11. NATIONAL DAFNE CLINICAL AND RESEARCH DATABASE

Transcription

1 11. NATIONAL DAFNE CLINICAL AND RESEARCH DATABASE The National DAFNE Clinical and Research database was set up as part of the DAFNE QA programme (refer to section 12) to facilitate Audit and was updated to incorporate research functionality. This is a secure, web-based database enabling access, data entry and report generation at local level. The database will also generate and send monthly reports to each centre for patients due for annual data collection and patients overdue for annual data collection. All patient data is in a pseudo anonymised format. Patient name and NHS or hospital numbers are not entered into the database. Each patient is allocated a unique DAFNE number (refer to section 11.1) when they commence their 5-day DAFNE course (refer to section 7). This unique DAFNE number should be recorded on the patient s hospital records, and should be the only identifier used on all hard copies of the data collected about the patient. Data is entered into the National DAFNE Clinical and Research database using this unique number. Patient course details and data from the Core Baseline Data Collection and Core Post Course Data Collection forms can be entered onto the database. Course information should be added to the database in two stages: Stage one: adding a new course - should be carried out as soon as the course date(s) have been agreed. Stage two: add course statistics should be carried out on or within 1 week of the last day of the course. The following patient data should be entered onto the database within 3 weeks of the last day of the DAFNE course for baseline data and 3 weeks of data collection/ receipt for post course data: Core Baseline Data Collection Core Post Course Data Collection Drop-outs Deaths Note: Information relating to the handling of research datasets is available separately to centres involved in DAFNE research programmes. The handling of research data can differ from that of core data therefore it is essential that the study specific SOPs are followed rather than the information in this section. The study specific SOPs can be located in the research study site files. DAFNE Centre Manual Section 11 Page 1 of 20 R04.011, Version 10 8 May 2014

2 11.1 DAFNE Patient Number A DAFNE patient number should only be allocated to an individual if they commence a DAFNE patient course. DAFNE numbers should not be allocated to individuals who attend baseline data collection but then do not go on to commence their course. The flowchart overleaf gives an overview to the process of patient number allocation and the entering of data onto the DAFNE database in a variety of situations, further details of which can be found in sections 11.2 to The DAFNE patient number is a two part number: _ / Part 1 Part 2 DAFNE Centre No Patient number Part 1 of the number consists of the centre number allocated to the diabetes unit where the patient will attend their DAFNE course. The DAFNE centre number can be found in Appendix I of this manual and is shown automatically on the database. For example Centre Centre No Sheffield 001 Leicester 008 Hull & East Riding 012 If you are at all unsure as to your particular DAFNE centre number, please contact the DAFNE Database Manager at Central DAFNE. Part 2 of the unique DAFNE patient number refers to the actual patient, and is allocated sequentially (from 0001 onwards) to each patient attending a Baseline Data Collection clinic. Example: DAFNE patient 008/0133 will be the 133 rd patient to begin DAFNE training at Leicester. At all data collection clinics this unique DAFNE patient number should be the only means of identifying the patient, and should be recorded on all data collection forms and questionnaires. It is your responsibility to ensure the anonymity of your patients data. DAFNE Centre Manual Section 11 Page 2 of 20 R04.011, Version 10 8 May 2014

3 Allocating DAFNE Patient Number and entering pre-course data on to the DAFNE audit database Patient provides baseline data Patient commences 5-day course? Yes No Allocate DAFNE patient number (if rescheduled course use previously allocated DAFNE patient number) Does patient intend to commence and complete a 5-day course in the near future? Does the patient complete their 5-day course? Yes No No Yes Enter baseline data on to audit database Continue to collect post course data on an annual basis Do not allocate DAFNE patient number Destroy data do not enter onto audit database Does the patient intend to complete their 5-day course at a later date? No Yes Enter baseline data onto audit database Complete Drop Out form on audit database Is rescheduled course date less than or equal to 12 weeks since date of pre course data collection? Yes No DAFNE Centre Manual Section 11 Page 3 of 20 R04.011, Version 10 8 May 2014

