Photodynamic Diagnosis of Bladder Cancer

Implementation Project

Three NHS Hospital Trusts (see Contacts and Links) in partnership with their PCT's have implemented the intra-operative technique into their clinical practice as a result of following the technology implementation project. This process has involved significant changes to the way that services have been structured and the way in which healthcare has been delivered within these Trusts.

On this page, you will have unprecedented access to the learning gathered from the teams and there are contact details available (see Contacts and Links) so you can make contact and hear from them directly about what really happened and the challenges they encountered. In addition there are support tools and resources for you to download, adapt and use, which all stem from the work completed at each participating Trust.
To explore this section please click on the headings below:

• Project background - gives an overview of the NTAC bladder cancer project, where you will be able to gain access to the data we collected as part of this process.
• Project Sites - gives an overview of the NHS Trusts who were involved in the project and what their biggest achievement was following their robust implementation processes.
• Mandate for Change - provides you with a step by step checklist of the essential questions that need to be answered to enable and plan for a change to clinical practice.
• Planning for Implementation - provides all of the information and resources that you may find useful when planning the implementation process for insulin pump therapy at a local level.
• Implementation - has been designed to help Trusts understand what implementation will mean locally and what needs to be put in place in order to make it happen.
• Patient Pathway - provides full and complete patient pathway diagrams that can be tailored as appropriate. These are currently being followed in the NHS Trusts that we worked with on this project.
• Impact on Theatres and Wards- this section explores the impact on theatres that may be required for Trusts in order to successfully implement this technique.
• Evaluate Success- provides a number of questions around evaluating success and advocates the need to continually monitor and maintain progress being made as implementation filters through.
• Measurements of success- details what Trusts need to put in place to ensure that a sustainable insulin pump therapy service can remain in place for future years.

Project Background

Three NHS hospitals across England are now implementing the intra-operative technique into their routine clinical practice. The teams agreed and secured the funding for this service improvement on the foundation of improving quality of life for patients whilst reducing the number of second operations and overall length of stay in hospital. Most importantly, a robust implementation process was followed to allow a greater number of patients to receive only one surgical procedure and therefore reducing the risk of co-morbidities and unnecessary length of stay.

After following this structured implementation process, patient outcomes and the effect on local health economies (clinical and non clinical) were measured in a total of 160 patients across all three project sites. Impact on service, financial consequences and the required clinical and patient support needed within the initiation phase was evaluated.

The evaluation measures and values were subjected to independent analysis undertaken by the NHS Technology Adoption Centre and York Health Economics Consortium. The data was also reviewed by the NHS Information Centre for Health and Social Care.

The following reports were created as part of this project:

PDD slides shows a summary presentation of the data collected during this project.

PDD Headline Report shows a headline of project data.

PDD Data Analysis Report shows a full breakdown of the data collected.

PDD Economic Report shows a full health economic analysis on this technology.

PDD Costing Model demonstrates a full costing model for this technology.

Project Sites

Northern Lincolnshire and Goole Hospitals NHS Foundation Trust

Clinical Implementation Lead: Mr Laurence Coombs

Northern Lincolnshire and Goole Hospitals NHS Foundation Trust was established as a combined hospital and community Trust on 1st April 2001 and achieved Foundation Status on 1st May 2007. It was formed by the merger of North East Lincolnshire NHS Trust and Scunthorpe and Goole Hospitals NHS Trust and operates all NHS hospitals in Scunthorpe, Grimsby and Goole. Its name reflects the wider geographical area in which the Trust is a major provider of health care.

The Trust works in partnership with the Hull York Medical School and Sheffield Medical School providing comprehensive undergraduate teaching for Year 3, 4 and 5 medical students.

Brighton and Sussex University Hospitals NHS Trust

Clinical Implementation Lead: Mr Charles Coker

BSUH is the regional teaching hospital working across two sites: the Royal Sussex County Hospital in Brighton and the Princess Royal Hospital in Haywards Heath. The Brighton campus includes the Royal Alexandra Children's Hospital and the Sussex Eye Hospital, and the Haywards Heath campus includes Hurstwood Park Regional Centre for Neurosciences.

