ACTA Summit 2016 What we know about the health and economic benefit of trials and registries in Australia

24 November 2016

Dr Robert Herkes Clinical Director

TRIM: D16-40837

Health and economic benefit of clinical quality registries and clinical trial networks?

• The Australian Commission on Safety and Quality in Health Care • Atlas of clinical variation • National Safety and Quality Health Service Standards

• Self improving health system • Australian cost benefit analysis of Clinical Quality Registries (CQR) • Prioritisation of Clinical Quality Registries • Australian cost benefit analysis of Clinical Trial Networks

The Long Room in the old library (1712) – Trinity College, Dublin (1592) (Doomsday Book 1086) (Oxford University 1096)

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• Australian Government agency, jointly funded by all governments

• Leads & coordinates national improvements in safety & quality of health care based on best available evidence

• Aims to ensure that the health system is better informed, supported & organised to deliver safe & high quality care

• Works in partnership with patients, consumers, clinicians, managers, policy makers & health care organisation

• Aims to achieve a sustainable, safe & high-quality health system

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Patient safety and quality

• Australia’s health system generally performs well compared to other OECD countries

• A significant proportion of Australian hospital admissions are associated with an adverse event

• Reduction in the rate of adverse events and unwarranted variation – could potentially produce productivity savings, as well as direct benefits to patients

• The economic benefits of improving patient safety and value are compelling

• National data systems are not sufficient on their own to support improvements

1Vital Signs (2015); 2Health Policy Analysis (2013) 5

Commission work

• National Safety & Quality Health Service Standards (NSQHS)

• Pricing for safety and quality • Clinical Care Standards

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National Safety & Quality Health Service Standards (NSQHS)

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• Commenced 2013 • National safety standards are designed to protect the public from harm and

to reduce preventable adverse events • Focus on reducing high risk adverse clinical events • Mandated by COAG-HC • All public and private hospitals and day procedure centres

Version 1 Version 2

The self improving health system

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Measurement is foundational to advancing healthcare improvement A robust safety and quality monitoring system requires multiple measurements of patient safety

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Measurement

Atlas of variation Clinical

Trials

HACs

Clinical care

standard indicators

SAMM/ PPH;

NAUSP; CARAlert;

NIMC CHBOI Sentinel

Events

NSQHS Standards

Patient experience

and PROMs

Incident surveillance

Clinical Quality

Registries

Australian Atlas of Healthcare Variation – Colonoscopy

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How can clinical quality registries help?

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What is a CQR?

• Commission published a Framework for Clinical Quality Registries in 2010

• Clinical quality registries are organisations that systematically monitor the quality (appropriateness and effectiveness) of health care, within specific clinical domains, by routinely collecting, analysing and reporting health-related information

• They provide severity of illness adjusted outcomes with peer comparisons to frontline clinicians, to allow peer comparison and improvement

What is a CQR?

What is a CQR?

What is a CQR?

0.00

0.25

0.50

0.75

1.00

0 10 20 30Years post transplant

2010-20142005-20092000-20041995-19991990-19941985-1989

Graft survival Australia & New Zealand primary deceased donor

0.00

0.25

0.50

0.75

1.00

0 10 20 30Years post transplant

2010-20142005-20092000-20041995-19991990-19941985-1989

Patient survival Australia & New Zealand primary deceased donor

CQR: Economic evaluation

• Conservatively evaluated the economic impact of five clinical quality registries in Australia

• Findings: • Significant net positive returns on investments and positive

benefit to cost ratio • Substantial benefits, reflecting improvements to clinical practice

and outcomes over time • Significant value for money, when correctly implemented and

sufficiently mature

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Selected CQRs

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Registry Hosted by Evidence of impact

Victorian Prostate Cancer Registry (Victorian PCR) Monash University

• Prostate cancer research international active surveillance (PRIAS) guideline compliance resulting in lower rates of unnecessary intervention

• Positive need surgical margin reduction - better survival and avoided for secondary therapy

• Earlier treatment

Victorian State Trauma Registry (VSTR) Monash University

• Reduced in-hospital mortality • Reduced average length of stay • Better longer term functional outcomes

Australia and New Zealand Intensive Care Adult Patient Database (ANZICS APD)

ANZICS

• ICU Standardised Mortality Rates • Adverse events – (e.g. central line infection rates) • Rates of re-admission • Length of stay in ICU • Sepsis

Australia and New Zealand Dialysis and Transplantation Database (ANZDATA)

Royal Adelaide Hospital

• Graft failure rate reduction over time • Mortality • Reduced rates of complications (e.g. peritonitis rates) • Changes in practices (e.g. shunt timing)

Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR)

University of Adelaide

• Reduction in arthroplasty revision rates • Early recall/removal from market of poorly performing prosthetic devices used in

joint replacement surgery

CQR: Economic evaluation results

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Current Evaluation (gross benefits) Extrapolation to full national coverage

