ISRCTN68786381进行中（未招募）未知
Evaluation of an integrated care pathway for out-of-hospital treatment of older adults with an acute moderate-to-severe lower respiratory tract infection or pneumonia
Haga Hospital0 个研究点目标入组 300 人开始时间: 2022年11月28日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
2023 Protocol article in https://doi.org/10.1136/bmjopen-2023-073126 (added 18/08/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 18/07/2023:
- •To be eligible to participate in this study, a patient must meet all of the following criteria:
- •1. Age =65 years
- •2. Clinical diagnosis of an acute moderate-to-severe (Pneumonia Severity Index (PSI) class =3 or CURB-65 =2) lower respiratory tract infection or pneumonia
- •3. Oxygen saturation =92% and respiratory rate =24/minute with maximum five litres of oxygen (or adjusted oxygen saturation cut-offs as clinically indicated (e.g. for patients with chronic obstructive pulmonary disease (COPD)) by the treating physician)
- •4. Written informed consent (IC) for participation in the study
- •To be eligible to participate in this study, an informal caregiver must meet all of the following criteria:
- •1. Age =18 years
- •2. Being an informal caregiver of a patient included in the study
- •3. Written IC for participation in the study
- •To be eligible to participate in this study, a treating physician must meet all of the following criteria:
- •1. Physician of a patient included in the study at the main location of treatment
- •2. The physician should have treated the patient at least =2 (consecutive) days
- •3. Written IC for participation in this study
- •Patients who fulfil the inclusion criteria and do not meet the exclusion criteria of the care pathway, and are hospitalised on weekdays outside office hours (18:00-08:00) or weekend days due to inactivity of the care pathway, will serve as a control group.
- •Previous inclusion criteria:
- •To be eligible to participate in this study, a patient must meet all the following criteria:
- •1. Age =65 years
- •2. Clinical diagnosis of an acute moderate-severe* lower respiratory tract infection or pneumonia
- •3. Written informed consent for participation in the study
- •4. Oxygen saturation =92% with a maximum of 5 litres O2** and a respiratory frequency =24/minute
- •*: moderate-severe is defined by a Pneumonia Severity Index class =3 or a CURB-65 =2
- •** = or adjusted oxygen saturation cut-offs for the patient as clinically indicated (for example for patients with chronic obstructive pulmonary disease) by the treating physician
- •To be eligible to participate in this study, a caregiver must meet all the following criteria:
- •1. Age =18 years
- •2. Caregiver of a patient included in the study
- •3. Written informed consent for participation in the study
- •To be eligible to participate in this study, a physician must meet all the following criteria:
- •1. Physician of a patient included in the study at the main location of treatment: hospital-at-home (general practitioner), nursing home (specialist in elderly care medicine) and hospital (ward doctor)
- •2. Physician should have treated the patient for at least =2 (consecutive) days
- •3. Written informed consent for participation in the study
排除标准
- •Current exclusion criteria as of 18/07/2023:
- •A potential patient who meets any of the following criteria will not be able to participate:
- •1. Chemotherapy for solid organ malignancy (<2 months before presentation)
- •2. Active hematologic malignancy
- •3. Immunocompromised status (e.g. solid organ transplants)
- •4. Severe dementia (Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) score 16-18)
- •Previous exclusion criteria:
- •A potential patient who meets any of the following criteria will not be able to participate:
- •1. Patients receiving chemotherapy (<2 months before presentation)
- •2. Patients with active hematologic malignancy
- •3. Immunocompromised patients (for example solid organ transplants)
- •4. Severe dementia (clinical dementia rating scale sum of boxes score 16-18)
研究者
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