The aim of the study is to assess the feasibility of conducting a definitive trial in terms of recruitment, use and acceptability of H@H, quality of care and the advantages and disadvantages of H@H in comparison to usual hospital care.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Cognitive and attention disorders and disturbances
- Age related factors
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the participation rate of the H@H trial among
patients 65 years and older with cognitive impairment at the ED and the reasons
for non-participation.
Secondary outcome
Furthermore the different steps in the H@H care process will be timed and
evaluated and if the quality of H@H care differs from usual hospital care will
be studied. In addition we investigate advantages and disadvantages of H@H care
and usual hospital care with regards to: time spent at home, number of
transfers needed, number of health care professionals involved, (medical)
equipment needed, functional status (ADL), health status, (health related)
quality of life and costs.
Background summary
Most of the older persons with cognitive impairment live at home with
assistance of informal care and specialized home care. An acute hospital
admission is a stressful life event for these patients and is often complicated
by hospital-related complications such as falls, delirium, malnutrition and
functional decline. The hospitalization of these patients is often followed by
nursing home admission and most of them never return to their own home again.
In order to decrease the risk on hospital-related complications and nursing
home admission, Hospital at Home (H@H) offers a new care trajectory which
provides hospital care in a patients* own home. The general aim of H@H is to
avoid hospital-related complications and nursing home admission in elderly
patients with cognitive impairment.
Study objective
The aim of the study is to assess the feasibility of conducting a definitive
trial in terms of recruitment, use and acceptability of H@H, quality of care
and the advantages and disadvantages of H@H in comparison to usual hospital
care.
Study design
Randomized controlled feasibility trial
Intervention
When hospital admission is indicated after a visit to the emergency department,
eligible patients with informed consent will be randomized to receive hospital
care in their own home (H@H-care) or usual hospital care, with a randomization
ratio of 4:1 to H@H care. The intervention is hospital level care delivered to
the patients* own home including: visits of heath care professionals,
diagnostics (laboratory tests, blood cultures) and treatment (iv medication,
fluids), all provided according to current Dutch treatment guidelines.
Measurements will be at inclusion, during admission, at discharge and at 3 and
6 months follow-up.
Study burden and risks
The questionnaires will take participants a maximum of 20-40 minutes at a time
to complete and do not contain burdensome questions. Participants will be
contacted by telephone at 3 and 6 months to avoid distress of an extra hospital
visit. Caregivers and medical professionals will be asked to complete a
questionnaire at discharge of the patient. The expected burden of being
allocated to the intervention arm (H@H) could involve psychological stress by
unfamiliarity with the H@H care, although patients are selected based on their
agreement to receive hospital level care at home. Occurrence of disease-related
complications which need additional care in H@H will result in a delay in the
time-to-intervention, to forestall this; strict inclusion- and exclusion
criteria are applied. The expected burden of being allocated to the control arm
(usual hospital care) could involve psychological stress by disappointment of
not being able to go home. In a study population of elderly patients with
cognitive impairment, there is a possibility of participants being
(temporarily) incapacitated. In case of participants being incapacitated, the
legal representative will be closely involved in informing on the study and
sign informed consent. Cognitive impaired patients are more prone to the risks
of an acute hospital admission and have higher in-hospital mortality and most
likely they will benefit most from care in their own homes and the expected
decrease in hospital related complications. The additional risk and burden of
the intervention are proved negligible in previous trials.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
> Age >= 65yr > Established dementia, delirium or other cause of cognitive impairment present Previously diagnosed or; Confirmed with the IQCODE-sf (family) or in a patient by the 4AT-test31 and/or Short Blessed Test on the ED > Presentation with a defined acute illness > Felt to require hospital admission by attending ED physician, but not expected to require emergency interventions MEWS <= 2 / VIEWS < 7 > Living in hospital catchment area > Ambulatory ability 24hrs prior to ED presentation > Informal caregiver present, able to understand and perform instructions > Appropriate home circumstances (running water, adequate heating, safety)
Exclusion criteria
- Need for medium or intensive care, based on MEWS-score and clinician judgment > Cut-off value emergency scores: MEWS >=3 / VIEWS >7 - Need for surgical assessment - Hospitalized within 7 days preceding ED presentation - Nursing home residents or awaiting a nursing home place on an active waiting list (excluding so called sleeping waiting list candidates) - Suspected acute coronary syndrome or cardiac arrythmia - Dialysis dependent patients - Expected terminal events or in need of palliative care due to oncological illness - Acute illness requiring hospital admission independent of the target diagnosis of presentation
Design
Recruitment
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 | NL60371.042.16 |