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Integrated Collaborative Care for Substance Use Disorders (SUMMIT)

25. april 2017 oppdatert av: RAND

Primary care settings (PCS) are a missed opportunity for delivering evidence-based treatments for opiate and alcohol-use disorders (OAUD). The investigators propose to evaluate the costs and effectiveness of two strategies to increase the delivery of OAUD treatments in PCS, integrated collaborative care (ICC) and education and resources (E&R). The investigators hypothesize that ICC will be more effective than E&R in promoting A. Implementation outcomes B. Service system outcomes and C. Patient outcomes.

Results from our study will help providers choose between two different strategies and advance the field of implementation research.

Studieoversikt

Detaljert beskrivelse

Most individuals with opiate and alcohol-use disorders (OAUD) do not receive treatment. Primary care is an ideal setting in which to deliver OAUD treatment, yet evidence-based OAUD treatment is rarely provided.

Barriers to delivery include insufficient organizational support and lack of provider role models and clinical support. The investigators propose to evaluate the effectiveness of two strategies for increasing use of evidence-based treatment for OAUD within primary care: integrated collaborative care (ICC) and education and resources (E&R). While both strategies provide primary care practices with the same clinical information, ICC addresses these barriers by including organizational and technical support for delivering evidence-based care. ICC is grounded in the chronic care model and includes a behavioral health provider working as part of the care team.

Essential elements of ICC strategy include a decision support component to help providers with complex patients, and a restructuring of the delivery and clinical information systems to support the delivery of evidence-based care. Our approach to implementing ICC is based on the organizational transformation model and quality improvement. The investigators define the E&R strategy as providing printed educational materials and access to resources along with provider education. Both strategies are designed to increase the delivery of two evidence-based practices: motivational enhancement therapy and medication assisted therapy.

The investigators propose a 5-year mixed methods study and will conduct a RCT, with randomization occurring at the level of the care team and patient. The investigators partner with 5 Venice Family Clinic (VFC) clinics, two hospitals in LA County, and COPE Health Solutions. VFC is a large federally qualified health center (FQHC) and the largest free clinic in the United States. Our approach includes document review, focus groups, interviews, and surveys for obtaining data on the adoption process and implementation outcomes; analysis of patient records and patient surveys on service system and patient outcomes; and analysis of provider financial records and patient records and surveys for estimating costs. The investigators will enroll 400 patients with an OAUD diagnosis and follow them at 3 and 12 months. Our specific aims are: 1) To measure the process and extent of ICC and E&R implementation; 2) To test the effectiveness of ICC compared to an E&R strategy in promoting A. Implementation outcomes B. Service system outcomes and C. Patient outcomes; and 3) To estimate provider costs for each strategy. The investigators define implementation outcomes as measures of the acceptability, adoption, appropriateness, feasibility, and sustainability of evidence-based OAUD treatment. The investigators define service system outcomes as 1) process measures of treatment quality and 2) treatment co-morbidities. The investigators define patient outcomes as hospital readmissions, OAUD outcomes, patient functioning, negative consequences from substance use, and unmet need. The investigators define cost outcomes as start-up costs, operating costs and medical/psychiatric cost offsets.

Studietype

Intervensjonell

Registrering (Faktiske)

397

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

    • California
      • Santa Monica, California, Forente stater, 90405
        • Venice Family Clinic-Simms Mann Health Center
      • Venice, California, Forente stater, 90291
        • Venice Family Clinic-Rose lAvenue

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • opiate or alcohol use disorder
  • not currently in substance use disorder treatment
  • past 30 day use of alcohol or opioids
  • English or Spanish speaking

Exclusion Criteria:

  • co-morbid severe mental illness
  • medically unstable

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: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: ICC
Integrated collaborative care
Aktiv komparator: E&R
Education and Resources--enhanced usual care

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
unmet need
Tidsramme: past 6 months
Of those identified as screening positive for an opiate or alcohol use disorder, proportion who did not receive treatment for their substance use
past 6 months
abstinent from alcohol and opioid use, past 30 days
Tidsramme: past 30 days
change in abstinence from alcohol and opioid use between baseline and 6 month follow up
past 30 days
negative consequences related to substance use
Tidsramme: past 3 months
SIP-AD frequency questionnaire
past 3 months
Functioning
Tidsramme: past 4 weeks
change in SF-12 between baseline and follow up
past 4 weeks
Engagement
Tidsramme: 30 days of initiation
Proportion with at least 2 SUD-related visits within 30 days of initiation, Washington Circle
30 days of initiation
initiation
Tidsramme: Within 14 days of index visit
Washington Circle initiation indicator--at least one SUD-related visit within 14 days of index visit
Within 14 days of index visit
heavy alcohol use
Tidsramme: 6 months
among people at baseline with heavy alcohol use, proportion with heavy alcohol use in past 30 days
6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion initiating Brief therapy
Tidsramme: 6 months
Proportion initiating brief therapy within 6 months
6 months
Proportion initiating MAT
Tidsramme: 6 months
Proportion initiating MAT within 6 months, among those eligible for MAT, and if N's are large enough, stratified by type of MAT
6 months
abstinence from alcohol, opioids and all other drugs in the previous 30 days
Tidsramme: collected at six months at the past 30 days
abstinence from alcohol, opioids and all other drugs in the past 30 days
collected at six months at the past 30 days

Samarbeidspartnere og etterforskere

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

Sponsor

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

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. juni 2014

Primær fullføring (Faktiske)

1. september 2016

Studiet fullført (Faktiske)

1. januar 2017

Datoer for studieregistrering

Først innsendt

11. mars 2013

Først innsendt som oppfylte QC-kriteriene

12. mars 2013

Først lagt ut (Anslag)

13. mars 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. april 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. april 2017

Sist bekreftet

1. april 2017

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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