Implementation Project

Two NHS hospitals implemented the new non-invasive bladder analysis procedure on their clinical practice with the aim of improving the quality of care for urology patients.

On this page, you can access the learning gathered from the urologists, clinical scientists, nurses and managers who have worked on this project. There are Two NHS hospitals available so you can email or phone the members of the implementation team 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.

To explore this section and view information relevant and useful to you and your organisation please click on the headings below:

• Project Background - gives an overview of the NTAC non-invasive bladder cuff test project.
• Project Sites - gives an overview of the two sites involved in the NTAC implementation project.
• Change Rationele - provides the rationale behind the results and how they influence future decisions
• structured implementation process - provides all of the information and resources that you may find useful when planning the implementation process for non-invasive bladder cuff test 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.
• 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 Evaluation - 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 non invasive bladder analysis service can remain in place for future years.
• Project Outcome Measures - the key deliverables to achieve planned outcomes.

Project Background

Invasive Urodynamics studies are regarded as the gold standard for diagnosing Bladder Outlet Obstruction (BOO), which is associated with a risk of urinary tract infection, morbidity and mortality for certain patients, particularly for those whom catheterisation is not possible. It is widely accepted that invasive diagnostic testing is not pleasant for patients and there are some for whom the discomfort and embarrassment associated with invasive testing can impede an accurate diagnosis.

The non-invasive cuff test described in this How to Why to Guide has been proven to be an accurate and reproducible non-invasive procedure that is well accepted by patients. Two NHS hospitals in England have implemented the non-invasive cuff test into routine clinical practice, which aimed at evaluating its diagnostic potential and accuracy, patient acceptability and its position in the pathway.

Project data supported the notion that the test is a reliable indicator of BOO and additionally showed that patients have a clear preference for the test over invasive Urodynamics (e.g. invasive testing). Project data further demonstrated that there is a widespread lack of knowledge and Understanding the technology. By reviewing patient outcomes following treatment for BOO and correlating them with the non-invasive cuff test results, it has been possible to pathway which incorporate the use of the non-invasive cuff test and provide guidance on the management of men with voiding symptoms.

Following a structured implementation process, patient outcomes and the effect on local health economies (clinical and non clinical) were measured in a total of 121 patients. Impact on service, financial consequences and the required clinical and patient support needed within the initiation phase was evaluated.

The benefits and barriers and impact of implementation on the use of NHS resources were also assessed across the patient cohort recruited to the project at both of the NTAC project implementation sites.

The evaluation measures and values were subjected to independent analysis undertaken by the hNHS Technology Adoption Centre and York Health Economics Consortium.

Click here to access summary data presentation in a pdf file.

Click here to access the full project data report in a pdf file.

Project Sites

North Bristol NHS Trust

Clinical Implementation Lead: Mr Marcus Drake, Consultant Urologist

North Bristol NHS Trust provides hospital and community health-care to the residents of Bristol area, South Gloucestershire and North Somerset. It is the largest teaching trust in the South West and treats over 250,000 patients per year.

The urology and urodynamic departments are actively involved in research and have close links with the University of Bristol, University of the West of England and the University of Bath. The Bristol Urological Institute (BUI) based at Southmead Hospital was established in 1993 with the aim to support and develop urological research, with particular emphasis on urological cancers (of the prostate, bladder, kidney and testes) and on the problems of urinary incontinence. The institute has gained a global reputation and has become a major national and international education centre.

Given Bristol's extensive experience within urodynamic techniques and the research that is carried out in this field, the BUI was chosen as one of the two centres involved in the non-invasive bladder analysis system adoption study commissioned by the NHS Technology Adoption Centre. BUI aimed to assess the benefits and barriers to implementation of the technology and sought to identify ways in which this non-invasive diagnostic test could be implemented into current diagnostic pathways. Through direct application of the test to patients in the clinical setting, diagnostic algorithms have been developed to guide use of the cuff test and maximise the diagnostic accuracy of the technology.

Leeds Teaching Hospitals NHS Trust

Clinical Implementation Lead: Mr Neil Harris, Consultant Urologist

Leeds Teaching Hospitals NHS Trust is amongst the very biggest in the UK and includes the largest teaching hospital in Europe (St Jame's University Hospital). The Trust provides high quality acute hospital services for the population of Leeds and the surrounding area and acts as a regional centre for a number of specialist services such as cancer and cardiac surgery. In total the trust employs around 14,000 staff across six main sites, treating well over a million patients every year with a budget of around £930 million.

