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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clinical Pharmacist Intervention.
- Who it may be relevant to
- Registry conditions: Severe Mental Illness, Substance Use Disorder (SUD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Optimizing Pharmacotherapy in Severe Mental Illness and Substance Use Disorder; Integrating a Clinical Pharmacist Into FACT Teams
Overview
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
- Other Clinical Pharmacist Intervention
A clinical pharmacist will perform medication reconciliation, medication reviews and patient counselling.
Primary outcome measures
- 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).]
Secondary outcome measures (2)
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Norway · 1 center
- FACT — Innlandet
Identifiers
NCT: NCT07597863 · 2026_3597_