Table 2 Implementation of the business model

Domains and Component

Issue Identified

Action Taken

1. Building brand values

1a. Developing brand values

Identify the key positive qualities which collaborators associated with the successful delivery of the previous CRASH trial (i.e. the 'CRASH brand').

Conducted a survey of key collaborators from the previous trial to ascertain reasons for participation in that trial and what aspects of the coordinating centre's performance could be improved. Identified that continued use of the theme from the previous trial was useful to build on positive image already established.

1b. Gaining legitimacy and prestige

Need to enshrine the factors identified by the CRASH trial collaborators into CRASH-2.

Trial was coordinated by an academic institution, funding was by a non-commercial organisation and respected individuals identified and engagement maintained throughout CRASH-2.

1c. Signalling worthiness

The trial increased workload for clinical teams and the need to keep this to a minimum.

Simplified design and minimised procedures. Emphasized the values of adding to the clinical evidence and knowledge and prestige gained from individual participation (e.g. training in trials/authorship potential).

2. Product and market planning

2a. Providing simple, complete processes

Recognised that, to maximise recruiting site participation and follow-up of participants, processes would have to be simple.

Minimised tasks that require to be done at recruiting sites and maximised those done by coordinating centre. Built in flexibility to accommodate varying local needs.

2b. Strategies to overcome resistance

Factors that may cause potential collaborator to reject or not fully commit to CRASH-2 were identified.

Coordinating centre created training responses and frequently asked questions were made available to collaborators to address issues (e.g. how to explain the trial, how to incentivise junior staff to recruit).

2c. Adopting an explicit marketing plan

Need for a marketing plan and to engage with a wide variety of people and organisations.

Developed a formal marketing plan including definition of groups that needed to buy into the trial.

3. Making the sale

3a. Engaging active sponsors, champions and change agents

Need to recognise who the groups, networks and experts in the disease area are.

Engaged and maintained support of groups such as disease specific networks and patients and their representatives, including within participating countries to ensure any local sensitivities were addressed.

3b. Delivering a multi-audience,

multi-level message

Different groups of people require the same information in varying formats to address concerns.

Ensured that when the same information was being presented to different groups (e.g. medical staff and nurses), the key messages were presented in ways that addressed all needs and concerns.

3c. Achieve buy-in (in public)

Recognition that the trial impacted on many more people at participating sites than the trial team and that a confirmation of commitment made publically by collaborators is more likely to result in their active participation.

Local collaborators were asked to raise awareness of the trial to anyone involved in the care of the trial participants. Collaborators were invited to state their commitment to the trial in public (e.g. at trial meetings).

4. Maintaining engagement

4a. Ensuring positive 'moments of truth'

The need to be efficient, honest and timeous.

The central coordinating team tried to ensure that all collaborators had a clear and complete response to any queries. Any failures in procedures were reported honestly, with an apology and with a plan as to how to resolve any problems.

4b. Providing frequent positive

reinforcement

Many local team members (e.g. doctors and nurses) were crucial contributors to ensuring the trial was successful at their site.

Recognised and rewarded acts (e.g. completing trial paperwork) by sending personalised texts, small tokens of appreciation and certificates of participation. Enabled networking and sharing of experiences.

4c. Facilitating incorporation into

routines

As many trial procedures as possible should be incorporated into local routine.

Supported this through provision of additional helpful processes (e.g. providing trial labels to be attached to blood transfusion forms) to assist clinical staff to remember the trial as part of their standard care routine.

2.2: Case study two - using the model as a diagnostic tool

Domains and Component

Issue Identified

Action Taken

1. Building brand values

1a. Developing brand values

TXT2STOP set out to establish itself as a high quality trial as reflected by the manner in which it dealt with participants. Some participants hearing about the trial via adverts reported concerns about the trial being a scam.

Team amended the way the trial was presented in information to address this, paying particular focus to the potential benefit of the intervention to the NHS if proven effective and stating links to university.

1b. Gaining legitimacy and prestige

A need to clarify that the trial was funded and endorsed by a respected Institute.

The University links were stated in letters and other trial documents. The trial was funded by a non commercial institution.

1c. Signalling worthiness

There was a need to ensure that the general practitioners were not 'out of pocket' as a result of participating in the trial.

Appropriate National Health Service support costs were secured to support the general practitioners in order that they were not financially compromised as a result of participating in the trial. The importance of the trial question and the potential benefit of the intervention to the NHS, if proven effective were outlined in study information.

2. Product and market planning

2a. Providing simple, complete processes

Workload at the sites had to be reduced as much as possible.

To facilitate recruitment and reduce the burden at recruiting general practices, letters were sent directly to smokers on the practice lists, thus negating the need for the doctors and nurses to tell their patients about the trial.

