Self-help Smoking Cessation and Maintenance Programs: A Comparative Study with 12-month Follow-Up by the American Lung Association

Transcription

1 Self-help Smoking Cessation and Maintenance Programs: A Comparative Study with 12-month Follow-Up by the American Lung Association ANNE L. DAVIS, MD, RICHARD FAUST, MPHIL, AND MARTINE ORDENTLICH, BA Abstract: One thousand two hundred thirty seven smokers responding to lung association announcements in five geographic areas were randomly assigned to one of four groups and mailed American Lung Association materials: 1) leaflets (L); 2) leaflets plus maintenance manual (L+M); 3) cessation manual (C); and 4) cessation and maintenance manuals (C+M). Five telephone interviews over one year achieved a 95 per cent follow-up completion rate. Nonrespondents as well as exclusive cigar and pipe users were classified as smokers. Twenty per cent quit initially, with 5 per cent continually abstinent in (C +M) at 12 months vs 2 per cent in (L) (p <.05). Nonsmoking prevalence rates (no tobacco smoking in the past month), on the other hand, gradually increased after six months; at 12 months those with the maintenance component, (L+M) and (C+M), had higher rates (18 per cent) than (L) (12 per cent) or (C) (15 per cent). Leaflets and manual alone were least cost effective. Rising nonsmoking prevalence rates observed in all groups suggest that successful attempts to quit increased over time and that a contributing factor might have been the follow-up method. Although achieving lower quit rates than methods requiring attendance at a course, the self-help intervention has the advantages of greater availability, flexibility, and in some instances lower cost. (Am J Public Health 1984; 74: ) Introduction Most smokers who have quit have done so on their own,' and most who want to quit would prefer to do so without formal programs requiring attendance.2,3 Self-help cessation programs are therefore appealing because of their potential for reaching large numbers of smokers at relatively little cost. However, there have been few evaluations of selfhelp materials, and these few have generally shown poor or inconclusive results.4-11 A review of self-help smoking cessation literature has suggested that a comprehensive and systematic approach to behavior change might improve success.'2 Although one study showed significant differences at the end of treatment between a group which received a written self-help cessation program and a control group which received self-assessment and self-monitoring materials but no cessation program,'3 no study has examined long-term results of different types of totally self-administered programs involving no face-to-face contact during treatment. In 1975, the American Lung Association (ALA) in collaboration with its medical section, the American Thoracic Society, and the Congress of Lung Association Staff launched a project to develop smoking cessation programs utilizing self-help, clinic, and mass media approaches. Selfhelp and clinic cessation programs were developed and subsequently evaluated. This paper presents the results of the self-help approach. Materials and Methods Self-Help Cessation Materials The 64-page cessation manual, entitled Freedom from Smoking in 20 Days, is designed to lead to complete cessa- Address reprint requests to Berton D. Freedman, MPH, American Lung Association, 1740 Broadway, New York, NY Dr. Davis is Associate Professor of Clinical Medicine, New York University School of Medicine, and was principal investigator of the ALA Smoking Cessation Research Study. Mr. Faust is Research Director, Calculogic Corporation, NYC; Ms. Ordentlich was Project Coordinator of the ALA Smoking Cessation Study, and is now Project Coordinator, Pace University Computer Center, NYC. This paper, submitted to the Journal July 11, 1983, was revised and accepted for publication July 18, Editor's Note: See also related editorial p 1198 this issue American Journal of Public Health /84 $ tion on the 16th day of a 20-day schedule, with an option to quit sooner if the smoker desires. It recommends a number of written exercises, including the Horn Test of why one smokes,'4 keeping a record of cigarettes smoked, identifying smoking triggers, and signing contracts to quit. In addition, it includes weight control information, deep breathing and muscle relaxation exercises, and ways to prepare oneself as a non-smoker for smoking situations that will arise. The 28-page maintenance manual, entitled A Lifetime of Freedom from