ISRCTN ISRCTN21608185
DOI https://doi.org/10.1186/ISRCTN21608185
Secondary identifying numbers N/A
Submission date
19/07/2013
Registration date
26/07/2013
Last edited
12/08/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Jo Kåre Herfjord
Scientific

Fylkesmannen i Hordaland
Kaigaten 9
Bergen
5020
Norway

Email fmhojkh@fylkesmannen.no

Study information

Study designParallel-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 designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleIntermediate care in nursing home after hospital admission: a randomized controlled trial with one year follow-up
Study objectivesThe 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(s)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.
Health condition(s) or problem(s) studiedAcute 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.
Intervention1. 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 typeOther
Primary outcome measureOur 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 measuresSecondary outcome measures were mortality, days spent in hospital, days in nursing homes and use of home care services.
Overall study start date15/08/2007
Completion date02/06/2009

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants400
Key inclusion criteria1. 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
Key exclusion criteria1. Severe dementia
2. Delirium
3. Need for surgery or intensive care treatment
Date of first enrolment15/08/2007
Date of final enrolment01/06/2008

Locations

Countries of recruitment

  • Norway

Study participating centre

Fylkesmannen i Hordaland, Kaigaten 9
Bergen
5020
Norway

Sponsor information

Kavli Research Centre for Ageing and Dementia (Norway)
Research organisation

Haraldsplass Deaconess Hospital
Ulriksdal 8
Bergen
5009
Norway

Email ida.kristine.sangnes@haraldsplass.no
Website http://kavlisenter.no/index.aspx?pageId=1
ROR logo "ROR" https://ror.org/03t3p6f87

Funders

Funder type

Government

The Western Norway Regional Health Authority (Norway)

No information available

Kavli Research Centre for Ageing and Dementia (Norway)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 09/12/2014 Yes No