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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Tobacco Use Cessation
- 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 group | Role | What they receive |
|---|---|---|
| Texas Quitline | Patients interested in smoking cessation treatment by calling the Texas Quitline. Receives: Behavioral: Quitline-Delivered Proactive Telephone Counseling; Behavioral: Follow-Up Phone Call | |
| Training Providers | Medical 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.
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)
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.
- First posted11 Feb 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2049 (estimated)
- Study completionApr 2049 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Therapy and Research Center, Texas
- Responsible party
- Sponsor
- Investigators
- Lorna H. McNeill, PHD, MPH, Principal investigator, M.D. Anderson Cancer Center
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
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of an Automated EMR System to Connect Smokers in a Safety Net Healthcare System With Smoking Cessation Treatment
- ClinicalTrials.gov ID
- NCT01788787
- Acronym / sponsor ID
- 2012-1112
- Conditions
- Tobacco Use Cessation
- Keywords
- Cancer Prevention, Tobacco Use Cessation, Ask Advise Connect, AAC, Smoking Cessation Treatment, Texas Quitline, Saliva sample, Telephone Counseling
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,212 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Cancer Therapy and Research Center, Texas
- Study start
- Apr 2013 (actual)
- Primary completion
- Apr 2049 (estimated)
- Study completion
- Apr 2049 (estimated)
- First posted
- 11 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Texas Quitline | – | Behavioral: Quitline-Delivered Proactive Telephone Counseling, Behavioral: Follow-Up Phone CallPatients interested in smoking cessation treatment by calling the Texas Quitline. |
| Training Providers | – | Behavioral: Smoking Cessation Training, Behavioral: Qualitative Interviews Concerning the Implementation of AACMedical staff (i.e., medical assistants, licensed vocational nurses, registered nurse and physicians). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the Harris Health System Community Health Clinics
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 1) None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quitline-Delivered Proactive Telephone CounselingSmokers 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. | Behavioural | Texas Quitline |
| Follow-Up Phone CallSix 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. | Behavioural | Texas Quitline |
| Smoking Cessation TrainingMedical 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. | Behavioural | Training Providers |
| Qualitative Interviews Concerning the Implementation of AACMD 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. | Behavioural | Training Providers |
Primary outcome
Evaluate the Reach of Ask Advise Connect (AAC) Smoking Cessation Program
Time frame: 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.
1 secondary outcome
Efficacy of Ask Advise Connect (AAC) Smoking Cessation Program
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Tobacco Use Cessation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorna H. McNeill, PHD, MPH principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
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.