YOU ARE INSTRUCTED TO READ THE FOLLOWING THOROUGHLY BEFORE PROCEEDING TO

Transcription

1 Title: Initiation and Receipt of Follow-ups Serial Number: OMB-MSOP 029 Version Approver: Enter name Version Number: 1.10 (Draft) Version Approval Date: [IN Version Effective: On release Version Author: Alison Turner (Admin Assistant), Tina Griifin (COASt Coordinator) Version Date: 08/08/2013 Area of Application: OMB Office Relevance: OMB Office Staff Date Details of Review Version number No. of pages Name of Reviewer Next Review 13/03/12 New SOP Gareth Bicknell July /08/13-12/09/14 Added reference to updating follow-up phone call field in database; clarifications of follow-up policy; added letter re-sending procedure Alison Turner, Tina Griffin, Gareth Bicknell Sep 2015 YOU ARE INSTRUCTED TO READ THE FOLLOWING THOROUGHLY BEFORE PROCEEDING TO UNDERTAKE THE METHODS DESCRIBED. UNDER NO CIRCUMSTANCES ARE THESE INSTRUCTIONS TO BE AMENDED OR ALTERED IN ANY WAY OTHER THAN BY THE AUTHOR / APPROVER. OMB-MSOP 029 Version 1.10 (Draft) Page 1 of 16

2 Table Of Contents 1 PURPOSE SAFETY INFORMATION DEFINITIONS HIGH COMPLIANCE CRS REQUIREMENTS & RESPONSIBILITIES GENERALLY SPECIFICALLY REFERENCES & RELATED DOCUMENTS PROCEDURE LETTERS AND BOOKLETS COURTESY CARD OUTWARD AND RETURN ENVELOPES RECEIPT OF RETURNED QUESTIONNAIRES UNRETURNED QUESTIONNAIRES AND INCOMPLETE QUESTIONNAIRES REQUESTING A CRS UPDATE FOLLOWING RECEIPT OF NEW INFORMATION SENDING A CORRECTED FOLLOW-UP IMPLEMENTATION TRAINING REQUIREMENTS STAFF RECORD OF ACKNOWLEDGEMENT OMB-MSOP 029 Version 1.10 (Draft) Page 2 of 16

3 1 Purpose 1.1 To describe the steps involved in patient follow-up. 2 Safety Information 2.1 Specific reference should be made to the University Occupational Health Service and their advice on Display Screen Equipment use with respect to eye strain and ergonomics. 3 Definitions 3.1 High Compliance A system that conforms to the data management requirements of the Medicines and Healthcare products Regulatory Authority regarding clinical trials. 3.2 CRS Clinical Record System a validated database maintained by the Trust for the storage of electronic patient records. 4 Requirements & Responsibilities 4.1 Generally It is the responsibility of the OMB Manager to ensure that follow-ups are performed appropriately and on time, so that data quality is maintained and patient wishes are respected It is also the responsibility of the OMB Manager to ensure that data security and patient confidentiality are maintained via appropriate systems. OMB-MSOP 029 Version 1.10 (Draft) Page 3 of 16

4 4.1.3 Where the University chooses to provide a core system for the storage of sensitive data, it is the responsibility of the University to ensure that the system is validated, regularly backed up, and subject to a contingency plan The OUH Trust is responsible for the maintenance and provision of the Clinical Record System (CRS). 4.2 Specifically Staff involved in patient follow-up are responsible for ensuring that booklets are posted in sufficient time as to be received by the patient before due date Such staff are also responsible for contacting patients as and when necessary in a courteous manner that is respectful of patient wishes Staff are further responsible for ensuring accurate and timely transfer of data between databases, and from follow-up booklets or verbal communication to the databases IMSU is responsible for maintaining a High Compliance system used by OMB to host its database of identifiable patient data The OUH Trust is responsible for maintenance, validation, back-up, and contingency planning of CRS. 5 References & Related Documents 5.1 OMB-MSOP 012 Retrieving Information from the NHS Care Records Service (CRS) 5.2 OMB-CRF 001 Post-Operative Six Week FU Knee 5.3 OMB-CRF 002 Post- Operative Six Week FU Hip 5.4 OMB-CRF 003 Post- Operative One Year FU Knee 5.5 OMB-CRF 004 Post- Operative One Year FU Hip 5.6 OMB-CRF 005 Post- Operative Two Year FU Knee OMB-MSOP 029 Version 1.10 (Draft) Page 4 of 16

