The efficacy of computer-tailored smoking cessation material as a supplement to nicotine patch therapy

doi:10.1016/S0376-8716(00)00237-4

Drug and Alcohol Dependence

Volume 64, Issue 1, 1 September 2001, Pages 35-46

https://doi.org/10.1016/S0376-8716(00)00237-4 Get rights and content

Abstract

The study evaluated the efficacy of the Committed Quitters Program (CQP), a computer-tailored set of printed behavioral support materials offered free to purchasers of NicoDerm® CQ® patches, as a supplement to the nicotine patch and the standard brief User's Guide (UG) and audiotape. Callers to the CQP enrollment were randomized to either CQP (n=1854) or just the UG (n=1829). Abstinence and use of program materials were assessed by telephone interview at 6 and 12 weeks (the latter falling 2 weeks after patch use was to be discontinued). Considering all respondents, abstinence rates did not differ significantly between the UG and CQP groups. As expected, among those who reported they used their assigned materials (80.1% of the sample) smokers who received CQP demonstrated higher quit rates at both 6 weeks (38.8% v. 30.7%) and 12 weeks (18.2% v. 11.1%), compared to the UG group. Among those who used it, the Committed Quitters Program proved to be an effective behavioral treatment, improving quit rates over nicotine replacement therapy and a brief untailored written guide and audiotape.

Introduction

Cigarette smoking causes more than 3 million deaths worldwide each year, with the global death rate projected to increase to more than 10 million per year early in the 21st century (Peto et al., 1994). Smoking-caused disease and disability is preventable and/or reversible by smoking cessation (Henningfield et al., 1994). Smokers are generally aware that smoking is harmful and one-third try to quit each year (Giovino et al., 1993). However, more than 90% relapse, leaving only 2–3% of cigarette smokers achieving one year abstinence annually (Giovino et al., 1993). Pharmacological and behavioral treatments to assist cessation have proven benefits (Fiore et al., 2000). Behavioral treatments have largely been developed and tested in the context of intensive multi-session, face-to-face clinics, but the utilization of such clinics is quite low, limiting their public health impact (Lichtenstein and Glasgow, 1992).

Attention has shifted to a public-health model of smoking control which emphasizes delivering cessation assistance on a mass scale. One step towards addressing this need has been enhanced access to nicotine replacement therapy (NRT), a pharmacological treatment of known efficacy (Fiore et al., 2000). Nicotine gum and patches are now sold directly to smokers through a wide range of retail outlets in the US. It is estimated that this change has increased utilization of these treatments by over 150%, and increased overall quitting in the US population by about 20% (Shiffman et al., 1997).

Attempts at mass dissemination of behavioral methods have relied heavily on distribution of written cessation guides. Written guides have many advantages: they can embody the content of proven behavioral programs; they are inexpensive; they are unintrusive, allowing the smoker to get help in private; and they can be distributed to areas that counseling resources do not reach. Unfortunately, standard written cessation guides do not appear to be effective in helping people quit smoking. For example, in a study of over 2000 subjects, Cuckle and van Vunakis (1984) found no incremental effect on cessation rates of a ‘quit kit’ mailer compared to no written materials. In a meta-analysis of 26 studies, Lancaster and Stead (1998) found that standard self-help guides, whether used alone or in combination with brief contact (e.g. from a health care provider), provide little incremental benefit in cessation outcome when compared to no materials, non-specific materials, or brief contact alone. A comprehensive literature review by the U.S. Agency for Health Care Policy and Research (Fiore et al., 2000) reached similar conclusions. Trials have also attempted to combine self-help materials with NRT. However, adding this behavioral intervention did not improve quit rates over NRT alone (Lancaster and Stead, 1998). Thus, the challenge of providing disseminable behavioral treatment remains.

