Ask Advise Connect (AAC) Harris Heath CPRIT

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01788787
Collaborator
Cancer Therapy and Research Center, Texas (Other)
5,212
1
432
12.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Quitline-Delivered Proactive Telephone Counseling
  • Behavioral: Follow-Up Phone Call
  • Behavioral: Smoking Cessation Training
  • Behavioral: Qualitative Interviews Concerning the Implementation of AAC

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

Study Type:
Observational
Anticipated Enrollment :
5212 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Implementation of an Automated EMR System to Connect Smokers in a Safety Net Healthcare System With Smoking Cessation Treatment
Actual Study Start Date :
Apr 1, 2013
Anticipated Primary Completion Date :
Apr 1, 2049
Anticipated Study Completion Date :
Apr 1, 2049

Arms and Interventions

Arm Intervention/Treatment
Texas Quitline

Patients interested in smoking cessation treatment by calling the Texas Quitline.

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.

Behavioral: 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.

Training Providers

Medical staff (i.e., medical assistants, licensed vocational nurses, registered nurse and physicians).

Behavioral: 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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Harris Health System Houston Texas United States 77030

Sponsors and Collaborators

  • M.D. Anderson Cancer Center
  • Cancer Therapy and Research Center, Texas

Investigators

  • Principal Investigator: Lorna H. McNeill, PHD, MPH, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01788787
Other Study ID Numbers:
  • 2012-1112
  • PP12019
First Posted:
Feb 11, 2013
Last Update Posted:
May 28, 2019
Last Verified:
May 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by M.D. Anderson Cancer Center

Study Results

No Results Posted as of May 28, 2019