Sedation AND Weaning In CHildren (SANDWICH): trial update

1

Professor Bronagh Blackwood, Chief InvestigatorWellcome-Wolfson Institute for Experimental Medicine

Queen’s University Belfast, N. Ireland

2

1. Alder Hey Children’s Hospital2. Royal Belfast Hospital for Sick Children3. Birmingham Children’s Hospital 4. Bristol Royal Children’s Hospital5. Royal Brompton Hospital6. Addenbrooke’s Hospital 7. Noah’s Ark Children’s Hospital for Wales8. Great Ormond Street Hospital PICU9. Great Ormond Street Hospital CCC10. Kings College Hospital11. Leeds General Infirmary12. Great North Children’s Hospital 13. John Radcliffe Hospital 14. Southampton General Hospital15. St George’s Hospital 16. St Mary’s Hospital17. Royal Stoke Hospital18. Sheffield Children’s Hospital

YOU have created a change in practice

3

Background

Trial design

Training and process evaluation

Progress summary

Discontinuing mechanical ventilation (MV) -important patient-relevant priority

• Adult ICUs, moderate quality evidence for weaning protocols in reducing clinically relevant duration of MV time (n=17 trials)1

• Spontaneous breathing trials (SBT) now recommended practice

• Paediatric ICUs, low quality evidence (n=3 trials)2

• 2011 Foronda (n=294, significant effect, 1.2d median difference, p0.01)3

4

1. Blackwood Cochrane Database Syst Rev. 2014; 11: CD0069042. Blackwood Cochrane Database Syst Rev. 2013; 7: CD0090823. Foronda Crit Care Med 2011; 39:11

Background to the trial

5

• Feasibility work1,2: visits 26 PICUs - variability in practice; low engagement junior staff; support from parents/children

• Paediatric Intensive Care Society prioritization exercise 2015 (#1 priority)

• Commissioned and funded by NIHR

1. Blackwood, Tume. Trials. 2015; 16: 3252. Tume, Preston, Blackwood. Nurs Crit Care. 2016 May;21(3):e10-8

More recently…

• 2015 Curley (n=2449, no effect duration of ventilation, both 6.5d median, p=6.1)

• 2019 Ferreira (n=110, significant effect, 83 vs 68%, p=0.02, extubation success)

6

JAMA. 2015;313(4):379-389. doi:10.1001/jama.2014.18399

Research Questions

7

Will the SANDWICH approach to managing sedation and weaning ventilation enable coordinated management of weaning and reduce delays in the weaning process?

• Does it result in patient benefit & no additional harm?

• Is it cost effective in the NHS?

• Is it sustainable and acceptable to staff delivering care?

8

Trial started 5 Feb 2018 Trial ended 14 Oct 2019 Study ends June 2020

Cluster randomised stepped wedge

design

Participants• 72% eligible UK PICUs

• Opt-out consent approach

• Inclusion: all children receiving IMV

• Exclusion: those who will not be extubated

• Target sample: N = 9,520, to achieve 80% power and 1d difference

9

1

2

3

4

6

7

11

12

13

14

17

18

5, 8, 9, 10, 15, 16

1. Alder Hey Children’s Hospital2. Royal Belfast Hospital for Sick Children3. Birmingham Children’s Hospital 4. Bristol Royal Children’s Hospital5. Royal Brompton Hospital6. Addenbrooke’s Hospital 7. Noah’s Ark Children’s Hospital for Wales8. Great Ormond Street Hospital PICU9. Great Ormond Street Hospital CCC10. Kings College Hospital11. Leeds General Infirmary12. Great North Children’s Hospital 13. John Radcliffe Hospital 14. Southampton General Hospital15. St George’s Hospital 16. St Mary’s Hospital17. Royal Stoke Hospital18. Sheffield Children’s Hospital

Intervention bundle incorporated…

1. Co-ordinated care with greater nursing involvement

2. Patient-relevant sedation plans linked to regular assessment using a COMFORT scale

3. Regular assessment of ventilation parameters with a higher than usual trigger for undertaking an extubation readiness test

4. Spontaneous Breathing Trial (SBT) on low levels of respiratory support to test extubation readiness

10

11

COMFORT Score Interpretation

COMFORT scores in red zone necessitate a pain assessment to indicate if the primary cause is a

Pain OR Sedation issue.

12

Comparator – usual care

• Sedation assessment by nurses mainly using COMFORT tool, variable assessment periods, no discussion of scores with doctors

• Nurses tend to use liberal sedation – delayed weaning

• Ventilation weaning led by consultants (some senior nurses) with little/no involvement of junior staff

• Weaning method involved a gradual reduction to very low levels of ventilatory support before extubation

13

Outcomes

• Intervention-specific (duration of IMV; successful extubation; self-extubation; reintubation; tracheostomy)

• Resource/economic (PICU, hospital length of stay; cost/respiratory complication avoided at 28 days)

• Harms (ICU, hospital mortality; complications)

• Process (factors related to undertaking the training; delivering the new approach; adherence)

14

SANDWICH Training

• Implementation Manager – educational development; implementation liaison; train the trainers

• Educational package – online (LearnPro); face-to-face delivery; training manual; promotional resources (pens, posters, stickers)

• SANDWICH nurses 0.5 WTE/PICU (research and educational role)

• Multi-disciplinary PICU ‘champions’ (average 1:10-12)

• Target 80% staff trained/PICU in 8-week training period

15

Process evaluation (PE)

• Qualitative exploration of context, mechanism and impact on outcomes (interviews with staff; adherence data)

• Necessary – complex intervention; multi-centre trial

• Susceptible to variations – implemented, received, delivered

• Helps distinguish between intervention and implementation failure

• Delivers information concerning sustainability and further adoption

16

Summary

• Largest paediatric ICU trial (>10,000 patients, >2000 staff)

• Impact of using this trial design - substantial change in practice (~71% children admitted to UK PICUs weaned using SANDWICH)

• Crucial to success in running the trial…fantastic PICU engagement; implementation science; PE to tell the story behind the data; efficient clinical trials unit

• Data queries/sign off – 31 Dec; data cleaning/analysis – May 2020; results expected June 2020

• SANDWICH training website under construction www.qub.ac.uk/sites/sandwich

• NHS – LearnPro – contact info@learnpro.co.uk

17

Thank you to the team & questions?@SANDWICHTrialUK

• PICUs – all staff• Clinical: Duncan Macrae (Royal Brompton, London), Kevin Morris

(Birmingham Children’s), Mark Peters (GOSH, London), Lyvonne Tume (Salford University)

• Methodological: Ashley Agus, Health Economist & Cliona McDowell, Statistician, NICTU), Karla Hemming (Birmingham University, SW Statistician), Mike Clarke & Danny McAuley (QUB), Walsh (Edinburgh University)

• Lisa McIlmurray (Implementation manager);Joanne Jordan (PE)• Roger Parslow (PICANet, Leeds University)• CTU: Margaret Murray, Roisin Boyle (trial coordinators); Pauline Bradley,

Gerard Quinn (data managers); Kevin Devlin (administrator)

18