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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Days Alive Outside of Hospital
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard care
The control group
Home-based treatment
The intervention group
干预措施: Admission avoidance Hospital at Home (Other)
结局指标
主要结局
Days Alive Outside of Hospital
时间窗: 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.
次要结局
- Early Warning Score, initial assessment(At initial clinical assessment (baseline, prior to initiation of treatment), day 0)
- Contact from CTU to the patient (Intervention-group)(Index home visit (day 0))
- Intitial assesment at home accepted by patient (Intervention-group)(Index home visit (day 0))
- Response-time for inititial contact (Intervention-group)(Index home visit (day 0))
- Video consultation during initial assessment (intervention group)(index home visit (day 0))
- Physician decision during initial assessment (intervention group)(index home visit (day 0))
- First treatment initiated at home (intervention group)(index home visit (day 0))
- Number of diagnostics performed during home-based treatment(from day 0 up until day 30)
- Hospitalization during index episode (Both Groups)(From index (treatment initiation, day 0) through 30 days of follow-up.)
- Readmission rates (Both Groups)(From index (treatment initiation, day 0) through 30 days of follow-up.)
- Readmissions related to infection (Both Groups)(From index (treatment initiation, day 0) through 30 days of follow-up.)
- Duration of Antibiotic Treatment(From index (treatment initiation, day 0) through 30 days of follow-up)
- Type of Antibiotic Treatment(From index (treatment initiation, day 0) through 30 days of follow-up)
- Number of complications/adverse events(From index (treatment initiation, day 0) through 30 days of follow-up.)
- Number of emergency contacts(Day 0 until day 30)
- Escalation of care(Day 0 until day 30)
- Total healthcare cost per patient(From day 0 until day 30)
- Microbiological sampling(First available value following initial clinical assessment (baseline, day 0))
- C-reactive protein (CRP) at Initial Assessment(First available value following initial clinical assessment (baseline, day 0).)
- total leukocyte count at Initial Assessment (value)(First available value following initial clinical assessment (baseline, day 0).)
- differential counts at Initial Assessment (value)(First available value following initial clinical assessment (baseline, day 0).)
- hemoglobin at Initial Assessment (value)(First available value following initial clinical assessment (baseline, day 0).)
- platelet count at Initial Assessment (value)(First available value following initial clinical assessment (baseline, day 0).)
- creatinine at Initial Assessment (value)(First available value following initial clinical assessment (baseline, day 0).)
- Urea at Initial Assessment (value)(First available value following initial clinical assessment (baseline, day 0).)
- sodium at Initial Assessment (value)(First available value following initial clinical assessment (baseline, day 0).)
- Potassium at Initial Assessment (value)(First available value following initial clinical assessment (baseline, day 0).)
- Chloride at Initial Assessment (value)(First available value following initial clinical assessment (baseline, day 0).)
- calcium at Initial Assessment (value)(First available value following initial clinical assessment (baseline, day 0).)
- Phosphate at Initial Assessment (value)(First available value following initial clinical assessment (baseline, day 0).)
- Plasma glucoseat Initial Assessment (value)(First available value following initial clinical assessment (baseline, day 0).)
- Alanine aminotransferase at Initial Assessment (value)(First available value following initial clinical assessment (baseline, day 0).)
- Albumin at Initial Assessment (value)(First available value following initial clinical assessment (baseline, day 0).)
- pH, Blood gas analysis (value)(First available value following initial clinical assessment (baseline, day 0))
- partial pressure of carbon dioxide, blood gas analysis (value)(First available value following initial clinical assessment (baseline, day 0))
- partial pressure of oxygen, Blood gas analysis (value)(First available value following initial clinical assessment (baseline, day 0))
- bicarbonate, Blood gas analysis (value)(First available value following initial clinical assessment (baseline, day 0))
- base excess, Blood gas analysis (value)(First available value following initial clinical assessment (baseline, day 0))
- anion gap, Blood gas analysis (value)(First available value following initial clinical assessment (baseline, day 0))
- lactate, Blood gas analysis (value)(First available value following initial clinical assessment (baseline, day 0))
- Suspected infection focus(At initial clinical assessment (baseline, prior to initiation of treatment), day 0.)
研究者
Josephine Lund Nielsen
Principal Investigator
Copenhagen University Hospital at Herlev