Registry Period of analysis National coverage Benefit Cost BCR Benefit Cost Extrapolated BCR

Victorian PCR 2009-13 11% $5.2m $2.7m 2:1 $44m $8.9m 5:1

VSTR* 2005-13 25% $36m $6.5m 6:1 $147m $12m 12:1

ANZICS 2000-13 80% $36m $9.8m 4:1 $45m $11m 4:1

ANZDATA 2004-13 100% $58m $8.8m 7:1 $58m $8.8m 7:1

AOANJRR ≤2002-14 100% $65m $13m 5:1 $65m $13m 5:1

*Crude estimate. Likely overestimate due to assumption of starting from zero coverage in other states. In reality, there is some existing coverage with different definitions of “major trauma” (BCR - Benefit-Cost Ratio)

CQR: Prioritised list of clinical domains

• Application of the prioritisation criteria (and other elements) in the Framework, to create a prioritised list of clinical domains for potential development of national clinical quality registries

• The process combined available data with the collective judgement of experts: • Shortlisted to identify a manageable list of diseases, conditions and interventions • Identified threshold criteria – prioritisation criteria essential to the successful functioning of a

clinical quality registry • Applied threshold criteria to remove diseases, conditions and interventions not suitable for

development • Grouped remaining diseases, conditions and interventions into clinical domains • Prioritised clinical domains against remaining prioritisation criteria.

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Prioritised list of clinical domains

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Clinical domain

Neonatal critical care

Mental health

Diabetes

Maternity

Major burns

Dementia

Renal disease

Stroke

Ischemic heart disease

Trauma

Adult critical care

Musculoskeletal disorders

High burden cancers

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Priority Summary

Serious consequences of poor quality care, high burden of disease and moderately high cost. Existing leadership group and national registry with substantial capture.

Serious consequences of poor quality care, very high burden of disease and very high cost. Clinical advocacy for registries but no identified leadership group or current registries. Initial registries may focus on sub-groups of patients where the entire population can be captured.

Serious consequences of poor quality care, moderate burden of disease and high cost. Current data collections by jurisdictions and through administrative data are substantial which could be drawn on to develop clinical quality registries.

Serious consequences of poor quality care, high burden of disease and moderate acute care costs. No current registries. Clinical advocacy for registry development in this area. Scoping study on potential to develop registry in this domain is underway.

Serious consequences of poor quality care, moderate burden of disease and moderate cost. Established leadership group and national registry with incomplete patient capture.

Serious consequences of poor quality care, high burden of disease and moderate cost. Clinical advocacy for the development of clinical quality registries.

Serious consequences of poor quality care, high burden of disease and moderately high cost to the system. Strong leadership and a national registry.

Serious consequences of poor quality care, very high cost and moderately high burden of disease. Established leadership group for dialysis and transplantation and expand to registries in this domain.

Serious consequences of poor quality care, very high burden of disease and cost to the health system. Strong clinical support registries in this domain. Current national registries and potential to expand into non-surgical interventions in the future.

Serious consequences of poor quality care, very high cost and high burden domain. A number of national registries in hip and knee procedures. Potential to expand to registries for non-surgical interventions in the future.

Serious consequences of poor quality care, very high burden of disease and high cost to the system. Established leadership group and national registry with incomplete capture as well as jurisdictional registries.

Serious consequences of poor quality care, very high cost to the health system and estimated high burden of disease. Very strong clinical support and leadership. National registry with close to complete coverage.

Serious consequences of poor quality care, very high cost and high burden of disease. Current national population based registers and a number of jurisdictional cancer specific registries. National registry for prostate cancer.

How can Clinical Trials Networks help?

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CTNs: Economic evaluation

• Evaluated the economic impact of late phase, investigator-initiated clinical trials conducted through three Australian clinical trials networks

• Preliminary findings: • Significant net positive returns on investments and positive benefit to

cost ratio • Substantial benefits – from better health outcomes and avoided

service costs • Increasing implementation of trial evidence into practice can lead to

considerable health and economic gains

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Selected clinical trials networks

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Network Years of operation Studies Funding Publications Number of trials

included Names of trials

included

Australasian Stroke Trials Network (ASTN)

19 40 Published 35 current

>$50m total >$10m NHMRC 180+ 7

ARCH AVERT

ENCHANTED EXTEND-IA

INTERACT-2 PROGRESS

QASC

Interdisciplinary Maternal and Perinatal Clinical Trials Network (IMPACT)

20 147 Published 150 current

$10-25m total >$10m NHMRC 146 10

ACHOIS ACTOMgSO4

ACTORDS COIN

COSMOS ICE MAP

M@NGO PPROMT VIBES+

Australian & New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG)

