SBIR-STTR Award

The prevalence of smoking among U.S. adults has remained relatively stable for the past five years at approximately 25%. Innovative approaches are needed to reach and treat the population of smokers. Preventive interventions which rely on behavioral counseling and social support, and which have large self-help components are well-suited to delivery via the Internet. Indeed, several recent studies have demonstrated efficacy of preventive health interventions delivered via the Internet. QuitNettm is a commercial website that implements the Tobacco Cessation Guidelines from the Surgeon General and the AHRQ. A key element of these guidelines, now regarded as the standard of care, is the use of pharmacotherapy. In order to have optimal effectiveness, pharmacotherapy requires support in the form of instructions for proper use, adjunct behavioral counseling, and follow-up. The primary threat to the efficacy of pharmacotherapy stems from problems with treatment compliance. The goal of this proposal is to develop a Medication Support System (MSS) that maximizes the efficacy of pharmacotherapy by addressing threats to compliance using proven cognitive and behavioral strategies. The MSS will be implemented as part of a comprehensive smoking cessation intervention offered on QuitNet.com and will consist of the following nine inter-related modules: 1) the Withdrawal Module conducts assessment of and intervention around withdrawal symptoms; 2) the Medication Trouble Shooting Module provides information and problem solving for patients experiencing difficulties (e.g., side effects) with medication use; 3) the Incentives and Rewards Module provides rewards contingent on the achievement of small goals and large milestones related to quitting smoking; 4) the Proactive Email Reminder Module generates proactive reminder messages to subscribers regarding medication-related behavioral goals; 5) the Ask the Expert Module provides intra-treatment support and guidance regarding pharmacotherapy through access to our smoking cessation expert; 6) the Bulletin Board Module facilitates the provision of social support among members around pharmacotherapy; 7) the Customized Medication Calendar and Journal encourage subscribers to self-monitor medication use and other smoking behaviors; 8) the Frequently Asked Question Module provides basic information that prepares and educates subscribers about nicotine dependence and its treatment, as well as the expected effects, side-effects, and benefits of pharmacotherapies; 9) the Buddy System Module encourages more intensive 1:1 support between subscribers and facilitates the identification of stage-matched buddies or stage- mismatched mentors. In Phase I, we will develop detailed specifications and conduct programming of all nine modules of the MSS system. A prototype will be presented to potential consumers in two rounds of focus groups to obtain detailed feedback. Current smokers and/or recent ex-smokers (N = 30) who used nicotine replacement and/or bupropion will be invited to participate in Round I focus groups to provide feedback on the MSS design and specifications. Focus group data will be used to finalize design specifications of the MSS system. In Round II focus groups, participants (N = 30) will use a working prototype of the system and provide feedback on usability, system layout and content areas. Feedback obtained in these sessions will be used to finalize development of the MSS system prior to launching on QuitNet. The goal of Phase II is to evaluate the efficacy of the MSS with respect to medication compliance and quitting outcomes in a randomized clinical trial.

Thesaurus Terms:
Internet, computer assisted patient care, computer system design /evaluation, smoking cessation, therapy compliance, tobacco abuse education cognitive behavior therapy, computer network, computer program /software, drug withdrawal, educational resource design /development, self help clinical research, human subject

Over 80% of smokers want to quit smoking and over half attempt to quit each year; however, less than 3% succeed in quitting. The PHS Clinical Practice Guideline [USPHS, 2000] reports the use of nicotine replacement therapy (NRT) approximately doubles quit rates and recommends use of NRT by all smokers who attempt to quit unless contraindicated. However, the effectiveness of NRT is limited in real-world practice by under-use of NRT by smokers attempting to quit and lack of adherence to dosing instructions. There is a clear need to reach more smokers with accessible behavioral treatment and support to increase the use of and adherence to NRT. The Internet is an ideal delivery channel for behavioral cessation treatment and medication support. Each year approximately 7 million Americans turn to the Internet for information and help quitting smoking. QuitNet.com is a field-tested website that provides cessation treatment in accordance with the PHS Guidelines and is interactive. The goal of this project is to improve the rate of utilization and adherence to NRT among smokers attempting to quit. In Phase I we developed a comprehensive Medication Support System (MSS) and tested it in focus groups with QuitNet subscribers. Feedback from the focus groups was very positive regarding its value and usability. In Phase II, we will complete integrative programming of the MSS system and conduct a randomized trial to test its efficacy. We will recruit 500 adult smokers through our partnership with Blue Cross Blue Shield of Rhode Island. Using a randomized, controlled design with repeated measures at baseline, 3-, 6-, and 12-months, smokers will be assigned to one of two treatments: 1) QuitNet (QN); or 2) QuitNet with the MSS (QN+MSS). We hypothesize that at month 12, participants in the QN+MSS group will have significantly higher quit rates compared to QN participants. We will also examine potential mediators of cessation including medication use and adherence as well as dose of behavioral treatment (e.g., number of logins to QuitNet). Lastly, we will examine normative patterns of medication use and adherence among participants in the control condition to establish a base- rate against which to compare the efficacy of QuitNet and QuitNet plus Medication Support. The proposed project could have significant public health impact by increasing the number of smokers who use NRT when quitting, and by improving quit rates through improved adherence with recommended NRT guidelines.

Thesaurus Terms:
Internet, behavior modification, biomedical automation, computer assisted patient care, computer system design /evaluation, human therapy evaluation, nicotine replacement, smoking cessation, therapy compliance clinical trial, health care service utilization, longitudinal human study, outcomes research, patient care management, public health, tobacco abuse prevention behavioral /social science research tag, clinical research, computer program /software, focus group, human subject