- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04398797
Prevention of AcuTe admIssioN Algorithm (PATINA)
October 25, 2022 updated by: Anders Fournaise, Region of Southern Denmark
Prevention of AcuTe admIssioN Algorithm (PATINA) - The Effect of a Notification Algorithm and a Digital Decision Support Tool
Utilization of public health care mirrors the older individual's overall health, and increased need for health care may precede more clear symptoms of acute disease.
In a previous retrospective study, we found a significant increase in municipal home care service (minutes/week) in a 12-month period prior to acute hospitalization.
This PhD-study aims at examining the effect of a software algorithm monitoring older citizens utilization of municipal home care.
When home care increases the community nurse is notified and special attention is paid to the individual's current health situation.
Pro-active health care initiatives may be launched in collaboration with the primary care physician.
The intervention is the algorithm.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2464
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
-
-
-
Odense, Denmark, 5000
- Odense University Hospital
-
-
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:
- Community dwelling citizens (+ 65) receiving home and social care in Odense, Kerteminde and Svendborg Municipalities.
Exclusion Criteria:
- Non
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention
Use of notification algorithm and nurse follow-up
|
Once a week community nurses receive a list of community dwelling citizens deemed at risk of deterioration that can lead to hospital admission.
Nurses assess each citizens situation and initiate intervention if needed (not part of the intervention).
|
NO_INTERVENTION: Control
Standard regime (usual care)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospitalizations
Time Frame: 30 days from identification by the algorithm (6 months for intervention phase)
|
Calculated based on data from the Danish National Patient Registry
|
30 days from identification by the algorithm (6 months for intervention phase)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital readmissions
Time Frame: 30 days from identification by the algorithm (6 months for intervention phase)
|
Calculated based on data from the Danish National Patient Registry
|
30 days from identification by the algorithm (6 months for intervention phase)
|
Outpatient contacts
Time Frame: 30 days from identification by the algorithm (6 months for intervention phase)
|
Calculated based on data from the Danish National Patient Registry
|
30 days from identification by the algorithm (6 months for intervention phase)
|
Use of temporary care in a skilled nursing facility
Time Frame: 30 days from identification by the algorithm (6 months for intervention phase)
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Calculated based on data from the three participating municipalities electronic care records
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30 days from identification by the algorithm (6 months for intervention phase)
|
Use of community home and social care services
Time Frame: 30 days from identification by the algorithm (6 months for intervention phase)
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Calculated based on data from the three participating municipalities electronic care records
|
30 days from identification by the algorithm (6 months for intervention phase)
|
Contacts to primary care physicians
Time Frame: 30 days from identification by the algorithm (6 months for intervention phase)
|
Calculated based on data from the Danish National Health Insurance Service Register
|
30 days from identification by the algorithm (6 months for intervention phase)
|
Mortality
Time Frame: 30 days from identification by the algorithm (6 months for intervention phase)
|
Calculated based on data from the Danish Cause of death register.
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30 days from identification by the algorithm (6 months for intervention phase)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Barriers and facilitators for nurse's acceptance of using the algorithm
Time Frame: 30 days from identification by the algorithm (6 months for intervention phase)
|
Calculated based on a survey battery collected 1 month pre intervention start, 14-7 days pre intervention start, 1 month post intervention start
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30 days from identification by the algorithm (6 months for intervention phase)
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Health economic analysis
Time Frame: 1 year
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The analytic details will be based on the primary and secondary results of the trail
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1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Anders Fournaise, MSPH, Region of Southern Denmark
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 (ACTUAL)
June 1, 2020
Primary Completion (ACTUAL)
May 31, 2022
Study Completion (ACTUAL)
May 31, 2022
Study Registration Dates
First Submitted
May 13, 2020
First Submitted That Met QC Criteria
May 18, 2020
First Posted (ACTUAL)
May 21, 2020
Study Record Updates
Last Update Posted (ACTUAL)
November 3, 2022
Last Update Submitted That Met QC Criteria
October 25, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 19/29873
- 9163-00002B (OTHER_GRANT: Innovation Fund Denmark)
- 19/20991 (OTHER_GRANT: Region of Southern Denmark)
- OP_1033 (OTHER: Open Patient data Explorative Network (OPEN))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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