The GRAPHIC2 study

Tags: LCBRU Study Category

Contact for the GRAPHIC study is Jay Gracey.

Label printing

The second phase of GRAPHIC (GRAPHIC2) will use labels produced from the LCBRU portal.

Output from the 'graphic_label' module will be:

1 x label for pathology form (S number, lab ID, patient name, DOB, Address)
1 x label with GP details for pathology form (GP surgery name, GP surgery address)
1 x label for serum gel bottle for pathology (S number, lab ID, patient name, DOB)
1 x label for fluoride / glucose bottle for pathology (S number, lab ID, patient name, DOB)

1 x label for serum vaccutainer (lab ID, bottle ID barcode? G2-lab number-s)
2 x edta red (lab ID, bottle ID barcode? G2-labnumber-e1, G2-labnumber-e2)
1 x citrate green (lab ID, bottle ID barcode? G2-labnumber-c)
1 x Paxgene for RNA processing (lab ID, bottle ID barcode? G2-labnumber-p)

1 x urine sterile container (lab ID, bottle ID barcode? G2-labnumber-u)

1 x label for consent form (lab number, ID number, name, DOB)
1 x Physical activity form (lab number, ID number)
1 x Physical examination form (lab number, ID number)
1 x Patient Diary for ABPM (lab number, ID number)
1 x spare for paper version of the questionnaire if necessary (lab number, ID number)

15 labels in total per patient.

Contact with patients for GRAPHIC 2

The plan is to load the GRAPHIC patients into CiviCRM, use Civi to track invitations etc, and then point the label module to the CiviCRM database to access the patient identities.

We have already written to all the families in GRAPHIC 1 (i.e. a letter to each 'mother'). Replies indicate 1,000 willing participants for GRAPHIC 2 - could be isolated individuals, could be families. This was not an 'invitation' but a feasibility study. Now ethics approval has been received, the 1000 need to be invited. At the same time, those mothers who did not reply will get a reminder, asking them to consider participating.

The 1,000 are in an access database (including their GRAPHIC ID numbers). May need some work but could export it into CiviCRM. The data have been exported to a csv file, and we can load them into CiviCRM from there.

Activity schedule is really just a one visit, but ABPM might be done on a separate visit. The activities should only be added to the record once the patient is recruited, so as not to clog up the diary.

FBC samples will be processed in the LCB lab, but this will need a specific data acquisition process which Richard is working on. Other blood results will come from pathology system, using the same DWH approach into i2b2 that we use for BRICCS Study and GENVASC Study.

GRAPHIC 2 commits us to send a summary to the patient's GP containing their blood results and ABPM data. The blood results will go directly from the pathology department. A pro forma can be sent by the nurse, using CiviCRM, commenting that the GP should already have received the results, so there is no need to transcribe them. But hard copies need to be sent to the patient.

Implications for the CiviCRM object model:

• Group for contacts: GRAPHIC2 - all imported contacts are placed in this group

• Custom data group: GRAPHIC2
  • Custom fields: GRAPHIC2/GRAPHIC ID, GRAPHIC2/LAB ID, GRAPHIC2/FAMILY ID, GRAPHIC2/CONSENT FOR FURTHER STUDIES, GRAPHIC2/G1 BLOOD CONSENT, GRAPHIC2/ PRE CONSENT TO GRAPHIC 2

• Study: GRAPHIC2
  • Standard activity timeline: Open Case. That's it. Nothing else.
  • Recruitment activity timeline: Arrange interview. Recruitment Interview. ABPM fitting. ABPM collection. Letter to GP.
  • Incidental activities: Reminder sent (this already exists in CiviCRM but needs adding to the Case XML definition) - this will happen twice, either by letter or phone, specified in 'encounter medium'. Response received.
  • The above activities will need adding to the activity type list.

• Additional Encounter medium - 'SMS text message' so reminders can be recorded when sent by text.

The study definition xml file will be attached to this page once completed.

