Implementation of Pharmacogenetic Testing in Hospital Wards

Admitted Multimorbid Patients Clinical Trial

— FAGLIS  

Official title:

Implementation of Pharmacogenetic Testing as Part of Medication Reviews in Hospital Wards

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04573491
• Other study ID #: IMP-CYP SA HF 2020-001
• Status: Completed
• Phase: N/A
• Start date: October 5, 2020
• Est. completion date: November 1, 2021

Study information

• Verified date: March 2023
• Source: Hospital Pharmacy Enterprise, South Eastern Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether it is feasible to implement pharmacogenetic testing as part of medication review while the patient is admitted to hospital.

Description:

Earlier studies have shown that pharmacogenetic testing may contribute to optimizing the efficacy of medication treatment and to reduce the risk of adverse effects. Inclusion of pharmacogenetic testing as part of medication reviews reveals more serious drug related problems and leads to more changes in medication treatment than medication review alone.

The use of pharmacogenetic testing as part of medication reviews has not earlier been systematically investigated in hospital patients in Norway. There is little documentation of what is needed to implement the use of pharmacogenetic testing in a hospital ward.

The investigators are conducting a descriptive study in two internal medicine wards at Akershus University Hospital. 50 patients using minimum 5 regular drugs including at least one relevant for pharmacogenetic testing will be enrolled in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• at least 2 long-term conditions

• at least 5 regular drugs of which at least one relevant for pharmacogenetic testing

• at least 2 years life expectancy

• able to communicate in Norwegian

• able to give informed consent

• summary care record

Exclusion Criteria:

• moderate to severe dementia

Related Conditions & MeSH terms

• Admitted Multimorbid Patients

Intervention

Genetic:
• Pharmacogenetic test
genotyping for genes that affect drug metabolism

Other:
• Medication review
systematic and interdisciplinary method aiming to increase quality of medication treatment

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lørenskog	Nordbyhagen

Sponsors (4)

Lead Sponsor	Collaborator
Hospital Pharmacy Enterprise, South Eastern Norway	Diakonhjemmet Hospital, University Hospital, Akershus, University of Oslo School of Pharmacy

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with results from pharmacogenetic testing included in medication review	Number of patients	from admission to discharge, an average of 1 week
Secondary	Acceptance of recommendations	Degree of acceptance of recommendations after pharmacogenetic testing, by prescribers	after medication review and before discharge, an average of 3 days
Secondary	Documentation of information from pharmacogenetic testing	Number of patients with information from pharmacogenetic testing documented in the patient journal	after medication review and before discharge, an average of 3 days