Developing, implementing and scaling up an acute care bundle for - - PowerPoint PPT Presentation

Developing, implementing and scaling up an acute care bundle for intracerebral haemorrhage in Greater Manchester

Adrian Parry-Jones NIHR Clinician Scientist & Honorary Consultant Neurologist

Manchester Academic Health Sciences Centre Salford Royal NHS Foundation Trust, Salford, UK

Intracerebral haemorrhage

• Common health problem

‒ Causes 10-15% of strokes ‒ More common in Asian populations

• Poor patient outcomes

‒ Case fatality 30-40% at 1 month ‒ Causes 5.8% of all global deaths (vs. 6.0% for ischaemic stroke) ‒ Only 20% regain independence ‒ Little improvement in outcomes

• ver last 30 years

Evidence of nihilism in ICH?

*Adjusted for sex, age, premorbid mRS, comorbidities of congestive heart failure, hypertension, AF, and diabetes, previous stroke/TIA, Level of consciousness, and ‘out of hours’. † also adjusted for early neurological deterioration (drop in NIHSS 1a of 1 or more in first week). Parry-Jones et al (2016) Int J Stroke 11:321-31

An illustrative case….

• 69 year-old female
• Chronic hypertension, atrial fibrillation
• DH: Perindopril, warfarin (INR target range 2-3)
• Baseline function normal (mRS = 0)
• Sudden onset slurred speech and right-sided weakness at 08:00
• Examination on arrival (09:00):
• GCS E3 M6 V5 – 14/15
• Severe R-sided weakness
• NIHSS 12
• BP 189/110

CT brain at 09:23 - 1.5 h post-onset

Acute management questions….

• 1. What should I do about the warfarin treatment?
• 2. Do I need to do anything about her blood pressure?
• 3. Should I refer her to the neurosurgeons?

Acute management questions….

• 1. What should I do about the warfarin treatment?
• 2. Do I need to do anything about her blood pressure?
• 3. Should I refer her to the neurosurgeons?

Anticoagulants – recent Salford audit data

Q3 2013 Q4 2013 Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016 Q2 2016 Q3 2016 No anticoag 32 39 39 39 36 43 59 49 65 72 63 61 28 VKA 2 6 11 6 4 14 3 8 6 11 6 6 1 DOAC 1 1 1 1 1 7 3 2 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% % of total ICH admissions

VKA-ICH: ‘Time is brain’

Kuramatsu et al. (2015) JAMA 313: 824-36.

VKA-ICH: Improving door-to-needle times

Three key changes: 1. PCC stock in the ED 2. Point-of-care INR device 3. Standard protocol to deliver PCC without Haematology referral for every case

Parry-Jones (2015) BMJ Qual Improv Rep 8

DOAC-ICH

Options for reversal:

• PCC (3-factor, 4-factor)
• Idarucizumab (for dabigatran)
• Andexanet alpha (for Xa inhibitors)

Drug Half life Mode of action Coagulation tests Dabigatran 12-17 h Direct thrombin (II) aPTT, TT Rivaroxaban 7-11 h Factor Xa PT, anti Xa Apixaban 8-15 h Factor Xa anti Xa Edoxaban 10-14 h Factor Xa PT, anti Xa

DOAC-ICH: current guidelines

What do the guidelines say?

• RCP (2016): idarucizumab for dabigatran; 4F PCC for others
• AHA/ASA (2015): PCC or rFVIIa ‘might be considered’; Activated

charcoal might be used if <2 h since last dose; Haemodialysis for dabigatran.

• ESO (2014): No recommendation

PCC:

• Animal and healthy volunteer data suggests partial reversal
• British Committee for Standards in Haematology (2013)

DOAC-ICH: Idarucizumab

• Dabigatran antidote, humanised Fab
• Dabigatran - 350x higher affinity for

idarucizumab than thrombin

• Rapid & complete reversal
• No prothrombotic effects in

volunteers; 1 in 90 pts (RE-VERSE AD)

• RE-VERSE AD included 18 ICHs
• £2400 per dose (5 g)

Pollack et al. N Engl J Med, 2015:373,511–20.

