NCT07458763

Rapid Response Home Care as an Alternative to Acute Admission

Home-Based Rapid Response Team Assessment and Treatment as an Alternative to Acute Hospital Admission for Adults Referred With Suspected Infection: A Single-Center Randomized Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Copenhagen University Hospital at Herlev · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infection

Interventions

Type	Name	Description
OTHER	Admission 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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2026-03-09
• Last updated: 2026-03-11

Locations

1 site across 1 country: Denmark