Clinical Trials Unit » News (tag [Recruitment])

Patient Information Sheet and Consent Form Clarification

Wed, 10 Feb 2021 08:20:00 GMT

Recent version control monitoring checks have revealed some discrepancies with the wrong versions of Patient Information Sheets and Consent forms used as sites have found the naming of documents confusing to navigate. We apologise for the confusion caused and to help provide clarity of which version to use please see the following table:

	Patient Information Sheet	Consent Form
For patients with mental capacity prior to randomisation	RECOVERY-RS PIS on commencement	RECOVERY-RS Consent Form on Commencement
For patient with mental capacity post randomisation	RECOVERY-RS Patient Information Sheet	RECOVERY-RS Patient Deferred Consent
For consultees where patients do not have capacity post randomisation or by/after hospital discharge	RECOVERY-RS Patient Information Sheet	RECOVERY-RS Declaration Consent Form Consultee

As a reminder, if you are unable to obtain consent from a patient with mental capacity or consultee post randomisation before they are discharged/transferred from hospital, you should attempt to contact the patient/consultee up to 3 times by telephone to seek verbal agreement. If you are unsuccessful in reaching them after 3 attempts you do not need to contact them further as we have permission from our REC for the patient’s data to remain in the trial.

RECOVERY-RS is now the largest global non-invasive respiratory support trial for COVID-19

Tue, 09 Feb 2021 17:02:16 GMT

RECOVERY-RS is now the largest global non-invasive respiratory support trial for COVID-19 with 1,106 patients recruited as of this morning. We would like to say a huge thank you to all the staff, patients and families involved for helping us reach this incredible milestone!

RECOVERY-RS DMC update

Mon, 01 Feb 2021 11:02:54 GMT

The DMC for RECOVERY-RS met at the end of January. They noted the considerable progress that had been made since the last DMC meeting, with over 1000 participants now enrolled, making the trial the world’s largest trial of non-invasive ventilation in acute respiratory failure. After careful consideration of the available data, the committee recommended that recruitment continues. A further review will be considered in 4 weeks time. The committee requested that we prioritise obtaining the outcome data for those enrolled to date. We plan to work with NHS Digital, ICNARC and our recruiting sites to obtain as much information as possible to inform the next review.

The investigator team would like to extend their sincere thanks to the patients, families, clinicians and research teams who have supported the trial to date. We plan to provide a further update following the next interim analysis.

RECOVERY-RS team.

900th patient recruited!

Tue, 19 Jan 2021 14:41:00 GMT

A big thank you to all of our recruitment sites, patients and families for helping us reach the milestone of 900 patients recruited. Recruitment has been phenomenal the last few weeks and your hard work does not go unnoticed. Thank you!

RECOVERY-RS 836 patients recruited!

Wed, 13 Jan 2021 10:46:31 GMT

836 patients have now been recruited to RECOVERY-RS. We would like to say a huge thank you to our recruitment sites, patients and their families for helping us to reach this milestone. These are very challenging times and we appreciate all of your hard work. Recruitment has been exceptional over the Christmas period with over 250 patients recruited in the last month alone. We look forward to our next interim analysis taking place soon and thank sites for your hard work with data collection.

RECOVERY-RS 500 patients recruited!

Thu, 03 Dec 2020 16:22:57 GMT

Over 500 patients have now been recruited to the RECOVERY-RS trial! Thank you to everyone involved for all your hard work at sites and to patients & families for your generous participation.

RECOVERY-RS Group Site Teleconference feedback

Thu, 03 Dec 2020 15:19:00 GMT

A big thank you to everyone who joined the recent site teleconferences for RECOVERY-RS. We appreciate all of your feedback and hope you found these sessions useful & informative. Recruitment has been phenomenal these last few weeks and we have now reached a total of 509 patients recruited! Thank you to all involved.

