- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01489579
Telephone Counseling for Tobacco Cessation
Evaluation of Brief, Structured, Telephone Counseling for Tobacco Cessation as Part of a Cardiovascular Risk Reduction Service
The purpose of this study is to determine whether giving more structured information to patients over the phone about quitting tobacco helps to increase the chance that they will try to quit. The results of this study will help provide direction in developing a more standard way of helping patients to quit.
Study Hypothesis:
Brief, structured, telephone tobacco cessation counseling delivered by clinical pharmacy specialists will significantly increase the percentage of self-reported tobacco cessation attempts compared to usual care among patients enrolled in a cardiovascular risk reduction program.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Colorado
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Aurora, Colorado, Stati Uniti, 80011
- Clinical Pharmacy Specialist, Clinical Pharmacy Cardiac Risk Service - Kaiser Permanente of Colorado
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Patients who meet the following criteria will be eligible for the study:
- Enrolled in CPCRS at the time of counseling (12/11-02/12),
- Current tobacco user as noted in KP HealthConnect as of the date of the routine CPCRS evaluation and counseling. For study purposes, tobacco use includes any use of cigarettes, pipe, cigars, snuff, and chew.
- Continuous KPCO Denver/Boulder membership during study time period
Exclusion Criteria:
- Patients who meet any of the following criteria will not be enrolled in the study:
- <18 years of age,
- Non-English speakers,
- Deceased at time of survey, and/or
- Unable to provide consent
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: BST counseling group
The patients in the Brief, structured, telephone tobacco cessation, BST, counseling group, will receive tobacco cessation counseling, intervention, by a trained CPCRS pharmacist as part of their routine CPCRS care.
The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C).
These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting.
A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources.
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The patients in the Brief, Structured, Telephone (BST) counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care.
The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C).
These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting.
A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources ("Ready to quit" patient handout)
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Comparatore placebo: Usual care group
Pharmacists randomized to Usual Care will continue to provide interventions/procedures they normally would according to usual care practices.
These interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications.
Pharmacists who are randomized to Usual Care will be asked to continue their current approach for tobacco cessation recommendations
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Pharmacists randomized to Usual Care will continue to provide interventions/procedures they normally would according to usual care practices.
These interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications.
Pharmacists who are randomized to Usual Care will be asked to continue their current approach for tobacco cessation recommendations
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The Percentage of Self-reported Tobacco Cessation Attempts Between Groups
Lasso di tempo: 3 months
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The proportion of patients in each group who report a tobacco cessation attempt during the follow-up telephone survey conducted three months following pharmacist contact
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3 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The Proportion of Patients in Each Group Who Participate in the Colorado Quitline (COQL) Within Three Months of Pharmacist Contact
Lasso di tempo: 3 months
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Information on COQL participation was obtained from a prevention department within KPCO that tracks these data.
Report was provided to capture who from study had participated in the COQL within 3 months of pharmacist contact.
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3 months
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The Proportion of Patients Who Attend Any KPCO Tobacco Cessation Program(s)or Webinar(s) Within Three Months Following Contact.
Lasso di tempo: 3 months
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The proportion of patients who attend any KPCO tobacco cessation program(s)or webinar(s) within three months following contact.
Classes include Stop Smoking the Basics and Freedom from Cigarettes.
Webinars include Break Free and Freedom from Tobacco
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3 months
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The Proportion of Patients in Each Group Who Purchase Tobacco Cessation Medication Aids From KPCO Pharmacies Within Three Months Following Pharmacist Contact.
Lasso di tempo: 3 months
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The proportion of patients in each group who purchase tobacco cessation medication aids from KPCO pharmacies within three months following pharmacist contact.
Medications include nicotine replacement therapy, bupropion, and varenicline
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3 months
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The Proportion of Patients in Each Group Who Report Tobacco Abstinence During at the Three Months Follow-up Telephone Survey
Lasso di tempo: 3 months
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The proportion of patients in each group who report tobacco abstinence during the follow-up telephone survey conducted three months following pharmacist contact
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3 months
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Alicia Cymbala, PharmD, BCPS, Kaiser Permanente
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- CO-11-1660
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Cessazione dell'uso del tabacco
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Poitiers University HospitalNon ancora reclutamentoTerapia sostitutiva della nicotina | Professionisti sanitari | Desiderio di Tabacco | Tabacco CessationFrancia