PatientsNCT01706744
Effect of Discharge Via an Intermediate Care Unit
A study testing Intermediate care unit, Local health care 1 and Local health care 2 in people with Patients and Aged, run by Norwegian University of Science and Technology at 4 sites in Norway.
Trial summary
The main goal is to investigate the following topics: 1. Can discharge via the Intermediate Care Unit in Stjørdal, compared to direct discharge to Verdal Municipality, be equally effective in preventing aggravation of disease and loss of function for patients over 60 years that have been hospitalized in Levanger… Read more about this study
- Who is it for?
- Ages 60 to 99 years
- What is being tested?
- Intermediate care unit, Local health care 1 and Local health care 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 4 sitesNorway
- Study dates
- Feb 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 60 years old or older from Stjørdal- or Verdal municipality,
- given consent,
- admitted from their home,
- diagnostics completed and necessary treatment started
- the patient need not less than 3-4 days institutionalization for treatment/rehabilitation/care
Who cannot join
- Patients with severe dementia
- Patients with severe disease who cannot give consent
- Patients with severe disease with short life expectancy (including severe cancer)
Trial locations and contacts
4 sites in 1 country.
Norway4 sites
Sykehuset Levanger
Levanger
Distriksmedisinsk Senter
Stjørdal
Stjørdal Kommune
Stjørdal
Verdal kommune
Verdal
About this study
Official title: Can Discharge Via an Intermediate Care Unit Prevent Aggravation of Disease and Loss of Functionality, Without Increasing the Level of Cost? A Controlled Observational Study
The main goal is to investigate the following topics:
- Can discharge via the Intermediate Care Unit in Stjørdal, compared to direct discharge to Verdal Municipality, be equally effective in preventing aggravation of disease and loss of function for patients over 60 years that have been hospitalized in Levanger hospital?
- Are the cost by discharge to the Intermediate Care Unit in Stjørdal, when the hospital is not located in the same Municipality, comparable to the cost by direct discharge to the Municipality of Verdal, for patients over 60 years that have been hospitalized in Levanger hospital?
- Which issues are considered important by patients and health personnel during discharge, arrival and follow up in the Municipality, to ensure an optimal interaction between the involved units.
- Being tested
- Intermediate care unit, Local health care 1, Local health care 2
- Keywords
- Hospital Readmissions, Community Health Services, Preventive Health Services, Norway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermediate care unitOther
Local health care 1Other
Local health care 2Other
| Study group | Role | What they receive |
|---|---|---|
| Intermediate care unit | Experimental | Follow-up treatment and care in a intermediate care unit after discharge from hospital Receives: Other: Intermediate care unit |
| Local health care 1 | Active comparator | Discharge from hospital to usual care as provided by the local health and social care (Verdal) Receives: Other: Local health care 1 |
| Local health care 2 | Active comparator | Discharge from hospital to usual care as provided by the local health and social care (Stjørdal) Receives: Other: Local health care 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital readmission
Acute admission to hospital within 30 days from previous discharge
Measured: 30 days
Use of local health care services
Measured: up to 1 year
Secondary outcomes (4)
death
Measured: up to 1 year
hospital admission
Measured: up to 1 year
functional assessment status
Measured: up to 6 months
Health service cost
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startFeb 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PatientsStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roar Johnsen, PhD, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706744
- Sponsor's protocol ID
- 2009/1697
- Status last verified
- Dec 2015
- First submitted
- 11 Oct 2012
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Dahl U, Johnsen R, Saetre R, Steinsbekk A. The influence of an intermediate care hospital on health care utilization among elderly patients--a retrospective comparative cohort study. BMC Health Serv Res. 2015 Feb 1;15:48. doi: 10.1186/s12913-015-0708-4.
PubMed 25638151Dahl U, Steinsbekk A, Jenssen S, Johnsen R. Hospital discharge of elderly patients to primary health care, with and without an intermediate care hospital - a qualitative study of health professionals' experiences. Int J Integr Care. 2014 Apr 30;14:e011. doi: 10.5334/ijic.1156. eCollection 2014 Apr.