Smoking, is designed to be used by exsmokers to maintain their nonsmoking behavior. This manual exphasizes techniques for coping with situations which trigger the urge to smoke. Participants who received the maintenance manual could also dial recorded telephone messages which were available 24 hours a day. Twenty twominute supportive messages were played, one each day in a repeating cycle, for two months after participants received their self-help materials. For the study we also used a package of eight existing ALA quit-smoking leaflets, including two brief cessation brochures illustrated with cartoon characters ("Me Quit Smoking? Why", and "Me Quit Smoking? How?"). The six other leaflets were on related smoking topics such as secondhand smoke, nonsmokers' rights, health effects of smoking, and the impact of parental smoking on children. Recruitment of Self-Help Study Participants Five local lung associations* were selected to participate in the self-help study. The criteria for selection included geographic diversity, willingness to follow the research protocol, and adequacy of resources. In 1979, the five local associations, which represent four major cities and an area of small cities and their rural surroundings, recruited participants through a standard newspaper advertisement provided by ALA and by flyers and media announcements. Smokers were enrolled in the study when they had signed a letter of informed consent, completed a 16-page intake questionnaire, agreed to participate in five follow-up interviews over the following year, and paid a $20 deposit. The deposit was designed to assure participation in the follow-up interviews and was refundable after the last interview whether or not participants had stopped smoking. *San Diego, CA, Salinas, CA, Minneapolis/St. Paul, MN, Baltimore, MD, and New York, NY. AJPH November 1984, Vol. 74, No. 11

2 SELF-HELP SMOKING CESSATION PROGRAMS The intake questionnaire included items about reasons for smoking, reasons for wanting to stop, smoking history, current smoking habits, smoking attitudes and opinions, the smoking habits of family members and close associates, major medical problems, current symptoms, use of coffee, alcohol, and other drugs, psychological characteristics, and standard demographic variables. The follow-up interviews included questions about current smoking, efforts to stop smoking since the last interview and the methods used, future plans for attempting to quit smoking, reactions to and use of the self-help materials, and any behavior changes in the areas covered in the intake questionnaire. Four Experimental Groups Participants were randomly assigned to one of four experimental groups: 1) ALA leaflets only (L); 2) leaflets plus maintenance manual (L+M); 3) cessation manual (C); and 4) cessation and maintenance manuals (C+M). Follow-up Procedures Follow-up data on most respondents were collected by means of telephone interviews at one, three, six, nine, and 12 months after the materials were mailed. However, participants who found the telephone interviews inconvenient were offered the option of completing questionnaires sent to them by mail. About per cent used the mail option at each follow-up. Follow-up of nonrespondents to the mail questionnaires was done by telephone. All follow-up interviewers participated in a training session where they reviewed the self-help materials and the goals of the study. Interviewers practiced on each other with the follow-up interview form and then conducted real telephone interviews with randomly called members of the public, using a special practice telephone interview form. The interviewers were trained by two experienced persons from the project staff and were observed until their practice interviews were considered satisfactory. Interviewers were specifically advised that their task was to collect data and not to encourage participants in their efforts to quit smoking. During the study, the project coordinator from the national office of the American Lung Association made periodic site visits to assure the quality and reliability of the data collection. Definitions of Nonsmoking Three measures of nonsmoking-initial quit rate, nonsmoking prevalence at each follow-up, and continuous nonsmoking since treatment at each follow-up-were used to determine the effectiveness offour different treatment conditions İnitial quit rate is based on response to one question: "Did you stop smoking after you got the materials?" Nonsmoking prevalence (often called the "quit rate" in