Thanks again to Dr Messer & Dr Rostron for sharing their local experiences during the meeting of recruiting to RECOVERY-RS and how they have overcome challenges to embed the trial in to their clinical pathways. Thank you also to Dr Stephen Webb at Royal Papworth who provided really insightful comments yesterday regarding his altered view on CPAP. Experience during the second wave has shown concerns from ECMO centres about barotrauma from prolonged CPAP/NIV. This has led to a change in NHS guidance regarding ECMO criteria. Prolonged use of CPAP therefore may preclude option for ECMO leading to potential harm for CPAP. The only way to resolve these uncertainties is in a trial setting and through recruitment to RECOVERY-RS which will provide us with the evidence we need.

Summary minutes from the teleconferences will be circulated in the near future.

- Recording from TC held 24 Nov 20: https://files.warwick.ac.uk/eskilton/files/RECOVERY-RS+recordings/Site+TC+24Nov20+recording.mp4

- Slides from the TC meeting

- Local poster used at Heartlands (patient cards & poster) to assist with recruitment as a useful tool

- Trial certificate of appreciation to use to award trainees/staff involved in the study

- Slides from a recent TRIC & RAFT trainee meeting to share amongst trainee colleagues. Trainees can be critical to helping capture patients early on in their clinical pathway. A recording of Prof Gavin Perkins delivering these slides can be found here: https://files.warwick.ac.uk/eskilton/files/RECOVERY-RS+recordings/RECOVERY-RS+RAFT++TRIC+presentation+recording_23Nov20_.mp4

As a reminder all trial documentation including other aid memoirs can be downloaded from our trial website: https://warwick.ac.uk/fac/sci/med/research/ctu/trials/recovery-rs/sitestaff/

RECOVERY-RS Group Site Teleconference 24 Nov 20

Wed, 25 Nov 2020 11:10:38 GMT

Thank you to everyone who was able to join our site teleconference yesterday. We really appreciated your feedback and we hope you found the session useful. Thank you to PI’s Dr Messer and Dr Rostron who provided valuable feedback on implementing the trial at their sites. Please see slides from the meeting and take note of the following important points:

CROSSOVER GUIDANCE

The following scenarios are exempt from crossover of trial intervention and going forward should not be reported on the e-CRF:

•Up to 6 hours of continuous use of crossover intervention

•Breaks for eating and drinking

•Bridge to intubation to stabilise the patient

•Palliative care purposes

Data collected up until this point may be queried in the new year with sites to reflect this guidance.

To note, expert consensus is to not use CPAP or HFNO for a second episode of non-invasive support. Should go straight to intubation.

TRAINEE COLLABORATION

A slide set and recording of Chief Investigator Gavin Perkins delivering this presentation aimed at TRIC & RAFT trainee networks is now available (please request recording from the trial team via email). We encourage you to circulate this amongst your trainees to encourage collaboration and to garner their support to help identify eligible patients. Capturing patients early on (e.g. ED, A&E) in their clinical pathway can be critical for success in the trial which trainees can assist with. To award trainee’s or anyone at your site working on the trial please feel free to use the certificate of appreciation template. If you have any further suggestions please let us know.

NEXT MEETING
The next session is taking place Wednesday 2 December 09:00 – 10:00 via Teams (please contact the trial team for joining information).

Recordings & minutes from the meeting will be distributed after next week’s session for anyone who cannot join.

Thanks again for all your hard work and efforts with recruitment which has been phenomenal over the last couple of months. We are now one of the largest non-invasive respiratory trials in the world which reflects the commitment and support for the trial.

RECOVERY-RS Group Site Teleconferences

Mon, 09 Nov 2020 11:18:00 GMT

We would like to extend a huge thank you to all of our sites for your continued dedication and support for the trial. Recruitment has excelled in the last month with a total of 365 patients now recruited. This is a phenomenal achievement and will ensure we reach 430 patients recruited before the end of the year to perform our first interim analysis. Together we can deliver this trial and resolve doubts regarding effective and safe respiratory support treatments for COVID-19 patients.

Please click here for a summary of the site teleconferences which took place in September. We really appreciated everyone’s involvement during the interactive feedback session and ask you to read the key messages on page 4 summarising the outcome of these discussions.

The next site teleconferences will take place:
24 November 09:30 - 10:30
02 December 09:00 - 10:00

Contact the trial team for further details recovery-rs@warwick.ac.uk