Condition category
Signs and Symptoms
Date applied
19/07/2013
Date assigned
26/07/2013
Last edited
12/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://kavlisenter.no/index.aspx?pageId=1

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

Publication citations

Additional files

Editorial Notes