other studies) is defined at the one-month follow-up by participants' self-reports of not smoking any cigarettes or a cigar or pipe in the past week. The question was restricted to the past week because participants in Groups 3 and 4 had been using the 20-day program during the first month. At all subsequent follow-ups, nonsmoking prevalence is defined as not smoking any cigarettes or a cigar or a pipe in the past month. Continuous nonsmoking at each follow-up is defined as no smoking of cigarettes, cigars, or pipes since initial quitting. For all three measures, participants who could not be reached for follow-up are classified as smokers. Cost-Effectiveness Analysis The cost-effectiveness analysis in this study is based on the actual costs for the printing (not development) of the selfhelp materials, the handling, and postage costs at the time of the study ( ), which were prorated to the number of participants in each group. It also includes costs for recruitment, training of interviewers, and the telephone follow-up interviews which were evenly allocated across all four experimental groups. Costs of recruitment, available from four of the test sites, were statistically imputed for the fifth site (Salinas, CA) by prorating the average from the other four sites by the number of subjects recruited at that site. A total direct cost of $12,451 was computed for the number of persons who expressed initial interest in the program. Costs of the telephone interviews are based on a calculation of total person-minutes of telephone contact with the participants and an assumed hourly wage of $4.50 for the interviewer, although most of the interviewers were actually volunteers. The total cost of the telephone interviews was $4, (1,093 person-hours x $4.50). The utility costs for the calls were assumed to be part of the normal operating expenses of the participating lung associations. Staff costs for training interviewers were based on the time spent at each site (total 11 days) and prorated at an assumed annual salary of $20,000 for each of two persons. Total direct costs for staff time were calculated at $ Cost-effectiveness ratios for each of the experimental groups were derived by scaling the total incurred costs within each cessation modality by the number of successful quitters at 12 months. This procedure yields the unit cost for producing one continuously abstinent ex-smoker, and one 30-day non-smoker, one year after the initial exposure to the particular self-help materials under investigation. Results Inquiries were received from 4,128 smokers desiring to use ALA self-help smoking cessation materials. All were sent the intake questionnaire and a full explanation of the study. A total of 1,237 (30 per cent) returned the completed questionnaire and the $20 fee and were enrolled. Interview completion rates were per cent for all five follow-ups. Characteristics of the Study Population There were no statistically significant differences among the four experimental groups in demographic characteristics, smoking habits, and past history of smoking.** The subjects were predominantly White, middle class and middle aged. By comparison with a national sample,'5 they were heavier smokers and a greater proportion had tried to stop smoking before (x = 3.2 prior attempts to quit). Written self-help materials were the most common method of quitting used in the past by those who had used any formal methods. Initial Quit Rate Quit rates are shown in Table 1. The initial quit rate of 20 per cent in the total self-help sample was followed immediately by substantial recidivism, with nonsmoking prevalence (per cent currently not smoking cigarettes, cigars or pipes) dropping to 10 per cent at one month follow-up. The group which received leaflets and the maintenance manual (L+M) had the highest initial quit rate and the group which received only leaflets (L) the lowest. **Data available on request to author. AJPH November 1984, Vol. 74, No