2b. Strategies to overcome resistance

It was necessary to identify what the benefits to each of the participating groups were.

The central team identified what would encourage the main participants (smokers, health care teams and smoking cessation services) to participate.

2c. Adopting an explicit marketing plan

Due to low recruitment figures during the early months of recruitment the marketing strategy had to be reviewed.

Adverts for the trial were evaluated and only effective adverts on effective media were repeated. We started to market the trial to potential participants who had registered interest but who had not gone on to either consent or not consent to trial inclusion.

3. Making the sale

3a. Engaging active sponsors, champions and change agents

Clarity was required as to who the main gatekeepers were.

Relationships were established with key gate keepers such as the Scottish and English smoking cessation websites who promoted the trial.

3b. Delivering a multi-audience, multi-level message

Appropriate wording and means of communication are required.

Letters and text messages to potential participants were worded to focus on the different motivations that smokers may have for attempting to quit and joining a trial.

3c. Achieve buy-in (in public)

There was a need to use different media sources to indicate endorsement and promote the study.

The smoking cessation service research network distributed information about the trial to all participating services.

4. Maintaining engagement

4a. Ensuring positive 'moments of truth'

Being allocated to the control group was a difficult experience for many participants.

We ensured that all research assistants involved in randomisation were trained in how to respond to participants' disappointment (and at time anger). It was acknowledged that being allocated to the control group was disappointing but reinforced that being involved in the trial would enable the intervention to be made publically available for everyone, if proven effective.

4b. Providing frequent positive reinforcement

Information provision requires not only to be regular but effective.

The effectiveness of all promotions were monitored and evaluated. Only effective strategies were repeated.

4c. Facilitating incorporation into routines

Clarity and ease of procedures were required.

All new processes were incorporated into standard operating procedures.

2.3: Case study three - using the model as an audit tool

Domains and Component

Issue Identified

Action Taken

1. Building brand values

1a. Developing brand values

Recognition that the brand values are vital in clarifying what the trial will deliver (to health care professionals' patients etc).

Continue to use distinct messaging and appropriately qualified professionals to develop trial brand.

1b. Gaining legitimacy and prestige

Recognise the key and appropriate individuals and institutions.

Ensure that it is obvious who the trial is associated with.

1c. Signalling worthiness

Ensured that any monetary costs to clinical investigators was reimbursed and provided training that would be generalisable in the trial setting and beyond.

Roll out any training and information to all participating clinicians at the end of trial so that the 'value' will be, eventually, available to all.

2. Product and market planning

2a. Providing simple, complete

processes

Assistance required with electronic queries to search for patients.

Provide assistance with any issues and consider reviewing protocol if necessary to amend and simplify processes.

2b. Strategies to overcome resistance

Initial assumption that resistance to participation would be low but barriers to participation were subsequently identified.

Be open minded about resistance and devise strategies in advance to overcome.

2c. Adopting an explicit marketing plan

There is a need for a formal marketing plan.

Identified trial's unique selling points for each of the categories in order to highlight benefits of involvement and supporting study.

3. Making the sale

3a. Engaging active sponsors, champions and change agents

Public advocates and patient representatives require to be on board the study from the outset and across a wide range of activities.

Team had failed in early attempts to recruit public advocates (GP champions, PCT R&D Staff) and it would have been beneficial if patient representative activities had been more extensive than only participation in the Trial Steering Committee.

3b. Delivering a multi-audience, multi-level message

One size does not fit all with regard to communicating and addressing motivation of different target groups.

Presentations (contents and style) were tailored to fit with the target audience (e.g. family doctors, nurses, practice managers).

3c. Achieve buy-in (in public)

Collaborators who make a silent decision to commit to the study forgot easily - it is necessary to get a senior person within the institution to announce their participation and support of the study to the rest of their team.

Collated anecdotal evidence that the lack of awareness in general practices suggested that team support would have been greater had the senior management announced involvement. Also realised that techniques such as publishing lists of signed up practices would have assisted in signalling the commitment of those sites to the study.

4. Maintaining engagement

4a. Ensuring positive 'moments of truth'

A clear and efficient system of handling queries is required in order to ensure an accurate and timely response.

The team set up a dedicated 'LIFELAX.queries@......' email address, which was checked routinely and messages passed to the most appropriate team member for response.

4b. Providing frequent positive reinforcement

There is a need to undertake training, including follow-up training, at all sites.

The study team largely achieved this component, the result being that sites which underwent training and became active recruiting sites remained committed to the trial until the end.

4c. Facilitating incorporation into routines

This aspect of the study was fairly difficult for LIFELAX as the patient search was a one-off.

The central team attempted to demonstrate to the staff at the participating general practice sites that the principles and techniques of behaviour change taught in LIFELAX could be incorporated into routine practice and should not be seen as study specific training only.