Infection
Conditions
Keywords
hospital at home, admission avoidance, rapid response team, home-based treatment, acute hospital-level care at home, infection
Brief summary
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.
Detailed description
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: * Hospital admission * Home-based treatment with scheduled follow-up visits by the mobile team * Subacute outpatient evaluation at the hospital * Discharge with or without treatment 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.
Interventions
OTHERAdmission avoidance Hospital at Home
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.
Sponsors
Copenhagen University Hospital at Herlev
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
This study is a randomized clinical non-blinded trial. Participants will be randomized in the ratio 1:1 using Zelen's design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Referred with suspected infection * Patients must be able to provide informed consent * Category C or D transports (non-emergency patient transport) and self-transported patients
Exclusion criteria
* Category A and B transport (emergency and urgent patient transport) * Suspected meningitis * Suspected sepsis * Suspected tropical disease * Suspected other time-critical infection * Immunodeficiency * Ongoing treatment with immunosuppressive/immunomodulating/chemotherapy treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days Alive Outside of Hospital | 30 days from inclusion | Number of days alive outside of hospital 30 days after initial referral (time of inclusion), including days receiving treatment at home. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Antibiotic Treatment | From index (treatment initiation, day 0) through 30 days of follow-up | 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) |
| Type of Antibiotic Treatment | From index (treatment initiation, day 0) through 30 days of follow-up | 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) |
| Number of complications/adverse events | From index (treatment initiation, day 0) through 30 days of follow-up. | Patient Safety: complications/adverse events during index episode (yes/no, with description; e.g., sepsis, clinical deterioration, new diagnoses) |
| Number of emergency contacts | Day 0 until day 30 | Patient safety: number of emergency contacts (112/1813) after first contact |
| Escalation of care | Day 0 until day 30 | 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, |
| Total healthcare cost per patient | From day 0 until day 30 | 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: * number of home visits by the mobile team * time spent per visit (minutes; from departure to completion) * number of video consultations per patient * DRG-based costs (DKK) for hospital admissions and outpatient contacts * team-related costs (DKK; calculated from time × salary and transportation costs) * laboratory costs (DKK; analyses and materials) * imaging procedures (type and number) * specialist consultations (ordered yes/no; number and type). 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. |
| Microbiological sampling | First available value following initial clinical assessment (baseline, day 0) | recorded as: * performed (yes/no) * type of specimen (e.g., blood cultures, urine culture, sputum, throat swab, wound swab) |
| C-reactive protein (CRP) at Initial Assessment | First available value following initial clinical assessment (baseline, day 0). | First available laboratory values obtained at initial clinical assessment. Unit mg/L, integer. |
| total leukocyte count at Initial Assessment (value) | First available value following initial clinical assessment (baseline, day 0). | First available laboratory values obtained at initial clinical assessment. Total leukocyte count (×10⁹/L, decimal) |
| differential counts at Initial Assessment (value) | First available value following initial clinical assessment (baseline, day 0). | First available laboratory values obtained at initial clinical assessment. Differential counts including lymphocytes, neutrophils, monocytes, eosinophils, and basophils (all ×10⁹/L, decimal) |
| hemoglobin at Initial Assessment (value) | First available value following initial clinical assessment (baseline, day 0). | First available laboratory values obtained at initial clinical assessment. Hemoglobin (mmol/L, decimal) |
| platelet count at Initial Assessment (value) | First available value following initial clinical assessment (baseline, day 0). | First available laboratory values obtained at initial clinical assessment. Platelet count (×10⁹/L, integer) |
| creatinine at Initial Assessment (value) | First available value following initial clinical assessment (baseline, day 0). | First available laboratory values obtained at initial clinical assessment. Creatinine (µmol/L, integer) |
| Urea at Initial Assessment (value) | First available value following initial clinical assessment (baseline, day 0). | First available laboratory values obtained at initial clinical assessment. Urea (mmol/L, decimal) |
| sodium at Initial Assessment (value) | First available value following initial clinical assessment (baseline, day 0). | First available laboratory values obtained at initial clinical assessment. Sodium \[Na⁺\] (mmol/L) |
| Potassium at Initial Assessment (value) | First available value following initial clinical assessment (baseline, day 0). | First available laboratory values obtained at initial clinical assessment. Potassium \[K⁺\] (mmol/L) |