St, James University Hospital is both a secondary and tertiary referral centre for urology and services are delivered in dedicated facilities known as the Paul Sykes centre. The facilities incorporate specialised Urodynamic services which delivers a range of investigations to patients'

Change Rationale

Existing urology services (set up and infrastructure) within provider organisations may have to shift as a result of implementation of the non-invasive cuff test. Realising the benefits that this test 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 test 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 stakeholder within Trusts may be required in order to answer these questions sufficiently and plan your mandate for change, which will set the precedent for the entire implementation process.

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

1. The speed of adoption (e.g. how quickly can this change be achieved),
2. ltimate 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 here 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 team based approach to implementation is essential if the non-invasive cuff test 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 rationale for change. 'Buy in' from the entire Multidisciplinary Team (MDT) from the outset must be made and only then can improved patient outcomes be achieved.

An implementation team must include:

Clinical Implementation Project Lead - Consultant Urologist with responsibility for clinical leadership and directing education in Urodynamics. This includes guideline and protocol development, identifying and overcoming barriers and promoting the implementation pathway.

Clinical Scientists and Research Associates - Responsibility for development and delivery of the implementation project, collection and analysis of results and promoting the cuff test as an alternative to full, invasive urodynamics to clinical colleagues both nationally and locally.

General Manager - Responsible for ensuring a systematic approach to implementation is taken including the development of a robust business case, informatics support and the provision of adequate resources for sustainable implementation.

Once an implementation team has been formed, the following questions need to be answered:

• Does the Trust understand the technology and how it will impact on the local health economy?
• Can the Trust identify its own potential adoption barriers and benefits at this early stage?
• Is it possible to overcome these barriers and resolve them quickly and can opportunities be harnessed?

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 showed that carrying out an analysis of your patient throughput before implementation is essential (e.g. what is the morbidity associated with invasive diagnostic testing and what impact does this currently have on the Trust?). If you are not aware of your patient numbers and projected impact that the technology will go on to have, implementation will prove to be difficult. This is an essential step in planning for implementation.

Implementation

The experience of the NTAC implementation sites suggests that the initiation, implementation and 'go live' process will take approximately 2-4 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 measurements of success been identified?
5. Do the resource and cost requirements (time, money, people, equipment,) appear reasonable and consistent with existing best practice?
6. Has the revised patient pathway been agreed?

Once implementation begins, the service demands will be real and the new infrastructure surrounding financial agreements and clinical time will be in place - there is no going back.

Pathway

Each Trust will have different needs and demands from what it wants a non invasive bladder analysis service to deliver, which is going to be important when pulling together an analysis of the current pathway locally. However, it is hoped that the patient 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.

Areas you may wish to consider before making any changes to a patient pathway include:

• Method of referral into Lower Urinary Tract Symptoms (LUTS) clinic - does one exist? Is it efficient? How could it be improved?
• Patient assessment and selection per NICE criteria integrating opportunities for patient choice.
• Provision of appropriate structured patient training and clinical education.
• What plans are in place locally for the management of LUTS?
• Training, education and increased awareness of the available technology for other front line health care professionals - are the clinicians in your area aware of what training services are available to them?

Three pathways were developed as part of the implementation process:

Algorithim 1

Algorithim 1A

Algorishim 1B

Each pathway provides guidance and thoughts as to how you might structure your service - but it is for local implementation teams to decide on which pathway (or which parts of the pathways provided) is right for them and the local health economy they serve. Discussing these pathways as an implementation team to assess their impact at a local Trust level is crucial.

Impact Evaluation

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.

Effective evaluation will allow 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. The following questions should be addressed when planning the evaluation of implementation.

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 Trust use the technology to evaluate teaching and learning?
6. What Trust-wide mechanism will be created to allow changes in the implementation of the technology and the plan itself?

