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van CCT (UK)

van CCT (UK)

Hospital at home care for older patients with cognitive impairment and an acute medical illness

- candidate number27582
- NTR NumberNTR6581
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-jul-2017
- Secondary IDsABR: NL60371.042.16 ZonMw projectnumber: 733050401
- Public TitleHospital at home care for older patients with cognitive impairment and an acute medical illness
- Scientific TitleHospital at Home care for older patients with cognitive impairment: a protocol for a randomized controlled feasibility trial
- hypothesisThe aim of the study is to assess the feasibility of conducting a randomized controlled trial in terms of recruitment, use and acceptability of Hospital at Home care, and to evaluate the quality of care and the advantages and disadvantages of the Hospital at Home care program in comparison to usual hospital care.
- Healt Condition(s) or Problem(s) studiedDementia, Hospitalization, Cognitive aging
- Inclusion criteria1. Age ≥ 65 years
2. Cognitive impairment; dementia, delirium or other cause of cognitive impairment, either previously diagnosed, documented in medical record or;Identified by the ED-clinician (e.g. with the IQCODE-sf, 4AT-test and/or Short Blessed Test or another screening test of choice)
3. Presentation at the ED with a defined acute illness
4. Felt to require hospital admission by attending ED physician, but not expected to require emergency interventions
o Modified Early Warning Score (MEWS) ≤ 2 points
5. Living in hospitalís catchment area (< 25 km)
6. Informal caregiver is present and able to understand and perform instructions and consented to participate in the trial
7. Home suitable for hospital at home care (available informal caregiver, running water, adequate heating, safety)
- Exclusion criteria1. Previously enrolled
2. Hospitalized within 7 days preceding ED presentation
3. Nursing home residents or awaiting a nursing home place on an active waiting list (excluding so called sleeping waiting list candidates)
4. Need for surgical assessment
5. Suspected acute coronary syndrome or cardiac arrythmia
6. Dialysis dependent patients
7. Expected terminal events or in need of palliative care due to oncological illness
8. Acute illness requiring hospital admission independent of the target diagnosis of presentation
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 4-dec-2017
- planned closingdate4-dec-2019
- Target number of participants143
- InterventionsAfter informed consent is obtained, the participant completes two brief cognitive tests and participant and caregiver complete the baseline assessment. Subsequently, randomization takes place to either (a) H@H-intervention; translocation of care from the hospital to a participantsí home or (b) Control; usual hospital care. In case of nonparticipation, reasons for declination, date of birth, sex and the presence of a caregiver are reported, if possible.
Participants allocated to Hospital at Home will receive hospital level care in their own home under responsibility of the hospital. Hospital at Home care will be described in care protocols.
- Primary outcomeParticipation rates, reasons for non-participation and data on characteristics of non-participants will be collected. Quality of care will be measured by collecting data on mortality, institutionalization (e.g. to hospital or nursing home), ADL-functioning, prevalence of hospital-associated geriatric syndromes, the length of stay in hospital or in Hospital at Home care program and the contact with health care professionals.
- Secondary outcomeAdvantages and disadvantages of the Hospital at Home care program will be assessed. Additional data will be collected on the time spent at home (home-time); total number of days alive and out of the hospital or a skilled nursing facility in the 6 months after the randomization at the emergency department, the number of transfers (home ↔ hospital) and the number of health care professionals involved. Data on costs will be collected as described by Drummond et al.; costs within health care system, costs to patient and family, costs in other sectors.
- TimepointsData will be collected at baseline at the emergency department, during admission (in Hospital at Home or hospital), at discharge and at three and six months following randomization, plus or minus two weeks.
- Trial web
- statusplanned
- CONTACT for SCIENTIFIC QUERIESProf. Sophia E. de Rooij
- Sponsor/Initiator Universitair Centrum Ouderengeneeskunde (UCO)
- Funding
(Source(s) of Monetary or Material Support)
Deltaplan Dementie (ZonMw), project number #733050401, Ministry of Health, Welfare and Sports (VWS), University Medical Center Groningen (UMCG)
- Publications
- Brief summaryHospital at Home care aims to avoid hospital-associated geriatric syndromes and nursing home admission in older patients with cognitive impairment by providing hospital care in a patientsí own environment. Hospital at Home is a monocenter, randomized, unblinded feasibility trial in older patients with cognitive impairment referred to the emergency department of the hospital for an acute medical illness. Eligible patients will be randomized either to hospital care in their own environment, Hospital at Home care, or usual hospital care. The intervention consists of hospital level care provided at the patientsí own home. The control group will receive usual hospital care. Measurements will be conducted at baseline, during admission, at discharge and at 3 and 6 months after the baseline assessment.
- Main changes (audit trail)4-nov-2017 -IK:

The Dutch Ministry of Health, Welfare and Sport (Ministerie van Volksgezondheid, Welzijn en Sport) and The University Medical Center Groningen were added.
- RECORD26-jul-2017 - 4-nov-2017

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