3 DAVIS, ET AL w o 1 a Group 1-leaflets only o---ogroup 2- leaflets & maintenance l*- *Group 3-cessation only ----o Group 4- cessation & maintenance I - -C,, Month of followur FIGURE 1-Comparison of Initial Quit Rates and Nonsm Rates at Five Periods over 12 Months in the Four Experimen See text for Definitions of Rates Nonsmoking Prevalence next 11 months. At 12 months, its nonsmoking prevalence rate at 18 per cent was equal to that of Group 4 (C+M). Continuous Nonsmoking The per cent of total smokers able to remain continuously abstinent after initial quitting dropped precipitously from 20 per cent to 10 per cent by one month (Table 1), and continued to decline through three months, gradually leveling off to 3 per cent at 12 months. Group 1 (L) was consistently the lowest in continuous nonsmoking rates, significantly different from Group 3 (C) at one month, and from Group 4 (C+M) at all follow-ups. Group 2 by 12 months was second to Group 4 (C+M) in continuous nonsmoking rate (4 per cent vs 5 per cent). Changes in Smoking Habits Changes in smoking habits between intake and followup are shown in Table 2. Excluding those who had quit, 51 Prevalence cent had increased it. Changes in rate of consumption and in ta Groups tar and nicotine content between intake and follow-up were 9 12 per cent had reduced their daily rate of cigarette consump- ) tion at 12 months, 39 per cent reported no change, and 10 per significant for each experimental group, but differences between experimental groups were not statistically significant at intake or follow-up. After the initial recidivism, nonsmoking prievalence was Use of ALA Materials stable through the first six months but ros;e thereafter, Participants in Groups 1, 3 and 4, who received either or culminating in a rate of 16 per cent for the total sample at the both of the new manuals, more often than those in Group 1 final (12 months) follow-up. Comparisons of thle four experi- (leaflets only) still had their materials at 12 months (86-89 mental groups show significant differences in tlhe patterns of per cent vs 78 per cent), more often thought they had cessation (Figure 1). The leaflets-only group, (L) had the received the "right amount" of materials (71-73 per cent vs lowest nonsmoking rates at every follow-up. Itss nonsmoking 48 per cent), and more of them would recommend their prevalence rates were significantly different firom Group 4 materials to a friend (73-84 per cent vs 58 per cent)., (C+M) at all follow-ups, from Group 2 (L+M) at 12 months, The number of cessation activities recommended in the and from Group 3 (C) at one and three month, s. materials which participants actually did (as reported in the Group 2 (L+M) had the highest initial quit rate, suffered one month follow-up) is modestly related to both nonsmok- the ing prevalence (r=.14, p-.05) and continuous nonsmoking the greatest decline at one month, and then exlperienced greatest recovery in nonsmoking prevalence rates over the (r=.10, p-.05) at 12 months. TABLE 1-initial Qult Rate and Nonsmoking Rates at Follow-up Experimental Groups Existing Leaflets Cessation Cessation Leaflets + Maint. Manual + Maint. Only Manual Only Manuals Total (L) (L+M) (C) (C+M) Sample N = 308 N = 312 N =308 N = 309 N = 1237 Initial Quit Rate Nonsmoking Prevalence Rates 1 mo mo mo mo mo Continuous Nonsmoking Rates 1 mo mo mo mo mo Pairs of groups significantly different at.05 by t-test: Initial Quit Rate (L vs L+M) Nonsmoking Prevalence Rates (1 and 3 mo: L vs C, L vs C+M; 6 and 9 mo: L vs C+M, 12 mo: L vs L+M, L vs C+M Continuous Nonsmoking Rates (1 mo: L vs C, L vs C+M; 3-12 mo: L vs C+M) 1214 AJPH November 1984, Vol. 74, No. 11

4 TABLE 2-Changes in Cigarette Consumption and Content by Those Still Smoking at Follow-up SELF-HELP SMOKING CESSATION PROGRAMS Experimental Groups Leaflets Leaflets Cessation Cessation Only + Maint. Only + Maint. Total (L) (L+M) (C) (C+M) Sample N = 308 N = 312 N = 308 N = 309 (1237) 1. Mean Number of Cigarettes Smoked per Day Intake Months (No.) (233) (234) (231) (228) (931) 2. Mean Tar Content in Milligrams per Cigarette Intake Months (No.) (195) (186) (168) (170) (719) 3. Mean Nicotine Content in Milligrams per Cigarette Intake Months (No.) (195) (186) (168) (170) (719) Cigarette content as reported by Federal Trade Commission16 on the basis of participants' reports of brands in the 9-month follow-up interview. Brand smoked at intake asked again at 9 months because the question at intake was not sufficiently detailed to allow brand identification. Correlations were also computed between successful cessation and participants' personal characteristics. By far the strongest correlate is the frequency with which smoking urges ("cravings") are experienced. The more frequent the cravings at follow-up, the less likely the participant will be a nonsmoker (standardized multiple regression coefficient = -.68, p <.001). By comparison, all other characteristics were found to have little impact. Cost-Effectiveness Table 3 itemizes the computed cost-effectiveness ratios for each of the four experimental