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Tobacco Use CessationNCT01788787

Ask Advise Connect (AAC) Harris Heath CPRIT

An observational study of Tobacco Use Cessation, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this behavioral research study is to learn about the outcomes of smoking cessation treatment. Researchers want to learn how many smokers stopped smoking after taking part in smoking cessation treatment with the Texas Quitline. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Tobacco Use Cessation
What is being tested?
Quitline-Delivered Proactive Telephone Counseling, Follow-Up Phone Call and Smoking Cessation Training
How many people
5,212 participants
Where
1 siteUnited States
Study dates
Apr 2013to Apr 2049
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients from the Harris Health System Community Health Clinics

Who may be able to join

  • 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

Who cannot join

  • 1) None

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Harris Health System

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Implementation of an Automated EMR System to Connect Smokers in a Safety Net Healthcare System With Smoking Cessation Treatment

The goal of this behavioral research study is to learn about the outcomes of smoking cessation treatment. Researchers want to learn how many smokers stopped smoking after taking part in smoking cessation treatment with the Texas Quitline.

Read the detailed description

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.

Being tested
Quitline-Delivered Proactive Telephone Counseling, Follow-Up Phone Call, Smoking Cessation Training, Qualitative Interviews Concerning the Implementation of AAC
Keywords
Cancer Prevention, Tobacco Use Cessation, Ask Advise Connect, AAC, Smoking Cessation Treatment, Texas Quitline, Saliva sample, Telephone Counseling, Nicotine replacement, Interviews
Medical subject headings
Tobacco Use Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quitline-Delivered Proactive Telephone CounselingBehavioural

    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.

  • Follow-Up Phone CallBehavioural

    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.

  • Smoking Cessation TrainingBehavioural

    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.

  • Qualitative Interviews Concerning the Implementation of AACBehavioural

    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.

Study groups in NCT01788787
Study groupRoleWhat they receive
Texas QuitlinePatients interested in smoking cessation treatment by calling the Texas Quitline.
Receives: Behavioral: Quitline-Delivered Proactive Telephone Counseling; Behavioral: Follow-Up Phone Call
Training ProvidersMedical staff (i.e., medical assistants, licensed vocational nurses, registered nurse and physicians).
Receives: Behavioral: Smoking Cessation Training; Behavioral: Qualitative Interviews Concerning the Implementation of AAC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the Reach of Ask Advise Connect (AAC) Smoking Cessation Program

    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.

    Measured: 2 years

Secondary outcomes (1)
  1. Efficacy of Ask Advise Connect (AAC) Smoking Cessation Program

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionApr 2049 (estimated)
  4. Study completionApr 2049 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,212 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01788787
Sponsor's protocol ID
2012-1112
Other IDs
PP12019
Status last verified
May 2019
First submitted
7 Feb 2013
Last updated
28 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Tobacco Use Cessation, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the Reach of Ask Advise Connect (AAC) Smoking Cessation Program (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.

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