5 5.7 OMB-CRF 006 Post- Operative Two Year FU Hip 5.8 OMB-CRF 007 Post- Operative Three Year FU Knee 5.9 OMB-CRF 008 Post- Operative Three Year FU Hip 5.10 OMB-CRF 009 Post- Operative Four Year FU Knee 5.11 OMB-CRF 010 Post- Operative Four Year FU Hip 5.12 OMB-CRF 011 Post- Operative Five Year FU Knee 5.13 OMB-CRF 012 Post- Operative Five Year FU Hip 5.14 Courtesy Card (uncontrolled document) 5.15 RSRRJSLZULTS Freepost Envelope (Post Office document) 5.16 RSRRJSLZULTS Freepost Envelopes x4 (Post Office document) 5.17 OMB-F 063 Request for CRS Update 5.18 OMB-MSOP 024 Withdrawal of Donor Consent 5.19 OMB-MSOP 014 Identification and Control of Non-Conformities 5.20 HADS Form Hospital Anxiety and Depression Score 5.21 OMB-MSOP 019 Processing Consent Forms and Patient Data 6 Procedure 6.1 Letters and Booklets NB OMB has tries not to follow patients up for more than one care pathway. This avoids over-burdening and confusing them. However, a few have made it clear that they are happy to be followed up for more than one care pathway Open the OMB Patient Monitor database. If you see a message about trusting the database, click the Options button, select the enable content option, and click OK. NB if you do not enable content, important scripts cannot run. OMB-MSOP 029 Version 1.10 (Draft) Page 5 of 16

6 6.1.2 On the OMB Master Form, click the View Follow-ups Due button Select the appropriate follow-up list (6 weeks, 1 year, etc.) using the Follow-up dropdown list. NB currently, follow-up is performed at 6 weeks post-operation, 1 year, 2 years, 3 years, 4 years, and 5 years Use the Advance options to tailor the list into displaying patients one week ahead (default) or two weeks ahead (e.g. for the Christmas period). NB lists actually operate on the principle that follow-ups will be sent at any time up to the Thursday preceeding the advance period. This should allow follow-ups to be delivered at least one full advance period ahead of the due date. (For example, for a one-week advance, a due date of Monday 18 th should be delivered by Monday 11 th, which entails posting at some time between Thursday 7 th all the way back to Friday 1 st.) Lists automatically exclude follow-ups that are more than 2 weeks overdue. You can override this behaviour by clicking the Since like forever button Use the large navigation buttons to navigate through the list. The binoculars button will open a search box and will enable you to search the list for your desired criterion For each patient in the list, use the NHS number and/or MRN to search the Demographics module of CRS for the most current details of the patient, as per OMB-MSOP 012 (Retrieving information from the NHS Care Records Service) If applicable, update the OMB Patient Monitor database with most current surname, address, phone number, and the actual side and procedure carried out on the date of the actual procedure. However, if there is sufficient proof that the details last used by OMB are more recent than those on CRS, request a CRS update as detailed in Section 6.6. OMB-MSOP 029 Version 1.10 (Draft) Page 6 of 16

7 NB if the Actual Procedure has changed from the Expected Procedure, ensure that the Category matches the Actual Procedure. This is very important to avoid mistakes with generating letters If CRS lists the patient as deceased, tick the Deceased box in the OMB Patient Monitor database, and choose the most appropriate reason. Ensure the Not For Follow-up box has auto-ticked Once all details have been checked for all patients in the list, click the Print Letters button. It may take a little time, but the database will generate personalised letters automatically. You may check the correctness of each letter using the small navigation buttons (at the bottom of the report) to move backwards and forwards through the letters Print the letters using the large Print button Close the report Print out the number of follow-up booklets (OMB-CRF ) indicated by the figures shown below the Print Letters button. Remember to choose 2-sided pages to print when printing, and ensure that patients who have given only OMB consent are followed up only with OMB CRFs, not those for other studies. NB it may be more time-efficient to print a single booklet and then colour photocopy it as many times as needed Staple each booklet together. On the front side of each one, fill in the: OMB number DOB Date of surgery Procedure Side of operation Date sent OMB-MSOP 029 Version 1.10 (Draft) Page 7 of 16

