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This information has been prepared by the Modernisation Agency and the National
Institute for Clinical Excellence to support the development of protocol-based care within
the NHS in England. It may also be of interest to those working in the NHS in Wales.
The documents do not represent formal NICE guidance to the NHS.
1
Key steps to developing protocols
Twelve Five
REVIEW THE BUILD
PROTOCOL AWARENESS &
COMMITMENT
Eleven Six
MONITOR GATHER
VARIATION INFORMATION
2
Key steps to developing protocols
Step One
Select and Prioritise a Topic
1. The topic to be covered by the protocol National standards 4. The following considerations may be
should be selected through two 2. These contain detailed guidance – based useful in selecting an area to work on:
main routes: on research evidence – on the processes • priority should be given to
• the publication of national standards of care that need to be in place at a development of protocols to support
• the identification of local service local level to deliver and achieve best the implementation of NICE guidance,
improvement priorities. practice. They will provide a framework NSFs, Department of Health (DH)
for local groups to develop protocol- strategies and modernisation initiatives
It is also important to consider the based care; an example is the NICE • also look for topics with one or more
context in which the protocol will be guideline on pressure ulcer risk of the following characteristics:
used, because this will determine the assessment and prevention.
– the disease follows a relatively
basis for its development. Examples are predictable course and the process
given below. Identification of local service
of care is relatively standardised
improvement priorities
– large numbers of people require
3. NICE guidance, National Service
care for the condition or disease
Frameworks (NSFs) and other national
standards do not cover all areas of – the procedure is very high cost
patient care. A number of – the procedure is low volume
organisations have used the – the area represents a high risk to
development of protocol-based care to the organisation
review and improve complex local
– the area is highlighted for action
systems, and to streamline the delivery
by the Commission for Health
of care – for example in hospital
Improvement, the Audit Commission
accident and emergency departments,
or Mental Health Act Commissioners
or in treating stroke patients –
according to local priorities. – clinical governance considerations
indicate that action is necessary
– information from patient complaints
suggests that action is necessary
Examples of types of protocols – new evidence has become available
– patients and service users express
Type of protocol Example interest in a particular issue or area.
disease-based diabetes, asthma, stroke, cancer
problem-based chest pain, disturbed behaviour, anxiety
treatment-based hip replacement, cataract removal
client-group-based people with learning disabilities,
neonates, older people
3
Step Two
Set up a Team
5. Experience has shown that the • administrative and clerical support to: 9. Once the team is established, it will
involvement of the staff responsible for – arrange meetings need to agree the role of the group
the hands-on delivery of care is central and its terms of reference. It may be
– minute discussions and decisions
to the successful development and use helpful for the group to manage its
of protocols. The first step in the – prepare documentation progress by agreeing:
process, therefore, is to set up a multi- • a protocol co-ordinator to: • a communications plan (see Annex 2)
disciplinary team, made up of all – link protocol development • the timescale for the project
clinical and non-clinical staff involved in projects across the organisation
care delivery. • a project plan and meeting schedule
– provide expert advice on the (see Annex 3)
development of protocols
6. In selecting members for the team, a • an implementation plan with links to
number of roles will need to be – support the clinical leader local commissioning and contracting
agreed, and some people may fill more – support implementation processes (see Step 10)
than one role. Although there are no • information support from NHS library • goals and objectives for the protocol
hard and fast rules about how many services, such as document search (see Step 4).
people to have in a team, experience and delivery.
suggests that large groups can become
10. Although there is no set view on the
unwieldy, and that the optimal number
7. The team should have access to clearly time that it should take to develop a
of people to have in a team is between
identified resources, for example, to protocol, the experience of people who
6 and 10. Those setting up the team
make notes of meetings, to record have successfully developed them
should consider including:
decisions taken and to prepare suggests that it is reasonable to expect
• a clinical leader to: documentation. In the early stages at the process to take between three and
– facilitate discussions least, the team may benefit if its work six months from start to implementation.
