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Table 2 Use of NPT in optimising trial parameters

From: Normalisation process theory: a framework for developing, evaluating and implementing complex interventions

NPT Components Questions to consider within the NPT framework Example: an NPT evaluation of the WISE trial
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?  
  1. The WISE trial (ISRCTN90940049 - Evaluation of the WISE (Whole System Informing Self-management Engagement) approach in primary care: improving outcomes in chronic conditions through effective self-management) [25]. The intervention involves training a whole practice team to provide self-care support to patients. An exploratory study undertaken prior to the full trial drew on NPT to help optimize the training content and sensitise research to the reaction, incorporation or rejection of the WISE approach from a service user, professional and organisational perspective.
  2. The context for this trial was UK primary care. Contextual issues that needed consideration in planning the trial included a policy framework which supported self-management; a performance management system which incentivises GPs to achieve specific clinical targets (the Quality and Outcomes Framework) which may conflict with self-management and places a requirement on GPs to collate and submit data on a range of performance issues with subsequent implications for practice income. These data are submitted annually, making the year end an exceptionally busy time for practices so trial-related work is likely to receive lower priority at this time.