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Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorder With Chronic Direct Acting Antiviral Treatment

5. mai 2016 oppdatert av: VA Office of Research and Development

Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorders With Chronic Hepatitis C Receiving Direct Acting Antiviral Treatment

To determine the effect of an integrated care protocol on antiviral treatment and sustained virologic response (SVR) rates following initiation of direct acting antiviral therapies (DAA) treatments in 2011.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Background and aims: Approval of direct acting antiviral (DAA) therapies in 2011 initiated a new era of more effective treatments for hepatitis C (HCV). The impact of more effective therapies on patient access to treatment is unknown. Integrated Care (IC) involving patient case management may overcome barriers to treatment access imposed by psychiatric and substance use disorders (SUD).

Methods: Prospective, randomized trial at a single medical center. Patients with HCV at risk for active psychiatric and SUD between Jan 2012 and Jan 2013 were recruited and randomized to IC or Usual Care (UC). A mid-level mental health practitioner was placed in the IC clinic and provided brief mental health care and case management.

Studietype

Intervensjonell

Registrering (Faktiske)

83

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • San Diego, California, Forente stater, 92161
        • VA San Diego Healthcare System, San Diego, CA

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

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patients with HCV infection who were referred to the VA HCV clinic and who received the usual initial evaluation in the clinic
  • All patients 18 and 75 years old with confirmed HCV infection
  • Patients were required to be classified as "high risk candidates for antiviral treatment" on any one of a set of screening measure in order to participate

  • Screening measures and cutoffs for inclusion were depression:

    • Beck Depression Inventory: (BDI) > 10
    • Alcohol use: Alcohol Use Disorders Identification Test (AUDIT-C) > 4
    • PTSD: VA Primary Care PTSD Screen = endorsement of three or more items or any single endorsement of item #3
    • Drug use: Drug Use Questionnaire = self-reported drug/alcohol use within 6 months prior to screen

Exclusion Criteria:

  • Lacked a confirmed test of HCV RNA
  • Had HIV/HCV co-infection and received care at San Diego or Palo Alto sites (these patients were treated in a separate clinic)
  • Had Hepatitis B (HBV) co-infection
  • Had decompensated liver disease with active or recent encephalopathy, variceal bleeding, or ascites or Child-Pugh class B or C
  • Had other significant near term life-threatening diseases
  • Were treatment non-responders with pegylated Interferon plus ribavirin

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: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Integrated Care
Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.
Atferdsmessig: Brief mental health interventions and case management
The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians.
Ingen inngripen: Usual Care
The usual care group received "standard of care" required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Sustained Viral Response (SVR)
Tidsramme: up to 24 weeks
The primary outcome for the study was the proportion of patients that achieve an SVR. Patient adherence to completing the prescribed therapy and SVR were both tracked with medical records. Viral load at 4, 12-and 24-weeks during treatment initiation have been shown to predict final SVR. Final SVR data consists of viral tests conducted at 6 months after the termination of therapy.
up to 24 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With Treatment Initiation and Completion
Tidsramme: up to 24 weeks
The main secondary outcomes for the study include rates of Interferon-based treatment initiation and completion. Treatment data from the HCV clinics were reviewed for each patient at each site. Participants who a) filled at least one prescription for Interferon and ribavirin, and b) had at least one treatment-related physician visit with a medical record note stating they began taking the medications were deemed to have initiated antiviral treatment. Patients were considered to have completed treatment if they a) were prescribed and received the full course of antiviral treatment recommended by their HCV physician, and b) had at least one medical record note stating they had completed treatment.
up to 24 weeks
Percentage of Participants That Completed Planned Duration of Treatment Using a Cutoff of 80%
Tidsramme: up to 24 weeks
Patients were considered to have completed treatment if they a) were prescribed and received the full course of antiviral treatment recommended by their HCV physician, and b) had at least one medical record note stating they had completed treatment.
up to 24 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

VA Office of Research and Development

Etterforskere

  • Hovedetterforsker: Samuel B Ho, MD, VA San Diego Healthcare System, San Diego, CA

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

1. januar 2012

Primær fullføring (Faktiske)

1. januar 2013

Studiet fullført (Faktiske)

1. februar 2014

Datoer for studieregistrering

Først innsendt

21. desember 2015

Først innsendt som oppfylte QC-kriteriene

4. januar 2016

Først lagt ut (Anslag)

6. januar 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

20. mai 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. mai 2016

Sist bekreftet

1. mai 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IIR 07-101-A

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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