PubMed 24868194Dahl U, Steinsbekk A, Johnsen R. Effectiveness of an intermediate care hospital on readmissions, mortality, activities of daily living and use of health care services among hospitalized adults aged 60 years and older--a controlled observational study. BMC Health Serv Res. 2015 Aug 28;15:351. doi: 10.1186/s12913-015-1022-x.
PubMed 26315779
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Discharge Via an Intermediate Care Unit Prevent Aggravation of Disease and Loss of Functionality, Without Increasing the Level of Cost? A Controlled Observational Study
- ClinicalTrials.gov ID
- NCT01706744
- Acronym / sponsor ID
- 2009/1697
- Keywords
- Hospital Readmissions, Community Health Services, Preventive Health Services, Norway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 15 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal is to investigate the following topics:
- Can discharge via the Intermediate Care Unit in Stjørdal, compared to direct discharge to Verdal Municipality, be equally effective in preventing aggravation of disease and loss of function for patients over 60 years that have been hospitalized in Levanger hospital?
- Are the cost by discharge to the Intermediate Care Unit in Stjørdal, when the hospital is not located in the same Municipality, comparable to the cost by direct discharge to the Municipality of Verdal, for patients over 60 years that have been hospitalized in Levanger hospital?
- Which issues are considered important by patients and health personnel during discharge, arrival and follow up in the Municipality, to ensure an optimal interaction between the involved units.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intermediate care unit | Experimental | Other: Intermediate care unitFollow-up treatment and care in a intermediate care unit after discharge from hospital |
| Local health care 1 | Active comparator | Other: Local health care 1Discharge from hospital to usual care as provided by the local health and social care (Verdal) |
| Local health care 2 | Active comparator | Other: Local health care 2Discharge from hospital to usual care as provided by the local health and social care (Stjørdal) |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients 60 years old or older from Stjørdal- or Verdal municipality,
- given consent,
- admitted from their home,
- diagnostics completed and necessary treatment started
- the patient need not less than 3-4 days institutionalization for treatment/rehabilitation/care
Key exclusion criteria (3 listed)
- Patients with severe dementia
- Patients with severe disease who cannot give consent
- Patients with severe disease with short life expectancy (including severe cancer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermediate care unit | Other | Intermediate care unit |
| Local health care 1 | Other | Local health care 1 |
| Local health care 2 | Other | Local health care 2 |
Primary outcome
Hospital readmission
Time frame: 30 days
Acute admission to hospital within 30 days from previous discharge
Use of local health care services
Time frame: up to 1 year
4 secondary outcomes
death
Time frame: up to 1 year
hospital admission
Time frame: up to 1 year
functional assessment status
Time frame: up to 6 months
Health service cost
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
- Results publication: PubMed 25638151Dahl U, Johnsen R, Saetre R, Steinsbekk A. The influence of an intermediate care hospital on health care utilization among elderly patients--a retrospective comparative cohort study. BMC Health Serv Res. 2015 Feb 1;15:48. doi: 10.1186/s12913-015-0708-4.
- Results publication: PubMed 24868194Dahl U, Steinsbekk A, Jenssen S, Johnsen R. Hospital discharge of elderly patients to primary health care, with and without an intermediate care hospital - a qualitative study of health professionals' experiences. Int J Integr Care. 2014 Apr 30;14:e011. doi: 10.5334/ijic.1156. eCollection 2014 Apr.
- Results publication: PubMed 26315779Dahl U, Steinsbekk A, Johnsen R. Effectiveness of an intermediate care hospital on readmissions, mortality, activities of daily living and use of health care services among hospitalized adults aged 60 years and older--a controlled observational study. BMC Health Serv Res. 2015 Aug 28;15:351. doi: 10.1186/s12913-015-1022-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roar Johnsen, PhD study director
Norwegian University of Science and Technology
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermediate care unit, Local health care 1 and Local health care 2 in people with Patients and Aged, run by Norwegian University of Science and Technology at 4 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital readmission (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01706744, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2015.