The Centre of Research Excellence (CRE) to Reduce Inequality in Heart Disease focuses on improving the heart health and outcomes of groups and communities i.e. Regional Australians, Indigenous Australians and International Health

WHICH? II Trial

Research Stream: Regional Australians

 

WHICHIIstudyimage.jpg - largeWhich Heart failure Intervention is most Cost effective in reducing Hospital care (WHICH?) II Trial: A multicentre, randomised trial of standard versus intensified management of metropolitan and regional-dwelling patients with heart failure.

 

Full Study Title

Which Heart failure Intervention is most Cost effective in reducing Hospital stay (WHICH?) II Trial

 

Trial Registration

Australian New Zealand Clinical Trials Registry number: 12613000921785 (http://www.anzctr.org.au)

 

Funding Source

National Health and Medical Research Council Project Grant (2013 - 2016) number 1049133

 

Click here for Trial Protocol

 

Rationale for the Study

Chronic heart failure management programs (CHF-MPs) are now the gold-standard to cost-effectively care for thousands of Australians hospitalised with CHF each year. In the original WHICH? Trial we demonstrated that home-based management is most cost-effective in reducing hospital stay in CHF.  However, this trial was confined to metropolitan dwelling individuals only and applied a “one size fits all” approach. The subsequent Which Heart failure Intervention is most cost-effective in reducing Hospital stay (WHICH?) II Trial, a multicentre, randomised study, will determine if more intensive care (via home visits and remote care contacts) further improves poor outcomes in CHF. It will, therefore, test a more individualised approach to post-discharge CHF management whilst examining the overall benefits of structured telephone support supplemented by home visits to those individuals living in regional Australia.

 

Study Aims

Although the overall evidence in favour of CHF-MPs to reduce readmission rates and prolong survival in high risk individuals discharged from hospital with CHF is now well established, there is still a need to undertake appropriately powered, randomised trials to determine the most cost-effective and consumer friendly components of care of CHF-MPs.

 

In the WHICH? II Trial we aim to:

  1. Explore the most cost-effective way to optimise CHF outcomes, by undertaking a head-to-head trial of standard post-discharge CHF care incorporating both face-to-face and structured telephone support (where appropriate) versus an enhanced form of CHF-MP that increases the intensity of care for those most at risk of recurrent hospitalisation and/or a premature death.
  2. Further explore patient preferences for the delivery of CHF-MPs – particularly from the perspective of those living in non-metropolitan regions.
  3. Further refine risk delineation in CHF (incorporating a combination of socio-demographic, clinical and cardiac imaging data) in order to individualise cost-effective CHF-MPs.

 

Study Hypothesis

The Which Heart failure Intervention is most Cost-effective in reducing Hospital stay (WHICH?) II Trial will test the hypothesis that: in typically older patients hospitalised with CHF and discharged to home, a more intense, nurse-led, post-discharge, multidisciplinary, CHF-MP incorporating outreach home-based intervention enhanced by structured telephone support (INT-CHF-MP) specifically targeting those at risk of recurrent (and costly) hospital stay will be superior to a standard form of CHFMP (S-CHF-MP) in reducing the total cost of health care (15% or more) during 18 month follow-up.

 

Study Design

The WHICH? II Trial is a multicentre, randomised controlled trial, registered with the Australian New Zealand Clinical Trials Registry. It will conform to the principles outlined in the Declaration of Helsinki and to the CONSORT guidelines for a pragmatic study comparing the efficacy of two non-pharmacological health interventions.

 

Primary and Secondary Outcomes

The primary end-point of the WHICH? II Trial is the total cost of health care (calculated as cost/day to adjust for potential variance in survival) during 18 month follow-up.

 

Secondary endpoints include rate of hospitalisation (all-cause, CVD and CHF-specific), all-cause mortality, event-free survival from death or hospitalisation, generic (EQ-5D-5L) and CHF-specific (Kansas City Cardiomyopathy Questionnaire) changes in quality of life from baseline, and uptake of gold-standard therapy (including prescribed doses of angiotensin converting enzyme [ACE] inhibitors and beta blockers) assessed at 12 months post index hospital discharge.

 

Study Conclusions & Translational Potential

N/A

 

Ongoing Research

This study is recruiting in 2013

 

Key Collaborators

  • Professor Simon Stewart: Australian Catholic University, Australia
  • Professor David Thompson: ACU, Australian Catholic University, Cardiovascular Research Centre
  • Professor John Horowitz: The Queen Elizabeth Hospital, Cardiology Unit
  • Associate Professor Melinda Carrington: Australian Catholic University, Australia
  • Professor Paul Scuffham: Griffith University, Population and Social Health Research Unit
  • Associate Professor Chiew Wong: Western Hospital, Cardiology Unit
  • Dr Phillip Newton: St Vincent’s Hospital Sydney, Postdoctoral Research Fellow
  • Associate Professor Amanda Rischbieth: SA Heart Foundation, Chief Executive
  • Professor Patricia Davidson: St Vincent’s Hospital Sydney, Faculty of Health
  • Professor Henry Krum: Monash University, Epidemiology and Preventative Medicine
  • Professor Peter Macdonald: St Vincent’s Hospital Sydney, Cardiology Unit
  • Professor Thomas Marwick: Menzies Research Institute, Director
  • Professor Christopher Reid: Monash University, Epidemiology and Preventative Medicine
  • Dr Yih Kai Chan: Australian Catholic University, Australia
  • Dr Jennifer Whitty: Griffith University, Population and Social Health Research Program

 

Study Publications

N/A