groups. Group 2 materials (L+M) and Group 4 materials (C+M) were about equally cost-effective in producing a 30-day abstainer at 12 months. In terms of continuous abstention, the materials with the maintenance component (Groups 2 and 4) were again the most cost-effective. Minimal intervention (leaflets only) was least cost-effective. Discussion This study shows that a maintenance component added to simple self-help leaflets produces higher quit smoking rates than the leaflets alone or a cessation manual alone. The fact that degree of involvement of subjects, as measured by the number of activities reported done, was related to successful cessation would suggest that content materials had an impact. The cessation rates observed in all four self-help experimental groups were lower than the per cent rates generally reported for cessation methods which involve personal contact or group support as part of the program.'7 This may be due, in part, to the fact that definitions of cessation rates in the present study are more stringent than those recommended by the National Interagency Council on Smoking and Health.'8 Counting all nonrespondents and those who smoke only cigars or pipes as smokers, and determining nonsmoking rates over the past month rather than the past week, tend to reduce cessation rates compared to those reported in most other studies. Prior cessation studies have generally given one "quit rate", corresponding to our nonsmoking prevalence rate, and have failed to provide separate measures of current nonsmoking and continuous nonsmoking since treatment. The substantial difference between the two rates in the present study has significant implications. The recently published study of cohorts of nonsmokers followed for four years from end of intervention in the MRFIT (Multiple Risk Factor Intervention Trial) also illustrates this point.'9 First, using only a measure of current nonsmoking tends to exaggerate the apparent success of cessation programs, since "current" nonsmokers at follow-up inevitably include many whose times of cessation substantially postdate their time of treatment. Thus, their cessation may be due only in part, or not at all, to their participation in the cessation program. Second, the rising nonsmoking prevalence rates suggest increasing successful attempts by previous recidivists and point up the need to devise programs to which would-be quitters will return when they are ready to try to stop smoking again. Documentation of the continuing nature of smoking cessation efforts is particularly pertinent to the TABLE 3-Cost-Effectiveness of American Lung Association Self-Help Smoking Cessation Programs Recruitment, Materials, Training, Postage, Telephone, Total Group Handling Follow-up Unit Cost Unit Cost per Current (30-day) Abstainer at 12 months (L) $16 $129 $ (L+M) $20 $85 $105 IlIl (C) $25 $101 $126 IV (C+M) $29 $87 $116 Unit Cost per Continuous Abstainer at 12 months I (L) $99 $822 $ (L+M) $96 $401 $497 IlIl (C) $133 $536 $669 IV (C+M) $98 $298 $396 L = Leaflets only L+M = Leaflets + Maintenance Manual C = Cessation Manual only C+M = Cessation + Maintenance Manuals AJPH November 1984, Vol. 74, No

5 DAVIS, ET AL. maintenance issue. About half of the current smokers indicated on the three month and subsequent follow-ups that they had tried to stop smoking since the last interview, and almost all indicated they would try again. Self-help materials which encourage renewed efforts and which are readily at hand may thus be more likely to succeed in the long run. The successful cessation effort may occur long after the first attempt to quit but still be inspired by materials received at that time. The 10- to 15-minute telephone follow-up interviews also may have acted as a spur to cessation efforts, even though interviewers were advised that their task was to collect data and not to encourage quitting. The present study showed some decrease in daily cigarette use, and declines in average tar and nicotine levels of the cigarettes smoked among those still smoking at followup. However, the ALA and most other cessation programs aim at complete cessation rather than reduction or substitution, as it is not yet determined whether reductions in tar and nicotine content really reduce the health effects of smoking, nor whether changing to brands with lower tar and nicotine might not be offset by compensating changes in smoking behavior.2-25 A review of cost-effectiveness data for earlier smoking cessation programs concluded that available data were