Individual Risk Profiles for Adverse Drug Reactions in Geriatric Patients

Individual Patient Risk Profiles for Adverse Drug Reactions: Establishing a Consecutive Research Cohort in an Interdisciplinary Polypharmacy Consultation Service of a Geriatric University Outpatient Department

This project will generate a prospective cohort of geriatric patients with polypharmacy which will be characterized for vulnerability profiles of adverse drug reactions.

Study Overview

• Status: Not yet recruiting
• Conditions: Drug-Related Side Effects and Adverse Reactions; Pharmacogenetics; Polypharmacy; Pharmacogenomic Testing
• Intervention / Treatment: Genetic: Pharmacogenomic testing of a panel of important pharmacogenes to detect genetic variants and evaluate the association between genetically predicted and measured drug metabolism; Other: Adverse Drug Reaction detection; Other: Falls Efficacy Scale International (FES-I)

Detailed Description

Adverse drug reactions are common in older patients and can lead to severe outcomes such as falls, hospitalizations and death. They are dose-dependent and may for example be caused by inappropriate dosing due to a reduced kidney function. Also, the use of potentially inappropriate medications in older patients can result in a negative benefit-/ risk-ratio. Additionally, drug metabolism in older patients is altered due to a variety of reasons and pharmacogenetic variants of drug metabolizing enzymes can lead to a more than 10-fold interinidividual variation of drug clearance. The risk of the individual patient to experience an adverse drug reactions is determined by many reasons. Therefore, this study aims to identify patient risk profiles with regard to pharmacogenetics, drug interactions, impaired functional and cognitive status and individual drug metabolism.

Participants for this study will be consecutively recruited from patients admitted to the Interdisciplinary Polypharmacy Consultation Service of the Department of Geriatric's University Outpatient Clinic in cooperation with the Institute of Clinical Pharmacology. Regardless of their participation in this study, patients in the outpatient clinic will perform several tests and questionnaires following the comprehensive geriatric assessment. The purpose of the cohort study is to document and evaluate routine health data collected in the outpatient clinic for polypharmacy in geriatric patients (laboratory tests as well as a comprehensive medication history with therapy recommendations issued by a subsequent pharmaceutical council for both the patients and the primary care physicians).

Procedures conducted specifically for this study are a long-term capture and detailed history of all suspected adverse drug reactions, examining the fear of falling (FES-I questionnaire) and blood sampling for exploratory pharmacogenomic analyses (on cohort level, not patient diagnostics).

Aim of the long-term cohort of geriatric patients with polypharmacy is to identify risk profiles for adverse drug reactions that are specific for the population of older individuals.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Mathias Freitag; Phone Number: +492418089134 +492417501116; Email: mfreitag@ukaachen.de
• Study Contact Backup: Name: Julia C. Stingl, MD, ScD; Phone Number: +492418089130; Email: jstingl@ukaachen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients admitted to the Interdisciplinary Polypharmacy Consultation Service of the Department of Geriatric's University Outpatient Clinic in cooperation with the Institute of Clinical Pharmacology

Description

Inclusion Criteria:

• 70 years or older
• Current drug therapy with three or more drugs
• Being a patient in the interdisciplinary polypharmacy consultation service of the geriatric university outpatient clinic
• Sufficient mobility (minimum: Wheelchair mobility)
• Written informed consent of the patient or the legal representative

Exclusion Criteria:

• No sufficient communication possible
• Patients classified as terminally ill by the medical staff
• Patients, that are incapable to give their informed consent and who do not have a legal representative

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients admitted to interdisciplinary polypharmacy consultation service; Patients admitted to the Interdisciplinary Polypharmacy Consultation Service of the Department of Geriatric's University Outpatient Clinic in cooperation with the Institute of Clinical Pharmacology

Genetic: Pharmacogenomic testing of a panel of important pharmacogenes to detect genetic variants and evaluate the association between genetically predicted and measured drug metabolism; All planned interventions are explorative analyses of biological and genetic risk profiles that can contribute to patients' individual risk for adverse drug reactions, i.e. due to variability in drug metabolism; Other: Adverse Drug Reaction detection; During appointments in the university outpatient clinic, patients will undergo a comprehensive adverse drug reaction (ADR) assessment based on an ADR diary they were handed at enrolment; Other: Falls Efficacy Scale International (FES-I); The FES-I wil be obtained to estimate fear of falling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of vulnerability profiles of adverse drug reactions	To investigate patient-specific risk profiles for adverse drug reactions, the focus of this study is on analizing patients' functional and cognitive status, pharmacogenetics, and individual metabolic capacity (phenotype/genotype relationship).	February 2022 - February 2032

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Collaborators: B. Braun-Stiftung
• Investigators: Principal Investigator: Julia C. Stingl, MD, ScD, Institute of Clinical Pharmacology, University Hospital RWTH Aachen

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): February 1, 2032
• Study Completion (Anticipated): February 1, 2032

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 17, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Aged; Medication Adherence; Geriatric Assessment; Aged, 80 and over; Medication therapy management; Clinical Pharmacology; Pharmacists; Medication reconciliation; Geriatricians; Hospital pharmacy services; Hospital outpatient clinics; nterdisciplinary Health Team
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: 21-216

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