Fall InjuryNCT07181993
The Impact of PRISCUS Medication on Fall Risks
An observational study of Fall Injury, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Purpose: This study aims to validate the medication entries in the PRISCUS list-a German expert-based compilation of potentially inappropriate medications for older adults-and to identify additional medications that may pose a fall risk but are not yet included. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall Injury
- How many people
- 932,912 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with patient records between 2016-2022 across 20 clinical departments with highest fall incidence
Who may be able to join
- All patients across 20 clinical departments with highest fall incidence
Who cannot join
- Age < 18yrs
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute for Medical Informatics | Charité Universitätsmedizin Berlin
Berlin, State of Berlin, 10115
About this study
Official title: The Impact of PRISCUS Medication on Fall Risks: A Retrospective Observational Study Based on Medication Data From a Tertiary Hospital
Purpose:
This study aims to validate the medication entries in the PRISCUS list-a German expert-based compilation of potentially inappropriate medications for older adults-and to identify additional medications that may pose a fall risk but are not yet included.
Study Design:
This is a retrospective observational study uses electronic health record data from a German research hospital. It includes over 900,000 patient records from multiple departments with a high incidence of falls, covering the period from 2016 to 2022. Statistical analyses, including chi-square tests and propensity score matching, will be employed to evaluate the relationship between medications and fall events.
Read the detailed description
The PRISCUS list is a catalogue of potentially inappropriate medications for older adults in Germany, derived by experts. However, the validity of its entries has not yet been systematically verified using large-scale patient data. This study aims to validate the current PRISCUS entries and determine whether additional medications should be considered for inclusion based on empirical evidence of an increased risk of falls.
This retrospective study uses data from a German research hospital comprising over 900,000 patient records collected between 2016 and 2022 across 20 clinical departments where falls are common, including oncology, haematology, geriatrics and psychiatry. A total of over 11,000 patients were recorded as having experienced at least one fall event during this period.
Medication data were mapped to German Anatomical Therapeutic Chemical (ATC) codes and linked to clinical records using data from the hospital's pharmaceutical database. Episodes were defined using clinical intervals and various covariates, including age, sex, number of diagnoses and number of procedures, were extracted. Chi-square tests and propensity score matching will be used to compare patients exposed to and unexposed to listed medications, adjusting for key covariates to minimise confounding factors. Candidate medications identified as high risk will undergo further review through clinical evaluation, with additional information sourced from drug package inserts to support risk assessment.
- Conditions
- Fall Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Fall Incidents
In-patients that have experienced a fall within the hospital premises
Measured: From January 2016 to October 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Sep 2024
- Primary completion1 Sep 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall InjuryStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 932,912 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Fürstenau, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181993
- Sponsor's protocol ID
- EA2/184/21
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of PRISCUS Medication on Fall Risks: A Retrospective Observational Study Based on Medication Data From a Tertiary Hospital
- ClinicalTrials.gov ID
- NCT07181993
- Acronym / sponsor ID
- EA2/184/21
- Conditions
- Fall Injury
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 932,912 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Sep 2025 (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.
Purpose:
This study aims to validate the medication entries in the PRISCUS list-a German expert-based compilation of potentially inappropriate medications for older adults-and to identify additional medications that may pose a fall risk but are not yet included.
Study Design:
This is a retrospective observational study uses electronic health record data from a German research hospital. It includes over 900,000 patient records from multiple departments with a high incidence of falls, covering the period from 2016 to 2022. Statistical analyses, including chi-square tests and propensity score matching, will be employed to evaluate the relationship between medications and fall events.
Detailed description
The PRISCUS list is a catalogue of potentially inappropriate medications for older adults in Germany, derived by experts. However, the validity of its entries has not yet been systematically verified using large-scale patient data. This study aims to validate the current PRISCUS entries and determine whether additional medications should be considered for inclusion based on empirical evidence of an increased risk of falls.
This retrospective study uses data from a German research hospital comprising over 900,000 patient records collected between 2016 and 2022 across 20 clinical departments where falls are common, including oncology, haematology, geriatrics and psychiatry. A total of over 11,000 patients were recorded as having experienced at least one fall event during this period.
Medication data were mapped to German Anatomical Therapeutic Chemical (ATC) codes and linked to clinical records using data from the hospital's pharmaceutical database. Episodes were defined using clinical intervals and various covariates, including age, sex, number of diagnoses and number of procedures, were extracted. Chi-square tests and propensity score matching will be used to compare patients exposed to and unexposed to listed medications, adjusting for key covariates to minimise confounding factors. Candidate medications identified as high risk will undergo further review through clinical evaluation, with additional information sourced from drug package inserts to support risk assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with patient records between 2016-2022 across 20 clinical departments with highest fall incidence
Key inclusion criteria (1 listed)
- All patients across 20 clinical departments with highest fall incidence
Key exclusion criteria (1 listed)
- Age < 18yrs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with Fall Incidents
Time frame: From January 2016 to October 2022
In-patients that have experienced a fall within the hospital premises
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fall Injury, run by Charite University, Berlin, Germany at 1 site in Germany.
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: under way, not looking for participants, as of the sponsor's last update on 19 Sep 2025. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
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 Participants with Fall Incidents (time frame: From January 2016 to October 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2025.