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Regulatory notice

HospitalsAescia for Hospitals is an investigational Software as a Medical Device under the TGA Class IIa pathway. Not yet available for commercial supply.

ClinicsAescia for Clinics is a workflow and patient-preparation tool. It does not propose clinical decisions and is not a medical device.

Clinical evidence

The published base, and how we add to it.

The published evidence base for structured post-discharge monitoring, and Aescia’s approach to generating product-specific evidence through rigorous clinical evaluation.

Published literature

The evidence base for post-discharge monitoring.

The published literature on early hospital readmission has been consistent across two decades of analysis. Jencks and colleagues, working in the United States Medicare population, established that a meaningful fraction of inpatient discharges are followed by readmission within 30 days. Van Walraven and colleagues, in a systematic review across multiple countries, reported that a substantial proportion of those readmissions are judged avoidable by treating clinicians on retrospective review.

Leppin and colleagues, in a meta-analysis of randomised trials, reported that interventions involving structured patient contact during the post-discharge window are associated with reduced readmission rates. Hansen and colleagues, in a parallel systematic review, classified the interventions that have been studied and noted that combinations of pre-discharge and post-discharge components tend to outperform single-element approaches.

The literature describes the territory; it does not characterise any specific software product, including Aescia. Citations are listed below.

The findings above are observations about the published literature on post-discharge care. They are not statements about the performance, intended use, or expected outcomes of Aescia for Hospitals.

Active programme

Our clinical programme.

Aescia’s product-specific evidence is generated through structured clinical evaluation. Our active programme is SAFE-Discharge: a prospective single-centre evaluation at the Royal Prince Alfred Hospital cardiothoracic surgical unit in Sydney. The trial is registered with the Australian New Zealand Clinical Trials Registry. This page does not recruit trial participants.

Registration
ACTRN12625001425482
Site
Royal Prince Alfred Hospital, Sydney
Unit
Cardiothoracic Surgery Unit
Sponsor
Sydney Local Health District (SLHD)
Principal Investigator
Dr Kei Woldendorp, The Baird Institute
Population
Adult patients post cardiothoracic surgery (CABG, valve, thoracic procedures)
Sample size
550 patients (50 interim + 500 main), single centre
Status
Ethics approved. Site-specific governance in progress.
Approach

How we evaluate.

Scoped evaluations
Each clinical evaluation is scoped to a defined service line, population, and post-discharge window. Generalisation beyond that scope is not claimed.
Predefined endpoints
Endpoints, sample sizes, and analysis plans are pre-specified before enrolment opens. Interim analyses are pre-specified where used.
Transparent reporting
We report what the trial shows, whatever it shows. Negative or null results are reported in the same form as positive results.
Ethics and governance
All evaluations run under approval from the relevant Human Research Ethics Committee and site-specific research governance.
Independent oversight
Sponsor responsibility sits with the trial-sponsoring institution. Aescia does not arbitrate clinical interpretation of trial outcomes.
Regulatory posture

Where we are with regulators.

Aescia for Hospitals is an investigational Software as a Medical Device. The intended classification is Class IIa under TGA Rule 3.4. A regulatory submission for ARTG inclusion is in preparation; the product has not been submitted, is not registered, and is not available for commercial supply.

The software lifecycle follows IEC 62304:2006+A1:2015 processes, implemented and documented internally. ISO 13485:2016 quality-system implementation and ISO/IEC 27001:2022 information-security controls are in place; certifications under those standards have not been obtained and no third-party conformity assessment has been undertaken.

Clinical outputs from Aescia for Hospitals are advisory and require clinician review. The product does not autonomously act on patient responses; the treating clinical team remains the decision-maker for any change in care.

Read full governance and security posture
References

Published references.

  1. Paper
    Jencks SF, Williams MV, Coleman EA (2009)
    Rehospitalizations among patients in the Medicare fee-for-service program.
    New England Journal of Medicine, 360:1418-1428
  2. Paper
    van Walraven C, et al. (2011)
    Proportion of hospital readmissions deemed avoidable: a systematic review.
    Canadian Medical Association Journal, 183(7):E391-E402
  3. Paper
    Leppin AL, et al. (2014)
    Preventing 30-day hospital readmissions: a systematic review and meta-analysis of randomized trials.
    JAMA Internal Medicine, 174(7):1095-1107
  4. Paper
    Hansen LO, et al. (2011)
    Interventions to reduce 30-day rehospitalization: a systematic review.
    Annals of Internal Medicine, 155(8):520-528

For the regulatory and security posture in detail:

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