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. (pharmaFACT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Severe Mental Illness; Substance Use Disorder (SUD)
• Intervention / Treatment: Other: Clinical Pharmacist Intervention

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: LIv Marit Seljeflot; Phone Number: +4799438311; Email: liv.marit.seljeflot@sykehuset-innlandet.no
• Study Contact Backup: Name: Anne Signe Landheim, Professor; Email: anne.signe.landheim@sykehuset-innlandet.no

Study Locations

• Norway
  • Innlandet, Norway
    • FACT
    • Contact: LIv Marit Seljeflot; Phone Number: +4799438311; Email: liv.marit.seljeflot@sykehuset-innlandet.no
    • Principal Investigator: Anne Signe Landheim, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Other: Clinical Pharmacist Intervention; A clinical pharmacist will perform medication reconciliation, medication reviews and patient counselling.; Other Names: Medication optimization
No Intervention: Control phase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sykehuset Innlandet HF
• Collaborators: Hospital Pharmacy Enterprise, South Eastern Norway; UiT The Arctic University of Norway
• Investigators: Study Director: Jørgen Bramness, Professor, UiT The Arctic University of Norway; Principal Investigator: Anne Signe Landheim, Innlandet Hospital Trust Norway

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): February 1, 2031

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Clinical pharmacist; Medication review; Medication reconciliation; FACT; Flexible assertive community treatment; Patient counselling
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Substance-Related Disorders; Mental Disorders
• Other Study ID Numbers: 2026_3597_

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No