The Focus is to Investigate Effect of a Case Management Interventions in Frequent Visitors to Emergency DepartmentsNCT01985074
A Case Management Study Targeted to Reduce Health Care Utilization for Frequent Emergency Department Visitors
A study testing Case-management intervention in people with The Focus is to Investigate Effect of a Case Management Interventions in Frequent Visitors to Emergency Departments, run by Health Navigator at 1 site in Sweden.
Trial summary
The aim of the study is to determine whether a nurse-managed telephone-based case-management intervention can reduce healthcare utilization and improve self-assessed health status in frequent emergency department users. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- The Focus is to Investigate Effect of a Case Management Interventions in Frequent Visitors to Emergency Departments
- What is being tested?
- Case-management intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,000 participants
- Where
- 1 siteSweden
- Study dates
- Jul 2010to Dec 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent history of frequent visits to emergency department
- Anticipated sustained high visit frequency
- Living in one of five Swedish counties where trial is ongoing
Who cannot join
- Moribund patients
- Psychosis
- Severe hearing impairment or language difficulties
- Other factors that may make it impossible or impractical for a patient to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to determine whether a nurse-managed telephone-based case-management intervention can reduce healthcare utilization and improve self-assessed health status in frequent emergency department users.
Read the detailed description
The study tests a nurse-run case-management intervention targeted towards frequent emergency department visitors. The aim is to reduce visits to emergency departments as well as to improve quality of life by facilitating coping mechanisms as well as redirecting these patients to more suitable health care facilities.
- Being tested
- Case-management intervention
- Keywords
- case management, disease management, emergency, department
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case-management interventionBehavioural
The participants in the intervention group receives a nurse-managed case-management intervention that is regularly delivered by telephone or, when necessary, in person.
| Study group | Role | What they receive |
|---|---|---|
| Case-management intervention | Experimental | Receiving nurse-managed intervention Receives: Behavioral: Case-management intervention |
| Control arm | No intervention | Control group not receiving any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of outpatient visits to medical doctor
Measured: During first two years of follow-up
Number of hospitalizations
Measured: During first two years of follow-up
Secondary outcomes (3)
Mortality
Measured: During first two years of follow-up
Length of hospital stay
Measured: During first two years of follow-up
Total health care costs
Measured: During first two years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startJul 2010
- Primary completionApr 2015
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for The Focus is to Investigate Effect of a Case Management Interventions in Frequent Visitors to Emergency DepartmentsStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Health Navigator
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, Ostergotland County Council, Sweden, Vastra Gotaland Region, Uppsala County Council, Sweden, Sormland County Council, Sweden
- Responsible party
- Principal investigator, Gustaf Edgren, Health Navigator
- Investigators
- Gsutaf Edgren, MD PhD, Principal investigator, Health Navigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985074
- Sponsor's protocol ID
- HN-AHS-MBS-1
- Status last verified
- Sep 2015
- First submitted
- 4 Nov 2013
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Reinius P, Johansson M, Fjellner A, Werr J, Ohlen G, Edgren G. A telephone-based case-management intervention reduces healthcare utilization for frequent emergency department visitors. Eur J Emerg Med. 2013 Oct;20(5):327-34. doi: 10.1097/MEJ.0b013e328358bf5a.
PubMed 22960802
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case Management Study Targeted to Reduce Health Care Utilization for Frequent Emergency Department Visitors
- ClinicalTrials.gov ID
- NCT01985074
- Acronym / sponsor ID
- HN-AHS-MBS-1
- Keywords
- case management, disease management, emergency, department
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Health NavigatorUniversity, hospital or other
- Collaborators
- Region Stockholm, Ostergotland County Council, Sweden, Vastra Gotaland Region, Uppsala County Council, Sweden, Sormland County Council, Sweden
- Study start
- Jul 2010
- Primary completion
- Apr 2015 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 15 Nov 2013 (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 aim of the study is to determine whether a nurse-managed telephone-based case-management intervention can reduce healthcare utilization and improve self-assessed health status in frequent emergency department users.
Detailed description
The study tests a nurse-run case-management intervention targeted towards frequent emergency department visitors. The aim is to reduce visits to emergency departments as well as to improve quality of life by facilitating coping mechanisms as well as redirecting these patients to more suitable health care facilities.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case-management intervention | Experimental | Behavioral: Case-management interventionReceiving nurse-managed intervention |
| Control arm | No intervention | –Control group not receiving any intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recent history of frequent visits to emergency department
- Anticipated sustained high visit frequency
- Living in one of five Swedish counties where trial is ongoing
Key exclusion criteria (4 listed)
- Moribund patients
- Psychosis
- Severe hearing impairment or language difficulties
- Other factors that may make it impossible or impractical for a patient to participate in the study
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 |
|---|---|---|
| Case-management interventionThe participants in the intervention group receives a nurse-managed case-management intervention that is regularly delivered by telephone or, when necessary, in person. | Behavioural | Case-management intervention |
Primary outcome
Number of outpatient visits to medical doctor
Time frame: During first two years of follow-up
Number of hospitalizations
Time frame: During first two years of follow-up
3 secondary outcomes
Mortality
Time frame: During first two years of follow-up
Length of hospital stay
Time frame: During first two years of follow-up
Total health care costs
Time frame: During first two years of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2015.
- Results publication: PubMed 22960802Reinius P, Johansson M, Fjellner A, Werr J, Ohlen G, Edgren G. A telephone-based case-management intervention reduces healthcare utilization for frequent emergency department visitors. Eur J Emerg Med. 2013 Oct;20(5):327-34. doi: 10.1097/MEJ.0b013e328358bf5a.
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.
Gsutaf Edgren, MD PhD principal investigator
Health Navigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case-management intervention in people with The Focus is to Investigate Effect of a Case Management Interventions in Frequent Visitors to Emergency Departments, run by Health Navigator at 1 site in Sweden.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
Results are not available in the source record.
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?
Number of outpatient visits to medical doctor (time frame: During first two years of follow-up). 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 NCT01985074, which also lists 1 linked publication.
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 15 Sep 2015.