Download Clinical audit tool

Crohn’s disease: inducing
remission
Clinical audit tool
Implementing NICE guidance
2012
NICE clinical guideline 152
Clinical audit tool: Crohn’s disease – inducing remission (2012)
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This clinical audit tool accompanies the clinical guideline: Crohn’s disease:
management in adults, children and young people.
Issue date: 2012
This document is a support tool for clinical audit based on the NICE guidance. It is not
NICE guidance.
Acknowledgements
NICE would like to thank the following people who have contributed to the development
of this clinical audit tool and have agreed to be acknowledged:
Wendy Lefort, Clinical Quality Review Manager, NHS Cambridgeshire
Josephine Onianwa, Quality Performance and Development Officer, London Borough
of Tower Hamlets
Gaynor Smith, Clinical Audit/R&D Training Co-ordinator, Burton Hospitals NHS
Foundation Trust
NICE has adapted the action plan template produced by the Healthcare Quality
Improvement Partnership (HQIP) in their template clinical audit report.
National Institute for Health and Clinical Excellence
Level 1A, City Tower, Piccadilly Plaza, Manchester M1 4BT; www.nice.org.uk
© National Institute for Health and Clinical Excellence, 2012. All rights reserved. This material
may be freely reproduced for educational and not-for-profit purposes. No reproduction by or for
commercial organisations, or for commercial purposes, is allowed without the express written
permission of NICE.
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Crohn’s disease clinical audit tool
This document can be used as a starting point for a local clinical audit project that aims
to improve treatment for inducing remission and add-on treatments in people with
Crohn’s disease. It contains:
 clinical audit standards
 a data collection form
 an action plan template.
The audit standards and data collection form can be adapted to focus on a smaller part
of the tool or expanded to include other local priorities.
The audit could be carried out in the following services: gastroenterology services and
dietetic services.
The audit should involve clinical and non-clinical stakeholders, which may include
gastroenterologists, pharmacy staff, clinical audit staff, patients and their families or
carers.
The audit sample should include all people with a diagnosis of Crohn’s disease
(auditors may wish to obtain a sample of patients using ICD-10-CM diagnosis code
K50.9 Crohn’s disease, unspecified). Advice on how to decide on sample size is
available on HQIP’s website.
The audit standards are based on the NICE clinical guideline for Crohn’s disease. In
developing this tool consideration has been given to the clinical issues covered by the
guideline, and the potential challenges of data collection. There may be other
recommendations within the guideline suitable for the development of audit standards
or an audit project.
A baseline assessment tool is available. This can help to compare practice with the
guideline’s recommendations and prioritise implementation activity, including clinical
audit.
The audit could be considered with other clinical audits such as:
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 NICE technology appraisal guidance 187 Infliximab and adalimumab for the
treatment of Crohn’s disease
 NICE clinical guideline 118 Colonoscopic surveillance for prevention of colorectal
cancer in people with ulcerative colitis, Crohn’s disease or adenomas.
The audit standards in this document include a reference to the guideline
recommendation numbers, and any associated NICE quality standard statements
and exceptions. Exceptions not explicitly referred to in the guideline can be added
locally, for example, patients declining treatment.
NICE recommends compliance of 100%. If this is not achievable an interim local target
could be set, although 100% should remain the ultimate aim.
A data collection form should be completed for each patient. There is a section for
demographic information that can be completed if this information is essential to the
project. Patient identifiable information should never be recorded.
Following the audit the action plan template can be used to develop and implement
an action plan to take forward any recommendations made.
Re-audit is a key part of the clinical audit cycle, required to demonstrate that
improvement has been achieved and sustained. Once a re-audit has been completed,
the shared learning database can be used to share the experience of putting NICE
guidance into practice.
For further information about clinical audit refer to a local clinical audit professional in
your own organisation or the HQIP website.
To ask a question about this clinical audit tool, or to provide feedback to help inform
the development of future tools, please email [email protected].
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Standards for Crohn’s disease clinical audit
Audit standard
Guidance
reference
Exceptions
Definitions
1.2.1
None
The guidance recommends that patients should
be offered this intervention. The recommendation
uses the word ‘offer’ rather than ‘prescribe’ to
emphasise the patient’s role in decision-making
and the need for them to consent to treatment.
1.2.3
None
The recommendation uses the word ‘consider’ to
reflect the strength of the recommendation. Before
using this audit standard local agreement should
be sought.
Inducing remission: monotherapy
1. All people with a first presentation or a single
inflammatory exacerbation of Crohn’s disease in a 12month period are offered monotherapy with a
conventional glucocorticosteroid (prednisolone,
methylprednisolone or intravenous hydrocortisone) to
induce remission.
[See data collection form, questions 1 and 3]
2. In all people with 1 or more of:

