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Out-of-hospital treatment of older adults with an acute moderate-to-severe lower respiratory tract infection or pneumonia

Not Applicable
Conditions
Out-of-hospital treatment (at home or in a nursing home) of older adults with an acute moderate-to-severe lower respiratory tract infection or pneumonia
Respiratory
Registration Number
ISRCTN68786381
Lead Sponsor
Haga Hospital
Brief Summary

2023 Protocol article in https://doi.org/10.1136/bmjopen-2023-073126 (added 18/08/2023)

Detailed Description

Not available

Recruitment & Eligibility

Status
Ongoing
Sex
All
Target Recruitment
300
Inclusion Criteria

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.

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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

Exclusion Criteria

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)

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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)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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