to PAT and one following a negative test result. All patients, on entering the trial, will have a consultation with a GP to answer questions and address concerns about PAT. We developed a patient booklet entitled “Penicillin Allergy Testing: going for a test” which included information on PAAP procedures and PAT safety (relevant BCTs for patients were ‘information about health consequences’ and ‘feedback on outcomes of the behaviour’).
The barriers to the prescription and consumption of first-line penicillin following a negative test result were patient and clinician beliefs about the accuracy of PAT and whether taking penicillin was safe. Clinicians also needed reassurance that colleagues saw de-labelling as beneficial and resources to support them in changing incorrect penicillin allergy records. We developed a second patient booklet entitled “Penicillin Allergy Testing: a negative test result”, which contained information about which antibiotics patients could safely take in the future following a negative test result, a negative result intervention card and a result letter which confirmed the patient allergy status to penicillin (relevant BCTs were ‘social support’ and ‘restructuring of the social and physical environment’). As part of the trial, clinicians received working instructions, which contained guidance on how to change the patient allergy label in medical records, result letter which confirmed the patient allergy status to penicillin, and an electronic-pop up, which included a reminder of the patient’s new allergy status (relevant BCTs were ‘feedback on outcomes of behaviour’ and ‘adding objects to the environment’).
Logic modelling
The next step included the development of a logic model, which summarised the behavioural analysis, providing a diagrammatic representation of the hypothesised processes and causal pathways from the intervention components to the desired outcomes (17, 18).
The research team opted for a process oriented iterative logic model which was refined during the whole intervention development stage.
Outcomes
The logic model (Figure 1) included four components:
Intervention components and techniques: Intervention components were organised based on the two target groups (clinicians and patients). Intervention techniques summarised the BCTs used as part of the intervention which were identified in the behavioural analysis.
Intervention processes: These were the psychological factors which explained the relationships between the intervention components and the outcome of the intervention: each intervention technique was hypothesised to mainly affect one of these processes. As part of the intervention, clinicians would receive information on penicillin allergy and implications of incorrect allergy records in order to increase their knowledge of PAT and allergies. In addition to this, providing medical and scientific evidence and current guidelines on how to perform PAT would change their professional identity related to their role in the referral process and act as reinforcement to increase their motivation to refer patients in the future. Regarding the processes affecting patient’s attendance of PAT, providing evidence of penicillin as best treatment and the safety of PAT would increase their beliefs of positive consequences of accurate records; informing them of common reactions during PAT and reassuring them of monitoring at the clinic and at home would increase their knowledge on PAT, decrease their negative emotions, such as anxiety, and act as positive reinforcement to attend the clinic.
Both patients and clinicians would receive evidence of the accuracy of PAT, and of safety of prescribing penicillin after a negative test result, in order to increase their belief about positive consequences of prescribing penicillin after a negative test result. Finally, providing a negative test result card to use with clinicians would affect patients’ expectations of social influences regarding clinician’s acceptance of the test result.
Purported mediators: These are the target behaviours of the intervention which directly affect the outcomes. In the logic model the assessment of potential incorrect penicillin records was operationalised as the referral of low risk patients to PAT and patient attendance at PAT. The introduction of the PAAP was hypothesized to affect the change of incorrect penicillin allergy records (clinician changing medical records and patient acceptance of change of penicillin allergy status) which would ultimately affect the consumption of penicillin.
Outcomes: The behavioural outcomes of the model were the prescription and consumption of first-line penicillin when indicated. The main outcome of the trial is “treatment response failure” to assess patient recovery from infection when taking antibiotics.
Stage 3: Optimising the intervention materials
Think-aloud interviews with GPs
Think aloud telephone interviews were conducted with 6 participants by MW; 2 additional participants provided feedback via email. Interviews asked about views of each section of the “Information for general practice leaflet” developed for clinicians.
Outcomes
The leaflet was well received. Participants reported that it was informative, useful and generally easy to read. The participants perceived it not only as information for themselves, but also a tool to use in a consultation with patients. Some participants felt that they knew about the consequences of incorrect penicillin allergy record; and therefore the leaflet could be shortened. Most participants understood the testing stages; however, a couple of participants were confused about which stages of the test patients could skip. One participant wanted exact doses of penicillin specific (rather than just amounts). Regarding the section on patient discussions, some clinicians felt that there was no need to discuss the test with patients. Participants queried whether being tested with amoxicillin meant that the patient could now take all penicillin based antibiotics and wanted more information.
Clinicians’ feedback was collated and organised in a ‘table of changes’ (see Additional Files 2) where suggested changes were listed and given a level of priority for that change, following the MoScoW framework (19), and the source of the suggested change (expert opinion, research team, clinical research team, literature review). Changes to the ‘Information for general practice’ included changes to the title, to the exact doses of penicillin given to the patients during the test, information about side effects and information about which antibiotics patients with a negative test result can take safely.
Think-aloud interviews with patients
Think aloud interviews telephone interviews were conducted with 7 patients (3 with experience of PAT and 4 with no experience) by MW. Interviews asked their views about the two patient booklets (“Penicillin Allergy Testing: going for a test”, “Penicillin Allergy testing: a negative test result”) and the intervention card.
Outcomes
The booklets and intervention card were very well received by the participants. Participants considered the booklets to have the right amount of information and felt they were generally easy to read. Patients reported that the booklets convinced them that going for a PAT could be beneficial. They felt that they could relate to the description of how people were given penicillin allergy labels. Patients thought the description of the test was clear and they knew what to expect. Statistics about the prevalence of allergy were not always understood by the participants, as the participants often thought that 1 in 10 people are allergic and they wanted a more visual presentation of this key information. Participants were unsure what narrow and broad spectrum antibiotics were and did not recognise MRSA abbreviation. Participants did not always know that penicillin is more than one antibiotic. The participants wanted to have a separate paragraph on what could happen during the test and what could happen during three days of taking penicillin at home. They also wanted reassurance that three days would be enough to detect delayed reactions. The participants wanted more reassurance that after being tested with one type of penicillin (e.g. amoxicillin), it would mean that they could safely take all penicillin antibiotics. The participants were slightly concerned about the risk of allergic reaction in the future (despite negative test results).
Patient feedback was collated in a table of changes. Changes made to the booklets were the selection of new images of patients for the front cover, inclusion of definitions of narrow and broad spectrum antibiotics, and reassurance that 3 days of oral challenge would be enough to detect delayed reactions to penicillin.
Intervention components
All Working Instructions developed to support clinicians and research nurses activities as part of the ALABAMA intervention package were shown to a group of clinicians to gain their feedback on content and layout. Among the clinicians who provided feedback there were two practice managers, and one nurse. Their overall feedback was positive and the main changes to the intervention materials included the identification of the best way of updating the patient’s medical records after PAT, and the introduction of screenshots of the medical record in the working instructions.
All participants letter (patient appointment letter, patient result letter, clinician result letter) were developed among the wider clinical and research team in order to make them effective in motivating patient to attend the penicillin allergy testing and in order to persuade clinician to change patient records and prescribe penicillin after a negative test result, and patient to consume penicillin after a negative test result.
At the end of the intervention development stage, a description of the intervention was completed following the TIDieR (20) guidance (see Additional Files 3) together with a description of the intervention components for clinicians and patients (Table 2).
The iterative process of intervention development and optimisation of intervention materials informed by the rapid review, qualitative work, expert consultation and think-aloud interviews is shown in Figure 2 and 3. It presents the example of this process for the development of one section of the “Penicillin allergy testing: going for a test” patient booklet and the “Information for General Practice” leaflet for clinicians.