The aim of the feasibility study is to test the home hospitalisation platform (care pathway empowered by the integrated home hospitalisation platform) through small scale pilots in three different hospitals: Isala, Jessa hospital and Maastricht UMC…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Study objective 1: Feasibility of home hospitalisation for HF patients.
Outcome measures: Acceptance of the technology by the patient will be assessed
with the SUTAQ (9,10). Satisfaction of the patient for the home
hospitalisation program supported by the integrated home hospitalisation
platform will be assessed with the *patiënt tevredenheid vragenlijst*.
Furthermore, we will assess the satisfaction of the cardiologist and nursing
team with respectively; *Vragenlijst evaluatie thuishospitalisatie voor
Hartfalen * Cardioloog* and *Vragenlijst evaluatie thuishospitalisatie voor
gespecialiseerd verpleegkundigen*. The SUS questionnaire will be used to assess
the usability of the home hospitalisation system for patients and the
caregiver dashboard for nurses.
To get an idea of the digital literacy of patients, a questionnaire on
smartphone usage will be filled in by the patients.
All questionnaires will be provided by the study nurse to the target group and
will be filled in on paper (source document).
Questionnaire
Target Moment
SUTAQ10
Patients End of the home hospitalisation
Satisfaction Home hospitalisation program Patients End of
the home hospitalisation
Satisfaction Home hospitalisation program Cardiologists At the end
of the home hospitalisation of the last patient
Satisfaction Home hospitalisation program Nurses At the
end of the home hospitalisation of the last patient
SUS questionnaire for patient application Patients End of
the home hospitalisation
SUS questionnaire for caregiver dashboard Nurses At the
end of the home hospitalisation of the last patient
Smartphone usage/digital literacy questionnaire Patients End of the
home hospitalisation
Caregiver Strain Index
Caregiver End of the home hospitalisation
Safety of the platform and the home hospitalisation program will be assessed by
the number of adverse events:
- Any type of medical problem or inconvenience for the patient related to the
use of the devices (patch, BP devices, weighing scale, etc)
- Occurrence of delirium for which medical treatment is started/up titrated
- Occurrence of infection for which antibiotic treatment is started
- Occurrence of falling trauma that requires trauma treatment
- Major adverse cardiovascular events (MACE)
- All-cause mortality
- % of unsuccessful treatment defined as death or regular hospitalisation
within 30 days after inclusion
MACE is a composite of death from cardiovascular causes, non-fatal myocardial
infarction, or non-fatal stroke in 30 days after the start of home
hospitalisation.
* Death from cardiovascular causes are defined as deaths resulting from
immediate cardiac causes (acute myocardial infarction, acute HF, fatal
arrhythmia). Unwitnessed death and death of unknown cause will be considered as
cardiac death. Vascular deaths are defined as deaths due to cerebrovascular
disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or
other vascular cause.
* A non-fatal myocardial infarction is defined as a rise and/or fall of cardiac
biomarkers (preferably troponins) with at least one value above the 99th
percentile of the upper reference limit and with at least one of the following:
i. symptoms of ischemia, ii. new or presumably new significant ST-T changes or
new left bundle branch block (LBBB), iii. development of pathological Q waves
on the electrocardiogram (ECG), iv. imaging evidence of new loss of viable
myocardium or new regional wall motion abnormalities [2].
* A non-fatal stroke is defined as an episode of focal or global neurological
deficit lasting > 24 hours with at least one of the following characteristics:
hemiplegia, hemiparesis, numbness with lateralisation, sensory loss with
lateralization, aphasia, dysphasia, hemianopia, change in the level of
consciousness.
Medium term safety will be assessed through follow-up till 30 days after the
start of the home hospitalisation intervention. All major cardiovascular
events, rehospitalisations and death will be recorded.
Lastly, platform use by the patients will be assessed by amount of missed
measurements by the patient and amount of reported technical problems.
Secondary outcome
Mapping the induced costs. Outcome measures: The induced cost will be
calculated as a composite cost of the estimated technical costs (devices and
platform), staff cost (time spent by nurses and cardiologist), transport cost
(number of kilometres, maintenance of car) and logistic costs (medical
material). The time spend by nurses will be calculated with the Toggl
application. Toggl is time tracking software that will be installed on the
smartphone of the project. The nurses can record their time spend for every
patient, logistics and transport. A informed consent with information about the
Toggl application and the use of data will be provided to the nurses.
The estimated technical cost will be delivered by the technical partners. For
equipment that can be used for several patients, there will be calculated a
unity cost per day. The study team will do the mapping of staff costs. The
logistic cost and transport cost will be calculated by mapping kilometres.