4 11.2 Patients providing baseline data who do not commence their 5-day course If a patient provides baseline data but then does not go on to commence their scheduled course, the first step is to determine if the patient intends to attend a course at a later stage. No longer wanting to attend a DAFNE course: If the patient decides that they no longer want to attend a DAFNE course, their baseline DAFNE data should be destroyed. They must not be allocated a DAFNE number and their data must not be entered onto the database. Want to attend a DAFNE course on an alternative date: If the patient decides that they do want to complete a DAFNE course at a later date you need to determine if the baseline data collected for their original course is valid for use for their rescheduled course. If the date for the rescheduled course is equal to, or less than, 12 weeks from the date of the original baseline data collection then the data provided prior to their original course is still valid for the rescheduled course. However, if the date of the rescheduled course is greater than 12 weeks after the date of their original baseline data collection, then the patient must provide fresh data prior to their rescheduled course. The patient will only be allocated a DAFNE patient number once they commence their rescheduled course. For further details refer to sections 11.3, 11.4, 11.5 and DAFNE Centre Manual Section 11 Page 4 of 20 R04.011, Version 10 8 May 2014

5 11.3 Patients that commence but do not complete the 5-day DAFNE course. If a patient commences their DAFNE course but then, for whatever reason, does not complete this course, you will need to: Determine and record the reason for non-completion. Determine if the patient wants to continue with DAFNE and be rescheduled to another course in the future; refer to section Determine whether the patient no longer wants to continue with DAFNE at all; refer to section DAFNE Centre Manual Section 11 Page 5 of 20 R04.011, Version 10 8 May 2014

6 11.4 Patient wants to continue with DAFNE and complete their training If a patient wishes to complete their DAFNE training, the team must decide the most appropriate way for the individual to do so, i.e. on a one to one basis or whether they need to attend a full 5-day course at a later stage. The decision should be based upon how much of the initial course was missed and how quickly the individual has picked up the DAFNE skills. For example, an individual who only managed to complete the first day and a half of their initial course would be expected to complete a full 5-days at a later stage, however someone who has completed the first 4 days of their initial course would probably be able to complete the remaining sessions with a DAFNE Educator on a one-to-one basis. Once it has been agreed how the patient will complete their DAFNE training a date for completion must be determined. This should be as soon as possible for those patients who have completed most of the initial 5-day course and who will be completing their DAFNE training on a one to one basis. This will enable the individual to consolidate their training and hopefully eliminate the need to collect fresh, baseline data. Fresh data would normally be required if the date for completion of their DAFNE training was more than 12 weeks from the date the original baseline data was collected. However, if the patient has already started to implement DAFNE following their partially completed 5-day course, this will no doubt impact on any fresh data provided. It is therefore imperative that this scenario is avoided at all costs. For those patients who need to attend a full 5-day course at a later stage, fresh baseline data will only be required if the date for completion of their DAFNE training is more than 12 weeks from the date of the original data collection. Once the patient has completed their DAFNE course (either on a one-to-one basis or the rescheduled course), baseline data should be entered onto the DAFNE database within 3 weeks of course completion. DAFNE Centre Manual Section 11 Page 6 of 20 R04.011, Version 10 8 May 2014

7 11.5 Patient does not wish to continue with DAFNE and does not complete their training If the patient decides that they do not want to continue with their DAFNE training and do not go on to complete the 5-day DAFNE course, they will be classed as a during course drop out and a drop out form must be completed. For further details refer to Section DAFNE Centre Manual Section 11 Page 7 of 20 R04.011, Version 10 8 May 2014

8 11.6 Patients who commence and complete a DAFNE course When a patient commences a DAFNE course they can be allocated a DAFNE number at the beginning of their 5-day course. When a patient completes a DAFNE course (either their original or rescheduled course), their baseline data should be entered onto the DAFNE audit database within 3 weeks of course completion. These patients should be followed up at 1-year post course and post course core data collected and entered on to the DAFNE audit database. These patients will be listed (via DAFNE patient number) on the DAFNE data due and overdue lists that are generated automatically by the database. It is a requirement for centres to collect and enter post course data at 1-year followup however if centres wish to continue annual post course data collection the DAFNE audit database provides the facility to enter this. DAFNE Centre Manual Section 11 Page 8 of 20 R04.011, Version 10 8 May 2014

