Severe Mental IllnesspharmaFACTNCT07597863
A Study to Investigate Health Related Quality of Life With a Pharmacist Intervention Compared to Treatment as Usual in Participants With Severe Mental Illness and Substance Use Disorder Receiving Treatment From FACT Teams.
A study testing Clinical Pharmacist Intervention in people with Severe Mental Illness and Substance Use Disorder (SUD), run by Sykehuset Innlandet HF at 1 site in Norway.
Trial summary
The study aims to evaluate the impact of integrating a clinical pharmacist into Flexible Assertive Community (FACT) teams on health-related quality of life and pharmacotherapy for individuals with severe mental illness and substance use disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Mental Illness, Substance Use Disorder (SUD)
- What is being tested?
- Clinical Pharmacist Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteNorway
- Study dates
- 1 May 2026to Feb 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age over 18 years old
- Included in and receiving treatment from a participating FACT team
- Diagnosed with severe mental illness and/or substance use disorder
- Prescribed one or more psychotropic medication
- Signed informed consent
Who cannot join
- Patients not being competent or have the decision-making capacity to consent
- Planned discharge from the team within the first three months of period 1
- Patients not able to communicate in Norwegian or English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anne Signe Landheim, Professor contact
Norway1 site
FACT
Innlandet
LIv Marit Seljeflot, +4799438311, liv.marit.seljeflot@sykehuset-innlandet.no
Anne Signe Landheim, Professor
About this study
Official title: Optimizing Pharmacotherapy in Severe Mental Illness and Substance Use Disorder; Integrating a Clinical Pharmacist Into FACT Teams
The study aims to evaluate the impact of integrating a clinical pharmacist into Flexible Assertive Community (FACT) teams on health-related quality of life and pharmacotherapy for individuals with severe mental illness and substance use disorders. This is a pragmatic effectiveness study using a stepped wedge cluster randomized trial design. Four FACT teams from FACT Innlandet will serve as clusters, transitioning from standard care (control) to intervention in a randomized sequence. The intervention involves integrating a clinical pharmacist into the interdisciplinary FACT teams. Participants will be adults (over 18 years old), receiving treatment from participating FACT teams, diagnosed with severe mental illness or substance use disorder and prescribed at least one psychotropic medication. Exclusion criteria include inability to provide informed consent, planned discharge within the first three months of period 1, or inability to communicate in Norwegian or English. The control group receives standard care provided by FACT teams. The intervention group will have a clinical pharmacist integrated into the FACT team performing medication reconciliation, comprehensive medication reviews, patient counselling, and interdisciplinary discussions to resolve medication-related problems. A sample size of 160 patients is estimated based on an effect size of 0.25, 80% power and alpha=0.05. The primary endpoint is change in patient-reported health related quality of life, measured using the EuroQoL-5 dimensions-5 levels (EQ-5D-5L) and Visual Analog Scale, EQ-VAS scores from baseline to the end of the intervention.
- Being tested
- Clinical Pharmacist Intervention
- Keywords
- FACT, Flexible assertive community treatment, Clinical pharmacist, Medication review, Patient counselling, Medication reconciliation
- Medical subject headings
- Mental Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Pharmacist InterventionOther
Also called Medication optimization
A clinical pharmacist will perform medication reconciliation, medication reviews and patient counselling.
| Study group | Role | What they receive |
|---|---|---|
| Control phase | No intervention | Not described |
| Intervention | Experimental | Not described Receives: Other: Clinical Pharmacist Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported health related quality of life
Questionnaire EuroQoL EQ-5D-5L and EQ-VAS. The results from the questionnaire EQ-5D-5L will be reported as a five digit health profile, an index value calculated using the Norwegian value set with a score between 0 and 1, where 0 is death and 1 is full health. The EQ-VAS (visual analogue scale) is reported on a scale between 0-100 where 0 is worst imaginable health and 100 is best imaginable health.
Measured: EQ-5D-5L and EQ VAS will be assessed in period 1 (baseline (time 0-4 months), period 2 (4-8 months), period 3 (8-12 months), period 4 (12-16 months, period 5 (16-20 months) and period 6 (20-24 months).
Secondary outcomes (2)
Change in patient reported psychiatric burden
Questionnaire SCL-90-R. The results from the questionnaire will be reported as a mean Global Severity Index between 0-4, where 0 is no reported symptoms and above 2 is severe distress.
Measured: The SCL-90-R will be assessed at control conditions and after completion of the pharmacist intervention per patient, estimated median of 2 months.
Change in patient reported attitudes towards pharmacological treatment
Questionnaire Beliefs about medicines - BMQ. Results from the questionnaire will be reported as mean +/- standard deviation for each subscale. Necessity-Concerns differential will be calculated, where a positive score indicates that perceived benefits outweigh conserns, a negative score indicates that concerns outweigh perceived benefits, and a score around zero indicates ambivalent beliefs.
