Results: intervention development and delivery

Parts of this chapter have been reproduced with permission from Gulliford et al.71 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/.

The initial sections of this chapter present empirical data for contextual themes and participants’ views on the prototype interventions that emerged from qualitative analysis of interview data. The final section of this chapter describes the main features of the REDUCE trial intervention.

Participants

Data collection for the intervention study was completed between March 2015 and September 2015. There were 28 GPs and three NPs who took part in the interviews and 35 interviews were conducted in total (three GPs and one nurse were interviewed on two occasions). There were 31 interviews conducted face to face in general practices and four were conducted over the telephone. Participants were recruited from 21 non-trial general practices covering several areas of England (London, Oxfordshire and Yorkshire) and from general practices of different sizes – ranging in the number of registered patients from 5891 to 17,797 (on average, 10,968 registered patients). Interviews lasted between 20 and 76 minutes.

Intervention development: emerging contextual themes

The interviews for intervention development provided contextual information, which contributed to the understanding of influences on practitioners’ interaction with the intervention materials. Table 4 summarises the main themes relevant to the implementation of the trial intervention.

Theme 1: researchers may not understand the general practice context

Participants considered that researchers did not have a good understanding of the way general practice operates, suggesting a number of reasons why the research might be difficult to sustain within the general practice environment.

Respiratory tract infection consultations are time-consuming

Clinicians were agreed that they see a high number of patients with RTIs during their daily medical practice:

I’ve seen loads [of patients with RTIs] this morning. And I’m sure I’ve got some in the afternoon. I can predict that I’ll have at least one or two in my 15 patients in the afternoon.

Many felt frustrated that patients would visit the practice several times during the same episode of RTI until they were given a prescription for antibiotics:

When we see patients, if I look at a consultation and the patient has been in two or three times for the same problem, you’ll end up giving them antibiotics because you know they’re going to keep coming back . . . And we probably know the patient doesn’t need antibiotics, but the problem is, they’re now taking up three consultations and they’ll probably come back a fourth time if we don’t give them.

Routine daily task

Participants were in agreement that seeing patients with RTIs is a routine daily task, and they felt confident in diagnosing respiratory infections. Some participants were surprised that the intervention is targeting such a well-established behaviour:

We wouldn’t click [on the intervention tools], because this is bread and butter stuff we will already be doing these things . . . And I don’t think anybody needs to really remind us [of] these things.

A majority of interviewed clinicians indicated that they are fixed in their approaches to dealing with patients presenting with RTIs as a time-saving strategy; a change of approach might increase their workload:

Although it’s there [i.e. the REDUCE trial notification] as a reminder, it won’t trigger in the brain as a reminder, because it’s like when you know you’re on the computer and you click ‘next’, you know what screen is coming next and you’re already ready to type . . . So it can become quite routine . . . So it may not have the effect that you want it to have.

It eats into our time. I personally will just tell them face to face. I wouldn’t like to go through this [study tools]. It just adds on to my consultation time.

Loss of clinical autonomy and judgment

Some participants perceived the intervention as a source of external pressure to withhold antibiotics for patients for whom clinicians considered antibiotics were recommended and felt this external pressure to not prescribe undermined their clinical judgment and autonomy:

Unless you’re the clinician sitting behind that desk, then don’t come and tell me what I can and can’t prescribe and in what condition and when I can’t, because you haven’t seen the patient . . . because my rate in this practice might be a 100% because every single patient who comes in might clinically need it.

Some participants were concerned that involvement in a trial, such as the REDUCE trial, might undermine their relationship and rapport with their patients or change the focus of the consultations from the patient to the study tools:

Then my concern is that if you just give them a leaflet, I feel they may just think I’m patronising them, because they feel like ‘Well actually I wanted antibiotics, I didn’t want a piece of paper.’ People can get annoyed very easily and they can kind of affect that doctor–patient relationship which isn’t ideal.

More consumerist patients

Many participants considered there was a shift in patient expectations and demands towards a more ‘consumerist’ approach:

People just don’t care, they want to be better by 1 day when they have a terrible cold. That’s what I think is one of the biggest barriers.

Adults are harder . . . because parents hear about antibiotics being bad and giving them diarrhoea and are quite keen to avoid them . . . it’s more when it’s for themselves. Because they want to get back to work and they think it will hurry it up.

