Standard Operating Procedure Completion of DAFNE data collection: Core baseline form F04.007

Transcription

1 Standard Operating Procedure Completion of DAFNE data collection: Core baseline form F DAFNE P version 10, February of 10

2 CONTENTS Introduction... 3 Patient DAFNE number... 3 Type of DAFNE course attended... 4 Number of course days attended... 4 Is the patient repeating a DAFNE course?... 4 Does the patient have Type 1 diabetes? Date of data collection Year of birth Year of diagnosis Course date Gender Ethnicity HbA1c Weight Height Are you being considered for insulin pump therapy? How many admissions due to DKA Number of blood glucose tests Have you had a hypoglycaemic episode you were unable to treat? Total number of hypoglycaemic episodes unable to treat themselves Total number of hypoglycaemic episodes requiring paramedic assistance Total number of hypoglycaemic episodes requiring A&E Blood glucose range when symptoms of hypoglycaemia usually occur... 6 Insulin Adjustment pre-course... 7 A. Pre-DAFNE Insulin type... 7 B. Pre-DAFNE Average daily dose... 7 C. Pre-DAFNE QA:CP Ratios... 7 D. Pre-DAFNE Number of injections per day... 7 E. Recommendations for insulin regimen for the start of the DAFNE course... 8 Signature... 9 DAFNE P version 10, February of 10

3 Introduction This document lists the acceptable responses for each question on the DAFNE data collection: core baseline form (F04.007). This data collection form must be used by all DAFNE centres. The core baseline form (F04.007) should not be used if the patient is involved in any DAFNE research programme as alternative data sets will be used for research. Everyone who completes a core baseline form (F04.007) must familiarise themselves with the contents of this SOP and complete their details in the table on the final page of this procedure. In addition a copy of this SOP should always be available for reference. The primary aims of this document are to enable uniformity of form completion across all centres and to help prevent inappropriate responses being recorded. It is of the utmost importance that every question is answered appropriately and no question is left blank. It is also important that clinical personnel appreciate that the people entering data onto the database may not be medically trained. Therefore please take care when recording responses. Patients should be reminded to bring along their blood monitoring diaries (if they have them) for the past 6 months, to enable question 12 to be completed accurately. If there are any queries regarding this SOP or the core baseline form itself, please contact the central DAFNE team on or dafne@nhct.nhs.uk. Patient DAFNE number Insert the patients unique DAFNE number at the top of the page. The patient s unique DAFNE number is a two-part number formed from the DAFNE centre number and a patient number --- / ---- Centre number Patient number Each DAFNE centre is allocated a three digit number. To find out your centre s DAFNE number please contact the central DAFNE team. The second part of the patient DAFNE number relates to the patient. Patients planning to complete a DAFNE course should be allocated their unique DAFNE number at the commencement of their course. This patient number should run sequentially from 0001 for the first DAFNE patient onwards. For example the 383 rd DAFNE patient to attend a DAFNE pre course data collection clinic at Anytown (999) would have the following unique DAFNE number. Patient DAFNE number: 999 / 0383 Note: The patient s name and hospital number must not be used as the DAFNE patient number. DAFNE P version 10, February of 10

4 Type of DAFNE course attended Record the type of DAFNE course (standard 1 week, DAFNE modified 5 week or DAFNE modified pump) attended by the patient by deleting the options which do not apply. Only select one option. Number of course days attended Record the number of days the patient attended the course by entering a value of 1 to 5. Is the patient repeating a DAFNE course? Indicate by placing a tick in the appropriate box whether or not the patient is repeating a DAFNE course. If yes, the following process applies: The patient is given a new DAFNE number. Core Baseline data is collected prior to the new DAFNE course. Select Yes on the data collection form for Is the patient repeating a DAFNE course? Enter previous DAFNE number in the relevant box on the new data collection form. Note: To complete the process a drop out form will need to be entered on the Clinical and Research Database for the old DAFNE number, with reason for drop out repeated a DAFNE course. Does the patient have Type 1 diabetes? Record whether the patient has Type 1 diabetes by placing a tick in either the Yes or No box as appropriate. If no, record the form of diabetes the patient has by placing a tick in the relevant box. Note: It is extremely important that patients with Cystic Fibrosis are not recorded as Type 1 in error. Please ensure care is taken when completing this section of the form. This section has been added to the form and database because some Type 2 patients have been included on DAFNE courses and have their data recorded on the database. Also, whilst we do not have any evidence to support beneficial outcomes for Type 2 insulin sensitive/ deficient patients following a DAFNE course, individuals can discuss the appropriateness of participating in DAFNE training with their local team. 1. Date of data collection Insert the day, month and year (dd/mm/yyyy) that the data is collected from the patient. 2. Year of birth Insert the year (yyyy) of the patient s birth. 3. Year of diagnosis Insert the year (yyyy) in which the patient was diagnosed as having diabetes. 4. Course date Insert the first day (i.e. the date on the Monday, or the first day of the 5x1 day course), month and year (dd/mm/yyyy) of the DAFNE course that the patient is scheduled to attend. 5. Gender Record the patient s gender by placing a tick in either the Male or Female box as appropriate. DAFNE P version 10, February of 10

