- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01985074
A Case Management Study Targeted to Reduce Health Care Utilization for Frequent Emergency Department Visitors
September 13, 2015 updated by: Gustaf Edgren, Health Navigator
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.
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
15000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Stockholm, Sweden
- Stockholms Läns Landsting
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Recent history of frequent visits to emergency department
- Anticipated sustained high visit frequency
- Living in one of five Swedish counties where trial is ongoing
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Case-management intervention
Receiving nurse-managed intervention
|
The participants in the intervention group receives a nurse-managed case-management intervention that is regularly delivered by telephone or, when necessary, in person.
|
No Intervention: Control arm
Control group not receiving any intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of outpatient visits to medical doctor
Time Frame: During first two years of follow-up
|
During first two years of follow-up
|
Number of hospitalizations
Time Frame: During first two years of follow-up
|
During first two years of follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mortality
Time Frame: During first two years of follow-up
|
During first two years of follow-up
|
Length of hospital stay
Time Frame: During first two years of follow-up
|
During first two years of follow-up
|
Total health care costs
Time Frame: During first two years of follow-up
|
During first two years of follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gsutaf Edgren, MD PhD, Health Navigator
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Actual)
April 1, 2015
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
November 4, 2013
First Submitted That Met QC Criteria
November 8, 2013
First Posted (Estimate)
November 15, 2013
Study Record Updates
Last Update Posted (Estimate)
September 15, 2015
Last Update Submitted That Met QC Criteria
September 13, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HN-AHS-MBS-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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