As a result of this consumerist attitude, combined with a feeling of constantly being audited by the NHS, some GPs felt uncertain about potential bacterial complications of the infection:

It’s the fear of litigation or things going wrong, and if you have arbitrary targets like this, which is way beyond the usual targets, it puts unnecessary pressure on GPs not to prescribe . . . And I don’t want to prescribe, but if it’s needed, then pressure of some sort of appraisal and maybe told off is not really needed.

Research involvement by clinicians

Participants emphasised a change within general practice towards more target-driven culture. As work began to shift towards this pattern, participants considered that the study should be aligned with the changes at the system level (incentives for meeting certain clinical targets). For many participants this would encourage them to take part:

If you want to make it work, incentivise the GPs to make use of it. Otherwise we’ve got cancer tools, we’ve got all these other tools coming through our system . . . and literally go straight into my dustbin. There’s no funding or extra incentive attached to it. There’s more paperwork there, bits to fill in, you have go from one screen to another screen, go to a website. You haven’t got time for all of that. So I pretend to use it when they come, ‘yes, yes, I’m using it, it’s great’. I’m not using it at all.

Others participants commented that, despite possible incentives for getting involved, there would be no recognition for the efforts of individual GPs:

Could you have this information [feedback on antibiotic prescribing] done on individuals rather than practices? . . . it’s a bit of a ‘name and shame’ situation, isn’t it if this data comes back and doctor so and so is prescribing 80% antibiotics and – you know, that would certainly probably make you think, ‘Blimey I need to do something about this’.

Theme 2: the problem may not be perceived as personally applicable

The problem does not belong to me

A majority of interviewed participants considered that they were familiar with current recommendations for antibiotic prescribing but were confident that own their prescribing was appropriate:

Personally I don’t think we would prescribe unnecessarily . . . I will only prescribe it when I think it’s needed rather when the patient is thinking they want it . . .

In several cases, participants reported that they do not overprescribe because high levels of prescribing is justified for their patient population:

Well if it [feedback] is population-based, then, you know, if your sick population who are poor, they are going to be sicker aren’t they? So you can’t compare us to [an affluent area] can you?

Distrust of the evidence

Some participants questioned the outline proposals for reduced antibiotic-prescribing rates for RTIs:

You can say it’s safe to half this amount of antibiotics. You don’t know what they’ve seen, you know. Who says it’s safe? What’s this? ‘You can safely aim to halve antibiotic prescribing.’ That means that half our patients didn’t need it. How do you know?

Other participants acknowledged the importance of following the NICE recommendations,6 but considered these recommendations may be unachievable in GP daily practice:

I just think it looks like the target is completely unachievable . . . It just looks, yes, it just looks like no one is ever going to get near it.

Out-of-hours prescribing

Participants identified groups of individuals or institutions which, in their view, were responsible for high antibiotic-prescribing rates:

I think 50% of our doctors at the moment are locum doctors and, you see, I don’t know if I’m being judgemental. But it just seems to be ‘chest infection, amoxicillin’ – when I did my audit, none of the regular doctors did it.

There was a visible tension in GPs accounts between general practices and out-of-hours services, which in the views of GPs, were not only responsible for high antibiotic-prescribing rates, but also for creating more workload for GPs:

I think GPs would also want to know what percentage of like A&E [accident and emergency] and walk-in centres are doing as well . . . because that’s another problem – we tell [patients] ‘no’, then they go to A&E and they get antibiotics. And the next time they come, they go, ‘Last time I had to go to A&E to get my antibiotics.’ We do get that quite a lot.

Many participants considered that the intervention should be directly targeting ‘high-prescribing’ practices or individuals:

It seems to me that it would make sense that before you go to all this trouble . . . you can see which practices are perhaps being excessive and then target those with all this material . . .

And I think much better would be this to be targeted to those doctors that are already prescribing high. Because what is it about them, you know, what – are they not doing what the others are doing.

Intervention development: feedback from interviews

Table 5 provides a summary of themes relevant to intervention design.