Acute management questions….

• 1. What should I do about the warfarin treatment?
• 2. Do I need to do anything about her blood pressure?
• 3. Should I refer her to the neurosurgeons?

Intensive BP lowering – INTERACT2

• 2839 ICH patients randomised
• RCT of acute intensive BP lowering
• To a target SBP 130-140 within 1 h
• Reduced disability with intensive treatment
• Ordinal shift analysis: OR 0.87; 95% CI, 0.77 to 1.00; P = 0.04
• Improved quality of life measures
• No effect on survival
• No safety concerns

Anderson et al.(2013) N Engl J Med.368:2355-65.

Intensive BP lowering – ATACH2

• 1000 patients randomised (ICH vol < 60 ml)
• Target SBP 110-139 vs 140-179 mmHg, IV nicardipine
• Neutral on all outcomes
• Increased renal AEs (9.0% vs. 4.0%, p=0.002)

Qureshi et al.(2016) N Engl J Med.375:1033-43.

ATACH INTERACT

Acute management questions….

• 1. What should I do about the warfarin treatment?
• 2. Do I need to do anything about her blood pressure?
• 3. Should I refer her to the neurosurgeons?

Neurosurgery for ICH

• Infratentorial ICH

‒ Risk of brainstem compression, herniation syndromes, hydrocephalus ‒ Procedures – EVD / posterior fossa decompression / haematoma evacuation

• Supratentorial ICH – procedures

‒ Early haematoma evacuation in the stable patient ‒ Haematoma evacuation in the deteriorating patient ‒ External ventricular drainage for hydrocephalus

Early haematoma evacuation

Gregson et al. (2012) Stroke 43: 1496-1504

• IPD meta-analysis – 2186 cases
• Overall benefit in cases:
• Onset to randomisation < 8h
• Age 50-70
• GCS 9-12
• ICH volume 20-50 ml

GCS 13-15 GCS 3-8 GCS 9-12

MISTIE III: MIS and tPA for ICH

• Catheter in situ from 1-2 days post onset, for 3-6 days
• tPA administered in to haematoma via catheter every 8 h
• Phase II trial:
• 96 patients (54 surgery, 42 conservative)
• 180d mRS ≤ 3: 21% cons vs. 33% MIS (adjusted for p=0.049)

Hanley et al. (2016) Lancet Neurol; 15: 1228-37

ABC-ICH project – Improving ICH outcomes

Aim: A 10 percentage point reduction in 30 day case-fatality after admission with acute ICH by the end of 2016. How:

• Using the Model for Improvement, supported by IS4Ac
• Project commenced June 2015

Analysis:

• Data collection period: July 2013 to July 2016
• Local ICH registry: case ascertainment via coding and SSNAP
• All baseline scans reviewed for location, ICH volume (ABC/2), IVH

Process targets

• A. Anticoagulant reversal: Deliver PCC < 90 min from arrival
• B. Blood pressure lowering: Deliver intensive blood pressure lowering

with needle-to-target time < 60 min

• C. Care pathway: Refer patients with good pre-morbid function and any
• f the following to Neurosurgery
• GCS < 9
• Posterior fossa ICH
• Obstructed 3rd/4th ventricle
• Haematoma volume > 30 ml

Anticoagulant reversal – DNT for PCC

QI project commenced Education and awareness work

50 100 150 200 250 300 350 400 450 500 May 14 Oct 14 Nov 14 Jan 15 Jun 15 Sep 15 Nov 15 Jan 16 Feb 16 Apr 16 May 16

DNT (min)

POC INR Ref sheet

Protocol introduced Change to GTN first Stay in ED until target reached

Intensive BP lowering – NTT time

200 400 600 800 1000 Jun 14 Nov 14 Mar 15 Apr 15 May 15 Jul 15 Aug 15 Sep 15 Oct 15 Nov 15 Dec 15 Jan 16 Feb 16 Mar 16 Apr 16 May 16 Jul 16

NTT (min)

