Hospital At HomeNCT07703995
Unplanned Emergency Department Visits, Hospital Admission, or Death During Hospital-at-Home Care for Acute Infections
An observational study of Hospital At Home and Emergency Service, Hospital, run by Chimei Medical Center at 3 sites in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital At Home, Emergency Service, Hospital, Acute Infection
- What is being tested?
- Integrated ED/Hospital-at-Home Model
- How many people
- 447 participants
- Where
- 3 sitesTaiwan
- Study dates
- 1 Aug 2024to 6 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites
Chi Mei Medical Center
Tainan, Tainan, 710033
Taipei Medical University Hospital
Taipei, 110301
Wanfang Hospital, Taipei Medical University
Taipei, 116081
About this study
Official title: Unplanned Care Escalation or Death in an Emergency Department-based Hospital-at-Home Model 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.
Read more
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.
- Being tested
- Integrated ED/Hospital-at-Home Model
- Keywords
- Treatment escalation, Unplanned hospitalization, Emergency Department Diversion
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated ED/Hospital-at-Home ModelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Integrated ED/Hospital-at-Home Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Aug 2024
- Primary completion1 Jan 2026
- Study completion6 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital At HomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 447 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chimei Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University WanFang Hospital, Taipei Medical University Hospital
- Responsible party
- Principal investigator, Hsin Min, Lee, Chimei Medical Center
- Investigators
- Hsin M Lee, MD, Principal investigator, Chi Mei Medical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703995
- Sponsor's protocol ID
- CMMC+11503-014
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unplanned Care Escalation or Death in an Emergency Department-based Hospital-at-Home Model for Acute Infections
- ClinicalTrials.gov ID
- NCT07703995
- Acronym / sponsor ID
- CMMC+11503-014
- Keywords
- Treatment escalation, Unplanned hospitalization, Emergency Department Diversion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- Chimei Medical CenterUniversity, hospital or other
- Collaborators
- Taipei Medical University WanFang Hospital, Taipei Medical University Hospital
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 6 Jul 2026 (actual)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Failed ED/Hospital-at-Home Cohort | – | Other: Integrated ED/Hospital-at-Home ModelA 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. |
| Successful ED/Hospital-at-Home Cohort | – | Other: Integrated ED/Hospital-at-Home ModelA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated ED/Hospital-at-Home ModelA 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. | Other | Failed ED/Hospital-at-Home Cohort, Successful ED/Hospital-at-Home Cohort |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsin M Lee, MD principal investigator
Chi Mei Medical Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospital At Home and Emergency Service, Hospital, run by Chimei Medical Center at 3 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.