Mapping of graphic participants source file to civicrm object model:

• ID Number => GRAPHIC2 / GRAPHIC ID
• S Number DO NOT IMPORT
• Discovered S number => UHL S Number
• Lab Number => GRAPHIC2 / LAB ID
• Family Number => GRAPHIC2 / FAMILY ID
• Date of Letter DO NOT IMPORT
• Title => Prefix (needs editing in spreadsheet to match CiviCRM prefixes)
• Surname => Last Name
• Forename => First Name
• Middle Name => Middle Name
• Date of Birth => Date of Birth (needs editing in spreadsheet to match YYYY-MM-DD
• Address 1 => NEEDS EDTING - SHOULD MATCH 'Additional Address 1'
• Address 2 => NEEDS CLEANING - SHOULD MATCH 'Street address'
• Address 3 => NEEDS CLEANING - SHOULD MATCH 'Additional Address 2'
• Address 4 => NEEDS CLEANING - SHOULD MATCH 'City'
• NEW COLUMN 'COUNTY' => COUNTY
• Post Code => Postal code
• Phone Number => Phone (HOME)
• Alternative contact no DO NOT IMPORT
• GP Title DO NOT IMPORT
• GP Surname DO NOT IMPORT
• GP Forename DO NOT IMPORT
• GP Address 1 DO NOT IMPORT
• GP Address 2 DO NOT IMPORT
• GP Address 3 DO NOT IMPORT
• GP Address 4 DO NOT IMPORT
• NEW COLUMN surgery civicrm code => Relationship to GP surgery
• Height DO NOT IMPORT
• Weight DO NOT IMPORT
• BMI DO NOT IMPORT
• Mean 24hr BP DO NOT IMPORT
• Mean Day Time BP DO NOT IMPORT
• Mean Night Time BP DO NOT IMPORT
• Sodium DO NOT IMPORT
• Potassium DO NOT IMPORT
• Urea DO NOT IMPORT
• Creatinine DO NOT IMPORT
• Glucose DO NOT IMPORT
• Urate DO NOT IMPORT
• Albumin DO NOT IMPORT
• Adjusted Calcium DO NOT IMPORT
• Total Cholesterol DO NOT IMPORT
• HDL Cholesterol DO NOT IMPORT
• Current Smoker DO NOT IMPORT
• Advised to stop smoking DO NOT IMPORT
• Known Diabetic DO NOT IMPORT
• Known Hypertensive DO NOT IMPORT
• CHD risk DO NOT IMPORT
• Stroke risk DO NOT IMPORT
• Consent(1) for contact re further studies => GRAPHIC 2 / Consent for further studies
• Consent(1a) for blood to be stored => GRAPHIC 2 / G1 Blood Consent
• Consent(2) requested re further studies DO NOT IMPORT
• Consent2 (nurse/interview?) DO NOT IMPORT
• Response to consent(2) request DO NOT IMPORT
• Reminder letter (Sub Study) DO NOT IMPORT
• Sub Study letter to be sent DO NOT IMPORT
• Qualitative Study DO NOT IMPORT
• Flap Gene Study DO NOT IMPORT
• EPC in CAD Study (Mother) DO NOT IMPORT
• Position in family DO NOT IMPORT
• GRAPHIC2 (Mother) letter => ACTIVITY - GRAPHIC 2 Mother letter
• GRAPHIC2 response => GRAPHIC 2 / Pre-consent to GRAPHIC 2
• GRAPHIC2 No of participants DO NOT IMPORT
• Comments DO NOT IMPORT

Laptop configuration

Two laptops have been purchased through the UHL for use on home visits for GRAPHIC2. Their service tags are 4MMVLX1 and JLMVLX1.

See GRAPHIC2 Laptop VM Configuration for details of the system installation, and for more information on the multi-machine setup of REDCap (asyncronous data collection) see REDCap Multi-server set up.

Device driver installations

Spirometry (Care Fusion Spirometer) software and drivers will need installing on the two laptops AND on desktop machines in the TMF (room one and room three, and OP53) and in BRU2/CRF (room three). Jay will ask Graeme Deveraux to do this work, while he configures the laptops.

SpaceLabs ABP reporting software and USB connection drivers will also need to go on the PC in clinical room one, in Jay's office, and in the CRF office (Sue Coolman's PC and Ellie Clarke's PC).

TO DO

Bulk upload of activities for invite letter from spreadsheet - export CiviCRM contact records, upload activity data keyed to CiviCRM contact ID. DONE. 991 letters logged.

Two outgoing results letters: one to patient (covering letter from CiviCRM, with REDCap extract - height, weight, BMI, ABPM summary data - only), and one to the GP (covering letter from CiviCRM, with REDCap extract, blood results, ECG). Completed in DRAFT on the test system. Jay is going to review them with Prof. Reviewed, amendments made, and additional civicrm hooks created in the LCBRU drupal module to enable additional tokens. Installed on live for Jay to use. DONE

REDCap questionnaire needs amending so that the data to be shared with the GP / patient are all in one questionnaire stage. Currently set up this way on the test system. Replicated on live system as of October 31, 2013. DONE.

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