Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT07181993
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-19
First Post:
2025-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of PRISCUS Medication on Fall Risks
Sponsor:
Charite University, Berlin, Germany
Organization:
Study Overview
Official Title:
The Impact of PRISCUS Medication on Fall Risks: A Retrospective Observational Study Based on Medication Data From a Tertiary Hospital
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: