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.

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Patient-reported health related quality of life [Срок оценки: 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).]

Вторичные конечные точки (2)

• Change in patient reported psychiatric burden [Срок оценки: 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 [Срок оценки: The BMQ will be assesed at control conditions and after completion of the pharmacist intervention per patient, estimated median of 2 months.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Норвегия · 1 центр

• FACT — Innlandet

Идентификаторы

NCT: NCT07597863 · 2026_3597_

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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