NCT04573491

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

October 5, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

March 9, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

September 25, 2020

Last Update Submit

March 8, 2023

Conditions

Keywords

pharmacogeneticsimplementationmedication review

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Acceptance of recommendations

    after medication review and before discharge, an average of 3 days

  • Documentation of information from pharmacogenetic testing

    after medication review and before discharge, an average of 3 days

Study Arms (1)

Pharmacogenetic test

EXPERIMENTAL

Medication review including results from pharmacogenetic testing

Genetic: Pharmacogenetic testOther: Medication review

Interventions

genotyping for genes that affect drug metabolism

Pharmacogenetic test

systematic and interdisciplinary method aiming to increase quality of medication treatment

Pharmacogenetic test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • moderate to severe dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akershus University Hospital

Lørenskog, Nordbyhagen, 1478, Norway

Location

Related Publications (1)

  • Hjemas BJ, Bovre K, Bjerknes K, Mathiesen L, Mellingsaeter MCR, Molden E. Implementation of pharmacogenetic testing in medication reviews in a hospital setting. Br J Clin Pharmacol. 2023 Oct;89(10):3116-3125. doi: 10.1111/bcp.15815. Epub 2023 Jun 22.

MeSH Terms

Interventions

Medication Review

Intervention Hierarchy (Ancestors)

Medication SystemsOrganization and AdministrationHealth Services AdministrationPatient Care Management

Study Officials

  • Kathrin Bjerknes, Ph.D

    Hospital Pharmacy Enterprise, South Eastern Norway

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2020

First Posted

October 5, 2020

Study Start

October 5, 2020

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

March 9, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations