- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02046408
Computer-Facilitated 5A's for Smoking Cessation in Primary Care
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This project develops and tests a computer-facilitated 5A's (CF-5A's) model that administers the 5A's intervention to patients then prompts providers for reinforcing next steps. CF-5A's could efficiently and effectively promote smoking cessation while educating providers about cessation resources and appropriate follow-up. Based on the Technology Acceptance Model, clinically tailored strategies to promote CF-5A's implementation will be developed and tested to ensure the appropriate use and uptake of this new service delivery model. Development of the model, materials, and strategies will occur in years 1 and 2.
Baseline data collection occurs in year 2, followed by a randomized trial of CF- 5A's where the provider is the unit of randomization. Provider use of the 5A's will primarily be assessed with a brief phone call to the patient after the primary care visit has occurred.
Although focused on 5A's for smoking cessation, this study examines the underlying implementation science of computer-aided service delivery models with important implications for the integration of other substance use or behavioral health interventions in primary care. Implementation factors will be assessed using qualitative interviews and brief pre-post surveys.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
California
-
San Francisco, California, Forente stater, 94110
- San Francisco General Hospital
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San Francisco, California, Forente stater, 94115
- UCSF Adult Primary Care Mt. Zion Clinic
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria: All primary care providers and clinic staff are eligible to participate. Patients must have
- a primary care appointment
- smoked a cigarette in past 7 days
- smoked at least 100 cigarettes in lifetime
- speak English or Spanish
- be cognitively able to use computer tablet
Exclusion Criteria:
- Moderate to severe cognitive impairment
- Does not speak English or Spanish
- acute intoxication on alcohol or illicit drugs
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Tablet Intervention
Primary care providers will be randomized into intervention or control conditions.
The patients of intervention providers will be given a computer tablet that provides 5A's for smoking cessation counseling.
Patients of control providers will not receive a tablet intervention.
|
|
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Ingen inngripen: Control
Primary care providers will be randomized into intervention or control conditions.
The patients of intervention providers will be given a computer tablet that provides 5A's for smoking cessation counseling.
Patients of control providers will not receive a tablet intervention.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
5A's Fidelity
Tidsramme: Baseline assessment 2013-14; Intervention 2014-2015
|
Baseline and post-tablet intervention assessments of primary care provider adherence to 5A's protocol for smoking cessation.
Patients are called after their primary care appointment and asked a series of questions to determine if (and which of) the 5A's were used during that visit.
|
Baseline assessment 2013-14; Intervention 2014-2015
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Tablet Usage
Tidsramme: 7/2014-7/2015
|
Intervention includes system strategies to improve usage of computer tablets in primary care waiting rooms.
Outcome = tablet saturation or proportion of patients given a tablet.
|
7/2014-7/2015
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Implementation Factors
Tidsramme: July 2013-2015
|
Qualitative interview data to assess the utility of the "Technology Acceptance Model" in explaining tablet and 5A's usage.
Variables assessed include perceived usefulness, social norms and influence, and facilitating conditions.
|
July 2013-2015
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Jason M Satterfield, PhD, University of California
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1R01DA034253-01 (U.S. NIH-stipend/kontrakt)
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