Both hospitals provide many of the same acute services for their local populations. In addition the Princess Royal carries out all elective surgery for patients from both Brighton and Hove City and Mid Sussex, whilst the Royal Sussex County Hospital is the emergency and critical care centre for the same population. Our specialist and tertiary services include neurosciences, paediatrics, cardiac, cancer, renal, infectious diseases and HIV medicine.

Royal Devon and Exeter Foundation Trust

Clinical Implementation Lead: Mr Malcolm Crundwell

The RD&E Trust provides acute hospital services to around 350,000 people in Exeter, East Devon and Mid Devon, and offers specialist services such as cancer care, plastic and reconstructive surgery, orthopaedic surgery, paediatric care and renal services to people living further afield in Devon, Cornwall and the Isles of Scilly, Dorset and Somerset.

Most of the RD&E's services, including specialist units such as the West of England Eye Unit and the internationally renowned Princess Elizabeth Orthopaedic Centre, are based at our main hospital at Wonford. The new Centre for Women's Health, encompassing maternity, neonatology and gynaecology services, relocated from the nearby Heavitree Hospital to a new purpose-built unit at Wonford in June 2007. Heavitree Hospital continues to provide a range of outpatient services, as well as accommodation for the Learning and Development team, and the new Peninsula Medical School dental school.

Mandate for Change

Existing bladder cancer surgery services (set up and infrastructure) within provider organisations is going to shift as a result of implementation of the technique. Realising the benefits that this technique can bring to your Trust, and understanding the change required to achieve these benefits is essential in order to answer the following questions:

1. Why is this technique important at a local level?
2. Why should we be implementing it?
3. What would the impact be of not implementing it?

Engagement with more than one PCT provider may be required in order to answer these questions sufficiently and plan your mandate for change. If more than one PCT provider needs to be involved, this will undoubtedly expand the overall scale of change locally. This was the case at X Trust who had to navigate around X number of PCT organisations before implementation discussions could begin. A strong and clear mandate for change sets the precedent for the entire implementation process.
Once the project's mandate and scope has been carried out, Trusts will be able to discuss the commissioning of a PDD service with commissioners. Conversations particularly around agreeing a cost-sharing agreement will be pertinent if implementation is to be a success. The commissioning requests will be within an "invest to save" framework - investing in the technology through reimbursing for increased provider costs in order to facilitate increased efficiences and savings in commissioning costs.

There are three underlying principles that underpinned the mandate for change in the NTAC project implementation and mentor sites, which include:

1. The speed of adoption (e.g. how quickly can this change be achieved),
2. Ultimate utilisation (e.g. how many people within the organisation need to be involved to see the technology successfully embraced) and
3. Proficiency (e.g. are the relevant skills in place to deliver this service).

Click to be taken to the Benefits 'vs' Barriers section, where the scale of the change that will be possible through implementing this technology can be found.

Planning for Implementation

A systematic and team based approach to implementation is essential if the technique is to be successfully adopted, and part of this approach involves establishing a core implementation team representative of all stakeholders who can drive forward the changes required and fulfill the Mandate for Change. Agreement from the Multidisciplinary Team (MDT) from the outset must be a long-term commitment so that improved patient outcomes and efficiencies can be achieved. Once an implementation team has been formed, the following questions need to be answered:

1. Does the Trust understand the technology and how it will impact on the local health economy (see PDD Introduction to Technology)?
2. Can the Trust identify its own potential adoption barriers and benefits at this early stage (see Benefits 'vs' Barriers)?
3. Is it possible to overcome these barriers and resolve them quickly and can opportunities be harnessed?
4. Are your commissioners engaged?
5. What are the operational changes that need to be addressed prior to implementation? i.e. instillation of photo-sensitising chemical 1 hour prior to surgery, scheduling of cases in theatre

The long term sustainability of this service improvement will stem from understanding these issues. Having an awareness of what adoption 'on the ground' will look like in order to work towards a detailed implementation plan is an important step in the planning process.

