The main objective of this study is to assess the feasibility, safety and (cost-)effectiveness of the HOME-ART intervention in comparison to regular hospital admission in patients with CA-ARTI.
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint will be the clinical effectiveness of the intervention,
defined as the difference in mean number of days alive out of hospital (DOAH)
within 30 days after randomization.
Secondary outcome
Secondary study outcomes are feasibility of the intervention in a regional
network, safety (in terms of ICU admissions, delirium, all-cause mortality,
patient's experienced safety during the intervention, disability-free survival
within 30 days after randomization), health resources use, patient autonomy,
strain on informal carers, user satisfaction and cost-effectiveness of the
intervention.
Background summary
Community acquired respiratory tract infections (CA-ARTI) pose a high burden on
our healthcare system. The continuous growing epidemiology of CA-ARTI, combined
with the growing number of elderly and reduced capacity of healthcare workforce
demand novel approaches to deliver safe and efficient care. The HOME-ART
intervention focusses on the development of a supported regional collaboration
in which patients with CA-ARTI can be treated with extensive treatment in the
at home setting. This includes oxygen treatment, intravenous antibiotic
treatment (if required) and continuous monitoring of vital signs at home. This
novel approach may have the potential to support patient autonomy and recovery
while consequently reducing the use of scarce hospital resources.
Study objective
The main objective of this study is to assess the feasibility, safety and
(cost-)effectiveness of the HOME-ART intervention in comparison to regular
hospital admission in patients with CA-ARTI.
Study design
This study starts with a feasibility study (PART 1) among 10-15 patients from
three hospitals in the Utrecht region, the Netherlands. After this, a
multicentre randomized controlled trial (PART 2) will be performed in 2:1 ratio
(home treatment : regular hospital care) in which we aim to include 252
patients in total. Besides quantitative data collection, the intervention and
progress will be evaluated monthly during process evaluation cycles among
involved stakeholders.
Intervention
For this HOME-ART intervention, we aim to align the medical treatment as
closely as possible with regular hospital care. This means that patients who
are randomized in the intervention group will receive oxygen therapy and/or
intravenous antibiotics, if required. Furthermore, vital parameters including
heart rate, blood pressure, oxygen saturation, respiratory rate and physical
activity will be monitored continuously using a sensor (Checkpoint Cardio) and
will be contacted by our medical coordination centre (MRC) to evaluate their
health status. If indicated, patients will be additionally supported by visits
of home care nurses. Patients randomized in the control group will receive
regular hospital care.
Study burden and risks
This study may entail a small risk as well as benefits for the group of
patients who are referred to the intervention group. These patients will not be
treated in the controlled setting of the hospital, which could delay medical
interventions if necessary. On the other hand, patients in the intervention
group will wear a wearable sensor for 24/7 vital signs monitoring at home
during the initial days of illness. This option allows the medical observation
centre to keep an eye on possible deviating vital sign trend patterns during
the day and night which is much more than the current manual spot checks
usually once every nursing shift once a patient is admitted to the hospital.
With this option for the HOME-ART intervention, we expect to minimize the risk
of any potential delays in medical interventions if needed. Furthermore, a
hospital stay isn*t without risks for patients either. Patients could
experience a delay in a medical intervention if patient deterioration is not
recognized on time (for example during the night when usually no manual
observations are done). In addition, home treatment could potentially reduce
the risk of hospital-related infections and delirium and initiate a faster
recovery in a patient*s own home environment which might be an additional
benefit from participating in this study among patients in the intervention
group. For all participants three questionnaires will be administered,
requiring investments of participants* time.
Universiteitsweg 100
Utrecht 3584CX
NL
Universiteitsweg 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a patient must meet the
following criteria:
- Mentally competent adult (>=18 years)
- Clinical diagnosis of community acquired respiratory tract infection in which
hospital admission is considered required
- Availability of informal caregiver who is willing to provide support at home
and agrees to participate in the study program and understands its implications
after being informed by the research staff
- A good command of the Dutch language
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Patients who lack adequate digital proficiency to properly conduct digital
aspects of the study
- Respiratory distress requiring more than 5 litres of oxygen therapy to
achieve comfort and a saturation of >= 94% at discharge from ER and/or a patient
with clinical signs of respiratory exhaustion
- Absence of haemodynamic stability at discharge from the ER, in which patient
required > 2 500cc fluid challenges during ER admission and/or maintenance i.v.
fluid suppletion is required
- Patients requiring follow-up diagnostics in clinical setting
- Serious risk of decompensation of pre-existent chronic illness, such as COPD,
heart failure, immune deficiency, kidney- or liver failure, warranting hospital
observation as judged by the responsible physician.
- Hospital admission 30 days prior to ED presentation.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87901.041.24 |