distal ileal

ileocaecal or

right-sided colonic disease
Choice is more likely to depend on a patient’s
values and preferences. A target compliance of
less than 100% may be appropriate.
who decline, cannot tolerate or in whom a conventional
glucocorticosteroid is contraindicated, budesonide is
considered for a first presentation or a single
inflammatory exacerbation in a 12-month period.
It is explained that budesonide is less effective than a
conventional glucocorticosteroid but may have fewer side
effects.
[See data collection form, questions 1, 2, 4, 9 and 10]
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Audit standard
Guidance
reference
Exceptions
Definitions
3. In all people who decline, cannot tolerate or in whom
glucocorticosteroid treatment is contraindicated, 5aminosalicylate (5-ASA) treatment is considered for a first
presentation or a single inflammatory exacerbation in a
12-month period.
1.2.4
None
The recommendation uses the word ‘consider’ to
reflect the strength of the recommendation. Before
using this audit standard local agreement should
be sought.
Choice is more likely to depend on a patient’s
values and preferences. A target compliance of
less than 100% may be appropriate.
It is explained that 5-ASA is less effective than a
conventional glucocorticosteroid or budesonide but may
have fewer side effects than a conventional
glucocorticosteroid.
[See data collection form, questions 1, 5, 9 and 11]
4. Budesonide or 5-ASA treatment are not offered for severe
presentations or exacerbations.
1.2.5
None
None
1.2.6
None
None
1.2.7
None
The recommendation uses the word ‘consider’ to
reflect the strength of the recommendation. Before
using this audit standard local agreement should
be sought.
[See data collection form, question 12]
5. Azathioprine, mercaptopurine or methotrexate are not
offered as monotherapy to induce remission.
[See data collection form, question 6, 7 and 8]
Inducing remission: add-on treatment
6. In all people in whom:

there are 2 or more inflammatory exacerbations in a
12-month period, or

the glucocorticosteroid dose cannot be tapered
Choice is more likely to depend on a patient’s
values and preferences. A target compliance of
less than 100% may be appropriate.
adding azathioprine or mercaptoturine to a conventional
glucocorticosteroid or budesonide is considered to
induce remission of Crohn’s disease.
[See data collection form, questions 13, 14, 15 and 16]
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Audit standard
7. All people have thiopurine methyltransferase (TPMT)
activity assessed before azathioprine or mercaptopurine
is offered.
Guidance
reference
Exceptions
Definitions
1.2.8 [key
priority]
None
None
1.2.9
None
The recommendation uses the word ‘consider’ to
reflect the strength of the recommendation. Before
using this audit standard local agreement should
be sought.
Azathioprine or mercaptopurine are not offered if TPMT
activity is deficient (very low or absent).
[See data collection form, questions 15, 16, 18 and 19]
8. In all people who cannot tolerate azathioprine or
mercaptopurine, or in whom TPMT activity is deficient,
methotrexate is considered as an addition to a
conventional glucocorticosteroid or budesonide to induce
remission if:

there are 2 or more inflammatory exacerbations in a
12-month period, or

the glucocorticosteroid dose cannot be tapered.
Choice is more likely to depend on a patient’s
values and preferences. A target compliance of
less than 100% may be appropriate.
[See data collection form, questions 13, 14, 17, 18, 19, 20 and
21]
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Data collection form for Crohn’s disease clinical audit: inducing
remission
Audit ID:
Sex:
Age:
The audit ID should be an anonymous code. Patient identifiable information should never be recorded.
White
British
Irish
Any other white
background
No
Mixed
White and black
Caribbean
White and black
African
White and Asian
Asian or Asian British
Indian
Black or black British
Caribbean
Other
Chinese
Pakistani
African
Bangladeshi
Any other black
background
Any other
ethnic group
Not stated
Any other mixed
background
Any other Asian
background
Question
Yes
No
Exception
/NA/Notes
Inducing remission: monotherapy
1
Was this:
 a first presentation

2
3
a single inflammatory exacerbation of Crohn’s in a
12-month period?
Did the person have (please tick all that apply):

distal ileal disease

ileocaecal disease

right-sided colonic disease?
Was the person prescribed:
 monotherapy with a conventional glucocorticosteroid
4

budesonide
5

5-ASA
6

azathioprine
7

mercaptopurine
8

methotrexate?
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9

10

11
12

Was a glucocorticosteroid:

not tolerated

contraindicated

declined?
Was it explained to the person that budesonide is less
effective than a conventional glucocorticosteroid but may
have fewer side effects?
Was it explained to the person that 5-ASA is less effective
than a conventional glucocorticosteroid or budesonide but
may have fewer side effects than a conventional
glucocorticosteroid?
Was the patient prescribed budesonide or 5-ASA following
a severe presentation or severe exacerbation?
Inducing remission: add-on treatment
13

Did the person have 2 or more inflammatory exacerbations
in a 12-month period? Or
14

Could the glucocorticosteroid be tapered?

Were any of the following added to the glucocorticosteroid
or budesonide to induce remission of Crohn’s disease:
15

azathioprine (go to question 18)
16

mercaptopurine (go to question 18)
17

methotrexate?
18

Was TPMT activity assessed before prescribing
azathioprine or mercaptopurine?
19

Was TPMT activity deficient (very low or absent)?

Were the following tolerated:
20

azathioprine
21

mercaptopurine?
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Action plan for Crohn’s disease clinical audit
KEY (Change status)
1 Recommendation agreed but not yet actioned
2 Action in progress
3 Recommendation fully implemented
4 Recommendation never actioned (please state reasons)
5 Other (please provide supporting information)
Action plan
lead
Name:
Title:
Contact:
The ‘Actions required’ should specifically state what needs to be done to achieve the recommendation. All updates to the action plan should be
included in the ‘Comments’ section.
Recommendation
Actions required
(specify ‘None’, if
none required)
Action by
date
Person
responsible
Comments/action status
(Provide examples of action in progress,
changes in practices, problems
encountered in facilitating change, reasons
why recommendation has not been
actioned etc.)
Change
stage
(see Key)
When making improvements to practice, organisations may like to use the tools developed by NICE to help implement the clinical guideline on
Crohn’s disease.
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