A summary of the issues found during the NTAC implementation project, which Trusts moving forward will need to consider as part of the overall evaluation process, include:

• Assessing the patient clinically and ensuring that there are no contra-indications to the performance of the test and this may include severe urinary incontinence for example.
• Despite being on the market for several years there is still a widespread lack of understanding amongst clinical staff about the appropriate use of the test.
• Identifying a suitable position in the patient pathway, where the technology is both safe and effective, required analysis of the data and major involvement of the clinical team.
• Patients must be well managed in order to get the best from the technology. This includes explaining the test to them fully and making sure they are truly ready and relaxed before voiding.
• Increased awareness of the technique is still necessary. Locally, it has been noted that there is an increased acceptance of the technique with training and clarification of the exact role the technology can play in managing patients.
• The number of patients who have unsuccessful tests can be significantly reduced with good management of patients.
• Patients tolerate the test extremely well; for the men who need to have invasive Urodynamics in addition to the non-invasive cuff test, this is minimal trouble
• The test in very easy to perform and staff can become confident and trained to use the machine in very little time.
• A change in attitude to the well established patient management in males with suspected obstruction must be made.
• Demonstrating locally that the non-invasive cuff test can have a positive impact on the management of patients with suspected Bladder Outlet Obstruction.

Measurements of Success

The primary task of implementing this technology is to improve patient outcomes during the diagnostic pathway. A fundamental goal for Trusts moving forward is to measure the impact of this technique and identify the potential benefits, costs and practical issues associated with the routine implementation of the non-invasive cuff test.

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:

• Assess the diagnostic accuracy and the patient acceptability of the penile cuff tes
• Assess the application of the technology to the clinical setting and the potential role that the penile cuff test could play in the diagnostic pathway of men complying of voiding Lower Urinary Tract Symptoms.

By using the diagnostic pathway, a successful implementation of the non-invasive cuff test should have no impact on quality of outcome for patients whilst reducing the number of invasive urodynamics test by up to 25% in some cases.

Staff at both of NTACs project implementation sites found that the non-invasive cuff test technology simple to use and no problems were experienced with implementation.

Project Outcome Measures

The Physiological Sciences group at Leeds St. James' Hospital set up an investigation to compare the diagnostic accuracy and patient acceptability of the non-invasive cuff test to the gold standard investigation for bladder outlet obstruction in men, invasive Urodynamics or pressure flow studies. The protocol is summarised below:

• Consenting males had routine pressure flow studies, as well as a non-invasive cuff test.
• Pressure flow studies were performed according to International Continence Society guidelines [link].
• BOO was classified by the International Continence Society nomogram and the Abraham Griffiths number.
• The bladder was then refilled and a non-invasive cuff test performed.
• Results from the pressure flow studies were independently compared with the results of the cuff test.
• Patients were asked to complete a questionnaire to indicate their level of discomfort and embarrassment

The key to delivering the guide was based upon the following framework below;

• To assess the technology adoption issues associated with real time clinical and operational use of the technology
• To identify the benefits and barriers to implementation
• To determine the impact that adoption of the non-invasive cuff will have on the use of NHS resources and the associated financial implications.
• To devise potential diagnostic algorithms which incorporate the cuff test and aim to maximise the cost effectiveness of the test by identifying the most appropriate patient pathway.

St. James University Hospital, Leeds

Click here for result data from St James Hospital.

In summary 61 cuff tests were performed as part of the investigation and many positive outcomes were found. The test compared extremely well with invasive urodynamics, in that where both investigations were successfully completed 25% of patients diagnosed as obstructed by pressure-flow studies were all classified as obstructed by the cuff test. In addition, the patient feedback showed a unanimous preference for the cuff test over catheter based pressure flow studies.

Most significantly:

• Every non-complicated patient diagnosed as obstructed by the cuff test was diagnosed as obstructed in invasive urodynamics.
• One fifth of the patients diagnosed as unobstructed or equivocal by the cuff test were actually diagnosed as obstructed on invasive urodynamics.

Southmeads Hospital, Bristol

A total of 60 men had non-invasive cuff tests performed and were recruited to the study. All the recruited men successfully completed the penile cuff test, with 92% of tests yielding interpretable results.

As such, the initial results suggest that clinicians can safely consider a result of obstruction on the non invasive cuff-test as a reliable indicator when treating patients suspected of BOO. Additionally, the fifth of men in whom a diagnosis of obstructed was missed by the cuff test , were not be misdiagnosed as they will be automatically sent for invasive urodynamics. The small amount of time taken and minimal trauma associated with the test mean that a minority of patients having two investigations is outweighed by the significant number of men avoiding invasive urodynamics.

The findings comparing the two diagnostic investigations can be found using the downloadable resouces located on the left colum of this page.

The conclusion of the work undertaken can be seen in the development of a new diagnostic pathway which includes the test and is further described in the pathway section.

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