21 41 Published 28 current

>$50m total >$10m NHMRC 130+ 8

ARISE CHEST DECRA EPO-TBI

NICE-SUGAR RENAL SAFE

SAFE-TBI

Represent over a third of completed trials, and a broad selection of clinical services

Acronym Trial Publication Reference

ARCH Clopidogrel plus aspirin versus warfarin in patients with stroke and aortic arch plaques. Stroke 2014; 45:1248-1257

EXTEND-IA Endovascular therapy for ischemic stroke with perfusion-imaging selection. N Engl J Med 2015; 372:1009-18

INTERACT2 Rapid blood-pressure lowering in patients with acute intracerebral haemorrhage. N Engl J Med 2013; 368:2355-65

PROGRESS Randomised trial of a perindopril-based blood-pressure lowering regimen among 6105 individuals with previous stroke or transient ischaemic attack. Lancet 2001; 358:1033-41

AVERT Efficacy and safety of very early mobilisation within 24h of stroke onset (AVERT): a randomised controlled trial. Lancet 2015; 386: 46–55.

QASC Implementation of evidence-based treatment protocols to manage fever, hyperglycaemia, and swallowing dysfunction in acute stroke (QASC): a cluster randomised controlled trial. Lancet 2011; 378:1699-1706

ENCHANTED Low-dose versus standard-dose intravenous alteplase in acute ischemic stroke. N Engl J Med 2016; 374:2313-2323

ICE Whole-body hypothermia for term and near-term newborns with hypoxic-ischemic encephalopathy. Arch Pediatr Adolesc Med 2011; 165(8):692-700

VIBES+ Preventive care at home for very preterm infants improves infant and caregiver outcomes at 2 years. Pediatrics 2010; 126:e171-e178

COSMOS Effects of continuity of care by a primary midwife (caseload midwifery) on caesarean section rates in women of low obstetric risk: the COSMOS randomised controlled trial. BJOG 2012 119:1483-1492

M@NGO Caseload midwifery versus standard maternity care for women of any risk: M@NGO, a randomised controlled trial. Lancet 2013; 382:1723-32

MAP Management of asthma in pregnancy guided by measurement of fraction of exhaled nitric oxide: a double-blind, randomised controlled trial. Lancet 2011: 378:983-90

COIN Nasal CPAP or intubation at birth for very preterm infants. N Engl J Med 2008; 358:700-8

ACTORDS Neonatal respiratory distress syndrome after repeat exposure to antenatal corticosteroids: a randomised controlled trial. Lancet 2006; 367:1913-19

ACHOIS Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med 2005; 352:2477-86

ACTOMGSO4 Effect of magnesium sulfate given for neuroprotection before preterm birth: a randomised controlled trial. JAMA 2003; 290(20):2669-76

PPROMT Immediate delivery compared with expectant management after preterm pre-labour rupture of the membranes close to term (PPROMT trial): a randomised controlled trial. Lancet 2015; 387: 444–4521

NICE-SUGAR Intensive versus Conventional Glucose Control in Critically Ill Patients. N Engl J Med 2009; 360:1283-97

DECRA Decompressive Craniectomy in Diffuse Traumatic Brain Injury. N Engl J Med 2011;364:1493

SAFE A Comparison of Albumin and Saline for Fluid Resuscitation in the Intensive Care Unit. N Engl J Med 2004; 350:2247-2256

RENAL Intensity of Continuous Renal-Replacement Therapy in Critically Ill Patients. N Engl J Med 2009;361:1627-38

CHEST Hydroxyethyl starch or saline for fluid resuscitation in intensive care. N Engl J Med 2012;367:1901-11

ARISE Goal-directed resuscitation for patients with early septic shock. N Engl J Med 2014; 371:1496-506

EPO-TBI Erythropoietin in traumatic brain injury (EPO-TBI): a double-blind randomised controlled trial. Lancet 2015; 386: 2499-506

Significant International Impact

CTNs: Economic evaluation results

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Network Gross benefit Cost BCR

ASTN $1bn $106m 9.5:1

IMPACT $682m $173m 3.9:1

ANZICS CTG $271m $57 4.8:1

Total $2bn $336 5.8:1

• Results if findings from the 25 trials are implemented in 65% of eligible patients seeking treatment in a year:

• Trial results only need to be implemented in 11% of the eligible patient population for benefits to exceed costs

• 9% of the gross benefit would break-even with all NHMRC funding awarded to all Australian clinical trials networks between 2004 to 2014* *As reported in the Profiling Networks Report

70% through better health outcomes

NOTE: Preliminary results

The self improving health system

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• Historical method of indexing and sorting data

• Used by practitioners and institutions to analyse patient data and outcome

• We moved past these days • Similarly data will provide new

tools for patients, practitioners and health systems

Edge notched cards