5 6. Ethnicity Record the ethnicity by placing a tick in the box indicating the most appropriate ethnic group. Note: Asian refers to Indian, Bangladeshi and Pakistani descent but not Chinese, for which there is a separate option. 7. HbA1c Ideally this test is to be performed on blood sample provided on the day of data collection. However, if the patient has an HbA1c recorded in either hospital notes or on your patient data system which is less than 12 weeks old this result may be used, rather than taking an additional blood sample. The mmol/mol values entered must be within the range 20 to 195. Values outside this range will not be accepted by the database. Where a value is entered, a corresponding date must also be entered. The date must be no more than 12 weeks before the date of data collection and must be no more than 8 days after the course date. If no data is available please select the relevant no data available tick box. 8. Weight Supply the patient s weight on the day of data collection. Weight must be recorded in Kg and not stones and pounds. The weight value entered must be within the range 30 to 200. Values outside of this range will not be accepted by the database. If no data is available please select the relevant no data available tick box. 9. Height Record the patient's height on the day of data collection. Record the height in centimetres not feet and inches. The height value entered must be within the range 100 to 300. Values outside of this range will not be accepted by the database. If no data is available please select the relevant no data available tick box. 10. Are you being considered for insulin pump therapy? Record whether or not patient is being considered for, or is already using, insulin pump therapy by placing a tick in the Yes, No or Already using pump box as appropriate. Where the patient is already using a pump enter the year pump therapy commenced. 11. How many admissions due to diabetic ketoacidosis (DKA) have you had? Record the total number of DKA episodes requiring admission since the onset of diabetes and the total number in the last 12 months. If the patient has never had any such episodes record 0 (zero) in each case. The value entered must be within the range 0 to 199. Values outside of this range will not be accepted by the database. If no data is available please select the relevant no data available tick box. 12. Number of blood glucose tests Record the total number of blood glucose tests the patient has: a) Performed: this is the average number of all blood glucose tests done each day. Record the number by placing a tick in the relevant box. If the patient is using DAFNE P version 10, February of 10

6 CGM, or does more than 7 blood glucose tests each day select the 7 or more category. If no data is available please select the relevant no data available tick box. b) Recorded: this is the average frequency, over the last 2 weeks, the patient has written down / recorded (ie personal diary, spread sheet etc.) the number of blood glucose tests performed. To obtain the correct response, calculate the percentage for number of blood glucose tests recorded compared to the number performed. Place a tick in the relevant box. If no data is available please select the relevant no data available tick box. 13. In the last year have you had a hypoglycaemic episode you were unable to treat yourself? Indicate by placing a tick or a cross in the appropriate box whether or not the patient has had a hypo that they were unable to treat themselves in the last year (ie had to have someone to help them). If the patient has experienced a hypo requiring third party assistance complete all remaining questions. If the patient has not had a hypo requiring third party assistance miss out questions 14 to 16 and proceed directly to question 17. If no data is available please select the relevant no data available tick box. 14 Total Number of hypoglycaemic episodes unable to treat themselves in last year Record the actual number of hypoglycaemic episodes that the patient was unable to treat themselves in the 12 months (i.e. had to have someone help them) by entering the number in the box. The value entered must be within the range 0 to 99. Values outside of this range will not be accepted by the database. If no data is available please select the relevant no data available tick box. 15. Total number of hypoglycaemic episodes requiring paramedic assistance in the last year. Record the actual number of hypoglycaemic episodes experienced by the patient in the last 12 months requiring paramedic assistance by entering the number in the box. The value entered must be within the range 0 to 99. Values outside of this range will not be accepted by the database. If no data is available please select the relevant no data available tick box. 16. Total number of hypoglycaemic episodes requiring A&E attendance or hospital admission in the last year. Record the actual number of hypoglycaemic episodes experienced by the patient in the last 12 months requiring A&E attendance or hospital admission by entering the number in the box. The value entered must be within the range 0 to 99. Values outside of this range will not be accepted by the database. If no data is available please select the relevant no data available tick box. 17. Blood Glucose range when symptoms of hypoglycaemia usually occur. Indicate the BG range when the patient s hypo symptoms usually occur or if the patient does not feel symptoms by placing a tick in the most appropriate box. DAFNE P version 10, February of 10