Advances in self-help materials hold promise for enhancing the efficacy of printed materials. Standardized self-help materials take a ‘one size fits all’ strategy that may cause them to lack focus or targeting. They are forced to cover all relevant content generically, which requires them to be extensive, and in turn may make them less interesting and less appealing to smokers. An alternative strategy aims for materials ‘targeted’ for particular groups, such as mothers of young children (Davis et al., 1992) or smokers at different stages in the quitting process (Prochaska et al., 1993). Lancaster and Stead (1998) conclude that targeted materials are not clinically effective. Going beyond such group targeting, ‘tailored’ materials are custom-tailored to each individual's needs, allowing them to be more focused, brief, and appealing. Individual tailoring requires collecting information about the individual's relevant characteristics and embodying that information in the resulting materials. The outcomes of tailored programs were the one bright spot in the meta-analysis carried out by Lancaster and Stead (1998) on written quitting aids, yielding consistently positive outcomes. Most specifically, Strecher et al. (1994) compared tailored and untailored guides and found an advantage of tailored guides, but only among light smokers. The success of tailored self-help materials among light smokers and their failure among heavier smokers suggests the promise of combining them with NRT.

Shiffman et al. (2000) examined the incremental efficacy of a package of computer-tailored materials, the Committed Quitters Program, provided free of charge to purchasers of over-the-counter nicotine chewing gum. The Committed Quitters Program is an international program designed to supplement and support the nicotine replacement medication (with pre-packaged instructions and cessation advice) through written guides individually tailored and mailed to the users during the indicated treatment. Results showed that the addition of the Committed Quitters Program to nicotine gum therapy significantly increased quit rates compared to the use of nicotine gum (with pre-packaged instructions and cessation advice) alone. At both 6 and 12 weeks, provision of the Committed Quitters Program increased quit rates by approximately 50% (6 weeks: 36.2 vs. 24.7%; 12 weeks: 27.6 vs. 17.7%).

In the present study, we used a similar design to evaluate a different version of the Committed Quitters Program (CQP) offered with nicotine patches. (As of this writing the program is available in the US, the United Kingdom, France, Belgium, Sweden, and Germany, with variants in Brazil, Mexico, and China). Like the nicotine gum program, the patch CQP consisted of written guides, mailed to the users during the period indicated for nicotine patch therapy (10 weeks). Smokers are offered free enrollment in CQP upon purchase of the NicoDerm^® CQ^® nicotine patch (NiQuitin^® CQ^® in Europe and Latin America; SmithKline Beecham Consumer Healthcare). The patch itself has been proven effective, both under conditions of intensive behavioral treatment (Transdermal Nicotine Study Group, 1991) and OTC conditions with no behavioral treatment (Shiffman, 1999). In the US, the standard package of NicoDerm^® CQ^® contains a User's Guide and audiotape that include behavioral advice; enrollment in the CQP is offered as a supplement to these. At enrollment in CQP (via a toll-free call), smokers are asked questions about their demographics, smoking history, motives for quitting, and perceived barriers or expected difficulties. These characteristics are then used to generate individually-tailored materials based on cognitive-behavioral methods (Shiffman et al., 1985, Fiore et al., 2000) such as stimulus control, self-efficacy enhancement, suggestions for coping, and encouraging compliance with NRT. The core of the program is embodied in a cessation calendar that takes the smoker through the first six weeks of quitting with week-to-week tips and suggestions. Other mailings are sent out at intervals through the early quit process (Table 1).

To evaluate the incremental benefit of the CQP program, we randomized patch users calling into the CQP to either receive the CQP materials (CQP group) or rely on the standard User's Guide and audiotape (UG group). Abstinence was assessed at 6 and 12 weeks. Since written materials can only be effective if they are used, it was expected that the impact on outcome would be observed primarily among those who reported using their assigned materials.