– ensure integration with clinical audit is facilitated by a co-ordinator who has
credibility with all its members. Most
– link work with teaching and
importantly, the team should reflect a
change management
broad range of opinions and ideas in
– maintain momentum for the project order to identify, and then implement,
– help group members to challenge the most effective standards of care.
current practice constructively
• a clinical champion 8. The team should also look at how it
will link into local priorities and its
• patient and user representation
organisation’s processes to secure and
(see Step 3)
provide services relevant to its
• an information specialist or analyst to population.
advise on the organisation’s systems for
information management, the analysis
of local information, and the use of
information technology
• a Caldicott guardian (or equivalent)
to advise on information sharing to
support the delivery of care
• clinical and non-clinical staff
representatives who cover the wide
range of groups involved in the
delivery of care
4
Key steps to developing protocols
11. Involving patients is essential in 12. Various mechanisms can be used to 13. It is important that any protocol should
planning service improvements. Indeed, involve patients and users in the be associated with clear objectives that
one of the key principles underpinning decisions on current service are specific, measurable and have targets
the NHS Plan and the Government’s development. For example, information for achievement (see table right). In
overall strategy for modernising the could come from: setting objectives, the development
health service is that the views of • patient representatives on the protocol team should identify targets that are
patients and their carers, relatives and development team achievable, but sufficiently challenging to
representatives should inform the way lead to real service improvements. NSFs
• consumer or interest group
local NHS services are designed and and guidance issued by NICE contain
representatives on the protocol
delivered. The involvement of patients audit criteria that can be used to inform
development team
and service users is, therefore, an local objectives.
essential part of the process of • patients’ forums – Patient Advice and
developing a protocol, and it is Liaison Services (PALS) need to be 14. It is important to ask staff what
extremely important that they should included because their reports will particular problems or barriers to
be actively involved in the decision- provide views effective care delivery they experience,
making process. It may be useful to • patient associations and agree which of these can be
produce a summary of the protocol for • complaints translated into objectives for the
patients and service users. protocol. The patient perspective will
• analysis of patient and user feedback –
also be useful here.
both positive and negative.
5
Examples of objective setting
Elimination of unexpected overnight Number of overnight stays, 50% reduction in one year
stays in acute unit after day surgery with reason
Reduction of inappropriately % of antibiotics inappropriately reduction by 50% in each of the next 3 years
prescribed antibiotics prescribed/per month
Reduction in the number % of medication errors/per month Increase reporting but decrease severity
of medication errors
Increased patient satisfaction with care Documented patient agreement to care 100% of patients
through the provision of information (including information sharing)
Elimination of long waits (> 4 hours) Number of patients waiting over 4 hours Nil
in A&E departments in A&E departments
Introduce nurse-directed requests % of requests initiated by nurses Could be variable, depending on the type
for radiology in A&E departments of request. For example, 100% requests
from a minor injuries patient stream or
suspected fracture neck of femur; 50%
increase in nurse-requested chest x-ray
Increase the number of patients % of patients attending each service Differentiate for different conditions.
transported after 999 calls to minor (separated by condition/presentation) For example, 15% of the total with
injury units, walk-in centres and an increasing target year by year
primary care centres as alternatives
to A&E departments
Reduction in the number of patients Present measures of delayed Reduce to <3% of acute beds
in hospital awaiting transfer of care transfer of care. % of patients
delayed for NHS reasons
6
Key steps to developing protocols
Step Five
Build Awareness and Commitment
7
Step Six
Gather Information
19. Information should be sought on: 21. The development team will also find it 23. Protocols should be built on an
• national standards useful to have a clear understanding, evidence base of what is required to
perhaps from their organisation’s achieve good care. If there are limited
• published evidence of good practice
business plan, of their service objectives sources of information about the area
• other organisations’ experience and and of any plans to change or develop of care under consideration, then the
protocols the organisation’s strategic direction. team will need to reach a consensus
• the views of patients and service This will help them decide which areas on good practice. It is not always easy
users, through local information and should be priorities for action. to reach a well-founded judgement
the programme of national surveys when there is a lack of reliable
of patient experience, and in relation 22. The booklet Where to Get More Help evidence. Therefore, it may be wise –
to NSFs. and Information describes a number of at least in early work – to develop
sources of information and how these protocols for diseases or conditions
20. The development team should clarify can be accessed. The National where there is a national standard of
and build on the arrangements within electronic Library for Health contains good practice.
