Project Overview +

Smoking is a leading cause of death in the US, killing more than 440,000 people a year. While effective treatments exist, their impact is significantly reduced by poor treatment adherence, particularly to pharmacotherapy. One way to improve the effectiveness of existing pharmacotherapy and to help more people stop smoking is to enhance treatment adherence.

The current study develops and pilot tests a prototype My Mobile Advice Program (MyMAP). MyMAP is designed to a) provide real-time, algorithm-driven, personalized guidance to smokers' regarding how to manage common, non-serious, bothersome medication side-effects and nicotine withdrawal symptoms, b) provide patients with timely, individually-tailored, supportive encouragement to enhance their motivation for quitting and promote better adherence to their prescribed treatment regimen; c) alert providers to potentially serious adverse events or persistent bothersome symptoms that warrant timely medical intervention; and d) provide patients and providers 24/7 access to relevant educational and behavioral self-help information that can either be viewed online (via computer or smart phone) or printed for reference.

Through this comprehensive web-based intervention, we hypothesize that MyMAP will promote treatment adherence, thereby ultimately improving cessation rates and treatment cost-effectiveness. Given the popularity, high frequency of bothersome, non-serious medication side-effects, and increased monitoring demands for varenicline use, the pilot prototype is designed to support varenicline pharmacotherapy, but if the proposed intervention strategy proves promising, MyMAP will be expanded to support nicotine replacement and bupropion use in the future.

Aims +

  1. Create a working prototype of the MyMAP program for use with varenicline, based on the design and content already created through iterative preliminary developmental work and with input from smokers and clinical experts in medicine, pharmacy, psychiatry, and clinical psychology.
  2. Conduct a randomized pilot test to inform the acceptability, feasibility, and potential impact of MyMAP based on self-report (quantitative and qualitative) data from participants and study clinicians, automated pharmacy records, and automated tracking of MyMAP use. If the program is found to be feasible and acceptable from the perspective of smokers and clinicians, we will use the estimated effects on adherence and cessation outcomes from the pilot to inform the sample size for a future RCT.
  3. Interview relevant clinicians (physicians, nurses, quitline counselors) about their willingness to use MyMAP, if it were available, and assess their reactions to the programís design and functionality.
  4. As warranted based on the results, we will refine the MyMAP design with input from an expert clinical advisory panel and plan for a randomized trial to evaluate program effectiveness and cost-effectiveness.

Participants +

Adult smokers (n=70) who are members of Group Health, a large not-for-profit health plan in the Pacific Northwest will test the intervention. Also, approximately 50 clinicians who represent potential future MyMAP users will be interviewed.

Intervention +

MyMAP integrates systematic patient monitoring, personalized ecological momentary intervention, and provider alerts with standard educational and behavioral skills training materials with the goal of promoting medication adherence and, ultimately, smoking abstinence.

All materials are accessed through a secure online system (using a unique id and password) and are designed to augment standard clinical care across providers, patients, and settings. Both patients (participants) and the clinical care team (study nurse and physician) will have access to the system.

After setting a target quit date and being prescribed pharmacotherapy (varenicline), study participants are given access to the online MyMAP program. After logging into the site with a unique user id and password, they are able to choose from four actions: complete a scheduled/prompted symptom assessment, report any current symptoms/side-effects (i.e., a user-initiated assessment), send a brief message to the study clinicians, or access the online educational and behavioral intervention materials. The content and formatting of the site is developed to be accessible via personal computer or smart phone Internet browser.

Control participants have access to the same self-help content for smoking cessation, but do not have access to the medication adherence behavioral skills training materials.

Participants will complete 4 assessments: baseline, 3 weeks post-varenicline initiation (which is also 2 weeks post-target quit date), 3 months post-treatment initiation (end of treatment), and 5 months post-treatment initiation. This allows us to assess treatment adherence at several critical time periods--early in treatment when medication discontinuation is common, at the end of scheduled treatment, and post-end of scheduled treatment to capture people who change their initial treatment schedule and have not completed their treatment after 12 weeks.

My Mobile Advice Program (MyMAP)

07/01/2013 - 06/30/2015

Sponsor(s)

National Institute on Drug Abuse

Principal Investigator:

Jennifer B. McClure, PhD

Co-Investigator(s):

Lawrence C. An, MD
Sheryl L. Catz, PhD