Section snippets

Participants

Participants for the study were recruited from U.S. purchasers of NicoDerm^® CQ^® calling into a toll-free number that offered free behavioral support materials. Eligible callers met the following criteria: 1) had a Target Quit Date that was within 7 days from the enrollment call date; 2) had not already quit for longer than 1 day;

Follow-Up rates

Of the 3683 participants enrolled, 2560 (69.5%) were contacted at 6 weeks. Contact rates were similar for the two treatment groups, with 1272 (68.6%) of the CQP group and 1288 (70.4%) of the UG group being reached at 6 weeks (χ²=1.43; p=0.232). Of those contacted, 108 (4.2%) refused the interview and were counted as treatment failures; refusal rates were similar for the two treatment groups (CQP: 3.7% and UG: 4.7%; χ²=1.72; p=0.190). Of the 2560 subjects that were contacted at 6 weeks, a total

Discussion

The study demonstrated the efficacy of the CQP tailored behavioral materials in promoting smoking cessation, when used as an addition to the NicoDerm^® CQ^® patch and a User Guide. Among those who reported they had used their assigned materials, the CQP increased quit rates significantly at both 6 and 12 weeks over the nicotine patch, User's Guide, and audiotape alone. Although the study did not specifically evaluate a tailored v. an untailored program, the effect is striking given the negative

Supplementary data

Acknowledgements

This research was supported by SmithKline Beecham Consumer Healthcare. We are grateful to a Scientific Advisory Board (Susan Curry, Ed Fisher, and Victor Strecher), which advised on the design of the study, and to Ed Fisher for feedback on a draft of the manuscript. Joel Greenhouse provided valuable statistical consultation. John Pinney provided invaluable support. Victor Strecher and Frank Vitale contributed to the development of the Committed Quitters materials, which were produced by

