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
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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. _____ 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
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) _____ 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 18/07/2023: Feasibility of the care pathway, which is defined as the percentage of patients treated outside the hospital, according to the care pathway, whom fully complete their treatment without the need for hospitalisation within 30 days of follow-up. This will be measured by the amount of hospitalisations within 30 days of follow-up in patients treated outside the hospital, by using the registration forms, electronic health records (EHRs) and the 30-day questionnaires. _____ Previous primary outcome measure: Feasibility of the care pathway is defined as the percentage of patients included in the care pathway that were not admitted to the hospital (treated outside the hospital). Feasibility will be measured on day 30 using the registration forms, electronic health records (EHRs) and the 30-day questionnaires. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 18/07/2023: 1. The safety of the care pathway will be measured using the 30-day mortality and occurrence of complications (readmissions, delirium, falls) within 30 days. This data will be measured using the registration forms, electronic health records (EHRs) and the 30-day questionnaires 2. The satisfaction, usability and acceptance of the care pathway will be measured using the 30-day questionnaires (with a five or ten point Likert scale) in patients, informal caregivers and treating physicians; and semi-structured interviews with the first ten patients and informal caregivers in the hospital-at-home group (and treating general practitioners), nursing home group and control group 3. Total number of days of bedridden status or hospitalisation will be measured on day 30 using the registration forms and EHRs 4. Sleep quantity measured by the core Consensus Sleep Diary on the first two days and on the seventh day after inclusion 5. Sleep quality measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance short form 8b on day 7 and 30 after inclusion 6. Functional outcomes will be measured by questionnaires (KATZ-15 and living situation) at 30 days, six and twelve months 7. Quality of life (QoL) will be measured by questionnaires (EQ-5D-5L) at 30 days, six and twelve months If possible: 8. Cost savings will be roughly measured using the length of the hospital or nursing home admission, or homecare use; and the average care costs per day for care in a hospital, care in a nursing home or homecare 9. Logistical impact on hospital bed capacities will be roughly estimated by simulating a scenario in which the patients treated outside the hospital (at home or in the nursing home) would have been admitted to the hospital at the time of care pathway inclusion _____ Previous secondary outcome measures: 1. Practical applicability of the care pathway (defined as the percentage of patients | — |
Countries
Netherlands