Webinar

There was a consensus among interviewed GPs and nurses that the webinar was positive and communicated messages that were relevant to health-care professionals, such as safety of reduced prescribing. Some GPs suggested that the webinar should be watched together during the practice meeting:

If it’s a clinical meeting, everyone is sitting there, you’re playing it, difficult to avoid it . . . It covers the whole, covers the whole practice. So in the meeting we have everyone, senior partners, salaried, nurses, health-care assistants, it would encompass everyone, even if say the health-care assistants are not directly involved, clinical staff would watch the video and would be aware that we were part of the study.

It was important to emphasise in the webinar that the intervention would not increase workload, as this might be a major barrier to involvement. In contrast, participation in the intervention might lower GPs’ consultation burden associated with RTIs (as patients would be less likely to re-consult with future RTIs):

What it’s saying, it’s addressing our concerns about spending more time talking to the patients . . . I guess probably, I guess that feeds back to the anxiety everyone has about their workload at the moment . . . guess if you market it to GPs by saying, ‘reduce your consultation rates,’ or something like that, you know, if the trial is going to show that if, you know, when you don’t prescribe, they don’t come back the next time.

Decision support tools: patient leaflets

A majority of GPs preferred a condition-specific patient leaflet, rather than the generic one, as the condition-specific leaflets appear more tailored to patient needs:

Once you’ve told someone, ‘You have a middle ear infection, this is some information about it,’ if it’s more specific to their condition, they might prefer it or it might give them more incentive to read it, although the information is pretty much the same as the other one.

Handing out a leaflet could help draw a consultation to a close and patients would not leave the GP office empty handed. Some GPs suggested adding condition-specific ways of easing and managing symptoms associated with upper respiratory infections:

Maybe suggest other options like, for example, sinusitis – consider steam inhalation, [nasal] spray, just give the option to the doctor what else they can do.

Participants particularly liked the idea of including expected illness duration and stressing that antibiotics will not reduce the duration of symptoms:

That’s really helpful. Well the infection is likely to last 21 days, that’s helpful because people come back every week.

However, others felt that there was a shift in patient expectations and demands towards a more ‘consumerist’ approach and that patients would request antibiotics irrespective of information presented on the patient leaflet:

People just don’t care, they want to be better by 1 day when they have a terrible cold. That’s what I think is one of the biggest barriers.

Intervention activation

Some GPs expressed a view that they would not type in a Read code (diagnosis) during the consultation, but would start with issuing a prescription. They considered that the study box should appear when a GP writes a prescription for a common RTI antibiotic (e.g. amoxicillin), not just in response to a Read code. However, other GPs considered this approach might not be appropriate as common antibiotics are commonly used to treat non-RTI infections, such as infected tooth:

The problem is there will be no Read code by the time it’s prescribed sometimes. So often the last thing that’s sometimes put in is a Read code . . . So if this was to pop up, then the best time for it to pop up would be as an antibiotic is prescribed. But obviously software wise you’d have to link it in to a diagnosis as well. And give some sort of warning there going, whatever, you know, ‘reduce antibiotics,’ or, ‘are you certain this is indicated?’ or something.

Some GPs felt that the addition of prescription indication criteria for each condition would be beneficial. This would help to reassure both the GP (that they are making a correct diagnosis) and patients (that the diagnosis and possible antibiotic prescription are based on official criteria):

I know there isn’t a scoring system for all of them [RTIs], but on, I mean, without a scoring system or something like that – I’m not sure how this is going to reduce the prescribing . . . if somebody pushes back, so if someone is insistent, you know, going back to the original script, if someone is insistent . . . you can come back and say, ‘Look I’ve put it, we’ve done – this is a recognised validated scoring system, and you don’t warrant antibiotics because your score is . . . whatever’.

Patient information screen

Some GPs were not keen on the use of a patient information screen, as they felt that this would lengthen consultation times:

If I say, ‘read this [patient information screen]’, then I have to sit there and wait for them to actually read it and then that would mean they’re not going with anything to take away with and they may forget it as well.

Prescribing reports

A majority of GPs considered that they did not prescribe antibiotics unnecessarily and some were surprised that their practice would be part of the intervention:

Personally I don’t think we would prescribe unnecessarily . . . I will only prescribe it when I think it’s needed rather when the patient is thinking they want it . . .

