COVID-19 Emergency Responsive Assessment (CERA)

COVID-19 Emergency Responsive Assessment (CERA)
COVID-19 Emergency Response Assessment
This research is a survey of the psychological health of frontline doctors across anaesthetics, emergency medicine and intensive care medicine at three different stages of the COVID-19 pandemic in the UK & Ireland.

Overview

The Study

The CERA study sought to examine the psychological impact of the COVID-19 pandemic on frontline doctors working in anaesthetics, emergency medicine & intensive care medicine. It was a study undertaken in collaboration with the Paediatric Emergency Research Network UK & Ireland (PERUKI), the Research and Audit Federation of Trainees (RAFT), Irish Trainee Emergency Research Network (ITERN) & Trainee Research in Intensive Care (TRIC).

The Data

We collected data on distress (using the General Health Questionnaire-12), post-traumatic stress symptoms (Impact of Events Scale – Revised), and personal & professional factors potentially associated with distress. We delivered three surveys, timed to coincide with the acceleration, peak, and deceleration of the first wave of the pandemic.

The Benefits

This research showed very high rates of distress at the acceleration & peak phase not previously seen in the literature, with some degree of natural recovery. There were a number of factors identified that were areas requiring further research. The high rates of trauma & distress has led to ongoing work examining how best we can help clinicians affected by their experiences, with follow-on work being performed in conjunction with the University of Bath, Oxford University & King’s College London.

The Results

Our acceleration survey response rate was 16% of all UK doctors (5440). The prevalence of psychological distress was 45% during the acceleration, 37% at the peak & 32% at the deceleration phase. The prevalence of trauma was 24% at the peak and 18% at deceleration. The prevalence of probably post-traumatic stress disorder was 13% at peak and 10% at deceleration. The factor that were most strongly associated with distress & trauma was worry of infecting family due to their clinical work.

Collaborative Work

COVID-19 Clinician Cohort (CoCCo) Study

Presentations

RCEM Annual Scientific Conference 2020

Media

Blog - RCEMLearning - Que CERA, CERA

Infographic - TERN - CERA Study

Article - Guardian - Doctors in UK and Ireland face 'ongoing distress' from Covid first wave

Article - Irish Examiner - Doctors suffered trauma and PTSD during and after first Covid-19 wave

Interview with LBC News - 18.01

Podcast - RCEM Learning - February 2021


TIRED / Need for Recovery

TIRED / Need for Recovery
Trainee-led evaluation of the need for Intershift Recovery among Emergency Department doctors in the United Kingdom.
This research examined the Need For Recovery (NFR) score among UK Emergency Physicians and examined the factors associated with a higher NFR.

Overview

The Study

The TIRED study sought to examine the Need for Recovery score in ED doctors in the UK & Ireland. The Need for Recovery score measures the feeling of needing to recuperate from the physical and mental demands of work. It was run as a pilot single-site study then as a large-scale multi-centre study.

The Data

We collected the Need for Recovery score for all emergency medicine doctors working in the UK & Ireland. We also examined individual and departmental factors that were thought would impact upon this score.

The Benefits

This research showed the highest group Need for Recovery score ever recorded in the literature. Factors associated with a higher score were poor access to study leave, annual leave, and a higher proportion of out of hours work.

The Results

The results of the first survey and the full manuscript are were published (see below) and widely disseminated across a range of media (see more below).

Publications

Pilot Survey

Full Manuscript

Second Paper

Presentations

RCEM Annual Scientific Conference 2019

EMTA Conference 2019

RCEM Academic Trainees Day 2020

South West Emergency Academic Training Day 2020

European Society of Emergency Medicine Congress 2020

EMTA Conference 2020

Media

Blog - RCEMLearning - TIRED

Podcast - RCEM Learning - September 2020

Blog - RCEMLearning - My Slice of the PI

Blog - Don't Forget The Bubbles - Take A Break

Summary - BMJ - Sixty seconds on... Need for Recovery

Infographic - TERN - NFR Study

Blog - BMJ - Top 10 Most Read in November


Subarachnoid Haemorrhage in the Emergency Department (SHED)

SHED
Subarachnoid Haemorrhage in the Emergency Department (SHED)
This research aims to evaluate different strategies for investigating serious causes of headache.
In particular, we are looking carefully at those patients who go on to have a scan of their brain and whether the timing of this affects the need for further investigations.

Overview

The Study

The SHED study aims to understand how acute headaches are dealt with by the Emergency Department (ED). This study doesn’t involve any additional treatments or tests, and no extra questions other than those that your Doctor will ask you routinely.

The Data

We will collect data from your medical records about the features of your headache, and the examination findings. We will also record the investigations you had whilst in hospital and the diagnosis provided

The Benefits

This research may change the way that headaches are managed in the future and therefore impact on your future treatment if you re-attend. It could also positively impact someone who comes to the hospital with the same problem as you.

The Results

The final outcomes from the study will be communicated via presentations in scientific meetings and by peer reviewed publications. We will aim to publish the results approximately 12 months after completion.

Publications

Study Protocol

Study documents for administration of the trial

Study Protocol

Word Document

Patient Information Sheet

Word Document

Study Inclusion Checklist

Word Document

Patient information poster

PDF Poster

Study Opt-Out Log

PDF Document

Delegation Log

Word Document

Opt Out Letter

Word Document

FAQ

What are the proposed GCP requirements for those providing patients with information sheets to opt-out?  

