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.

NCT07597863 | Not Yet Recruiting

• 1 other identifier: 2026_3597_
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Mental Illness; Substance Use Disorder (SUD)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  The BMQ will be assesed at control conditions and after completion of the pharmacist intervention per patient, estimated median of 2 months.

Study Arms (2)

Control phase

NO INTERVENTION

Intervention

EXPERIMENTAL

Other: Clinical Pharmacist Intervention

Interventions

Clinical Pharmacist Intervention OTHER

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

Also known as: Medication optimization

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sykehuset Innlandet HF: lead
• Hospital Pharmacy Enterprise, South Eastern Norway: collaborator
• UiT The Arctic University of Norway: collaborator

Study Sites (1)

FACT

Innlandet, Norway

Location

MeSH Terms

Conditions

Mental Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Jørgen Bramness, Professor

  UiT The Arctic University of Norway

  STUDY DIRECTOR

• Anne Signe Landheim

  Innlandet Hospital Trust Norway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liv Marit Seljeflot

CONTACT

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

Anne Signe Landheim, Professor

CONTACT

anne.signe.landheim@sykehuset-innlandet.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Stepped wedge cluster randomized trial

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 19, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): February 1, 2031
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)