It seems to me that it would make sense that before you go to all this trouble . . . you can see which practices are perhaps being excessive and then target those with all this material . . .

A majority of GPs did not favour the use of prescribing target rates or of optimal prescribing rates. Some perceived the target prescribing rate as unachievable, as it was much lower than current rates:

Yes, because otherwise you’ll get this and think, ‘where on earth are they getting 22% from?’

Whereas I think, with this, people are going to be aiming to be better than other people (other CCGs [Clinical Commissioning Groups]). But I just think it looks like the target is completely unachievable. It just looks, yes, it just looks like no one is ever going to get near it.

A majority of GPs considered that a comparison with local practices/local CCGs should be presented in the reports, as then the results would feel relevant. Many GPs acknowledged though that they would not aim to lower their prescribing if they were at the same level as or a lower level than other local practices:

The national rate is useful, but we’d probably be comparing ourselves within our CCG . . . similar population, similar ways of practising, probably meeting each other in our CCG meetings, similar budgets, similar pressures.

There was no agreement among interviewees about whether feedback reports should present data for different RTI types separately or combined:

If we are looking at individual conditions, this is easier to interpret, it’s easier to understand and it’s a summary, it’s an overall summary. Whereas if you have 1, 2, 3, 4, 5, five graphs to look at, five graphs to interpret and the people will say, ‘We are better than the CCG in cough, we are not so good in rhinosinusitis and we are average in sore throat, so where are we overall?’

All participants welcomed the idea that feedback reports would count as an audit towards practice or individual GP appraisals:

I was looking to see well what are practices going to get out of it, but I think if the practice did it, they’d all feel they could write it on their appraisal and that they participated.

Trial interventions

A summary of the main features of the final versions of trial interventions is given in Table 6. There were no modifications to the interventions following the start of the trial.

Webinar

Purpose

A webinar was developed to fulfil several functions:

• making practice staff aware of their practice’s participation in the trial
• raising awareness of and concern at the problem of AMR
• introducing the REDUCE trial DSTs and providing training by demonstrating how to use the support tools
• introducing and outlining the value of the monthly antibiotic-prescribing reports that were produced for the trial
• reassuring GPs about the safety of reduced antibiotic prescribing
• identifying potential benefits of this approach to the practice, including a reduced number of RTI consultations in the future.

The webinar was narrated by an academic GP member of the study team and was recorded in a general practice setting. Initial versions of the webinar were recorded and presented to interview respondents on a tablet computer. The final version of the webinar, which incorporated suggestions from the qualitative interviews and patient advisory group feedback, was produced professionally.

The main elements of the webinar narrative were as follows, with the narrator:

• drawing attention to the increasing problem of AMR, referencing the Chief Medical Officer’s report1 and highlighting AMR as a potentially ‘catastrophic threat’
• discussing general practice antibiotic prescribing, emphasising that RTIs represent the most frequent indication for antibiotic prescribing in primary care, observing that RTI consultations can be time-consuming and recognising that GPs may find it difficult to withhold antibiotics
• introducing the REDUCE trial DSTs, explaining that these were developed by leading GPs, explaining that the tools are easy to access and may help to manage RTI consultations
• demonstrating the use of the DSTs, showing how the ‘banner’ is triggered by entering Read codes for RTIs
• introducing the condition-specific patient information leaflets, noting that these are patient friendly and have been based on good evidence and developed with input from practising GPs and patients
• explaining that the REDUCE trial tools are designed to safely help antibiotic prescribing, demonstrating that the ‘prescription indication’ page can be used to decide whether or not patients are at risk of complications
• introducing the REDUCE trial antibiotic-prescribing reports, explaining that these reports can be used as evidence of audit and can be included in appraisals
• commenting that reducing antibiotic prescribing is expected to be associated with reducing RTI consultations and that investing time in improved management may be associated with future benefits
• explaining that reducing the rates of antibiotic prescribing is not associated with reduced patient satisfaction when patients are explained the reasons for the no antibiotic strategy.

Each intervention trial arm practice was encouraged to identify a GP ‘champion’ for the study, who was asked to ensure that all prescribers at the practice were aware of the trial and had seen the webinar, ideally through the presentation of the webinar at practice meetings.

