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

NCT07703995 | Completed

• 1 other identifier: CMMC+11503-014
• Study Type: observational
• Target: 447
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Hospital At Home; Emergency Service, Hospital; Acute Infection; Treatment Failure

Keywords

Treatment escalation; Unplanned hospitalization; Emergency Department Diversion

Outcome Measures

Primary Outcomes (1)

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

  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.

  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).

Study Arms (2)

Failed ED/Hospital-at-Home Cohort

A retrospective cohort of adult patients with common acute infections (e.g., pneumonia, urinary tract infection, cellulitis) who were managed under the integrated Emergency Department/Hospital-at-Home model across multiple centers, but subsequently experienced program failure. Program failure is defined as a priori as any unanticipated care escalation or death occurring during the HaH episode before planned completion. Unanticipated care escalation encompassed: emergency department transfer; inpatient admission; or intensive care unit (ICU) admission within 48 hours of ED transfer.

Other: Integrated ED/Hospital-at-Home Model

Successful ED/Hospital-at-Home Cohort

A retrospective cohort of adult patients with common acute infections who were successfully managed and discharged from the integrated Emergency Department/Hospital-at-Home model across multiple centers without experiencing program failure during the planned treatment period.

Other: Integrated ED/Hospital-at-Home Model

Interventions

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.

Failed ED/Hospital-at-Home Cohort; Successful ED/Hospital-at-Home Cohort

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study description focuses on patients who participated in Model C of the National Health Insurance Administration's Acute Care at Home Pilot Program across three participating medical centers between August 1, 2024, and January 1, 2026. The population comprises individuals initially presenting to the emergency department with any of the target primary acute infections-specifically pneumonia, urinary tract infection, or skin and soft tissue infection(either alone or in combination)- who were subsequently transitioned to the Hospital-at-Home care model.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chimei Medical Center: lead
• Taipei Medical University WanFang Hospital: collaborator
• Taipei Medical University Hospital: collaborator

Study Sites (3)

Chi Mei Medical Center

Tainan, Tainan, 710033, Taiwan

Location

Taipei Medical University Hospital

Taipei, 110301, Taiwan

Location

Wanfang Hospital, Taipei Medical University

Taipei, 116081, Taiwan

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hsin M Lee, MD

  Chi Mei Medical Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Attending Physician, Department of Emergency Medicine

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 15, 2026
• Study Start: August 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: July 6, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (3)