Plain English Summary
Background and study aims
Intermediate care services are thought to provide adequate care closer to home, preventing hospital admissions and facilitating early discharge. The goal of this study is to assess the effectiveness of intermediate care services. We will compare patients transferred to intermediate care service with patients staying in hospital. The study's findings will help us choose the correct treatment and care for elderly persons with acute illness.
Who can participate?
The study recruited men and women 70 years and older, living at home who were admitted to hospital for acute illness in Bergen, Norway. Patients could participate if they had a medical or orthopedic condition (disorders related to muscles and joints) which did not require surgery or intensive care.
What does the study involve?
Patients were randomly allocated to be either treated in hospital as usual or transferred to intermediate care in a nursing home unit for a stay of maximum three weeks. For the next 12 months, patients' mortality, subsequent admissions to hospital or nursing home and use of home care serviceswere recorded
What are the possible benefits and risks of participating?
A potential benefit in transfer to intermediate care could be longer stay before returning home. A potential disadvantage could be less access to diagnostic procedures like x-ray.
The two treatment options were considered equally safe and appropriate for these patients.
Where is the study run form?
The study was initiated by Bergen municipality, Haraldsplass Deaconess Hospital and Haukeland University Hospital and set up in cooperation with Kavli Research Centre for Ageing and Dementia and Institute of Medicine, University of Bergen, Norway. Centers taking part in the study are Storetveit Nursing Home, Haraldsplass Deaconess Hospital and Haukeland University Hospital, all located in Bergen, Norway.
When is the study starting and how long is it expected to run for?
Recruitment started in August 2007 and ended in June 2008. The study period lasted for a further 12 months after enrolment of the last patient.
Who is funding the study?
Funding has been provided by The Western Norway regional Health Authorityand Kavli Research Centre for Ageing and Dementia.
Who is the main contact?
Dr Jo Kåre Herfjord
fmhojkh@fylkesmannen.no
Trial website
Contact information
Type
Scientific
Primary contact
Dr Jo Kåre Herfjord
ORCID ID
Contact details
Fylkesmannen i Hordaland
Kaigaten 9
Bergen
5020
Norway
-
fmhojkh@fylkesmannen.no
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Intermediate care in nursing home after hospital admission: a randomized controlled trial with one year follow-up
Acronym
Study hypothesis
The objective of the study is to evaluate effect and safety of early transfer to community-based intermediate care, compared to traditional hospital treatment.
Ethics approval
The Regional Committee for Medical Research Ethics in Norway approved the study on 21/05/2007, ref: S-07096a. Extension of the observation period and new outcome measures were approved on 24/09/2009, ref: 2009/821.
Study design
Parallel-group randomized intervention study. Blinding was not possible. The setting of the study and data collection took place at a nursing home and two hospitals.
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Acute illness or trauma in frail elderly patients with co-morbidity, resulting in hospital admission. Choice of post-acute management and care. Collaboration between hospital and community health services.
Intervention
1. Patients in the intervention group went to intermediate care unit within the next working day after randomization. A multi-disciplinary team of physicians, nurse and physiotherapists examined each patient after a model of comprehensive geriatric assessment. As well as continuing treatment for the acute illness or injury, therapy focused on mobilization, physical exercise, optimal nutrition and critical evaluation of prescribed medication. The aim was maximum independence, enabling patients to resume living at home. Information about home situation and caregivers were obtained and if necessary increased home care services were requested. Length of stay in the unit was limited to maximum 3 weeks
2. Patients in the control group received usual care in hospital.
For both treatment arms there was a follow-up period of 12 months.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Our pre-specified primary outcome was the number of days patients would be alive and living at home throughout the first year after randomization. Data were obtained from patient registers at the hospitals and the community health care services for a period of 365 days for each patient after randomization.
Secondary outcome measures
Secondary outcome measures were mortality, days spent in hospital, days in nursing homes and use of home care services.
Overall trial start date
15/08/2007
Overall trial end date
02/06/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients aged 70 years or older
2. Living at home
3. Resident in Bergen municipality
4. Acutely admitted to medical or orthopaedic departments
5. Respiratory and circulatory stable
6. Deemed able to return home within three weeks
7. Intermediate care considered suitable by attending physician
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
400
Participant exclusion criteria
1. Severe dementia
2. Delirium
3. Need for surgery or intensive care treatment
Recruitment start date
15/08/2007
Recruitment end date
01/06/2008
Locations
Countries of recruitment
Norway
Trial participating centre
Fylkesmannen i Hordaland, Kaigaten 9
Bergen
5020
Norway
Sponsor information
Organisation
Kavli Research Centre for Ageing and Dementia (Norway)
Sponsor details
Haraldsplass Deaconess Hospital
Ulriksdal 8
Bergen
5009
Norway
-
ida.kristine.sangnes@haraldsplass.no
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
The Western Norway Regional Health Authority (Norway)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Kavli Research Centre for Ageing and Dementia (Norway)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
A publication in Norwegian reporting patient selection, randomization process and treatment groups is accessible online at http://www.ks.no/PageFiles/4039/900208_Bergen%20kommune%20sluttrapport.pdf
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25487353