9 11.7 Recording drop outs on the DAFNE audit database In terms of audit, it is essential that we record the reasons why individuals do not continue with DAFNE. This data will enable us to identify, via retrospective audit, any characteristics (both biomedical and psychological) of individuals who are more likely not to complete DAFNE training or continue with the DAFNE approach. For the purposes of the DAFNE audit database, drop outs can occur: During course Individuals commence but never complete their DAFNE training. Please refer to Section 11.3 for further information. Post course Individuals who complete their DAFNE training but decide at some later date that they no longer wish to continue with the DAFNE approach. Please note there is no classification for a pre-course drop out in terms of the database because individuals who provide pre-course data but do not commence a DAFNE course are not classed as DAFNE patients and should never be allocated a DAFNE patient number. Please refer to Section 11.1 for further information. DAFNE Centre Manual Section 11 Page 9 of 20 R04.011, Version 10 8 May 2014

10 11.8 During course drop outs In terms of the DAFNE audit database the following information must be entered for individuals who commence but do not complete their DAFNE training. Baseline Core Data Collection Form DAFNE Drop out form Please note: if this form is not completed after pre-course data has been entered, the individual will appear on the DAFNE post course data due and overdue reports that are automatically generated by the database Once this data has been entered on the DAFNE audit database, no further action needs to be taken and no further DAFNE data should be collected for these individuals. DAFNE Centre Manual Section 11 Page 10 of 20 R04.011, Version 10 8 May 2014

11 11.9 Post course drop outs Once again recording why individuals decide not to continue with DAFNE post course will provide interesting audit data. However, unlike a during course drop out, which is very clearly defined (i.e. commence but decide not to continue to complete their DAFNE training) defining what constitutes a post course drop out is more difficult. For this reason, the only options provided for a post course drop out on the database are: Personal illness: if the individual has developed an additional long-term or terminal illness which impacts on their ability to self manage or results in their diabetes being less important to them. DAFNE not for them: individual decides that upon completion of their DAFNE course they find DAFNE too difficult /does not suit their personal needs and they decide to return to their old insulin regimen. Moved away: the patient has moved out of the service area and has not provided the diabetes team with their new address making contact impossible. No longer in contact with the diabetes team: this refers to patients who remain within your service, but who continually fail to respond to reminders from the diabetes team. Transferred to another centre (non DAFNE): the patient has moved out of the service area and continually fails to respond to reminders from the diabetes team. Attended refresher DAFNE Course: the patient has completed a DAFNE course previously but wishes to complete another DAFNE course to refresh themselves with the DAFNE principles. Please note: moved away, no longer in contact with the diabetes team and transferred to another centre (non DAFNE), are not intended as a way out of following up patients who have returned to primary care. We believe it is essential that we collect 1-year post course data for all DAFNE graduates, even those who have moved away from the service area, provided that the individual is happy to provide data, unless they move to another DAFNE centre for their care. Patients who transfer to another DAFNE centre will not be classified as a drop out but as a transferred patient. See section for more information. Much of the data collection can be completed via post, with most recent biomedical results being supplied by the patient. There are some DAFNE centres that continue to keep in touch and receive post course data from DAFNE graduates who have emigrated. If patient data is being received from patients who have moved away or have transferred to another centre (non DAFNE) such individuals will not be classified as a drop out. DAFNE Centre Manual Section 11 Page 11 of 20 R04.011, Version 10 8 May 2014

12 DAFNE graduates who cease to use DAFNE principles for a while may very well return to them at some point in the future. If the centre has recorded them as a post course drop out and they return to the service, the drop out form should be deleted and post course data entered. DAFNE Centre Manual Section 11 Page 12 of 20 R04.011, Version 10 8 May 2014