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A number of computerized and Web-based approaches recently have been applied in substance abuse treatment settings and hold tremendous potential for expanding the reach of evidence-based treatment. Web-based approaches have been demonstrated to be efficacious in the delivery of empirically supported nicotine cessation strategies (Glenn & Dallery, 2007; Shiffman, Paty, Rohay, Di Marino, & Gitchell, 2001; Strecher, Shiffman, & West, 2005), motivational enhancement strategies (Ondersma, Chase, Svikis, & Schuster, 2005; Ondersma, Svikis, & Schuster, 2007), moderation management (Hester, Squires, & Delaney, 2005; Squires & Hester, 2004), and HIV prevention strategies (Marsch & Bickel, 2004). In addition, three separate research groups have shown the benefit of using a computerized approach to behavioral therapies (Bickel, Marsch, Buchhalter, & Badger, 2008; Carroll et al., 2008; Kay-Lambkin, Baker, Lewin, & Carr, 2009).
Computerized therapy approaches may expand the reach of evidence-based treatment; however, it is unclear how to integrate these therapies into community-based treatment. We conducted a two-phase pilot study to explore (a) whether clients' use of the Therapeutic Education System (TES), a Web-based community reinforcement approach (CRA) learning program, would benefit them in the absence of counselor support and (b) whether counselors and clients would use the TES in the absence of tangible research-based reinforcement. In Phase 1, clients in the TES condition (n = 14) demonstrated large improvements in knowledge, F(1, 20) = 8.90, p = .007, d = 1.05, and were significantly more likely to select CRA style coping responses, F (1, 20) = 11.95, p = .002, d = 1.16, relative to the treatment-as-usual group (n = 14). We also detected small, nonsignificant, between-group effects indicating TES decreased cocaine use during treatment. In Phase 2, counselors referred only around 10% of their caseload to the TES, and the modal number of completed modules in the absence of tangible reinforcement was three. Computer-based therapy approaches are viable in community-based treatment but must be integrated with incentive systems to ensure engagement.
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The multicomponent intervention yielded a 50% 1-year quit rate compared to 18% in standard treatment. Several studies provide promising results for tailored interventions83–87 as well as culturally tailored support geared to the needs of specific subgroups of smokers.88,89 A meta-analysis showed that smokers who were provided with individually tailored self-help materials were more likely to succeed in their quit attempt than those who were provided nontailored materials (OR=1.42).90
Only large increases in adult cessation will rapidly reduce population smoking prevalence. Evidence-based smoking-cessation treatments and treatment policies exist but are underutilized. More needs to be done to coordinate the widespread, efficient dissemination and implementation of effective treatments and policies. This paper is the first in a series of three to demonstrate the impact of an integrated, comprehensive systems approach to cessation treatment and policy. This paper provides an analytic framework and selected literature review that guide the two subsequent computer simulation modeling papers to show how critical leverage points may have an impact on reductions in smoking prevalence. Evidence is reviewed from the U.S. Public Health Service 2008 clinical practice guideline and other sources regarding the impact of five cessation treatment policies on quit attempts, use of evidence-based treatment, and quit rates. Cessation treatment policies would: (1) expand cessation treatment coverage and provider reimbursement; (2) mandate adequate funding for the use and promotion of evidence-based state-sponsored telephone quitlines; (3) support healthcare systems changes to prompt, guide, and incentivize tobacco treatment; (4) support and promote evidence-based treatment via the Internet; and (5) improve individually tailored, stepped-care approaches and the long-term effectiveness of evidence-based treatments. This series of papers provides an analytic framework to inform heuristic simulation models in order to take a new look at ways to markedly increase population smoking cessation by implementing a defined set of treatments and treatment-related policies with the potential to improve motivation to quit, evidence-based treatment use, and long-term effectiveness.
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To describe the design, implementation, baseline data, and feasibility of establishing a disease management program for smoking cessation in rural primary care.
The study is a randomized clinical trial evaluating a disease management program for smoking cessation. The intervention combined pharmacotherapy, telephone counseling, and physician feedback, and repeated intervention over two years. The program began in 2004 and was implemented in 50 primary care clinics across the State of Kansas.
Of eligible patients, 73% were interested in study participation. 750 enrolled participants were predominantly Caucasian, female, employed, and averaged 47.2 years of age (SD = 13.1). In addition to smoking, 427 (57%) had at least one additional major risk factor for cardiovascular disease (diabetes, hypertension, high cholesterol, heart disease or stroke). Participants smoked on average 23.7 (SD = 10.4) cigarettes per day, were contemplating (61%) or preparing to quit (30%), were highly motivated and confident of their ability to quit smoking, and reported seeing their physicians multiple times in the past twelve months (Median = 3.50; Mean = 5.48; SD = 6.58).
Initial findings demonstrate the willingness of patients to enroll in a two-year disease management program to address nicotine dependence, even among patients not ready to make a quit attempt. These findings support the feasibility of identifying and enrolling rural smokers within the primary care setting.
Nonpharmacologic Therapy for Smoking Cessation: Characteristics and Efficacy of Current Approaches
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Although nonpharmacologic interventions alone can significantly improve cessation rates in smokers attempting to quit, research shows that a multimodal approach combining nonpharmacologic methods with medication is necessary to optimize cessation rates.22 For instance, when combined with behavioral interventions—as recommended by DHHS guidelines22—both first- and second-line agents significantly increase continuous abstinence rates.5,57,58 The greatest increases in abstinence rates occur when multiple concomitant smoking cessation agents are combined with behavioral treatment over an extended period.59,60
This article reviews the most common nonpharmacologic approaches used to support smoking cessation and, where possible, provides estimates of their efficacy in controlled clinical trials. Virtually all of the approaches that have been systematically evaluated to date have demonstrated modest efficacy in increasing quit rates. A cornerstone of effective treatment is tobacco dependence counseling, for which there is a dose-response relation between the intensity of counseling (total minutes of contact) and its effectiveness. New approaches in which treatment is tailored to individual patient characteristics appear promising for the future but require further study. Also, new technologies that permit delivery of smoking interventions to a wider range of patients could have a significant impact on reducing smoking prevalence worldwide in the future. Overall, the clinical literature strongly endorses combining nonpharmacologic interventions with pharmacotherapy to optimize support for smokers who are trying to quit.
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Literature review of studies examining trends in NRT utilization pre- and post-switch, the efficacy and safety of NRT in the OTC setting, and patterns of OTC NRT use.
OTC availability of NRT increased access to and utilization of treatment. Studies show that OTC NRT has been used safely and effectively, without substantial misuse or abuse, and with continued physician engagement and wide access to proven behavioral treatment.
With other medications that challenge the traditional OTC paradigm being proposed for OTC switch, the NRT case study serves as a useful example in highlighting the potential role that Rx-to-OTC switch can play in addressing public health challenges. The NRT experience suggests that advance identification and analysis of concerns, implementation of plans to manage concerns, including appropriate marketing and post-marketing surveillance, can ensure that OTC switch of medications for behavior change and disease prevention can help minimize risks and maximize public health benefits.
Physicians' counseling of patients when prescribing nicotine replacement therapy
2007, Addictive Behaviors
Citation Excerpt :
It also suggests that there may have been little loss in physician instruction and counseling with the switch to OTC because those physician contributions were not there in the first place. Our findings are consistent with prior studies showing that physicians rarely initiate treatment with NRT (Shiffman, Paty, Rohay, Di Marino, & Gitchell, 2001; Ward & Sanson-Fisher, 1996) and do not follow-up with their patient on how treatment is progressing. This suggests that physician input into NRT treatment is not particularly intensive — instead, the onus seems to be on the patient to initiate and monitor their cessation attempt.
Nicotine patches and gum are now available without a prescription in many countries. Some have expressed concern that allowing access to these medications without a prescription may deprive smokers of the instruction and support they would otherwise have received from their physician. We assessed the value of physician involvement in NRT prescription.
We analyzed data interviews from 993 subjects who had filled prescriptions for patch (n = 669) or gum (n = 324) about physician behavior when prescribing patch and gum when these were available only by prescription.
82% of smokers actually met with the physician; however, only 67% received some instruction in using the medication; only 50% were told about potential side effects; and substantial fractions were prescribed a dose that differed from that recommended on the usage instructions (patch: 24%; gum: 33%). Participants who received no intervention from their physicians were significantly more likely to be abstinent than those participants who received smoking cessation advice and support, likely because physicians offered help to those who most needed it, biasing the association.
These findings suggest that physicians did not typically perform the helpful behaviors often expected of them or attributed to them.