Antibiotic-prescribing reports

Antibiotic-prescribing reports were presented on professionally designed templates, including the logos of the NIHR and King’s College London. The main features of the antibiotic-prescribing reports were as follows:

• The intervention trial arm practices were sent antibiotic-prescribing reports at the start of the trial, and after each completed month of the 12-month intervention period.
• At the end of the trial, practices received a final report accompanied by a certificate of completion of the trial.
• Prescribing reports were portable document format (PDF) files each presented as a single side of A4 paper.
• The reports presented data in a table, including a count of the number of RTI consultations and number of antibiotic prescriptions, together with the proportion of RTI consultations with antibiotics prescribed for each month of the intervention period.
• Data were compared with the preceding 12 months at the same practice for reference.
• A brief accompanying narrative explained the numerical data included in the table and summarised any change in antibiotic utilisation based on the proportion of RTI consultations with antibiotics prescribed.
• The narrative also included a reminder on how to access the REDUCE trial DSTs.
• A bar chart illustrated changes in the proportion of RTI consultations with antibiotics prescribed in comparison with the preceding 12 months at the same practice.
• Based on interview feedback, it was decided not to include an external comparator (such as antibiotic-prescribing data for the whole of the CPRD) because this might offer little incentive for those practices already prescribing fewer antibiotics than average.
• Data reported were aggregated across all ages and for men and women.
• No changes were made to the overall design of the prescribing reports during the course of the trial.
• Data analysis and report writing were performed using bespoke code written in the R program.

Decision support tools

The REDUCE trial DSTs (Figure 1) were delivered into trial practices using proprietary software known as DXS Point-of-Care, which is integrated with the Vision practice system. The DSTs were triggered when a Read code for a RTI was entered into the practice system. A ‘banner’ then appeared in the DXS Point-of-Care tool bar. Practitioners gained access to the DSTs by clicking on the toolbar. The process was explained in the introductory webinar.

FIGURE 1 Map of DSTs. (Figure not reproduced here; see the original article.)

Figure 1 provides a map of the DSTs. After clicking on the DXS Point-of-Care toolbar, practitioners were presented with a ‘landing page’ that offered advice for the five groups of self-limiting RTI, including common cold, sore throat, sinusitis, otitis media and cough/bronchitis. Advice for the last two conditions was specifically tailored for either children or adults, based on clinical advice from GP members of the study team. For each group of conditions, practitioners were offered the alternative of accessing a patient information leaflet (Figure 2) or a prescription indication page (Figure 3).

FIGURE 2 Part of one of the REDUCE trial patient information leaflets. (Figure not reproduced here; see the original article.)

FIGURE 3 Screenshot showing the REDUCE trial prescription indication page. (Figure not reproduced here; see the original article.)

The REDUCE trial patient information leaflets included the following items of information:

• the expected duration of symptoms from the specified class of self-limiting RTI
• evidence concerning antibiotic utilisation including:
  • lack of clinical effectiveness of antibiotics at reducing the duration or severity of symptoms
  • increased risk of common drug side effects
  • risks to individuals and families from AMR
• advice on self-management of symptoms including:
  • need for rest
  • fluid intake
  • management of fever with paracetamol or ibuprofen
  • obtaining advice on symptomatic treatments from a pharmacist
• advice on seeking help when there are possible warning signs including:
  • possible signs of meningitis (headache or vomiting)
  • respiratory difficulties (rapid breathing, cyanosis)
  • possible signs of septicaemia (cold skin, discoloration, rash)
  • local complications (difficulty swallowing, drooling)
  • ‘feeling a lot worse’.

The patient information leaflets were professionally designed and included the NIHR and King’s College London logos. The leaflets were presented as a single side of A4 in a PDF, which could be viewed on a computer screen or printed and handed to patients.

The REDUCE trial prescription indication page drew on the criteria for antibiotic prescribing in the NICE guidelines (see paragraph 1.7);6 these guidelines identify patients at risk of complications using criteria that include how unwell the patient is, whether or not there are clinical features suggestive of complications if comorbidity is present, or if the patient is of an older age and having features that suggest a higher level of risk. The prescription-indication page enabled practitioners to evaluate with patients whether or not an indication for an immediate antibiotic prescription was present.