Background summary
1.1 Introduction into the NWE-Chance INTERREG project
Heart failure (HF) is a growing epidemic: in the European Union about 15
million people are now living with HF. Between 1-2% of total healthcare
expenditure can be associated with this condition, of which 50% is due to
hospitalisation. Digital health is widely recognised as one of the most
promising solutions to this societal challenge: in the field of cardiovascular
diseases, current eHealth tools primarily focus on rehabilitation and
monitoring after hospitalisation (~disease management strategies). Today, there
is a transition taking place from dedicated hospital care to the home setting,
combined with eHealth applications and miniaturised diagnostic and therapeutic
devices. This INTERREG project, NWE-Chance, aims at enabling co-creation of
eHealth concepts for admitting HF patients at home. By combining the expertise
of eHealth focused companies, hospitals specialised in HF treatment and
research institutes, a home hospitalisation platform will be developed. This
platform integrates portable devices for blood pressure (BP) and weight (W)
measurements and a wearable patch to monitor vital functions like heart rate
(HR), respiration rate, activity level and posture and an eCoach.
NWE-Chance will support during the project three eHealth companies in further
developing and testing their technologies accompanied by strategic
recommendations for successful clinical implementation. The NWE-Chance
Innovation Hub, which will be established at the end of the project, will
support the collaboration and knowledge exchange between SMEs and hospitals in
the process of developing and implementing new digital health technologies to
support hospitalisation at home.
Part of the project is a feasibility study, where the feasibility of the
technology and organisational aspects are tested in a patient/healthcare
environment. In this study the technology will be assessed without interfering
with treatment policy.
1.2 Introduction into the NWE-Chance feasibility study
HF is associated with a reduced quality of life, frequent hospitalisation and
high mortality. (1)
Up to 50% of the patients are readmitted in the hospital within the 60 days
post discharge period. Hospital admissions, especially for the elderly, have a
substantial additional hazard for serious complications. (2) These
complications are amongst others: delirium, falling trauma, and hospital
infection. They result in longer hospital stay, higher ICU admission rate,
higher mortality and irreversible loss of physical and/or mental condition. (3)
Because of these hospitalisation related complications, we notice that
worldwide hospitals increasingly explore the possibilities of providing
clinical healthcare at home as a safe alternative for hospitalisation. (4)
Hospital-at-home care has been evaluated (mostly in pilot setting and/or with
small number of patients) for different groups of patients; surgical and
non-surgical. The general conclusion is that the hospital-at-home formula is
feasible, can be conducted safely and is cost-effective for specific groups of
patients (5,6,7) Admitting patients at home is not only highly innovative but
is also a promising approach both from health care and economic perspective.
NWE-Chance will explore the possibilities of providing hospital care at home
supported by digital technologies in three centers with different levels of
experience in home care, within a feasibility study. To take the next step in
implementing hospital-at home strategies there is a need for bigger multicenter
studies.
From 2005 hospital-at-home care in the Zwolle area has been provided for HF
patients who are severely decompensated and need intravenous treatment (8). The
experiences were positive; low incidence of delirium and infections and high
patient satisfaction. Modern technologies are able to facilitate
hospitalisation at home; point of care laboratory testing, telemonitoring,
eHealth and mobile broadband communication service, make expansion of these
services possible. eHealth is widely recognised as being one of the most
promising solutions for a sustainable healthcare organisation.
In this NWE-Chance feasibility study we will evaluate the technical and
organisational feasibility of home hospitalisation for HF patients using an
integrated home hospitalisation platform. This platform is supported by
different technological companies:
* HC@Home, a Dutch company specialised in eHealth solutions, created a
telemonitoring platform that forms the basis of the home hospitalisation
platform. Currently only BP, pulse, activity and W can be measured in the home
setting of HF patients. For this project, HC@Home developed an expansion of the
platform with functionalities such as monitoring of posture and movement and
the possibility to videoconference and measure pulsoximetry.
* Sensium, a UK based company, developed a wearable patch to remotely monitor
vital signs (e.g. HR, RR, posture, movement) of hospitalised patients.
* Sananet, a Dutch company specialised in eCoaches for telemonitoring and
tele-education on a distance.
Each technology has separately been validated and is certified for commercial
use in Europe by a CE certificate. For the INTERREG NWE-Chance, the two
technical partners integrated their technology into an integrated eHealth home
hospitalisation platform. During this NWE-Chance feasibility study, we will
evaluate this integrated home hospitalisation platform for HF patients.
In summary, HF has a major societal impact. Hospitalisation at home seems to be
an attractive alternative for clinical hospitalisation and modern insights and
technology may support large-scale implementation.
Study objective
The aim of the feasibility study is to test the home hospitalisation platform
(care pathway empowered by the integrated home hospitalisation platform)
through small scale pilots in three different hospitals: Isala, Jessa hospital
and Maastricht UMC+ hospital. The aim of the pilots is to prove the technical
and organisational feasibility of the concept of home hospitalisation of HF
patients. Through these pilots, knowledge will be acquired for further
development of the technologies and implementation strategy. Decisions on
treatment policy can be made from the findings of the assessed technology.
Results of the platform can be compared with traditional / standard care.