13 11.10 DAFNE graduates moving between DAFNE centres A small number of DAFNE graduates, due to relocation, move from one DAFNE centre to another, and this has raised the issue of which centre is responsible for data collection. It has been decided that the patient s DAFNE audit data should remain in the original centre until the date at which the patient transfers, and then any subsequent data should be input at the new centre under the new centre/patient number. A link between both centres will be established for the patient to ensure any reports can capture baseline as well as post course data for the patient, regardless of which centre the data is stored in. Therefore, if you are made aware that one of your DAFNE graduates is moving from your area to be cared for by another DAFNE centre, or if you receive a new referral from an individual who has completed a DAFNE course at another DAFNE centre, please contact the DAFNE Database Manager at Central DAFNE. The DAFNE Database Manager will liaise between both centres involved to identify the original patient number, allocate a new patient number and establish the link between the patient numbers on the database. Such DAFNE graduates should not be recorded on the database as a post course drop out. They will be automatically registered as a transfer patient by the database DAFNE Centre Manual Section 11 Page 13 of 20 R04.011, Version 10 8 May 2014

14 11.11 DAFNE Graduates repeating a DAFNE course In the event that a DAFNE graduate chooses to complete another DAFNE course to refresh themselves with the DAFNE principles 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 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. See section 11.9 for more information. DAFNE Centre Manual Section 11 Page 14 of 20 R04.011, Version 10 8 May 2014

15 11.12 Recording deaths In terms of audit, it is essential that we have a death recording facility on the DAFNE audit database to record the reason for death of patients that die using the DAFNE approach. The options available for the cause of death are: Severe hypoglycaemia Dead in bed DKA MI Stroke PVD End Stage Renal Failure Sudden cardiac death Suicide Myocardial infarction Unknown Other DAFNE Centre Manual Section 11 Page 15 of 20 R04.011, Version 10 8 May 2014

16 11.13 User Name and Password In accordance with the Data Protection Act access to the national database should be on a need to have basis. Although patient data is pseudo anonymised, it is each centre s responsibility to comply with their local data governance/caldicott requirements. Before you can gain access to the National DAFNE Clinical and Research Database you will require: Access to the internet. An address. A user name. A password. In order to get a user name and password, the Lead Physician or Lead Educator from each centre should contact the DAFNE Database Manager at Central DAFNE in writing, with the name, address and access level required of the individual who requires access. Once the account has been created, the individual to have access will be contacted directly by the DAFNE Database Manager with details of their username and initial password. To maintain the security of the database and the user accounts, passwords should be changed by individual users regularly. If a user account has not been accessed for more than 26 weeks, the database security function will automatically make the account inactive. If, at a later date, this account is to be made active again, the user should contact the DAFNE Database Manager at Central DAFNE. DAFNE Centre Manual Section 11 Page 16 of 20 R04.011, Version 10 8 May 2014

17 11.14 Access Levels There are 4 access levels, these are: Level 1: Level 2: Level 3: Level 4: View patient data only View patient data, data entry and data edit View and input course date and completion statistics only Report generation from local data and comparison to national DAFNE data Any combination of the above access levels is permitted. For example, a user requiring full access to enter and edit course statistics data, enter and edit patient data and generate reports would request access levels 2, 3 and 4. Alternatively, if a user was only required to view data and generate reports they would request access levels 1 and 4. Ideally you will have one person with access to enter and edit course statistics data, patient data and generate reports when requested. Other users for your centre would have more limited access. It is the responsibility of the Lead Physician or Lead Educator at each centre to ensure that the correct level of access is allocated to individuals (refer to section 4.1). Please bear in mind that this is your patients data. Even though it is pseudo anonymised, access to the data and the database should be restricted only to those individuals who need to have access. It is each centre s responsibility to ensure that access to the patient data complies with their local employing organisation s governance and Caldicott guidelines. DAFNE Centre Manual Section 11 Page 17 of 20 R04.011, Version 10 8 May 2014

