Background
Complex interventions
Normalisation Process Theory
Discussion
Use of NPT to develop a complex intervention
Define the context
NPT Components | Questions to consider within the NPT framework | Example: NPT evaluation of the ImPACT back pain study |
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Coherence
| Is the intervention easy to describe? | Participating GPs did not differentiate the new intervention from current practice and were unable to perceive the projected benefits to patients, primary care teams and physiotherapists. |
Is it clearly distinct from other interventions? | ||
(i.e., meaning and sense making by participants) | Does it have a clear purpose for all relevant participants? | |
Do participants have a shared sense of its purpose? | ||
What benefits will the intervention bring and to whom? | ||
Are these benefits likely to be valued by potential participants? | ||
Will it fit with the overall goals and activity of the organisation? | ||
Cognitive participation
| Are target user groups likely to think it is a good idea? | Participating GPs saw it as research (i.e., recruiting patients to the study), and peripheral to their main task of delivering patient care. Projected benefits were not obvious to the GPs so they were insufficiently motivated to invest thought and energy into changing their practice. |
(i.e., commitment and engagement by participants) | Will they see the point of the intervention easily? | |
Will they be prepared to invest time, energy and work in it? | ||
Collective action
| How will the intervention affect the work of user groups? | Participating GPs were expected to use a computer-based decision-support tool during consultations. Many GPs did not access the computer until after the consultation was completed. GPs were unconvinced that such a brief tool could form an appropriate basis for decisions about referral. |
Will it promote or impede their work? | ||
(i.e., the work participants do to make the intervention function) | What effect will it have on consultations? | |
Will staff require extensive training before they can use it? | GPs were not fully aware of the additional training received by participating physiotherapists, and did not therefore realise that the physios were well equipped to deal with emotional or psychological components of back pain. | |
How compatible is it with existing work practices? | GPs already felt under pressure of time in consultations, and felt that using the decision-support tool was an unjustified additional use of time. | |
What impact will it have on division of labour, resources, power, and responsibility between different professional groups? | ||
Will it fit with the overall goals and activity of the organisation? | ||
Reflexive Monitoring
| How are users likely to perceive the intervention once it has been in use for a while? | Despite regular feedback from the research team GPs did not perceive benefits to the new system as they did not use it enough. |
(i.e., participants reflect on or appraise the intervention) | Is it likely to be perceived as advantageous for patients or staff? | |
Will it be clear what effects the intervention has had? | ||
Can users/staff contribute feedback about the intervention once it is in use? | ||
Can the intervention be adapted or improved on the basis of experience? |
Define the intervention
Undertake an NPT analysis of the intervention
Use of NPT to optimise evaluation of a complex intervention
NPT Components | Questions to consider within the NPT framework | Example: an NPT evaluation of the WISE trial |
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Coherence
| Is the trial easy to describe? | Yes, practices understood the trial explored whether providing training to the practice team affected patient ability to self-care. |
(i.e., meaning and sense making by participants) | Is it clearly distinct from other studies? | Recruitment was in two stages: practice recruitment and randomisation to either immediate training or training after 1 year, and then patient recruitment in the first year. Outcomes data collected at the level of the individual patient, so good communication about the timing of training and patient recruitment was required. |
Does it have a clear purpose for all relevant participants? | Providing self-care support may require clinicians to challenge current patient behaviours and risks disrupting existing relationships. Hence during practice recruitment the emphasis was on the benefits of the training, including development of practical strategies and improving skills which would benefit patient care. | |
Do participants have a shared sense of its purpose? | ||
What benefits will the trial bring and to whom? | Patients were unlikely to perceive any direct personal benefit from participation, and so financial incentives were required to improve completion of postal questionnaires. The initial informed consent process was found to be a potential 'trial killer' as it had a very negative impact on patient recruitment rates. Ethical approval was sought and obtained to simplify the process. | |
Are these benefits likely to be valued by potential participants? | ||
Will it fit with the overall goals and activity of the organisation? | ||
Cognitive participation
| Are target user groups likely to think the trial is a good idea? | Clinicians may hold the view that their patients do not want to be self-managers, and provide evidence to challenge this. Alternatively, they may see potential benefits in reduced workload with these patient groups. |
(i.e., commitment and engagement by participants) | Will they see the point of the trial easily? | |
Will they be prepared to invest time, energy and work in it? | Patients may have altruistic reasons for participating (e.g., improving future provision of self care support for others) which can be drawn on to encourage continuing participation. | |
Collective action
| How will trial procedures affect the work of user groups? | Participation ensures controlled access to desired resources such as additional Cognitive Behavioural Therapy and patient information books which may incentivise participation. |
Will they promote or impede their work? | ||
(i.e., the work participants do to make the intervention function) | What effect will it have on consultations? | General practice staff concerns about increased time burden will need to be addressed. |
