Telephone Counseling for Tobacco Cessation
4 december 2018 uppdaterad av: Kaiser Permanente
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
While physician-delivered care may have the greatest impact on tobacco abstinence rates, recent data indicate that other health care providers such as nurses and pharmacists improve tobacco abstinence rates more than self-help and/or no intervention.5
Thus, pharmacists continue to expand their clinical practice areas to include smoking cessation interventions.
A meta-analysis of studies involving pharmacist-delivered smoking cessation services found quit rates at 6 to12 months follow-up ranged from 14% to16%.6
The results of this meta-analysis demonstrate that pharmacists can successfully deliver tobacco-cessation interventions and the evidence strongly suggests they are effective in helping increase tobacco cessation rates.
Proactive telephone counseling can be more effective at increasing tobacco abstinence rates than self-help or no intervention.5
Telephone counseling is an effective system to help increase tobacco abstinence rates for a variety of reasons.
From the tobacco user's standpoint, there are no transportation inconveniences and fewer scheduling conflicts.
In addition, receiving counseling in the privacy of one's own home provides treatment access to individuals who are less willing to seek out counseling.
At Kaiser Permanente Colorado (KPCO), members with a history of CVD are enrolled in the Clinical Pharmacy Cardiac Risk Service (CPCRS).
The CPCRS is a clinical pharmacy specialist-managed, physician-directed program which provides secondary prevention care to over 14,000 patients.
Clinical care includes evaluating and treatment of major cardiovascular risk factors, including tobacco use, for members.
Currently, CPCRS has no standard of care with regard to addressing tobacco use.
Clinical pharmacy specialists working in CPCRS deliver tobacco cessation advice at their own discretion, through various methods.
The purpose of this pilot study is to determine whether brief, structured, telephone tobacco cessation counseling delivered by a clinical pharmacy specialist increases the number of smoking cessation attempts compared to usual care.
Studietyp
Interventionell
Inskrivning (Faktisk)
192
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Colorado
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Aurora, Colorado, Förenta staterna, 80011
- Clinical Pharmacy Specialist, Clinical Pharmacy Cardiac Risk Service - Kaiser Permanente of Colorado
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 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.
|
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)
|
|
Placebo-jämförare: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The Percentage of Self-reported Tobacco Cessation Attempts Between Groups
Tidsram: 3 months
|
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
|
3 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The Proportion of Patients in Each Group Who Participate in the Colorado Quitline (COQL) Within Three Months of Pharmacist Contact
Tidsram: 3 months
|
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.
|
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.
Tidsram: 3 months
|
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
|
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.
Tidsram: 3 months
|
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
|
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
Tidsram: 3 months
|
The proportion of patients in each group who report tobacco abstinence during the follow-up telephone survey conducted three months following pharmacist contact
|
3 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Alicia Cymbala, PharmD, BCPS, Kaiser Permanente
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2011
Primärt slutförande (Faktisk)
1 december 2014
Avslutad studie (Faktisk)
1 januari 2015
Studieregistreringsdatum
Först inskickad
8 december 2011
Först inskickad som uppfyllde QC-kriterierna
8 december 2011
Första postat (Uppskatta)
9 december 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 mars 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 december 2018
Senast verifierad
1 december 2018
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- CO-11-1660
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