8 Repeat the checks, letters and booklets procedure for each list (1 year, 2 year, etc.) as appropriate. 6.2 Courtesy Card NB OMB usually includes a courtesy card in order to remind patients of the usefulness of their data, and to thank them for their time. The format of the courtesy card may change from month to month, or season to season Load the printer with 200 g/m 2 cardboard Print out as many copies as needed. For courtesy cards saved as a 4x PDF document, ensure that: the Multiple option is on 4 pages are printed per sheet auto-rotate is ticked a guillotine is used to cut the four cards apart and to trim excess white-space NB it is very important to ensure neat edges with no untidy unprinted areas the courtesy card should always present the OMB in a professional light. 6.3 Outward and Return Envelopes Load the printer with A4 sheets of 4x sticky labels (facing upwards in the bottom tray), and print out as many RSRRJSLZULTS Freepost x4 (return) envelope labels as needed. Stick the labels to as many C5 envelopes as needed Alternatively, load the printer with C5 envelopes in the top tray with their seals facing up and towards you, and print out as many RSRRJSLZULTS Freepost (return) envelopes as needed For each patient, place the personalised letter, a return envelope, the courtesy card, the personalised booklet, and a HADS form into an A4 windowed (outbound) envelope. OMB-MSOP 029 Version 1.10 (Draft) Page 8 of 16

9 6.3.5 Ensure the patient s address shows through the window. Seal the outbound envelope, and place it into the NDORMS mail-out tray Using the View Follow-ups Due lists, update each patient in each follow-up list using the Mark as Sent button. NB this is important to avoid duplicate letters being sent. 6.4 Receipt of Returned Questionnaires As questionnaires are returned, write the date of receipt on the front of the return envelope (if not opening immediately), or on the front of the booklet (if opening immediately) Open the OMB Patient Monitor database. If you see a message about trusting the database, click the Options button, select the enable content option, and click OK. NB if you do not enable content, important scripts cannot run On the OMB Master Form, click the View Follow-ups Sent button Select the appropriate follow-up list (6 weeks, 1 year, etc.) using the Follow-up dropdown list Click the Show only unreceived records button If a patient has provided written confirmation of a new name, sex, address, or phone number, request a CRS update as detailed in Section If a patient is deceased, navigate to the correct record in the OMB Master Form, and tick the Deceased and Not For Follow-up boxes. Inform the OMB Manager, since a letter of condolence/apology may be appropriate If a questionnaire has been returned with an expressed desire of no further follow-up, navigate to the correct record in the OMB Master Form, and tick the Not For Follow-up box. If there is any uncertainty about whether the patient also OMB-MSOP 029 Version 1.10 (Draft) Page 9 of 16

10 wishes to withdraw consent, you must follow the procedure for withdrawal of consent (OMB-MSOP 024) If a questionnaire has been returned unopened: re-check CRS for the correct patient address if necessary, request a CRS update as detailed in Section 6.6 navigate to the correct record in the OMB Master Form, and note in the relevant follow-up Comments box that the address is no longer valid (use minimal address information, e.g. just the road name) consult the OMB Manager about sending a new pack out If a questionnaire has been returned opened by a recipient other than the intended patient (or immediate relatives, in the event of death), there is a potential breach of confidentiality, which must be addressed as per OMB-MSOP 014 (Identification and Control of Non-Conformities). if necessary, request a CRS update as detailed in Section 6.6 navigate to the correct record in the OMB Master Form, and note in the relevant follow-up Comments box that the address is no longer valid (use minimal address information, e.g. just the road name) consult the OMB Manager about sending a new pack out Input the noted date of receipt into the Postal Return box of the appropriate record, except if the questionnaire has been returned-to-sender by Royal Mail or the patient has returned it blank For each successfully-returned questionnaire, go through each question, highlighting those where the answer is unclear or incomplete Questionnaires that are properly completed should be placed in the appropriate OMB Patient Folder. OMB-MSOP 029 Version 1.10 (Draft) Page 10 of 16

11 Questionnaires with unclear or incomplete questions should be treated as below Questionnaires that are returned-to-sender by Royal Mail, or that have been returned blank by the patient, should be regarded as not for further follow-up by patient request. Update the database as per OMB-MSOP 019 (Processing Consent Forms and Patient Data). 6.5 Unreturned Questionnaires and Incomplete Questionnaires Open the OMB Patient Monitor database. If you see a message about trusting the database, click the Options button, select the enable content option, and click OK. NB if you do not enable content, important scripts cannot run On the OMB Master Form, click the View Follow-ups Sent button If you wish to see only those follow-ups not yet marked as received, click the Show only unreceived records button For each patient in the list that is more than 2 weeks overdue (from the due date), or for incomplete questionnaires, use CRS to contact the patient: Introduce yourself Confirm the patient s identity positively. For unclear or incomplete questionnaires, explain that you are calling because we need to clarify some of the questions on the returned questionnaire. For unreturned questionnaires, explain that you are calling because we were anticipating a follow-up that has not yet arrived. Ask if the patient has had any problems with the form, and if s/he would like any help completing it (avoid coercive language). OMB-MSOP 029 Version 1.10 (Draft) Page 11 of 16

