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.

Optimizing Pharmacotherapy in Severe Mental Illness and Substance Use Disorder; Integrating a Clinical Pharmacist Into FACT Teams

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07597863

Acronym

pharmaFACT

Enrollment

160

Registered

2026-05-19

Start date

2026-05-01

Completion date

2031-02-01

Last updated

2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Mental Illness, Substance Use Disorder (SUD)

Keywords

FACT, Flexible assertive community treatment, Clinical pharmacist, Medication review, Patient counselling, Medication reconciliation

Brief 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. 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.

Interventions

OTHERClinical Pharmacist Intervention

A clinical pharmacist will perform medication reconciliation, medication reviews and patient counselling.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Intervention model description

Stepped wedge cluster randomized trial

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Patient-reported health related quality of life	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.

Secondary

Measure	Time frame	Description
Change in patient reported psychiatric burden	The SCL-90-R will be assessed at control conditions and after completion of the pharmacist intervention per patient, estimated median of 2 months.	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.
Change in patient reported attitudes towards pharmacological treatment	The BMQ will be assesed at control conditions and after completion of the pharmacist intervention per patient, estimated median of 2 months.	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.

Countries

Norway

Contacts

CONTACTLiv Marit Seljeflot

liv.marit.seljeflot@sykehuset-innlandet.no+4799438311

CONTACTAnne Signe Landheim, Professor

anne.signe.landheim@sykehuset-innlandet.no

STUDY_DIRECTORJørgen Bramness, Professor

UiT The Arctic University of Norway

PRINCIPAL_INVESTIGATORAnne Signe Landheim

Innlandet Hospital Trust Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026