Understanding the technology and its impact on the local health economy is not always straight forward but it will be the precedent for moving forward. The NTAC project data (see Evidence Base) showed that carrying out an analysis of your patient throughput before implementation is essential (e.g. how many primary operations currently take place and how many of these would otherwise have been saved a second operation if the technology was in place). NTAC project implementation sites agreed that an appropriate patient selection protocol would be critical to ensure the effective and appropriate utilisation of PDD.

The technology was used on all patients with newly diagnosed or suspected bladder cancer and/or carcinoma in situ undergoing TURBT.

It is recommended you are aware of your patient numbers and projected impact that the technology will go on to have.

Implementation

Trusts and respective PCTs will have to continually re-think and revise local objectives, priorities, and strategies in order to effectively implement innovative technology in the treatment of bladder cancer. The experience of the NTAC implementation sites suggests that the initiation, implementation and 'go live' process will take approximately 6-8 months. The following questions were explored in the NTAC implementation sites which facilitated a successful implementation phase:

1. Has a clinical and board level champion been identified?
2. Has an implementation team been created that will initiate, oversee and Evaluate Success?
3. Can the team understand the dynamics of what is required to take the plan forward, and has it experience of similar adoption issues?
4. Have the key tasks been identified?
5. Have the Measurements of success been identified?
6. Do the resource and cost requirements (time, money, people, equipment,) appear reasonable and consistent with existing best practice? (See the Business Case section).
7. Have the key risks of each of the main components been identified and managed (designed out, shared, and mitigated)?
8. Has the revised Patient Pathway been agreed?
9. Has the team got a review mechanism in place for managing and communicating delivery against the implementation plan and for identifying and managing risk?

Once implementation begins, the service demands will be real and the new infrastructure surrounding financial agreements and clinical time will be in place.

It is recommended that a 3 month recurrence rate audit is carried out to help inform the likely impact of implementation of this technique. This data can be gathered either through your hospital administration systems or through the cancer MDT database.

Procurement is also an essential part to implementation, and the purchasing of the technology can be perceived as complex and time consuming - but it doesn't need to be. The Procurement section of this How to Why to Guide will explain what processes need to be followed for purchasing this technology, which should be discussed as an implementation team. The protocols that underpin procurement will also impact on the speed at which implementation can take place locally.

The Pathway: how will it change?

The experience from the NTAC project implementation and mentor sites suggests that there are five core areas of consideration when thinking about how the patient pathway will change:

1. Method of referral to the bladder service - Will this change as a result of implementation? Will patient demand increase? How will the Trust manage a possible increase in referrals?
2. Patient assessment and selection - how will the theatre schedule change as a result of implementation?
3. Provision of appropriate structured training and clinical education.
4. Managing patient support and the consent process - what local plans are currently in place locally? Does anything need to be amended?
5. Increased awareness of the technology (see PDD Introduction to Technology) and the impact it may have on other members of the clinical team - e.g. who will see a change to clinical practice as a result of implementation? For example, are medical and nursing staff aware of the impact it will have on them?

Each Trust will have different needs and demands from what it wants an enhanced bladder surgery service to deliver, which is going to be important when pulling together an analysis of how local pathways of care are currently being delivered. However, it is hoped that the patient and clinical staff pathway documents, which have been formulated as part of the NTAC implementation project, will provide Trusts with a clear insight into what needs to change and why.

Impact on Theatres and Wards

Introducing this technology into the organisation is going to require some reconfiguration of theatres (particularly around scheduling lists) and managing patients on hospital wards pre and post their surgical procedure.

It is important that a surgeon is appropriately trained in the technique.

Nurse training will be required for catheterisation and administration of the photo-sensitising chemical.

The chemical should be prepared and administered as specified in the supplier's instructions of use.

Ideally the photo-sensitising chemical should be instilled in a designated area to ensure safe and timely administration

The bladder should be emptied of urine immediately on catheterisation prior to instillation of the photo-sensitising chemical which should be retained in the bladder for an hour.

Prior to cystoscopy the bladder should be drained of the photo-sensitising chemical.

Consideration needs to be given to the scheduling of theatre lists to ensure all of the steps can be undertaken within the appropriate intervals.