| Chloride at Initial Assessment (value) | First available value following initial clinical assessment (baseline, day 0). | First available laboratory values obtained at initial clinical assessment. Chloride \[Cl-\] (mmol/L) |
| calcium at Initial Assessment (value) | First available value following initial clinical assessment (baseline, day 0). | First available laboratory values obtained at initial clinical assessment. Ionized and total calcium \[Ca²⁺\] (mmol/L) |
| Phosphate at Initial Assessment (value) | First available value following initial clinical assessment (baseline, day 0). | First available laboratory values obtained at initial clinical assessment. Phosphate (mmol/L) |
| Plasma glucoseat Initial Assessment (value) | First available value following initial clinical assessment (baseline, day 0). | First available laboratory values obtained at initial clinical assessment. Plasma glucose (mmol/L) |
| Alanine aminotransferase at Initial Assessment (value) | First available value following initial clinical assessment (baseline, day 0). | First available laboratory values obtained at initial clinical assessment. Alanine aminotransferase (ALAT, U/L) |
| Albumin at Initial Assessment (value) | First available value following initial clinical assessment (baseline, day 0). | First available laboratory values obtained at initial clinical assessment. Albumin (g/L). |
| pH, Blood gas analysis (value) | First available value following initial clinical assessment (baseline, day 0) | pH in arterial or venous blood gas according to local clinical practice. |
| partial pressure of carbon dioxide, blood gas analysis (value) | First available value following initial clinical assessment (baseline, day 0) | partial pressure of carbon dioxide (pCO₂) in arterial or venous blood gas according to local clinical practice. |
| partial pressure of oxygen, Blood gas analysis (value) | First available value following initial clinical assessment (baseline, day 0) | partial pressure of oxygen (pO₂) in arterial or venous blood gas according to local clinical practice. |
| bicarbonate, Blood gas analysis (value) | First available value following initial clinical assessment (baseline, day 0) | bicarbonate (HCO₃-) in arterial or venous blood gas according to local clinical practice. |
| base excess, Blood gas analysis (value) | First available value following initial clinical assessment (baseline, day 0) | base excess (BE), in arterial or venous blood gas according to local clinical practice. |
| anion gap, Blood gas analysis (value) | First available value following initial clinical assessment (baseline, day 0) | anion gap (AG) in arterial or venous blood gas according to local clinical practice. |
| lactate, Blood gas analysis (value) | First available value following initial clinical assessment (baseline, day 0) | lactate in arterial or venous blood gas according to local clinical practice. |
| Suspected infection focus | At initial clinical assessment (baseline, prior to initiation of treatment), day 0. | 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. |
| Early Warning Score, initial assessment | At initial clinical assessment (baseline, prior to initiation of treatment), day 0 | 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 |
| Contact from CTU to the patient (Intervention-group) | Index home visit (day 0) | For the intervention group, important events and related timestamps will be collected, indcluding "contact attempted by Central Triage Unit (CTU)" (yes/no) |
| Intitial assesment at home accepted by patient (Intervention-group) | Index home visit (day 0) | 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) |
| Response-time for inititial contact (Intervention-group) | Index home visit (day 0) | 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) |
| Video consultation during initial assessment (intervention group) | index home visit (day 0) | Video consultation with emergency physician performed during initial assessment? (yes/no). |
| Physician decision during initial assessment (intervention group) | index home visit (day 0) | Physician decision during initial assessment, with the following categorical options: hospital admission; home-based treatment; subacute hospital evaluation; General Practitioner follow-up; or discharge. |
| First treatment initiated at home (intervention group) | index home visit (day 0) | 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. |
| Number of diagnostics performed during home-based treatment | from day 0 up until day 30 | Diagnostics performed during the index episode (expected up to three days, but potentially during the entire follow-up period) * vital signs * blood tests * blood gas * ECG * other |
| Hospitalization during index episode (Both Groups) | From index (treatment initiation, day 0) through 30 days of follow-up. | Clinical course outcomes will be collected for both intervention and control groups: * hospital admission during the initial episode (yes/no) * date and time of first admission (related to index episode) (dd-mm-yyyy hh:mm); * date and time of corresponding discharge |
| Readmissions related to infection (Both Groups) | From index (treatment initiation, day 0) through 30 days of follow-up. | 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) |
| Readmission rates (Both Groups) | From index (treatment initiation, day 0) through 30 days of follow-up. | Clinical course outcomes will be collected for both intervention and control groups: * number of acute readmissions within 30 days, * time of admission and discharge (dd-mm-yyyy hh:mm) |
Countries
Denmark
Contacts
STUDY_CHAIRKasper K Iversen, MD, Prof.
University Hospital of Copenhagen Herlev
Outcome results
None listed