Implementation of Pharmacogenetic Testing in Hospital Wards (FAGLIS)

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

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.

Study Overview

• Status: Completed
• Conditions: Admitted Multimorbid Patients
• Intervention / Treatment: Genetic: Pharmacogenetic test; Other: Medication review

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathrin Bjerknes, Ph.D; Phone Number: +4767960304; Email: kathrin.bjerknes@sykehusapotekene.no
• Study Contact Backup: Name: Bodil J Hjemås, M.Sc.Pharm; Phone Number: +4767960302; Email: bodil.jahren.hjemas@sykehusapotekene.no

Study Locations

• Norway
  • Nordbyhagen
    • Lørenskog, Nordbyhagen, Norway, 1478
      • Akershus University Hospital
      • Contact: Kathrin Bjerknes, Ph.D; Phone Number: +4767960304; Email: kathrin.bjerknes@sykehusapotekene.no
      • Contact: Bodil J Hjemås, M.Sc.Pharm; Phone Number: +4767960302; Email: bodil.jahren.hjemas@sykehusapotekene.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmacogenetic test; Medication review including results from pharmacogenetic testing	Genetic: Pharmacogenetic test; genotyping for genes that affect drug metabolism; Other: Medication review; systematic and interdisciplinary method aiming to increase quality of medication treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance of recommendations	Degree of acceptance of recommendations after pharmacogenetic testing, by prescribers	after medication review and before discharge, an average of 3 days
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

Collaborators and Investigators

• Sponsor: Hospital Pharmacy Enterprise, South Eastern Norway
• Collaborators: Diakonhjemmet Hospital; University Hospital, Akershus; University of Oslo School of Pharmacy
• Investigators: Study Director: Kathrin Bjerknes, Ph.D, Hospital Pharmacy Enterprise, South Eastern Norway

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: September 25, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: pharmacogenetics; implementation; medication review
• Other Study ID Numbers: IMP-CYP SA HF 2020-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No