View all citing articles on Scopus

^☆: Readers interested in seeing examples of the computer-tailored smoking cessation material can view them on the journal Internet home page at http://www.elsevier.com/locate/drugalcdepsuppmat/

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The efficacy of computer-tailored smoking cessation material as a supplement to nicotine patch therapy☆

Abstract

Introduction

Section snippets

Participants

Follow-Up rates

Discussion

Supplementary data

Acknowledgements

Addict Behav.

Use of FDA-approved pharmacologic treatments for tobacco dependence.

Epidemiology Branch, Office on Smoking and Health, Centers of Disease Control and Prevention 2000: Morbidity and Mortality Weekly Report

The effectiveness of a postal smoking cessation ‘kit’

Community Medicine

The impact of tailored self-help smoking cessation guides on young mothers

Health Education Q.

Measuring nicotine dependence: A review of the Fagerström Tolerance Questionnaire

J. Behav. Med.

Treating Tobacco Use and Dependence: Clinical Practice Guideline

Methods used to quit smoking in the United States: do cessation programs help?

J. Am. Med. Assoc.

Trends in cigarette smoking cessation in the United States

Tob. Control

Smoking and the workplace: realities and solutions

J. Smoking Related Dis.

Combining behavioral therapy and pharmacotherapy for smoking cessation: An update

Assessing the generalizability of smoking studies

Addiction

The bogus pipeline: a new paradigm for measuring affect and attitude

Psychol. Bull.

Tobacco dependence, restraint and time to the first cigarette of the day

Addict Behav.

Self-help interventions for smoking cessation

The Cochrane Library