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This single-center, randomized, unblinded quality-improvement study evaluates whether a structured home-based rapid response team (RRT) intervention can safely reduce total hospital days among adults referred to the emergency department with suspected infection. Patients referred from general practitioners or the regional medical helpline (1813) between 09:00 and 22:00 are randomized 1:1 using Zelen's design to either standard in-hospital evaluation or a home-based assessment pathway delivered by a mobile clinical response team.
Background and Rationale:
Infections are among the most common causes of acute hospital admissions. Evidence and clinical experience suggest that a substantial proportion of patients referred with suspected infection could be safely assessed and treated in their home environment, thereby avoiding unnecessary inpatient stays. At Herlev-Gentofte Hospital, approximately 40 patients per day are referred by primary care physicians or the regional medical helpline (1813) due to suspected infection. Many of these patients require only basic diagnostics, focused clinical evaluation, or short-course treatment - services that may be feasible to deliver outside the hospital setting.
The rationale for this study is to determine whether a structured home-based intervention pathway - implemented by trained mobile healthcare personnel and supervised remotely by hospital physicians - can reduce hospital bed-days without compromising patient safety or clinical outcomes.
Study Design:
This is a single-center, randomized (1:1), non-blinded study using Zelen's design. Randomization is conducted at the time of referral by an independent coordinating unit (CVI) via a computer-generated algorithm. Participants are allocated to the home-based intervention or to standard hospital-based evaluation. Patients randomized to the intervention arm are contacted by phone and offered a home visit; if they decline, they will be managed conventionally in the hospital emergency department. All analyses will follow the intention-to-treat principle.
Intervention (Home-Based Care Program):
Participants randomized to the intervention arm will receive a visit from a mobile clinical response team within one hour of randomization. The team consists of trained, non-physician healthcare personnel who perform a structured assessment, including an ABCDE evaluation, vital-sign measurement, and diagnostic tests such as venous blood sampling, point-of-care CRP measurement, and blood gas analysis when indicated. Following the initial assessment, the team initiates a real-time video consultation with a hospital-based senior physician, who provides diagnostic guidance and treatment decisions.
Possible outcomes of the home visit include:
The mobile team may deliver intravenous antibiotics via infusion pump, oxygen therapy, repeated monitoring of vital parameters, and follow-up assessments as required. All delegated treatments are ordered by the hospital physician, and the hospital retains full medical responsibility for care decisions and treatment oversight.
Control Group:
Participants in the control group will receive standard acute evaluation and management in the hospital emergency department, with no deviations from usual clinical practice.
Data Collection and Analysis:
Data will be collected by medical doctors employed by the participating hospital. Analyses will be conducted by these medical doctors in collaboration with statisticians at Amager and Hvidovre Hospital. Study results will be submitted for publication in peer-reviewed scientific journals.
Sample Size and Power Calculation:
Based on an estimated average of 27 days alive outside the hospital (SD 5) within 30 days in the control group, detecting a 1.5-day increase (to 28.5 days) requires 176 participants in both groups (α=0.05, β=0.2). To account for potential drop-outs or missing data, we aim to include 220 participants in each group.
Ethical Considerations:
The study has been assessed by the National Committee on Health Research Ethics, which determined that it does not require formal approval (Reference F-24054107). The project has instead been approved by the Legal Office (Sundhedsjura) in the Capital Region of Denmark (Region H) as a quality-improvement initiative (case no. p-2025-19264). Patients may decline home-based assessment at any time and will instead undergo standard hospital evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-based treatment | Experimental | The intervention group |
|
| Standard care | No Intervention | The control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Admission avoidance Hospital at Home | Other | The intervention group is evaluated in their homes by a mobile rapid response team to determine whether they can be safely treated at home instead of being admitted to the hospital. If deemed suitable, the patient receives treatment at home. |
| Measure | Description | Time Frame |
|---|---|---|
| Days Alive Outside of Hospital | Number of days alive outside of hospital 30 days after initial referral (time of inclusion), including days receiving treatment at home. | 30 days from inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Suspected infection focus | Evaluated for both groups. The anatomical focus of infection is categorized as one of the following: eyes, ears, upper respiratory tract, lower respiratory tract, gastrointestinal tract, urinary tract, genital/sexually transmitted disease (STD), bones/joints, skin and soft tissue, unclear focus, or other. | At initial clinical assessment (baseline, prior to initiation of treatment), day 0. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kasper K Iversen, MD, Prof. | University Hospital of Copenhagen Herlev | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Copenhagen Herlev | Herlev | Denmark |
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| ID | Term |
|---|---|
| D007239 | Infections |
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This study is a randomized clinical non-blinded trial. Participants will be randomized in the ratio 1:1 using Zelen's design.