7 Insulin adjustment pre-course Sections A - D record the patient s insulin regimen pre-dafne. Section E records what changes were recommended to bring insulin doses in line with the DAFNE insulin regimen and guidelines for insulin adjustment for the start of the DAFNE course (T01.025) at the pre-course appointment, irrespective of whether the patient makes these changes or not. Recommendations for insulin changes must only be made by active DAFNE educators or doctor educators who understand the DAFNE insulin regimen and guidelines for insulin adjustment for the start of the DAFNE course. A. Pre-DAFNE insulin type Record the type of quick acting, background and/or pre mix insulin used by the patient pre-dafne by ticking the appropriate responses. B. Pre-DAFNE average daily dose Record the patient s average daily dose pre-dafne of quick acting, background and/or pre mix insulin as appropriate. Minimum and maximum values for insulin regimen are shown in the example below. Values outside of this range will not be accepted by the database. Insulin Regimen Minimum Maximum Format Value Value Quick Acting (QA) Whole Background Insulin (BI) Whole Pre-mixed Insulin (Mix) Whole C. Pre-DAFNE QA:CP ratios (if used) The option to record QA:CP ratios is available in the event that ratios are in use prior to DAFNE. Minimum and maximum values for QA:CP ratios are shown in the example below. Values outside of this range will not be accepted by the database. Insulin Regimen Minimum Maximum Format Value Value QA:CP Ratios Decimal to 2 places D. Pre-DAFNE number of injections per day Record the total number of quick acting, background and pre mix insulin injections the patient has each day pre-dafne. Minimum and maximum values for number of injections per day are shown in the example below. Number of Minimum Maximum Format injections per day Value Value QA 0 10 Whole BI 0 4 Whole Mix 0 4 Whole DAFNE P version 10, February of 10

8 E. Recommendations for insulin regimen for the start of the DAFNE course Record all recommendations discussed with the patient pre-dafne for insulin regimen for the start of the DAFNE course. No changes recommended i) Only tick this box if the patient is on a twice daily background insulin and is using ratios of QA:CPs pre course which are in line with the DAFNE insulin regimen. ii) iii) QA type a. if no changes to QA insulin type are recommended tick QA type unchanged box and go to iii). b. If a change to QA insulin type has been recommended tick the box which corresponds to the new QA insulin type. QA ratio changes a. If the patient is using QA:CP ratios before the pre-course appointment and they are in line with the DAFNE insulin regimen tick the QA ratio unchanged box. b. If the initial use of ratios has been recommended, or ratio changes in line with the DAFNE insulin regimen, complete the boxes for ratios at each meal and snacks. Minimum and maximum values for QA:CP ratios are shown in the example below. Values outside of this range will not be accepted by the database. Insulin Regimen Minimum Maximum Format Value Value QA:CP Ratios Decimal to 2 places Record the date the recommendation was made as the from date i.e. the date of the pre course data collection appointment, or the day of/before the course according to the advice given (dd/mm/yyyy format) iv) BI type a. If no changes to BI type have been recommended tick the BI type unchanged box and go to v) b. If a change to BI type has been recommended tick the box which corresponds to the new BI insulin type v) Recommended doses a. If no changes to BI dose have been recommended (i.e. doses are in line with DAFNE insulin regimen) tick the BI doses unchanged box and go to vi) b. If a change to BI dose(s) has been recommended enter the recommended dose as whole numbers of units for morning (am) and evening (pm) doses Enter zero appropriately if only once daily. Insulin Minimum Maximum Format Value Value Background Insulin (BI) Whole DAFNE P version 10, February of 10

9 Record the date the recommendation was made as the from date i.e. the date of the pre course data collection appointment, or the day of/before the course according to the advice given (dd/mm/yyyy format). vi) BI frequency a. If no changes to BI frequency have been recommended tick the BI frequency unchanged box and sign the form. b. If a recommendation to change from once daily to twice daily BI has been made record the date the recommendation was made as the from date i.e. the date of the pre course data collection appointment, or the day of/before the course according to the advice given (dd/mm/yyyy format). Signature Ensure that the person who has collected the data prints their name and signs the form at the bottom of the page. This will enable the data entry clerk to contact the relevant person, should there be any queries regarding the data. Recommendations for insulin changes must only be made by active DAFNE educators or doctor educators who understand the DAFNE insulin regimen and guidelines for insulin adjustment for the start of the DAFNE course. DAFNE P version 10, February of 10

10 DAFNE P version 10, February of 10