To mitigate the risk of a patient not being ready for theatre within the above time requirements, PDD patients should be clearly indicated on theatre lists and a good communication protocol should be established between theatre users and pre-op ward staff to cater for situations where a re-arrangement of a list is required or where there are difficulties on the pre-operative ward that could prevent timely administration of the photo-sensitising chemical.

The number of PDD cases that it will be possible to do on a list will be determined by a combination of factors including the number of PDD-enabled resectoscopes available and sterilisation turn-around times. NICE guidelines for outsourced centralised sterilisation services require two complete sets of sterile equipment at the beginning of each procedure.

Equipment logistics

If a mixture of PDD-enabled and non-PDD enabled equipment exists, it must be ensured that all necessary PDD-enabled equipment is available for the correct time in theatre. Camera covers or cold sterilisation will be required for the camera and lead as these items cannot be autoclaved (heat sterilised). It must also be ensured that sufficient numbers of PDD-enabled equipment such as resectoscopes, cameras, and light leads are available on site for a particular theatre list. The following are examples of issues to take into account:

• Sterilisation turn-around times, especially if this is carried out off-site.
• NICE guidelines for outsourced centralised sterilisation services require two complete sets of sterile equipment at the beginning of each procedure.
• The distribution and location of equipment across a multi-site Trust.

Stocking of the Chemical Agent on Ward

The NTAC project teams put in place a strategy to minimise wastage by keeping minimal stock on ward. To enable this, a judgement should be developed between the pre-op ward and the hospital pharmacy about immediate needs, possibly on a daily level. Arrangements should then be established by the pharmacy to regularly review ward stock levels and maintain as necessary.

Care should be taken to prevent lack of stock from delaying the readiness of a patient, potentially causing the missing of a theatre slot or even not being able to undergo a PDD-assisted TURBT because of the above time requirements.

This will need to be discussed as an implementation team, however, if careful thought is not given to case mix and planning theatre capacity, successful embedment of this technology could be significantly hampered in the embryonic stages of implementation.

Evaluation of Effectiveness

Technology implementation is a continuous process that will by its very nature adapt to the Trusts changing circumstances and the needs of the local health economy. It is important however to continually evaluate the effectiveness on a technology in terms of efficiency and impact. The following questions should be addressed when planning the evaluation of implementation. They can also assist in planning and agreeing infrastructural changes within the acute setting:

1. How and when will you evaluate the impact that implementation has had on patient care and service efficiency?
2. Who will be responsible for collecting ongoing data to assess the effectiveness of the plan and its implementation
3. What windows of opportunity exist for reviewing the impact of implementation? (For example, the plan might be reviewed as part of the Trusts/Departments regular performance review meetings.)
4. How will accountability for implementation be assessed?
5. How will the level of technological proficiency gained by clinical staff be reviewed?
6. How will the Trust use the technology to evaluate teaching and learning?
7. What Trust-wide mechanism will be created to allow changes in the implementation of the technology and the plan itself?

Effective evaluation will allow commissioners and Trust Management to rethink and adapt local objectives, priorities, and strategies as 'implementation proceeds'. Continuous evaluation also facilitates making changes if aspects of the plan are not working.

Measurements of Success

The primary task of implementing this technology is to improve patient outcomes during and following use of the PDD technique. A fundamental goal for Trusts moving forward is to measure the impact of this technique and identify the potential benefits, costs (see Business Case) and practical issues associated with the routine implementation of the technique.

The following measurements may be used to assess patient outcomes and impact on productivity and the use of resources, which will allow Trusts to provide relevant information to help providers and commissioners make informed choices about how the adoption of this technique and to assess how it could make a positive difference to NHS performance and the well being of patients:

• Recurrance rate at first cystoscopy following PDD assisted TURBT
• Length of overall hospital stay
• Readmission and reoperation rates
• The use of the technology (and its financial implications)
• Patient impact
• Endoscopy capacity / changes to waiting lists

Another mechanism for evaluating the effectiveness of implementation is through some of the concepts laid out by the Improving Surgical Outcomes Group (ISOG).
ISOG is an independent medical group comprising surgeons, anaesthetists, critical care consultants and others involved in operative management and care. The group is concerned with improving patient outcomes and modernising care for patients undergoing major surgery.

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