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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) 1 of 10 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. Clinical audit tool: Crohn’s disease – inducing remission (2012) 2 of 10 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: Clinical audit tool: Crohn’s disease – inducing remission (2012) 3 of 10 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]. Clinical audit tool: Crohn’s disease – inducing remission (2012) 4 of 10 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] Clinical audit tool: Crohn’s disease – inducing remission (2012) 5 of 10 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] Clinical audit tool: Crohn’s disease – inducing remission (2012) 6 of 10 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] Clinical audit tool: Crohn’s disease – inducing remission (2012) 7 of 10 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? Clinical audit tool: Crohn’s disease – inducing remission (2012) 8 of 10 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? Clinical audit tool: Crohn’s disease – inducing remission (2012) 9 of 10 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. Clinical audit tool: Crohn’s disease – inducing remission (2012) 10 of 10