Avoid Acute HospitalizationsNCT04398797
Prevention of AcuTe admIssioN Algorithm (PATINA)
A study testing PATINA algorithm in people with Avoid Acute Hospitalizations, run by Region of Southern Denmark at 1 site in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Avoid Acute Hospitalizations
- What is being tested?
- PATINA algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,464 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2020to 31 May 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Community dwelling citizens (+ 65) receiving home and social care in Odense, Kerteminde and Svendborg Municipalities.
Who cannot join
- Non
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Avoid Acute Hospitalizations
- Being tested
- PATINA algorithm
- Keywords
- Algorithm, Community dwelling, Health care utilization, Acute hospitalization
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PATINA algorithmOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Use of notification algorithm and nurse follow-up Receives: Other: PATINA algorithm |
| Control | No intervention | Standard regime (usual care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalizations
Calculated based on data from the Danish National Patient Registry
Measured: 30 days from identification by the algorithm (6 months for intervention phase)
Secondary outcomes (6)
Hospital readmissions
Calculated based on data from the Danish National Patient Registry
Measured: 30 days from identification by the algorithm (6 months for intervention phase)
Outpatient contacts
Calculated based on data from the Danish National Patient Registry
Measured: 30 days from identification by the algorithm (6 months for intervention phase)
Use of temporary care in a skilled nursing facility
Calculated based on data from the three participating municipalities electronic care records
Measured: 30 days from identification by the algorithm (6 months for intervention phase)
Use of community home and social care services
Calculated based on data from the three participating municipalities electronic care records
Measured: 30 days from identification by the algorithm (6 months for intervention phase)
Contacts to primary care physicians
Calculated based on data from the Danish National Health Insurance Service Register
Measured: 30 days from identification by the algorithm (6 months for intervention phase)
Mortality
Calculated based on data from the Danish Cause of death register.
Measured: 30 days from identification by the algorithm (6 months for intervention phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start1 Jun 2020
- Primary completion31 May 2022
- Study completion31 May 2022
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 Avoid Acute HospitalizationsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Step-wedge, open label, cluster randomized controlled trial with 1 year follow up. Area home care teams from three Danish municipalities are randomized to cross-over from the control phase to the intervention phase. Participants automatically follow their area home care team into the allocated group.
- Masking
- None (open label)
- Enrolment
- 2,464 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense Municipality, Denmark, Kerteminde Municipality, Denmark, Svendborg Municipality, Denmark
- Responsible party
- Principal investigator, Anders Fournaise, Region of Southern Denmark
- Investigators
- Anders Fournaise, MSPH, Principal investigator, Region of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398797
- Sponsor's protocol ID
- 19/29873
- Other IDs
- 9163-00002B, 19/20991, OP_1033
- Status last verified
- Oct 2022
- First submitted
- 13 May 2020
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fournaise A, Lauridsen JT, Bech M, Wiil UK, Rasmussen JB, Kidholm K, Espersen K, Andersen-Ranberg K. Prevention of AcuTe admIssioN algorithm (PATINA): study protocol of a stepped wedge randomized controlled trial. BMC Geriatr. 2021 Feb 27;21(1):146. doi: 10.1186/s12877-021-02092-2.
PubMed 33639833
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of AcuTe admIssioN Algorithm (PATINA) - The Effect of a Notification Algorithm and a Digital Decision Support Tool
- ClinicalTrials.gov ID
- NCT04398797
- Acronym / sponsor ID
- 19/29873
- Conditions
- Avoid Acute Hospitalizations
- Keywords
- Algorithm, Community dwelling, Health care utilization, Acute hospitalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,464 participants (actual)
- Lead sponsor
- Region of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense Municipality, Denmark, Kerteminde Municipality, Denmark, Svendborg Municipality, Denmark
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 21 May 2020 (actual)
- 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Step-wedge, open label, cluster randomized controlled trial with 1 year follow up. Area home care teams from three Danish municipalities are randomized to cross-over from the control phase to the intervention phase. Participants automatically follow their area home care team into the allocated group.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: PATINA algorithmUse of notification algorithm and nurse follow-up |
| Control | No intervention | –Standard regime (usual care) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Community dwelling citizens (+ 65) receiving home and social care in Odense, Kerteminde and Svendborg Municipalities.
Key exclusion criteria (1 listed)
- Non
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 |
|---|---|---|
| PATINA algorithmOnce 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). | Other | Intervention |
Primary outcome
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
6 secondary outcomes
Hospital readmissions
Time frame: 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)
Use of temporary care in a skilled nursing facility
Time frame: 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)
Contacts to primary care physicians
Time frame: 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)
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 3 Nov 2022.
- Background: PubMed 33639833Fournaise A, Lauridsen JT, Bech M, Wiil UK, Rasmussen JB, Kidholm K, Espersen K, Andersen-Ranberg K. Prevention of AcuTe admIssioN algorithm (PATINA): study protocol of a stepped wedge randomized controlled trial. BMC Geriatr. 2021 Feb 27;21(1):146. doi: 10.1186/s12877-021-02092-2.
- Individual participant dataSharing planned: Undecided
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.
Anders Fournaise, MSPH principal investigator
Region of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PATINA algorithm in people with Avoid Acute Hospitalizations, run by Region of Southern Denmark at 1 site in Denmark.
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 1 inclusion and 1 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 3 Nov 2022. 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 Denmark. 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?
Hospitalizations (time frame: 30 days from identification by the algorithm (6 months for intervention phase)). 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 NCT04398797, 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 3 Nov 2022.