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Improved Outcomes in Complex Heart Disease: Home-based Intervention

This study examines the impact of a nurse-led, multidisciplinary home-based intervention on event-free survival in 1,226 patients with heart disease. The results show prolonged event-free survival in more complex cases of heart disease compared to standard care.

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Improved Outcomes in Complex Heart Disease: Home-based Intervention

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  1. Prolonged event-free survival in more complex cases of heart disease: outcome data from 1,226 patients from 3 randomised trials of nurse-led, multidisciplinary home-based intervention S Stewart, JF Wiley, YK Chan, J Ball, DR Thompson & MJ Carrington simon.stewart@acu.edu.au │http://mmihr.acu.edu.au

  2. Acknowledgements • Trial Investigators: • A/Prof. Melinda J Carrington & Dr Yih Kai Chan (ACU/Baker IDI) • Prof. John D Horowitz & Dr Gnanadevan Mahadevan (The Queen Elizabeth Hospital, South Australia) • Dr ChiewWong (Western Hospital, Victoria) • Prof. Walter P Abhayaratna (Canberra Hospital, ACT) • Prof. Thomas H Marwick (Princess Alexander Hospital, Qld) • Prof. David R Thompson & Dr Jocasta Ball (Baker IDI/ACU) • Prof. Paul Scuffham (Griffith University, Queensland) • Prof. Garry Jennings (Baker IDI) • Prof. Peter MacDonald & Dr Phillip Newton (St Vincent’s Hospital, NSW) • Trial Statistician:Professor Adrian Esterman (Uni SA, SA) All trials were independently designed, funded (NHMRC of Australia) and conducted. A number of Investigators are also funded by the NHMRC of Australia

  3. Background & study hypotheses • Despite a wealth of evidence, the role of disease management across the full spectrum of heart disease remains unknown • Integrated program of trials of nurse-led, home-based intervention (HBI) recently completed • Prospectively tested the following hypothesis: • HBI is superior to high levels of standard care in preventing recurrent hospitalisation and premature mortality overall • Compared to high-level standard care, HBI is increasingly more effective as the clinical complexity (and potential to prevent poor health outcomes) increases

  4. Composite analysis of a family of 3 trials • Stewart S & WHICH? Trial Investigators. Prolonged impact of home versus clinic-based management of chronic heart failure: Extended follow-up of a pragmatic, multicentre randomized trial cohort. International Journal of Cardiology. Jul 2014; 174(3):600-10. doi: 10.1016/j.ijcard.2014.04.164. • Stewart S & SAFETY Investigators. Standard versus atrial fibrillation-specific management strategy (SAFETY) to reduce recurrent admission and prolong survival: pragmatic, multicentre, randomised controlled trial. The Lancet. 2015; 385(9970):775-784. • Stewart S & NIL-CHF Study Investigators. Impact of a nurse-led home and clinic-based secondary prevention programme to prevent progressive cardiac dysfunction in high-risk individuals: the Nurse-led Intervention for Less Chronic Heart Failure (NIL-CHF) randomized controlled study. European Journal of Heart Failure. 2015 Apr 21. doi: 10.1002/ejhf.272.

  5. Spectrum of heart disease/management • NIL-CHF Study – enrolled cardiac patients, mostly ACS & without CHF (echo confirmed) • SAFETY Trial – enrolled patients with chronic AF & without CHF (echo confirmed) • WHICH? Trial – enrolled patients with CHF (echo confirmed) with HFrEF & HFpEF • ALL cases recruited during acute hospitalisation, returning to home (metropolitan) & subject to high level standards of care

  6. WHICH? Trial • Multi-centre RCT • CONSORT compliant • 1:1 blinded randomization (HrEF vs. HFpEF) • Standardized clinical management • Independent data management/trial statistician • Blinded endpoint acquisition & adjudication • Follow-up: minimum 3 years

  7. SAFETY Trial • Multi-centre RCT • CONSORT compliant • 1:1 blinded randomization (rate vs. rhythm control) • Standardized clinical management • Independent data management/trial statistician • Blinded endpoint acquisition & adjudication • Follow-up: minimum 2 years

  8. NIL-CHF Study • Single centre RCT • CONSORT compliant • 1:1 blinded randomization • Standardized clinical management • Independent data management/trial statistician • Blinded endpoint acquisition & adjudication • Follow-up: minimum 3 years

  9. CONSORT flow chart

  10. Study Cohort • Typically older patient cohort • ~1/3 women (older) • Full-spectrum of heart disease • Multimorbidity & high clinical complexity • Appropriate levels of treatment • Well-matched for all baseline profiling

  11. Clinical Complexity Score • Comprising a combination of clinical, functional and socio-demographic variables • Generalized linear model with multiple imputations & boot-strapping of baseline profiling • 10-15 key variables important in explaining days alive and out-of-hospital • Sensitivity analyses - clinical complexity score versus other tools (e.g. Charlson & MAGGIC) & mortality versus hospital stay

  12. Recurrent hospital stay • Unplanned Hospital Stay (All-Cause) • HBI accumulated 7469 days of hospital stay from 1336 unplanned hospitalisations • Standard management group accumulated 10448 days from 1412 hospitalisations

  13. All-cause mortality • Adjusted HR 0·56, 95% CI 0·41-0·78; p=0·001 for HBI versus standard management

  14. Days alive & out-of-hospital • HBI achieved mean of 1210±463 days event-free (90·1%, 95% CI 88·2-92·0). • Standard management achieved 1184±494 days event-free (87·2%,95% CI 85·1-89·3) - p=0·02. • However…… • At low clinical complexity HBI conferred worse event-free survival • At high clinical complexity HBI conferred better event-free survival • Similar pattern noted in relation to all-cause mortality/survival

  15. Limitations • Pragmatic trials (non-blinding of participants) • Post-hoc/composite analysis of individual trials • Historical context of clinical management • No formal study power calculations • More detailed justification of clinical complexity score required • Mechanism(s) of effect need to be explored: • Why would HBI increase events/mortality at low complexity (clinical cascade)? • What are the benefits of HBI at increased complexity?

  16. Summary • First reported individual trial analysis to examine benefits of HBI across full spectrum of heart disease • Over long-term follow-up, HBI was associated with: • Significantly less hospital stay (~200 days/100 patients) • Significantly better survival (~5 deaths/100 patients) • Significantly prolonged days alive & out-of-hospital (~1100 days/100 patients) • Consistent across all 3 trials - HBI should be preserved for clinically complex cases to avoid harm • Pending confirmation, these data support careful application of HBI beyond a single cardiac diagnosis

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