- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02094040
Municipality-based Post-discharge Follow-up Visits
March 19, 2014 updated by: Holbaek Sygehus
Effect of Municipality-based Post-discharge Follow-up Visit Including the Primary Physician on Early Re-hospitalization in High Risk People of 65+ Years. A Randomised Controlled Trial.
The purpose of this study is to determine whether discharge follow-up visit by primary physician and community-based nurse affects the risk of early re-hospitalisation among high risk older people discharged from a medical ward.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
531
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
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-
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Holbæk, Denmark, 4300
- Medicinsk Afdeling, Holbæk Sygehus
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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
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient geography (The participant live in; Holbæk Kommune, Odsherred Kommune or Kalundborg Kommune.)
- Discharged from medical ward Holbæk Sygehus.
- Frailty (Rated by following criterion: dementia or a minimum of two of the following conditions; two or more hospitalisations within 12 month prior to follow up, los of physical function, treatment of two or more concurrent medical and/or surgical conditions, psychiatric disease, multi-pharmacy of more than 6 prescription medication, suspicious of congenital disturbances, substance abuse problem, disadvantaged social network, need for increasing home care following index hospitalization.)
Exclusion Criteria:
- Not discharged to home (If the patient are not discharged to home.)
- No written consent (If the patient does not wish to participate / written consent are not signed.)
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Follow-up visit
Receive municipality-based follow-up visit including primary physician.
|
Systematic electronic referral from hospital to municipality of high risk people at discharge from a medical ward.
Contact from municipality service to primary physician and citizen, to arrange first home visit within 7 days with focus on: medication, rehabilitation plan and health care appointments, functional level and need for further health care initiatives.
The visit is concluded by planning of further visits (up till tree) and division of responsibilities between primary physician and the municipality service.
Other Names:
|
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No Intervention: Usual care
Does not receive follow-up visit
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Re-admission
Time Frame: Within 30 days from discharge
|
The primary outcome is re-hospitalisation rate within 30 days from discharge.
Data is obtained from the official register of danish patients (Landspatientregistret).
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Within 30 days from discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Long-term hospitalization rate
Time Frame: Within 180 days from discharge
|
Secondary outcome concerns hospitalization rate measured at 30 and 180 days post discharge.
Data is obtained from the official register of Danish patients (Landspatientregistret).
|
Within 180 days from discharge
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Long-term death rate
Time Frame: Within 180 days from discharge
|
Other pre-specified outcome concerns death rate measured at 30 and 180 days post discharge.
Data is obtained from the official register of Danish patients (Landspatientregistret).
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Within 180 days from discharge
|
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Long-term use of primary health care services
Time Frame: Within 180 days from discharge
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Other pre-specified outcome concerns the use of primary health care services measured at 30 and 180 days post discharge.
Data is obtained from the official register of primary health care in Denmark (Sygesikringsregistret) and registration from 3 Danish municipalities.
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Within 180 days from discharge
|
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Long-term use of secondary health care services
Time Frame: Within 180 days from discharge
|
Other pre-specified outcome concerns the use of secondary health care services measured at 30 and 180 days post discharge.
Data is obtained from the official register of Danish patients (Landspatientregistret).
|
Within 180 days from discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas Gjørup, Medicinsk Afdeling, Holbæk Sygehus
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
February 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
March 12, 2014
First Submitted That Met QC Criteria
March 19, 2014
First Posted (Estimate)
March 21, 2014
Study Record Updates
Last Update Posted (Estimate)
March 21, 2014
Last Update Submitted That Met QC Criteria
March 19, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3800H0.52-0059
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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