Measured: The BMQ will be assesed at control conditions and after completion of the pharmacist intervention per patient, estimated median of 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 May 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Mental IllnessStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Stepped wedge cluster randomized trial
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Pharmacy Enterprise, South Eastern Norway, UiT The Arctic University of Norway
- Responsible party
- Principal investigator, Anne Landheim, Sykehuset Innlandet HF
- Investigators
- Jørgen Bramness, Professor, Study director, UiT The Arctic University of NorwayAnne Signe Landheim, Principal investigator, Innlandet Hospital Trust Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597863
- Sponsor's protocol ID
- 2026_3597_
- Acronym
- pharmaFACT
- Status last verified
- May 2026
- First submitted
- 30 Apr 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Pharmacotherapy in Severe Mental Illness and Substance Use Disorder; Integrating a Clinical Pharmacist Into FACT Teams
- ClinicalTrials.gov ID
- NCT07597863
- Acronym / sponsor ID
- pharmaFACT / 2026_3597_
- Keywords
- FACT, Flexible assertive community treatment, Clinical pharmacist, Medication review, Patient counselling, Medication reconciliation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Collaborators
- Hospital Pharmacy Enterprise, South Eastern Norway, UiT The Arctic University of Norway
- Study start
- 1 May 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 19 May 2026 (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 study aims to evaluate the impact of integrating a clinical pharmacist into Flexible Assertive Community (FACT) teams on health-related quality of life and pharmacotherapy for individuals with severe mental illness and substance use disorders. This is a pragmatic effectiveness study using a stepped wedge cluster randomized trial design. Four FACT teams from FACT Innlandet will serve as clusters, transitioning from standard care (control) to intervention in a randomized sequence. The intervention involves integrating a clinical pharmacist into the interdisciplinary FACT teams. Participants will be adults (over 18 years old), receiving treatment from participating FACT teams, diagnosed with severe mental illness or substance use disorder and prescribed at least one psychotropic medication. Exclusion criteria include inability to provide informed consent, planned discharge within the first three months of period 1, or inability to communicate in Norwegian or English. The control group receives standard care provided by FACT teams. The intervention group will have a clinical pharmacist integrated into the FACT team performing medication reconciliation, comprehensive medication reviews, patient counselling, and interdisciplinary discussions to resolve medication-related problems. A sample size of 160 patients is estimated based on an effect size of 0.25, 80% power and alpha=0.05. The primary endpoint is change in patient-reported health related quality of life, measured using the EuroQoL-5 dimensions-5 levels (EQ-5D-5L) and Visual Analog Scale, EQ-VAS scores from baseline to the end of the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped wedge cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Control phase | No intervention | – |
| Intervention | Experimental | Other: Clinical Pharmacist Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age over 18 years old
- Included in and receiving treatment from a participating FACT team
- Diagnosed with severe mental illness and/or substance use disorder
- Prescribed one or more psychotropic medication
- Signed informed consent
Key exclusion criteria (3 listed)
- Patients not being competent or have the decision-making capacity to consent
- Planned discharge from the team within the first three months of period 1
- Patients not able to communicate in Norwegian or English
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 |
|---|---|---|
| Clinical Pharmacist InterventionAlso: Medication optimizationA clinical pharmacist will perform medication reconciliation, medication reviews and patient counselling. | Other | Intervention |
Primary outcome
Patient-reported health related quality of life
Time frame: EQ-5D-5L and EQ VAS will be assessed in period 1 (baseline (time 0-4 months), period 2 (4-8 months), period 3 (8-12 months), period 4 (12-16 months, period 5 (16-20 months) and period 6 (20-24 months).
Questionnaire EuroQoL EQ-5D-5L and EQ-VAS. The results from the questionnaire EQ-5D-5L will be reported as a five digit health profile, an index value calculated using the Norwegian value set with a score between 0 and 1, where 0 is death and 1 is full health. The EQ-VAS (visual analogue scale) is reported on a scale between 0-100 where 0 is worst imaginable health and 100 is best imaginable health.
2 secondary outcomes
Change in patient reported psychiatric burden
Time frame: The SCL-90-R will be assessed at control conditions and after completion of the pharmacist intervention per patient, estimated median of 2 months.
Change in patient reported attitudes towards pharmacological treatment
Time frame: The BMQ will be assesed at control conditions and after completion of the pharmacist intervention per patient, estimated median of 2 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
Related trials for Severe Mental Illness
Not yet recruiting
Virtual Reality to Advance Dementia Care and Quality of Life
Dementia, Agitation
RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
RecruitingPhase 2
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD)
Recruiting
Defining Neurobiological Links Between Substance Use and Mental Illness
Major Depressive Disorder, Substance Use Disorder
RecruitingPhase 1
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
Healthy Volunteer, Major Depressive Disorder
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.
Anne Signe Landheim, Professor contact
Jørgen Bramness, Professor study director
UiT The Arctic University of Norway
Anne Signe Landheim principal investigator
Innlandet Hospital Trust 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 Clinical Pharmacist Intervention in people with Severe Mental Illness and Substance Use Disorder (SUD), run by Sykehuset Innlandet HF 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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 19 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liv Marit Seljeflot (+4799438311, liv.marit.seljeflot@sykehuset-innlandet.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported health related quality of life (time frame: EQ-5D-5L and EQ VAS will be assessed in period 1 (baseline (time 0-4 months), period 2 (4-8 months), period 3 (8-12 months), period 4 (12-16 months, period 5 (16-20 months) and period 6 (20-24 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2026.