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)
13. mai 2026 oppdatert av: Anne Landheim, Sykehuset Innlandet HF
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
160
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: LIv Marit Seljeflot
- Telefonnummer: +4799438311
- E-post: liv.marit.seljeflot@sykehuset-innlandet.no
Studer Kontakt Backup
- Navn: Anne Signe Landheim, Professor
- E-post: anne.signe.landheim@sykehuset-innlandet.no
Studiesteder
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Innlandet, Norge
- FACT
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Ta kontakt med:
- LIv Marit Seljeflot
- Telefonnummer: +4799438311
- E-post: liv.marit.seljeflot@sykehuset-innlandet.no
-
Hovedetterforsker:
- Anne Signe Landheim, Professor
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Innblanding
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A clinical pharmacist will perform medication reconciliation, medication reviews and patient counselling.
Andre navn:
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Ingen inngripen: Control phase
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Patient-reported health related quality of life
Tidsramme: 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).
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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.
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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).
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in patient reported psychiatric burden
Tidsramme: The SCL-90-R will be assessed at control conditions and after completion of the pharmacist intervention per patient, estimated median of 2 months.
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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.
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The SCL-90-R will be assessed at control conditions and after completion of the pharmacist intervention per patient, estimated median of 2 months.
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Change in patient reported attitudes towards pharmacological treatment
Tidsramme: The BMQ will be assesed at control conditions and after completion of the pharmacist intervention per patient, estimated median of 2 months.
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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.
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The BMQ will be assesed at control conditions and after completion of the pharmacist intervention per patient, estimated median of 2 months.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Jørgen Bramness, Professor, UiT The Arctic University of Norway
- Hovedetterforsker: Anne Signe Landheim, Innlandet Hospital Trust Norway
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. mai 2026
Primær fullføring (Antatt)
1. april 2028
Studiet fullført (Antatt)
1. februar 2031
Datoer for studieregistrering
Først innsendt
30. april 2026
Først innsendt som oppfylte QC-kriteriene
13. mai 2026
Først lagt ut (Faktiske)
19. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026_3597_
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