their own organisation for receiving examples of protocols that have been
national standards such as NICE used elsewhere in the service. While 24. Sources of data for establishing a
guidance and NSF publications, and these may need to be adapted or baseline of current performance can
ensure that these are distributed to the enhanced to satisfy emerging also be identified at this stage.
appropriate areas and their requirements, they can be useful to the Remember to seek advice from
implementation monitored. development team, since they can give Caldicott guardians if handling
ideas on the content and format of the confidential patient information. Links
protocol. NHS libraries can also offer should also be made into the local
access to a wide range of relevant audit team and their procedures. The
knowledge sources, and early contact published national indicators of clinical
with library staff will enable them to performance may also be a fruitful
best assist the team. Some areas have source for identifying areas for
designated clinical librarians working development. Likewise, the annual
within clinical teams. consultation exercise on what should
be included in national performance
indicators, and the responses to
consultation, may help identify areas
for future coverage by protocols (see
also paragraph 47).
8
Key steps to developing protocols
Step Seven
Baseline Assessment
25. The next step is to determine the 27. The high-level map will form the basis
baseline of current performance. of a more detailed mapping process.
This can help the team to analyse This process should describe how care
local services and to identify where is delivered in practice, and should
improvements might be made. Sources include a timeframe of interventions
of data for evaluating the baseline and the points at which decisions are
will have been collected during the normally taken. An analysis of case
information-gathering stage, and notes may also offer a good insight
analysis of the data should begin to into how care is delivered under the
highlight where there are shortcomings current arrangements. It may also be
in the current service and where the helpful to use one-to-one interviews
most valuable improvements can with key stakeholders, and group
be made. sessions with patients and staff, to get
a wide perspective on service provision.
26. The development team will need to
map the care provided for the chosen 28. An important objective will be to
group of patients. For some conditions understand who needs to see what
this can be complex. The Service information about patients. This will
Improvement Directorate, part of the ensure that a clear statement of
Modernisation Agency, has worked information-sharing proposals are
with more than 500 local clinical teams provided to patients and
and their experience has shown the agreement/consent on these is
clear benefits of the creation of a obtained at the same time as
simple, high-level process map giving agreement to the protocol.
the main elements that are currently
used to deliver the care objective. An
example of a process map is given in
Annex 4. To establish the areas for
improvement, a process map will need
to go to a deeper level, revealing a
greater number of process steps.
9
Step Eight
Produce the Protocol
29. The development team will need to 32. The level of patient and carer access to • specifies which groups of staff, in
review and confirm their objectives for the protocol should also be agreed at which organisations, will require access
the protocol before starting the this stage. Ideally this will be full to confidential patient information, and
creation of the document. Successful access, perhaps to a concise, lay links appropriately to information-
protocols are simple documents that reader’s version, since the protocol is a sharing protocols and security policies
guide staff through the process. They valuable source of information and developed through work on Caldicott
are not comprehensive documents that supports effective communication and information governance
describe how each procedure is between the patient and the • can be tested against the targets and
delivered to the patient. professional team. objectives agreed at the start of the
development process
30. Electronic patient records and decision- 33. The protocol should be submitted for
• gives a name and contact number –
support systems can be an integral part approval so that it can be signed off at
the clinical leader or protocol co-
of the development and application of a corporate level before proceeding to
ordinator, for example – for questions
a protocol. However, good, paper- the pilot phase. Each organisation
or further copies of the protocol
based records systems are currently the should have its own system of
most frequently used, can readily delegated authority for such approval, • has a reference at the bottom of the
support protocol-based care, and can which could include the patients’ document to the date of the protocol
form the basis of an electronic system forum. As a final check before sign off, or version number, and the review date.
once the necessary information the development team may find it
technology infrastructure is in place. helpful to confirm that their protocol:
The use of protocols will also link into • focuses on the needs of patients and
the use of disease management users of the service
registers and standard templates.
