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Completed

NCT Number: NCT07703995

Unplanned Emergency Department Visits, Hospital Admission, or Death During Hospital-at-Home Care for Acute Infections

This is a retrospective, multicenter, non-interventional cohort study based on data derived from existing electronic medical records. The study collects data on patient demographic and clinical characteristics, infection diagnosis, triage vital signs, laboratory values, and comorbidities in adults enrolled in the Emergency Department-initiated Hospital-at-Home (ED-HaH) model under Taiwan's National Health Insurance Administration (NHIA) Acute Care at Home (ACAH) Pilot Program.

For patient selection, enrollment in the this pathway was used as the index event. All adult patients (aged ≥18 years) with a primary diagnosis of pneumonia, urinary tract infection (UTI), or skin and soft tissue infection (SSTI) - confirmed by ICD-10 codes - who were enrolled directly from the emergency department at one of three participating tertiary medical centers (Chi-Mei Medical Center, Wan-Fang Hospital, and Taipei Medical University Hospital) during August 1, 2024 to January 1, 2026 were considered for inclusion. Patients were identified through electronic medical record queries, and data were abstracted using a standardized case record form applied uniformly across all sites.

The primary outcome was unplanned escalation or death during hospital-at-home (HaH), defined as unanticipated emergency department transfer, hospital admission, or intensive care unit admission, plus all-cause death prior to planned completion. As a secondary objective, exploratory multivariable analysis will examine whether demographic and clinical variables measured at ED enrollment show potential associations with this composite outcome.

A total of 472 HaH episodes from 420 unique patients were analyzed. Statistical analyses will be performed for the overall cohort.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chi Mei Medical Center, Tainan, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Enrolled under Model C of the National Health Insurance Administration (NHIA) Acute Care at Home (ACAH) Pilot Program at one of the three participating centers.
  • Formally assessed and cleared for home care by the specialized interdisciplinary Hospital-at-Home (HaH) team using a standardized screening tool.
  • Functional status meeting at least one of the following: a Barthel Index score of less than 60, or documented difficulty accessing outpatient care due to the nature of the illness, as assessed by the attending emergency physician.
  • A primary diagnosis of pneumonia, urinary tract infection (UTI), or skin and soft tissue infection (SSTI), either alone or in combination, confirmed by ICD-10 codes.
  • Clinical requirement for antimicrobial therapy, including intravenous antibiotic administration.
  • Written informed consent obtained from the patient or their legal representative during the historical clinical encounter.

Exclusion criteria

  • Hemodynamic instability, defined as persistent systolic blood pressure <90 mmHg despite initial fluid resuscitation, or any clinical requirement for intensive care unit (ICU) level monitoring or care.
  • Immediate need for inpatient-only medical resources, including immediate surgical intervention, initiation of hemodialysis, or advanced diagnostic procedures not feasible in a home setting.
  • Unsafe or unsuitable home environment, including absence of adequate caregiver support, hazardous living conditions, or severe cognitive or behavioral conditions that preclude adherence to the home treatment plan.

Treatment and study plan

Integrated ED/Hospital-at-Home Model

Other

A care delivery model where patients presenting to the emergency department with common acute infections are transitioned to receive acute hospital-level care at home. This study retrospectively reviews medical records to examine cases within this model that resulted in treatment failure versus success.

Primary outcomes

  1. Unplanned Care Escalation or Death During the Hospital-at-Home episodes

    Time frame: Through the completion of the care episode under national guidelines: up to 14 days for pneumonia (target 10), and up to 9 days for urinary tract and skin/soft tissue infections (target 7).

    The primary outcome was unplanned escalation or death during hospital-at-home (HaH) episodes, defined as a composite endpoint of any unanticipated emergency department (ED) transfer, inpatient admission, intensive care unit (ICU) admission within 48 hours of ED transfer, or all-cause death prior to planned completion. ED transfers or hospitalizations for pre-planned diagnostic procedures, routine scheduled evaluations, or conditions unrelated to the infectious process (e.g., minor trauma) were excluded from the definition.

Sponsors and collaborators

Lead sponsor

Chimei Medical Center

Other

Collaborators

  • Taipei Medical University Hospital
  • Taipei Medical University WanFang Hospital

Registry information

Official study title

Unplanned Care Escalation or Death in an Emergency Department-based Hospital-at-Home Model for Acute Infections

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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