Embedded Files
Updated 23/06/2020
Platform Randomised trial of Interventions against COVID-19 In older peoPLE
As yet, there are currently no known treatments for COVID-19 that have been proven to be effective. Our trial aims to evaluate potential treatments as they are identified. To be able to do this, we aim to test one or more suitable, potential treatments for COVID-19, as soon as they become available. the trial design is such that treatments can be added and withdrawn. Azithromycin is the current medication being evaluated buy the study. Azithromycin has antiviral, antibacterial and inflammatory properties and is used to treat community acquired pneumonia which is a common complication of Covid illness. This drug may have benefit in Covid illness or may be of no benefit and this information will it support antimicrobial stewardship
Information for other Clinical Research Networks:
Note to all practices:
The searches will identify lots patients, generally about 15% of your practice list size, dependent on demographics. Patients on the Dementia, mental health and palliative care registers are excluded as are, housebound, those with a recent cancer diagnosis and patients who have previously dissented from information sharing. You may wish to adjust the searches to exclude further patients such as those in care homes/housebound/terminal illness etc. Residents of care and residential homes are eligible to take part.
The text message is meant to raise awareness about the study so we don't expect you to go into detail when checking the final patient list.
Depending on your practice set-up model (site or PIC) a GP or a CTU nurse will check the patient eligibility - what we have experienced so far is that there isn't a huge influx of patients waiting to sign up after receiving the text - this may change following any relaxation of lock-down requirements. You can choose to send texts in batches if you prefer.
You can send text messages invites more than once if you have capacity within your team. However, the study reimbursement is fixed and there is no additional funding for sending messages more than once. However, sending additional reminders may help with your recruitment to the study.
You can do mailouts to patients without mobile phones. The trial team will not be creating a Docmail account for practices to use. Due to the remote nature of the trial, and the need for completion of patient reported outcomes via an e-diary, it's important to consider ability to take part (however, patients will be supported to undertake telephone follow ups if needed).
EMIS Resources
EMIS Resources
SEARCH FILE: PRINCIPLE trial possibles with mobile search_update 05.02.21 - this is a search file (containing multiple searches in one) which identifies all patients who may be eligible to take part if they develop symptoms. This file includes multiple searches in one and those identified by the search as potentially eligible. Patients on the Dementia, mental health and palliative care registers are excluded as are, housebound, those with a recent cancer diagnosis and patients who have previously dissented from information sharing. There an upper age limit as requested by the trial manager. You may wish to adjust the search to exclude these patients before sending the text messages.
POP-UP PROTOCOL: Eligible PRINCIPLE trial Covid 14d PROTOCOL update 05.02.21 - this is a protocol for the pop-up. The pop-up activates when a potentially eligible patient presents with symptoms. If you are replacing a previous version of the pop-up protocol you will need to add the trigger codes (e.g. cough, temp, suspected Covid etc.) again. Also you will need to deactivate the previous version(s) or you will either get an incorrect prompt ((e.g. if patient on Digoxin) the new protocol excludes that but the old one allowed it)), or you will get multiple pop ups.
Instructions for importing and installing the PRINCIPLE protocol (for Template Manager). If you use Resource Publisher or a different system for imports please use your normal route for importing files.
Changes to the latest EMIS search and protocol can be found here.
SystmOne Resources
SystmOne Resources
Join the South West S1 Sharing group to quickly access reoruces Download Guide here
SEARCH FILE: *UPDATED 01.02.2021* SystmOne Search File 20210201
The search report should also be imported as a filter to ensure that ineligible patients are filtered out from the pop-up. It doesn’t serve any other purpose. You don’t need to ever actually look at the list of patients this report generates. V5.0 has had some correction to the excluded medication list, or where there is drug sensitivity. Click here for a a guide.
POP-UP PROTOCOL: *UPDATED 02.02.2021*
SystmOne Protocol PRINCIPLE 20210202 & SystmOne Protocol Word letter template. This is a protocol for the pop-up. The pop-up will activate when potentially eligible patients present and free text is entered which relates to COVID symptoms. It will code whether patients are potentially eligible, or ineligible, and lead to a word document invitation populated with the patient and site’s details.
Please note:
The Word template MUST be imported for the Protocol to work.
Please deactivate previous version(s) and replace with the update.
Instructions for importing SystmOne reports and pop-ups
if you want to de-activate the pop ups on the sharing group or form this search file please follow these instructions
Troubleshooting
Troubleshooting
EMIS practices:
If your protocol has been imported and fails to run correctly please check you're testing it on a patient who is eligible for the study. The text box/alert will not be displayed for patients who are not eligible for the study.
check that the protocol .xml is being imported into the protocols section and the search.xml is imported into the search folder. Although they both end in .xml they are different and if to try to import into the incorrect section you will get a wrong format error.
Some practices are experiencing problems with importing the EMIS search and have been successful when trying a second time.
If an EMIS pop-up appears with:
"The following concept(s) already exist and will be overwritten by the import...(lists concepts), do you want to continue?" - click 'yes' and continue as it's just picking up that you already have concepts on your system with the same name.
Some practices are experiencing problems with importing the EMIS search and have been successful when trying a second time.
There may be problems if different EMIS sites have overlapping database infrastructure, so practice B's database 'thinks' it already has a copy of what you're importing (although it's really a ghost copy - you can't see it on the practice system). There is no workaround apart from re-saving every component (concept, library item, protocol, template, document) involved as a new version on your site, then rebuilding the protocol. Someone at the practice should be able to assist and if not, try contacting your local CRN for advice - one of your local GP Research Champions may be able to help.
All other patient systems:
All: Please use GOOGLE CHROME when downloading files from the IT Solutions website (often IE is out of date on older NHS machines)
All: Remote working can cause problems. You must ensure you are downloading onto the machine you are attached to via VPN and not the local machine you are working on if you do not have EMIS on this. If problems continue it may be better to wait until you're back at the surgery.
If you're experiencing problems with importing searches or installing the pop-up protocol, please contact jamesw.davies@nhs.net
Compatibility issues:
These resources have been developed in partnership with experienced GPs using the inclusion and exclusion criteria from the protocol. While every effort has been made to make them universally implementable they rely on read codes and the data stored in the individual practice's clinical system. It is the responsibility of the practice to adjust the search templates provided or to build your own search using the inclusion criteria in the protocol (currently page 17-18).
Disclaimer:
Please note the resources provided are designed to assist with the identification of potentially suitable patients and to appropriately code these patient if required.
These resources have been developed based on the criteria provided by the relevant study team and whilst every effort has been made to make them universally implementable they rely on read codes and the data stored in the individual practice's clinical system. These resources are intended to assist with identification but should be used in conjunction with clinical oversight and a clear understanding of the study parameters.
While we endeavour to keep the information, tools and resources provided up to date and correct, we make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability with respect to the tools provided for any purpose. Any reliance you place on such information is therefore strictly at your own risk.
In no event will we be liable for any loss or damage including without limitation, indirect or consequential loss or damage, or any loss or damage whatsoever arising from loss of data or profits arising out of, or in connection with, the use of the tools provided.
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