• creates a single record of care (it
should contain information about all
31. The team will need to agree an
aspects of the care and treatment
appropriate format and try it out to
delivered to the patient during a
ensure that it is easy to use. Some
sequence of care)
organisations may have developed a
corporate format for protocols that • is simple in design and easy to use
contains standardised core elements. • is short and concise
This has benefits for staff caring for • follows a logical sequence
patients on more than one protocol, for
• makes information easy to find – some
example a patient with diabetes who
organisations use colour coding of
also requires a hip replacement.
sections to assist rapid retrieval of
However, there can be merit in allowing
information
flexibility for non-core features, to make
sure that it meets the needs of staff • includes realistic goals, timeframes, and
who will be using the subsequent measurable outcomes
record as their principal record of care. • makes variations from care, the reasons
As always, care will need to be taken to for them, and the alternative actions
ensure that patient agreement and taken, easy to record
consent is gained for the treatment • facilitates audit
plan, including the use of the protocol
and to the information sharing • highlights responsibilities, including
described in it. accountability for the completion of
each part of the protocol
10
Key steps to developing protocols
Step Nine
Pilot the Protocol
34. Implementation should start with a 37. It should be audited against the agreed • Is the number of patients included in
pilot phase. This will help to address objectives. Comparative before-and-after the pilot sufficient to ensure that it can
any operational problems, and will studies could be helpful, depending on be properly evaluated?
provide reassurance to staff that the the length of the pilot phase. • How will staff be trained to use the
new system is not set in stone but can protocol?
be modified if necessary to make sure 38. Once the pilot phase has been
• How will staff be supported in the use
that it delivers the expected benefits. completed, the protocol should be
of the protocol after the initial training?
amended if necessary and then
35. Before work starts, the team should submitted for approval so that it can • How will compliance with the protocol
make sure that staff who will be using be signed off corporately as well as at be monitored and how will patients
the protocol fully understand it and an operational level. and users of the service be involved in
have received any training they need to the process?
use it. They will also need to agree Suggestions for implementation • Is the data on variances collected
how the pilot phase will be evaluated of the pilot phase and can this be incorporated into
and how long it will last. It is important 39. Factors that may need to be considered clinical audit?
to nominate a particular person to be when setting up the pilot include the • How can good feedback be obtained
responsible for collecting the following. and who will collect it?
information necessary for evaluation.
• When will the pilot phase start and • How will issues and problems be dealt
finish? with as they arise?
36. At the end of the pilot phase, the
protocol will need to be evaluated for • Which part of the service(s) will do the • How will people know what is
its ease of use, its effectiveness, and pilot? happening during the pilot phase?
its impact on: • How many patients should be included • How will the success of the pilot phase
• patients in the pilot and, if a sample is used, be evaluated?
how will monitoring be undertaken to
• staff
see how well the protocol is being
• clinical and social care teams followed?
• supporting departments
• clinical governance and clinical audit.
11
Step Ten Step Eleven Step Twelve
Implement the Protocol Monitor Variation Review the Protocol
40. The pilot phase should iron out the 44. Documenting variations from the 46. It is important to keep protocols under
majority of operational problems with protocol helps to establish what review to:
the protocol and highlight areas for happens in practice. It provides a • measure and quantify benefits to
training, and its evaluation should mechanism that allows staff to seek patients and staff
provide clear evidence of its feedback from a patient or a user
• ensure that objectives continue to be
effectiveness. Early links should be group, to assess if patients are
met and remain appropriate
made with local commissioning and progressing as expected, and to use
contracting processes. This will their clinical judgement to agree with • ensure that all new staff receive
support the implementation of the the patient what action is best, or to training in the use of protocols
protocol and commissioners may want review the overall operation of the • take account of additional information
to include agreed protocols in their protocol. It also makes it easier, should such as new and revised NICE
Service Level Agreements. Once the something go wrong or become the guidance, or patient safety alerts issued
team is satisfied that the protocol is subject of a complaint, to explain why by the National Patient Safety Agency
operating satisfactorily and capable of a particular course of action was taken. • keep up-to-date with changes in
delivering the expected results, staff clinical practice
should proceed to implementation. 45. The information recorded as a variation
• ensure full integration with clinical
should include:
governance arrangements
41. Experience has shown that full • details of the variation
implementation should be supported • support the implementation of national
• the action taken standards, which are regularly reviewed
by a detailed training programme for
the staff who are to use the protocol. • the date and time to ensure that they remain up-to-date.