Reduction in DNR orders at < 24 h

QI project commenced

0% 10% 20% 30% 40% 50% 60% 70% May 14 Jun 14 Jul 14 Aug 14 Sep 14 Oct 14 Nov 14 Dec 14 Jan 15 Feb 15 Mar 15 Apr 15 May 15 Jun 15 Jul 15 Aug 15 Sep 15 Oct 15 Nov 15 Dec 15 Jan 16 Feb 16 Mar 16 Apr 16 May 16 Jun 16 Jul 16

% all ICH admissions

Admissions to critical care

QI project commenced

LCL

0% 10% 20% 30% 40% 50% 60% May 14 Jun 14 Jul 14 Aug 14 Sep 14 Oct 14 Nov 14 Dec 14 Jan 15 Feb 15 Mar 15 Apr 15 May 15 Jun 15 Jul 15 Aug 15 Sep 15 Oct 15 Nov 15 Dec 15 Jan 16 Feb 16 Mar 16 Apr 16 May 16 Jun 16 Jul 16

% all ICH admissions

Factor Pre QI (n=363) Post QI (n=316) p Age 72.0 (57.1 – 81.1) 69.6 (55.2 – 80.1) 0.34 Premorbid mRS (0-2) 289 (79.6%) 260 (82.3%) 0.15 Anticoagulant 54 (14.9%) 41 (13.0%) 0.51 Sex (female) 172 (47.4%) 163 (51.6%) 0.28 GCS 14 (10-15) 14 (10-15) 0.60 Infratentorial 42 (11.6%) 40 (12.7%) 0.66 IVH 141 (38.8%) 127 (40.2%) 0.61 ICH volume (ml) 20.0 (6.5 – 54.1) 15.8 (5.0 – 45.2) 0.055

Analysis of mortality – Baseline characteristics

Pre QI: Jul 2013 – May 2015; post QI: Jun 2015 – Jul 2016. Excluded 33 cases not under stroke or neurosurgery (14 pre, 19 post)

QI project – unadjusted analysis of survival

Pre-QI:

• Jul 2013 – May 2015
• 363 cases admitted
• 30-day case fatality = 35.3%

Post-QI:

• Jun 2015 – Jul 2016
• 316 cases admitted
• 30-day case fatality = 25.3%

Logrank test: p=0.002

Factor HR 95% CI Sig. GCS 0.85 0.83 to 0.88 <0.0001 Anticoagulant 1.27 0.94 to 1.73 0.124 Infratentorial 1.79 1.29 to 2.49 0.001 IVH 1.44 1.12 to 1.86 0.04 ICH vol 1.006 1.004 to 1.008 <0.0001 Age 1.053 1.043 to 1.063 <0.0001 Post QI 0.70 0.54 to 0.90 0.006

QI project – Cox regression analysis

Post QI (unadj) 0.68 0.52 to 0.86 0.002

Mortality analysis – vs. rest of England & Wales

Mean 30d mortality p

Jul 13 – May 15 Rest of SSNAP 29.0% Salford 35.3% Difference 6.2% <0.0001 Jun 15 – Jul 16 Rest of SSNAP 27.0% Salford 25.3% Difference

• 1.8%

<0.0001 Difference in Difference

• 8.1%

<0.0001

ABC-ICH: GM scale-up

Aim: A 10 percentage point reduction in death and severe disability after acute ICH by April 2018 in Greater Manchester Implementation:

• Launch bundle at Stepping Hill and Fairfield from Apr 2017
• Appointment of ICH Specialist Nurse at Salford from Feb 2017

Measurement:

• App/EPR tools for acute team linked to dashboard of key measures
• Automated ICH registry by text mining of regional radiology database

Evaluation:

• Qualitative Research Associate to be appointed in Mar 2017
• Health Economics

• Salford: H Patel, Kyri Paroutaglou, Luca Cecchini, Emily Birleson
• Fairfield: Khalil Kawafi
• Stockport: Appu Suman, Claire McQuaker, Irfan Malik
• GM ODN: Sarah Rickard, Chris Ashton, Jane Molloy
• SSNAP: Ben Bray

Funding & support:

Acknowledgements