The primary objective of the NWE-Chance feasibility study is to investigate
whether a home hospitalisation strategy for HF is technically and
organisationally feasible for the patient and the professional. Feasibility
will be assessed with following endpoints:
I. Acceptance of patients and professionals for both: technology &
hospital-at-home care with a questionnaire
II. Satisfaction of patients and professionals for both: technology &
hospital-at-home care with a questionnaire
III. Usability of the patient application by the patient and usability of the
caregiver dashboard by the professional with a questionnaire
IV. Digital literacy of patients will be assessed with a questionnaire
V. Burden on the primary informal caregiver will be assessed with a
questionnaire
VI. Safety of the technology & hospital-at-home care organisation
VII. Actual use of the patient application and the caregiver dashboard
The second objective is to get an image of the induced costs of a home
hospitalisation programme. We will use following endpoints to assess the
induced costs.
I. Purchase price of the devices and costs to use the home hospitalisation
platform
II. Staff costs
III. Transport and logistics costs
The third objective is making a blueprint of the operational organisation plan
based on experiences of this feasibility study. We will use following endpoints
to create the blueprints.
I. Evaluation of logistics and organisation of care
II. Time spend for education and patient follow-up
III. Communication between patient, nurse and cardiologist
The main hypothesis of the study is that the NWE-Chance programme is a feasible
strategy for clinical HF treatment in the living environment of the patient.
The main goal of this research is to investigate the feasibility of home
hospitalisation for HF not only for patients but for health care professionals
as well. Secondary goals are to map the organisational issues, patients* and
health professionals* comments to optimise the home hospitalisation strategy
for the randomised controlled trial that is planned in the future.
Study design
The NWE-Chance feasibility study is an international, multicenter, single-arm
prospective and interventional study.
Intervention
Patients participating in the NWE-Chance study will be transferred to their
home supported by the integrated home hospitalisation platform and a daily
visit by a specialised nurse. The home hospitalisation platform allows
monitoring vital signs of patients by using the Sensium patch and a connected
weighing scale and BP equipment of HC@home and an eCoach of Sananet. Patients
will get a smartphone to receive reminders for measurements of BP and W and
will be able to see the evolution of their BP and W values. The patient
application also contains educational information for the patient on home
hospitalisation and on how to take the measurements correctly.
Patients are treated by a team of specialised nurses under supervision of a
cardiologist. The nurses visit patients at least once a day and are equipped
with laboratory equipment and IV medication administering equipment. These
devices and equipment are currently used in standard HF care and are not part
of the newly developed home hospitalisation platform. Patients receive
treatment similar to in-hospital treatment, according to the cardiologist*s
best knowledge and insight.
In the case of Jessa Hospital, if there would be a need for IV medication
during the home hospitalisation period, this will lead to rehospitalisation of
the patient and the ending of the intervention. In Isala, the nurses have a
24/7 duty service and can be called by patients or their relatives on their own
initiative. In Jessa hospital and MUMC+, the nursing team can be contacted
between 9 AM and 17 PM. During other hours, the patients can contact the
cardiologist on call.
In case of treatment failure or severe deterioration, patients will be
transported to the hospital. In case of emergency, ambulances will transport
patients to the hospital (conversion to regular hospitalisation). If in
follow-up, condition worsens, the patient can be readmitted at home again. In
theory, patients may undergo repeated hospitalisations at home.
The home hospitalisation period will last at least 5 days and can be extended,
till a maximum of 13 days, after consultation of a cardiologist. Patient will
be asked to fill in questionnaires to assess feasibility at the end of the home
hospitalisation period (last visit of nurse). At the last visit of the nurse,
they will take all the devices with them.
Study burden and risks
not applicable
Dr van Heesweg 2
Zwolle 8025AB
NL
Dr van Heesweg 2
Zwolle 8025AB
NL
Listed location countries
Age
Inclusion criteria
Patients with known and well assessed chronic heart failure
Age >18 years
Indication for hospital admission for acute decompensated heart failure
Stable physical condition with or without IV medication
Living within a wide proximity of the hospital
-<30 km for Jessa Hospital and Isala
-Within the region Maastricht Heuvelland for MUMC
Living independently and/or sufficiently supported at home and/or living in
nursing homes (or other supported living modalities)
Signed written informed consent
Exclusion criteria
Indication for IC/CCU admission
Not fulfilling the inclusion criteria for home hospitalisation
Mental implairment leading to inability to cooperate
Severe comorbidity requiring simultaneous hospital care
History of severe liver disease
Unstable blood pressure (Systolic blood pressure <90mmHg)
Unstable heart rhythm (in case of synus rhythm heart rate >110/min, in case of
atrial fibrillation >150/min
Need for intravenous inotropic medication
Unstable respiratory condition (spO2<90% without additional O2
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 |
|---|---|
| ClinicalTrials.gov | NCT04084964 |
| CCMO | NL71016.075.19 |