The sponsor has clarified that due to the study being low risk and involved collection of routinely collected data that ONLY the principal investigators need to be GCP trained. All others involved in data collection, recruitment and delivery of opt-out consent leaflets DO NOT require a GCP certificate

What were the discussions around feasibility if a site doesn’t have Clinical Research Nurse available for recruitment?

Although not having a research nurse may feel like a significant barrier to sites that currently have a research nurse, across our 100 sites we anticipate the majority will not have clinical research nurses.The good news is we know that from the TIRED UK study, sites that don’t have research nurses can still recruit exceptionally well.

Plan / Build a small study team

Organise for team members to take study leave (as per the study leave letter in the study pack)

Use study leave for site set-up and follow-up

The key is to informing doctors and nurses about the inclusion checklist and opt-out consent leaflet and empowering them to recruit patients using these documents

The inclusion checklist includes all poorly documented prospective data that we need

The process of completing the inclusion checklist and opt-out consent should take less than 2 minutes, therefore we anticipate it could be done 24/7, 7 days per week

All other data can be collected retrospectively

Study team organises time to complete REDCap data collection, using study leave at a later date

The local study team will be encouraged to ask their local R+Ds to second a research nurse to ED for the study period for the specific task of completing REDCap data collection during office hours (as per Research Nurse R+D Letter in the study pack).

28 day follow up – please confirm who does this? I think it will be us! – This is done by whoever is able to do it. If research nurses are available they would be a great asset. Otherwise Trainees will have some study leave time too.

Is there anyway on RedCaps to save the data and come back to continue inputting at a later stage?

REDCap saves automatically. When you open a new entry, it produces a new record which you can revisit and update at any stage later.

For the Hb question does this relate to the result of the Hb on a formal FBC sample taken on the day of attendance if there is one? Is the result on a VBG acceptable? Or are you looking for the most recent historical result?

We are looking for the result on the day of attendance. Formal lab Hb is best but a VBG is acceptable. The reason for this is, if a patient is significantly anaemic it is more difficult to identify blood on CT. Therefore, a SAH could be missed on brain CT due to anaemia and significantly affect our overall sensitivity.

I note CT scanners are to be labelled 1,2,or 3. I’m assuming we will need to send information regarding the configuration / type / slices / speed etc of each of our scanners in order for these to be identified prior to the trial starting. Is that correct?

Yes. There will be a CT questionnaire coming out prior to attendance. Locally you will have define which CT scanner is 1, 2 etc.

The data collection relates to data at least 28 days after attendance. Does all data have to be inputted at the same time – i.e. do we need to wait until all the information is available and hence wait at least 28 days to do this or will the system “save things as we go along” I.e. can we put the first bits in and then come back to it later?

REDCap autosaves as you go, so I would anticipate the data is collected on different occasions. REDCap will list all your local patients with the REDCap number plus the PIS number – this is how you will be able to identify the patients to re-enter their record. 

When we open the patients GP record it asks specifically if we have the patient’s consent to access their notes.

Good to raise this. We brought this up with ethics to ensure they were happy. In the Patient Information Sheet/opt out leaflet it explicitly states:

“we will check your hospital and GP medical records to check that you weren’t re-admitted to a hospital with headache for a 4-week period after today”

Ethics have approved this approach and I can confirm that we are covered by ethical approval to tick a box asking if we “approval” or “consent” to access GP or hospital records.

We estimate that around 60% of headaches present to the ED dept, and the remainder go via their GP into a day unit.  Would we still be able to take part in the SHED study as the inclusion criteria specifically mentions the ED dept?

Yes, you would still be able to take part.

As you know we are keen to recruit patients who present with “acute severe headache with maximal intensity within one hour”.

The growth of ambulatory care/medical day units or whatever your hospital calls them, is a UK system change over the last 5ish years. Prior to this all the patients who are managed here would have presented to ED.

If the patient presents to one of these units we would still be keen to recruit them if possible. We understand this may produce some logistical challenges. The department the patient is seen in, doesn’t really change their presenting complaint, our UK system has just “streamed” them to somewhere else.

So as long as the patient who presents to ambulatory care is >18 years old and has a severe headache with maximal intensity that peaks within one hour, we are keen to recruit them. It may be worth exploring with the medical day unit if these are the sort of patients they are seeing or are they seeing more chronic headaches?

Our research team are starting to question the feasibility of us joining in on this study.

I know you aim to recruit 90 in 3 months – as we are a small dept, we unlikely to get!

….is there a minimum number per site required?

Target recruitment is an interesting one. I understand its important to upload and prospectively declare your target recruitment. The truth is we don’t know the prevalence of acute severe headache in the UK, therefore its impossible for your to give an accurate target. I’m happy for you to state whatever you want!

Is there any funding available to support this study.  I seem to remember something about paying for stamps?

If you require stamps for the mailed opt-out consent then these can be provided.

These have not been included on any direct communication from the Sponsor as for something as small as stamps, it is not worth formulating official finance agreements between the 100 sites

What is the time period required by the sponsor for the retention of study documents post study closedown at site?

January 8th Meeting

Attendance certificate

Available here:

Recording:

Available here:

Minutes:

See website document page


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