18 11.15 How to use the National DAFNE Clinical and Research Database The National DAFNE Clinical and Research Database is easy to use, and there are safeguards built in to minimise incorrect data entry (e.g. expected ranges for data and data formats). There are Help facilities on the database however if you experience a particular problem that cannot be resolve with the Help facilities or the How to Use document below, please contact the DAFNE Database Manager at Central DAFNE. As with all data entry, the quality of the data depends upon the accuracy of data input. Particular care should be taken when entering the patient number and course date How to Use the National DAFNE Clinical and Research Database The database has been developed to allow all DAFNE centres throughout the UK and Republic of Ireland to enter patient information into a centralised database over the Internet. The information is entered using the standard forms listed below: Baseline core data collection form Post course core data collection form DAFNE Drop Out Deaths Recording Centres are also requested to enter details of the scheduled and completed courses including course date and the statistics (numbers attended and graduated). As each DAFNE centre enters their information into the database they can automatically generate reports relevant to their data against key indicators from all the other centres aggregated up to a national level Accessing the National DAFNE Clinical and Research Database To access the database, load up your version of Internet Explorer and type the following into the address bar and then press the enter key. You should then see the DAFNE logon screen which asks you to enter your username and password. For further details on how to obtain a username and password refer to Section Type in the username and password you have been supplied with and then click the submit button. If you have entered your details correctly, then you will be allowed into the database. If you have entered your username and password and the system will not authenticate you, then contact the DAFNE Database Manager at Central DAFNE for assistance. If you know your username but have forgotten your password then click on Forgot your password. Enter your username and address in the popup window and then click the submit button. Within a few minutes, the database will you with a link to reset your password. If you do not receive an , contact the DAFNE Database Manager at Central DAFNE for assistance. DAFNE Centre Manual Section 11 Page 18 of 20 R04.011, Version 10 8 May 2014

19 Navigating around the Database When you have entered the main part of the National DAFNE Clinical and Research Database, there is a menu across the screen which allows you to carry out various tasks. The tasks available are dependent on the access level privileges. For details of these refer to section The information below contains the options available along with a description of what each option is used for. Database Menu Options Courses: This option will let you input, view or edit the course statistics data for your centre. Data entry: This option will let you input, view or edit the patient data for your centre. Reports: Once you have started entering your data, you can then use this option to generate reports for your site. Help: Clicking on this option displays Frequently asked questions including the appropriate contact details to obtain assistance. In addition to the above menu options there are also links available in the top, right hand corner of the screen. These are: Feedback: Send feedback directly to the software company s technical team. This will be used to improve the system where possible. Please note: for technical issues, general use of the database or if your question relates to DAFNE procedures please contact the DAFNE Database Manager at Central DAFNE in the first instance. If the DAFNE Database Manager is unable to assist then your query will be passed to the software company. My Account: Gives details of the user s username, address and assigned access levels. This screen also provides links to change password and change address. Logout: Provides a link to log out of the database securely. You should always log out of the database when it is not in use to prevent unauthorised access to the information it contains. Click on this link to log out of the database and return to the Log In screen. Once the Log In screen is displayed the web browser may be closed. DAFNE Centre Manual Section 11 Page 19 of 20 R04.011, Version 10 8 May 2014

20 History of previous version of this document: Date Issue Review Contact Version Approved Date Date Person August January Central DAFNE March March Central DAFNE August August Central DAFNE May May Central DAFNE March March Central DAFNE 4 Central DAFNE 3 Central DAFNE 2 Central DAFNE 1 Central DAFNE Statement of changes made from previous version Version Date Description 10 8 May Page 1 paragraphs 5 and 6 updated 2. Section 11.5 has been updated giving reference to the completion of a drop out form. 3. The following sections have been updated to incorporate the new post course data collection requirements: Section 11.6 updated. Section 11.9 updated. 4. Section has been added to provide details for DAFNE Graduates repeating a DAFNE course 5. Original sections to numbers amended to to respectively. 9 August National DAFNE Database amended to National DAFNE Clinical and Research database throughout document 2. Page 2 Note added 3. Section 11.5 Reference to section 11.8 added 4. The following sections have been updated to incorporate the new database functionality and requirements: Section 11.9 Post Course Drop Outs Section DAFNE graduates moving between DAFNE centres Section Recording deaths Section Access levels Section How to use the National DAFNE Clinical and Research Database DAFNE Centre Manual Section 11 Page 20 of 20 R04.011, Version 10 8 May 2014