- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01788787
Ask Advise Connect (AAC) Harris Heath CPRIT
Implementation of an Automated EMR System to Connect Smokers in a Safety Net Healthcare System With Smoking Cessation Treatment
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Study Test:
If you agree to take part in this study, you will collect a saliva sample to test for cotinine to confirm your smoking status. Cotinine is a chemical released in your body when it breaks down nicotine. You will receive a kit in the mail with supplies for the testing. The study staff will call you to make sure that you received the kit and to discuss the instructions with you. To collect the saliva, you will put a small piece of cotton in your mouth for a few minutes. You will mail the saliva sample back to the study staff, using a postage-paid envelope.
Length of Study:
Your participation in this study will be complete after you collect the saliva sample and mail it back to the study staff. Study data will be destroyed 5 years after the study has been completed and the data has been analyzed. Data collected in this study will not be used for future research.
This is an investigational study.
Up to 1,459 participants will be enrolled in this study. All will be enrolled at Harris Health System clinics.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
-
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Texas
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Houston, Texas, Förenta staterna, 77030
- Harris Health System
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- 18 years of age or older
- Self-reported current smoker
- Present for care at one of the 13 Harris Health System (HHS) community clinics
- Has a working telephone number
Exclusion Criteria:
1) None
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
Texas Quitline
Patients interested in smoking cessation treatment by calling the Texas Quitline.
|
Smokers who enroll in treatment receive standard counseling protocol offered by the Quitline.
This includes up to five proactive telephone counseling calls, each designed to provide practical expert support to help smokers develop problem-solving and coping skills, secure social support, and design a plan for successful cessation and long-term abstinence.
Six months after enrolling in treatment with the Texas Quitline, an MD Anderson research team member will contact patients to assess their smoking status via telephone.
|
Training Providers
Medical staff (i.e., medical assistants, licensed vocational nurses, registered nurse and physicians).
|
Medical staff (i.e., medical assistants, licensed vocational nurses, registered nurse and physicians) receive initial face-to-face group training on how to ask patients about their smoking status, advise them to quit, and connect them with the Quitline.
The specific content of the session will include information on quitting smoking, how to implement AAC, the effectiveness of telephone counseling for smoking cessation delivered via quitlines, and pharmacotherapies including nicotine replacement.
MD Anderson staff conduct individual in-depth interviews with administrative leadership as well as those medical staff who are authorized to enter patient information into the EMR and are trained in the Ask-Advise-Connect approach.
All in-depth interviews will be recorded and transcribed.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Evaluate the Reach of Ask Advise Connect (AAC) Smoking Cessation Program
Tidsram: 2 years
|
Reach defined as the proportion of smokers that enroll in treatment with the Quitline.
To evaluate the reach of AAC, we will calculate the proportion of smokers seen at the 13 Harris Health System community health clinics during the two-year treatment dissemination period that enroll in treatment with the Quitline.
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2 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Efficacy of Ask Advise Connect (AAC) Smoking Cessation Program
Tidsram: 6 months
|
Efficacy is defined as the proportion of smokers who agree to be connected to the Quitline that enroll in treatment who successfully achieve abstinence assessed 6 months following treatment enrollment.
|
6 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 2012-1112
- PP12019 (Annan identifierare: Cancer Prevention and Research Institute of Texas (CPRIT))
Läkemedels- och apparatinformation, studiedokument
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