Admitted Multimorbid PatientsFAGLISNCT04573491
Implementation of Pharmacogenetic Testing in Hospital Wards
A study testing Pharmacogenetic test and Medication review in people with Admitted Multimorbid Patients, run by Hospital Pharmacy Enterprise, South Eastern Norway at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Admitted Multimorbid Patients
- What is being tested?
- Pharmacogenetic test and Medication review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteNorway
- Study dates
- 5 Oct 2020to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- moderate to severe dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Admitted Multimorbid Patients
- Being tested
- Pharmacogenetic test, Medication review
- Keywords
- pharmacogenetics, implementation, medication review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenetic testGenetic
genotyping for genes that affect drug metabolism
Medication reviewOther
systematic and interdisciplinary method aiming to increase quality of medication treatment
| Study group | Role | What they receive |
|---|---|---|
| Pharmacogenetic test | Experimental | Medication review including results from pharmacogenetic testing Receives: Genetic: Pharmacogenetic test; Other: Medication review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with results from pharmacogenetic testing included in medication review
Number of patients
Measured: from admission to discharge, an average of 1 week
Secondary outcomes (2)
Acceptance of recommendations
Degree of acceptance of recommendations after pharmacogenetic testing, by prescribers
Measured: 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
Measured: after medication review and before discharge, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start5 Oct 2020
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Admitted Multimorbid PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Pharmacy Enterprise, South Eastern Norway
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Akershus, Diakonhjemmet Hospital, University of Oslo School of Pharmacy
- Responsible party
- Sponsor
- Investigators
- Kathrin Bjerknes, Ph.D, Study director, Hospital Pharmacy Enterprise, South Eastern Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573491
- Sponsor's protocol ID
- IMP-CYP SA HF 2020-001
- Acronym
- FAGLIS
- Status last verified
- Mar 2023
- First submitted
- 25 Sep 2020
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37277227
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Pharmacogenetic Testing as Part of Medication Reviews in Hospital Wards
- ClinicalTrials.gov ID
- NCT04573491
- Acronym / sponsor ID
- FAGLIS / IMP-CYP SA HF 2020-001
- Conditions
- Admitted Multimorbid Patients
- Keywords
- pharmacogenetics, implementation, medication review
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hospital Pharmacy Enterprise, South Eastern NorwayUniversity, hospital or other
- Collaborators
- University Hospital, Akershus, Diakonhjemmet Hospital, University of Oslo School of Pharmacy
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacogenetic test | Experimental | Genetic: Pharmacogenetic test, Other: Medication reviewMedication review including results from pharmacogenetic testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- moderate to severe dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacogenetic testgenotyping for genes that affect drug metabolism | Genetic | Pharmacogenetic test |
| Medication reviewsystematic and interdisciplinary method aiming to increase quality of medication treatment | Other | Pharmacogenetic test |
Primary outcome
Number of patients with results from pharmacogenetic testing included in medication review
Time frame: from admission to discharge, an average of 1 week
Number of patients
2 secondary outcomes
Acceptance of recommendations
Time frame: after medication review and before discharge, an average of 3 days
Documentation of information from pharmacogenetic testing
Time frame: after medication review and before discharge, an average of 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Derived from this study: PubMed 37277227Hjemas 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.
- Individual participant dataSharing planned: No
Related trials for Admitted Multimorbid Patients
Not yet recruiting
Poland Integrated Medicines Management (PL-IMM) - Study Assessing the Provision of Complex Clinical Pharmacy Services to Hospitalized Patients
Acute Admitted Multimorbid Patients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathrin Bjerknes, Ph.D study director
Hospital Pharmacy Enterprise, South Eastern Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacogenetic test and Medication review in people with Admitted Multimorbid Patients, run by Hospital Pharmacy Enterprise, South Eastern Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with results from pharmacogenetic testing included in medication review (time frame: from admission to discharge, an average of 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04573491, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.