Members of the development team • the signature of the person completing
could undertake this, or be involved in the information. 47. The review process will also feed back
the design and planning of training to into the account of the Trust’s
be carried out by others, since they will performance against the Performance
be familiar with the protocol and the Assessment Framework
rationale behind it. (www.doh.gov.uk/nhsexec/nhspaf.htm),
support local clinical governance
42. Training should be supported by arrangements, and inform the further
written instructions on how to use development of local planning
the protocol and contact details of (www.doh.gov.uk/ldp2003-2006/).
a nominated member or members
of the development team in case 48. In addition, results from the review
there are difficulties in using the process may be useful in informing
protocol document. national consideration of the
information needed to support clinical
43. Many organisations have found it care, and the implementation of
useful to identify an individual within electronic patient records as part of the
the team delivering care to be Information for Health initiative. The
responsible for maintaining the review process may also help to inform
protocol, in order to ensure that it responses to the annual national
forms an integral part of daily practice consultation on performance indicators
and is sustained over time. by giving evidence of the derivation of
standards, and ways of monitoring
quality, that are applicable nationally as
well as locally.
12
Annex 1 Decision Support Systems
More information about PRODIGY can be In addition to its use in NHS Direct, NHS
found at www.prodigy.nhs.uk/ CAS is also being developed to be used in
face-to-face nurse consultations, for
example, in NHS walk-in centres, A&E
departments and primary care settings.
13
Annex 2 Preparing A Communications Plan
The communications plan Agree themes and messages Implement and receive responses
It is important to develop a formal, In deciding on the themes and Having developed a communications
written communications plan. This messages you want to convey, it may plan, ensure that it is followed by
will enable you to share the plan, be helpful to define the objective of monitoring progress against the agreed
gain agreement and commitment to the protocol, and then take from this schedule. An important part of the
it, and demonstrate an organised, the information that you want to implementation process will be to
systematic approach. emphasise. It is vital to keep the receive feedback from the target
audience in mind, and to make sure audience which could come from:
In preparing a communications plan, that the messages you share are: • questionnaires and surveys
there are a number of steps to take: • clear • evaluation and feedback forms
• identify the audience • simple • an interactive website
• agree themes and messages • precise • local networks
• identify and develop tools • concise • meetings.
• implement and receive responses • relevant to users.
• review effectiveness. Review effectiveness
Identify and develop tools The audience’s responses will help you to
The communications plan needs to test the success of the communications
Identify the audience take account of the resources available plan, to evaluate whether it has
The first step is to identify those people locally, and to decide which internal influenced the audience’s behaviour, and
with whom you want to share the and external vehicles will be most if necessary, to revise and re-deliver it.
protocol. The audience may include: effective in reaching the target
• patients and service users audience. A number of different tools
can be used, such as:
• the local community
• information leaflets – for example for
• staff who will be expected to use
patients and service users
the protocol, including locum and
agency staff • posters and presentations
• the wider organisation, including the • newsletters
chief executive, senior managers and • regular reports to the Board
non-executive directors • the annual report
• other local organisations • clinical governance reporting processes
• other organisations regionally and • liaison meetings with partner
nationally, in order to share learning. organisations
• study days
You may want to make a list of contacts.
• the organisation’s website.
14
Annex 3 Preparing a Project Plan
15
Annex 4 Preparing a Process Map
Project Name
Project Definition
Task Allocation
Estimate of
Resource Requirements
Project Scheduling
Project Review
16
Annex 4 Preparing a Process Map
A process map is, in essence, a plan of the Non-acute admission to community hospital
patient’s journey through care. It allows the
care team to identify each of the stages in
delivering care to a client group, and to Onset of Illness
understand the relationships between
these stages. It also enables the care team
to identify points of potential improvement
in the care process, points at which
GP Visit
unnecessary duplication is likely to occur,
and to identify staff roles/hand-offs.
Often, a process map will be quite GP Referral
straightforward, but this depends on what
you are trying to show. An example of a
process map is included below. (NB For
the purpose of process redesign and the Referral Processed
delivery of a service improvement, the
process will need to be mapped in more
detail, to reveal the many process steps.)
Admission
Assessment
Care Plan
(PLUS ARRANGEMENTS FOR DISCHARGE)
Care Management
Discharge
(HOME OR PRIMARY AND/OR COMMUNITY HEALTH AND SOCIAL CARE)
17