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.

Sponsor
Sykehuset Innlandet HF
Study ID
NCT07597863
Status
Not Yet Recruiting

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Conditions

  • Severe Mental Illness
  • Substance Use Disorder (SUD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Clinical Pharmacist Intervention — OTHER
    A clinical pharmacist will perform medication reconciliation, medication reviews and patient counselling.

Study Details

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.

Key Dates

First listed
May 19, 2026
Start date
May 1, 2026
Status verified
May 2026
Primary completion
Apr 30, 2028
Completion
Feb 28, 2031

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: Control phase
  • Experimental: Intervention

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). ]

Central Contacts

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