Ask Advise Connect (AAC) Harris Heath CPRIT

Tobacco Use Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01788787
• Other study ID #: 2012-1112
• Secondary ID: PP12019
• Status: Active, not recruiting
• Start date: April 2013
• Est. completion date: April 2049

Study information

• Verified date: May 2019
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5212
• Est. completion date: April 2049
• Est. primary completion date: April 2049
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years of age or older

2. Self-reported current smoker

3. Present for care at one of the 13 Harris Health System (HHS) community clinics

4. Has a working telephone number

Exclusion Criteria:

1) None

Related Conditions & MeSH terms

• Tobacco Use Cessation

Intervention

Behavioral:
• Quitline-Delivered Proactive Telephone Counseling
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 Call
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 Training
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 AAC
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.

Locations

Country	Name	City	State
United States	Harris Health System	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Cancer Therapy and Research Center, Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	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.	6 months

External Links

•   University of Texas MD Anderson Cancer Center Website