12 If the patient is amenable, obtain the desired clarification. This may include answers to individual questions, or the fact that the patient has lost the form and desires a new copy, or that the returned questionnaire has been lost in the post, or that the patient no longer wishes to take part (in which case, follow the withdrawal of consent procedure, OMB-MSOP 024). NB only answer queries from the patient that you are competent by training to answer Once clarified, thank the patient for his/her time and conclude the phone call Update the appropriate Phone Success or Postal Return date as below: For postally-returned questionnaires requiring clarification by phone, update the relevant Postal Return date, and ensure the phone date is blank. For unreturned questionnaires that the patient has opted to have you complete on his/her behalf by phone, update the appropriate Phone Success date, and ensure that the returned date is blank Questionnaires that are now completed should be placed in the appropriate OMB Patient Folder. 6.6 Requesting a CRS Update Following Receipt of New Information NB unless you are an active clinician, you must not update CRS yourself. This is to reduce the risk of creating a serious incident through accidental corruption of CRS data Complete a copy of OMB-F 063, including details of any relevant phone calls Make a photocopy of the completed form, and also of any written proof provided Place the completed OMB-F 063, including orginals of any written proof provided, into the relevant OMB Patient Folder. OMB-MSOP 029 Version 1.10 (Draft) Page 12 of 16

13 6.6.4 Take the photocopy of the completed form, and the photocopy of any written proof, to the NOC Admissions Office. 6.7 Sending a Corrected Follow-Up If an incorrect follow-up has been sent, it may be necessary to send a corrected follow-up. This is achieved as follows Click the appropriate follow-up tab in the OMB Patient Monitor database Note in the appropriate Comments that the original follow-up was sent on the Sent date indicated Blank the appropriate Sent date and save the record Click the View Follow-ups Due button Click the Print Old Letter button Provide the relevant OMB number and click the OK button Print the letter using the large Print button Close the report Print out the correct follow-up booklet (OMB-CRF ). Remember to choose 2-sided pages to print when printing, and ensure that patients who have given only OMB consent are followed up only with an OMB CRF, not one for another study Staple the booklet together. On the front side of each one, fill in the: OMB number DOB Date of surgery Procedure Side of operation OMB-MSOP 029 Version 1.10 (Draft) Page 13 of 16

14 Date sent Proceed as in Section 6.2 onwards. To mark the follow-up as sent, it may be necessary to use the Since Like Forever button. 7 Implementation 7.1 Failure to follow this SOP properly is likely to result in one of several scenarios: An incomplete dataset is obtained from the patient, resulting in research of reduced quality Booklets are sent to the wrong address, or communication is made with the wrong individual, resulting in a potential, or actual, breach of patient confidentiality Booklets are sent to a patient who has either requested no further follow-up, or has withdrawn consent, resulting in anything from wasted resources to an official complaint. Booklets are sent to, or communication is made with, the relatives of a deceased patient, causing upset, and possibly resulting in an official complaint Coercion, rudeness, or lack of professionalism is perceived by the patient, resulting in a reduced willingness to participate or an official complaint. 8 Training Requirements 8.1 Basic office and computer training. Computer skills may be enhanced through course available from the University of Oxford or the OUH NHS Trust. 8.2 Practical training by a senior member of OMB Staff. 8.3 CRS training, as required by the OUH Trust. OMB-MSOP 029 Version 1.10 (Draft) Page 14 of 16

15 9 Staff Record Of Acknowledgement 9.1 I understand the contents of this document. 9.2 I have received the training appropriate to the procedures and feel competent to undertake them. 9.3 My supervisor agrees that I am able to perform the work covered by this SOP. 9.4 I understand that further on the job or other training supervision may be required before working independently. 9.5 I understand that I may discuss my needs with my manager. Trainee Trainer (if applicable) Name Position Signature Date Signature Date OMB-MSOP 029 Version 1.10 (Draft) Page 15 of 16

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