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| Early Warning Score, initial assessment | Calculated Early Warning Score (EWS or cEWS) derived from the recorded vital parameters according to a standardized algorithm (i.e. multiple measurements will be aggregated to arrive at one reported value): Highest measured body temperature (°C, decimal), heart rate (beats per minute), respiratory rate (breaths per minute), peripheral oxygen saturation (SpO₂, %, measured at rest on room air if possible; otherwise oxygen supplementation specified), blood pressure (mmHg, systolic/diastolic, automated or manual), level of consciousness assessed using the AVPU (Alert, verbal, pain, unresponsive) scale | At initial clinical assessment (baseline, prior to initiation of treatment), day 0 |
| Contact from CTU to the patient (Intervention-group) | For the intervention group, important events and related timestamps will be collected, indcluding "contact attempted by Central Triage Unit (CTU)" (yes/no) | Index home visit (day 0) |
| Intitial assesment at home accepted by patient (Intervention-group) | For the intervention group, important events and related timestamps will be collected, including "home-visit with clinical assesment accepted by the patient" (yes/no; analyzed by intention-to-treat) | Index home visit (day 0) |
| Response-time for inititial contact (Intervention-group) | For the intervention group, important events and related timestamps will be collected, including response-time by the Rapid response team, calculated as the difference between "time of call" from the CTU to the patient and "time of arrival" of the rapid response team at the patients home (hh:mm) | Index home visit (day 0) |
| Video consultation during initial assessment (intervention group) | Video consultation with emergency physician performed during initial assessment? (yes/no). | index home visit (day 0) |
| Physician decision during initial assessment (intervention group) | Physician decision during initial assessment, with the following categorical options: hospital admission; home-based treatment; subacute hospital evaluation; General Practitioner follow-up; or discharge. | index home visit (day 0) |
| First treatment initiated at home (intervention group) | First treatment initiated at home, with the following categorical options: IV antibiotics; PO antibiotics; oxygen; IV fluids; inhaled bronchodilators (SABA+SAMA); analgesics; antiemetics; laxatives; glucocorticoids (IV/PO); urinary catheter; airway suctioning; wound care; or other. | index home visit (day 0) |
| Number of diagnostics performed during home-based treatment | Diagnostics performed during the index episode (expected up to three days, but potentially during the entire follow-up period)
| from day 0 up until day 30 |
| Hospitalization during index episode (Both Groups) | Clinical course outcomes will be collected for both intervention and control groups:
| From index (treatment initiation, day 0) through 30 days of follow-up. |
| Readmission rates (Both Groups) | Clinical course outcomes will be collected for both intervention and control groups:
| From index (treatment initiation, day 0) through 30 days of follow-up. |
| Readmissions related to infection (Both Groups) | For each readmission, primary diagnosis will be registered for both intervention and control groups, and it will be assessed whether it was associated with the infection in the index event (yes/no) | From index (treatment initiation, day 0) through 30 days of follow-up. |
| Duration of Antibiotic Treatment | Total duration of therapy (integer; continuous days from start date (date of first documented dose), until end date (date of last documented dose) for all episodes with antibiotic treatment from day 0 until day 30) | From index (treatment initiation, day 0) through 30 days of follow-up |
| Type of Antibiotic Treatment | Type of antibiotic treatment for all episodes with antibiotic treatment from day 0 until day 30), including primary route of administration (intravenous [IV] or oral [PO]), antibiotic agent (name and, if available, dose) | From index (treatment initiation, day 0) through 30 days of follow-up |
| Number of complications/adverse events | Patient Safety: complications/adverse events during index episode (yes/no, with description; e.g., sepsis, clinical deterioration, new diagnoses) | From index (treatment initiation, day 0) through 30 days of follow-up. |
| Number of emergency contacts | Patient safety: number of emergency contacts (112/1813) after first contact | Day 0 until day 30 |
| Escalation of care | For the intervention group, incidents of escalation of care (including transfer to hospital during home-based treatment) will be recorded, including: Event: yes/no; date and time [dd-mm-yyyy hh:mm]; and reason in free text, | Day 0 until day 30 |
| Total healthcare cost per patient | Economic evaluation comparing the intervention and control groups based on the mean total cost per patient (DKK) during the follow-up period. Multiple resource utilization measures will be collected and aggregated to estimate the total cost per patient. These include:
All resource use will be valued using relevant unit costs and summed to calculate a total cost per patient (DKK). The reported outcome will be the mean total cost per patient in each study group. | From day 0 until day 30 |