Will participation in the trial require extensive training for staff involved? | For staff, the trial provides an opportunity to have protected training time together which is unusual and appreciated but needs additional financial resources. | |
How compatible is the trial with existing work practices? | Initial input is needed from practice staff to recruit patients to the trial and service support costs provided by the research body are an encouragement for practices. Once patients are recruited, the research team takes over the burden of patient follow-up. | |
What impact will it have on division of labour, resources, power, and responsibility between different professional groups? | It is hard to engage GP practices with research, and sustained support from the PCT and early adopters (practices who participated first and champion the research) have been key to engaging other practices in the PCT. | |
Will the trial fit with the overall goals and activity of the organisation? | ||
Reflexive Monitoring
| How are users likely to perceive the trial once it's been on-going for a while? | Trainers in self care support can provide ongoing contact, feedback and help the practice access resources for their patients, so effects should be visible quickly. |
Is it likely to be perceived as advantageous for patients or staff? | ||
(i.e., participants reflect on or appraise the intervention) | Will it be clear what effects the study has had? | |
Can users/staff contribute feedback about study procedures? | Quick action in obtaining substantial amendments from ethics to improve trial procedures (e.g., informed consent procedure; incentives for patients; information about accessing resources for clinicians and patients) helped to ensure progress of the trial. | |
Can the study procedures be adapted/improved on the basis of experience? |
Define the context
Define the trial parameters and consider all the different patient and professional groups likely to be affected
Undertake an NPT analysis of the trial parameters
Implementation
Consider the context
Define the intervention to be implemented
Undertake an NPT analysis of the implementation
NPT Components | Questions to consider within the NPT framework | Example: an NPT evaluation of robotic urological surgery |
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Coherence
| Is the intervention easy to describe? | The intervention is easily distinguishable from current surgical techniques by the technology involved, new skills required, new operating theatre equipment needed and higher costs of the service. |
Is it clearly distinct from other interventions? | ||
(i.e., meaning and sense making by participants) | Does it have a clear purpose for all relevant participants? | |
Do participants have a shared sense of its purpose? | ||
What benefits will the intervention bring and to whom? | It is expected to improve the performance and the clinical outcomes of minimally invasive techniques. | |
Are these benefits likely to be valued by potential participants? | ||
Will it fit with the overall goals and activity of the organisation? | ||
Cognitive participation
| Are target user groups likely to think the intervention is a good idea? | Professionals offered the technology are likely to be enthusiastic and prepared to invest their time and training in it. |
(i.e., commitment and engagement by participants) | Will they see the point easily? | |
Surgeons not offered the technology might not see it as advantageous and might discourage their patients from accessing the technology, particularly as this would mean the patient transferring to another centre. | ||
Will they be prepared to invest time, energy and work in it? | ||
Collective action
| How will the intervention affect the work of user groups? | Surgeons working in centres not offering robotic surgery may hesitate to offer this treatment option which requires onward referral of the patient and may adversely affect the surgeon-patient relationship. |
Will it promote or impede their work? | ||
(i.e., the work participants do to make the trial function) | What effect will it have on consultations? | |
Will staff require extensive training before they can use it? | Most surgeons do not have the necessary skills and knowledge to use the new technology. New training programmes with defined content and assessment procedures will be needed to ensure accountability and confidence. | |
How compatible is it with existing work practices? | Establishing a highly specialized surgical network, where patients are referred from 'nondoers' to 'doers' and where surgical teams move between hospitals, will contribute to the development of a surgical elite, which will attract patients, resources, research resources and prestige. The impact of this will need to be monitored. | |
What impact will it have on division of labour, resources, power, and responsibility between different professional groups? | ||
Will it fit with the overall goals and activity of the organisation? | Centres which are offered and choose to adopt the new service are likely to view it as having a positive impact on their goals, as it is likely to increase patient numbers. However, they will have to invest resources to achieve the structural and organizational changes required and take responsibility for accommodating the expected increased flow of patients, for training programmes and for specific risk management programmes. | |
Reflexive Monitoring
| How are users likely to perceive the intervention once it has been in use for a while? | Systematic review evidence details the expected clinical impact of the new technology. Clinical audit will be undertaken to determine whether the expected benefits are being achieved in routine clinical practice. |
(i.e., participants reflect on or appraise the trial) | ||
Is it likely to be perceived as advantageous for patients or staff? | Impact on equity of healthcare for patients and impact on development of the surgical network and surgical centres should be monitored through administrative data. | |
Will it be clear what effects the intervention has had? | ||
Can users/staff contribute feedback about the intervention once it is in use? | Individual centres will be encouraged to ensure users have 'ownership' of the systems around the new surgical technique (training, accreditation, patient flow) and can adapt these as appropriate. | |
Can the intervention be adapted/improved on the basis of experience? |