| Microbiological sampling | recorded as:
| First available value following initial clinical assessment (baseline, day 0) |
| C-reactive protein (CRP) at Initial Assessment | First available laboratory values obtained at initial clinical assessment. Unit mg/L, integer. | First available value following initial clinical assessment (baseline, day 0). |
| total leukocyte count at Initial Assessment (value) | First available laboratory values obtained at initial clinical assessment. Total leukocyte count (×10⁹/L, decimal) | First available value following initial clinical assessment (baseline, day 0). |
| differential counts at Initial Assessment (value) | First available laboratory values obtained at initial clinical assessment. Differential counts including lymphocytes, neutrophils, monocytes, eosinophils, and basophils (all ×10⁹/L, decimal) | First available value following initial clinical assessment (baseline, day 0). |
| hemoglobin at Initial Assessment (value) | First available laboratory values obtained at initial clinical assessment. Hemoglobin (mmol/L, decimal) | First available value following initial clinical assessment (baseline, day 0). |
| platelet count at Initial Assessment (value) | First available laboratory values obtained at initial clinical assessment. Platelet count (×10⁹/L, integer) | First available value following initial clinical assessment (baseline, day 0). |
| creatinine at Initial Assessment (value) | First available laboratory values obtained at initial clinical assessment. Creatinine (µmol/L, integer) | First available value following initial clinical assessment (baseline, day 0). |
| Urea at Initial Assessment (value) | First available laboratory values obtained at initial clinical assessment. Urea (mmol/L, decimal) | First available value following initial clinical assessment (baseline, day 0). |
| sodium at Initial Assessment (value) | First available laboratory values obtained at initial clinical assessment. Sodium [Na⁺] (mmol/L) | First available value following initial clinical assessment (baseline, day 0). |
| Potassium at Initial Assessment (value) | First available laboratory values obtained at initial clinical assessment. Potassium [K⁺] (mmol/L) | First available value following initial clinical assessment (baseline, day 0). |
| Chloride at Initial Assessment (value) | First available laboratory values obtained at initial clinical assessment. Chloride [Cl-] (mmol/L) | First available value following initial clinical assessment (baseline, day 0). |
| calcium at Initial Assessment (value) | First available laboratory values obtained at initial clinical assessment. Ionized and total calcium [Ca²⁺] (mmol/L) | First available value following initial clinical assessment (baseline, day 0). |
| Phosphate at Initial Assessment (value) | First available laboratory values obtained at initial clinical assessment. Phosphate (mmol/L) | First available value following initial clinical assessment (baseline, day 0). |
| Plasma glucoseat Initial Assessment (value) | First available laboratory values obtained at initial clinical assessment. Plasma glucose (mmol/L) | First available value following initial clinical assessment (baseline, day 0). |
| Alanine aminotransferase at Initial Assessment (value) | First available laboratory values obtained at initial clinical assessment. Alanine aminotransferase (ALAT, U/L) | First available value following initial clinical assessment (baseline, day 0). |
| Albumin at Initial Assessment (value) | First available laboratory values obtained at initial clinical assessment. Albumin (g/L). | First available value following initial clinical assessment (baseline, day 0). |
| pH, Blood gas analysis (value) | pH in arterial or venous blood gas according to local clinical practice. | First available value following initial clinical assessment (baseline, day 0) |
| partial pressure of carbon dioxide, blood gas analysis (value) | partial pressure of carbon dioxide (pCO₂) in arterial or venous blood gas according to local clinical practice. | First available value following initial clinical assessment (baseline, day 0) |
| partial pressure of oxygen, Blood gas analysis (value) | partial pressure of oxygen (pO₂) in arterial or venous blood gas according to local clinical practice. | First available value following initial clinical assessment (baseline, day 0) |
| bicarbonate, Blood gas analysis (value) | bicarbonate (HCO₃-) in arterial or venous blood gas according to local clinical practice. | First available value following initial clinical assessment (baseline, day 0) |
| base excess, Blood gas analysis (value) | base excess (BE), in arterial or venous blood gas according to local clinical practice. | First available value following initial clinical assessment (baseline, day 0) |
| anion gap, Blood gas analysis (value) | anion gap (AG) in arterial or venous blood gas according to local clinical practice. | First available value following initial clinical assessment (baseline, day 0) |
| lactate, Blood gas analysis (value) | lactate in arterial or venous blood gas according to local clinical practice. | First available value following initial clinical assessment (baseline, day 0) |