too incomplete to allow any judgments,26 but suggested that methods which require less participation by highly paid professionals would probably be more cost-effective. The unit cost to produce a current nonsmoker at 12 months, even with the least cost-effective minimal self-help intervention, ($135) is considerably less than the costs of commercial clinic programs. Recruitment accounted for the greatest portion of the expense, and telephone follow-up interviews the next. These expenses and the costs of training interviewers would not necessarily apply to other situations in which these self-help materials might be used. Because of the investigative nature of this project and the need for a large number of subjects from multiple sites and careful follow-up, the costs were greater than might be incurred in a physician's office or at the work site. Our costs to produce one 12- month continuous quitter seem high ($396-$921), but comparable data from other programs are not available for comparison. Applying the same cost-benefit analysis to ALA clinics, excluding costs of recruitment and telephone followup but including costs of staff time, materials, refreshments, and costs of organizing the clinics, ALA clinics were two to four times less cost-effective than these self-help programs.*** A criticism of this study could be the reliance on selfreporting of abstinence. Data from the MRFIT study, however, suggest a good correlation between participants' reports of complete cessation and thiocyanate levels when variables known to influence thiocyanate determinations have been controlled.27 In addition, our participants had little reason to falsify their smoking status since their $20 deposit was refunded solely for participating in the study, regardless of whether they quit, and since, in contrast to the MRFIT subjects, there was little reason they should try to please telephone interviewers with whom they had no direct personal contact. In summary, self-help materials appeal to smokers who want to quit but do not want to attend a formal program. ***Davis AL, Faust R, Ordentlich M: Clinic Smoking Cessation Programs: A Comparative Study with 12 month followup by the American Lung Association. Paper presented at Fifth World Conference on Smoking and Health, Winnipeg, Canada, July 10-15, While this study showed that continuous abstinence after 12 months was achieved by only 2-5 per cent of the subjects, the rising nonsmoking prevalence rate over the 12-month period demonstrates that smokers keep trying to stop smoking and that some eventually succeed. A maintenance component appears to be more important to success than the particular cessation program. Finally, self-help cessation materials may be recommended readily by physicians and other health care professionals and they have the advantage of being able to reach large numbers of smokers. Although the proportion of quitters is somewhat lower than with methods employing intensive face-to-face encounters, this advantage may be offset by the greater availability, flexibility, and relatively lower cost of self-help intervention. REFERENCES 1. National Cancer Institute: The Smoking Digest. 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6 SELF-HELP SMOKING CESSATION PROGRAMS 23. Tobin MJ, Sackner MA: Monitoring smoking patterns of low and high tar cigarettes with inductive plethysmography. Am Rev Respir Dis 1982; 126: Kaufman DW, Helmrich SP, Rosenberg L, Miettinen OS, Shapiro S: Nicotine and carbon monoxide content of cigarette smoke and the risk of myocardial infarction in young men. N Engl J Med 1983; 308: US Surgeon General: The Health Consequences of Smoking: Chronic Obstructive Lung Disease. A Report of the Surgeon General, HHS Pub No. (PHS) Washington, DC: Govt Printing Office, 1984; Green LW, Rimer B, Bertera R: How cost-effective are smoking cessation methods? In: Schwartz JL (ed): Progress in Smoking Cessation: International Conference on Smoking Cessation, New York, June 21-23, New York: American Cancer Society, 1978; Hughes GH, Hymowitz N, Ockene JK, Simon N, Vogt TM: The multiple risk factor intervention trial (MRFIT): V. intervention on smoking. Prev Med 1981; 10: ACKNOWLEDGMENTS Portions of this paper were presented by Dr. Davis at the Fifth World Conference on Smoking and Health, Winnipeg, Canada, July 12, TAKE A DAY OFF FROM SMOKING NOVEMBER 15,1984 Ameican ADVERTISERS' INDEX American Journal of Public Health November 1984 Academic Press, Inc Agency: Flamm Advertising, Inc. Bolchazy Carducci Publishers CMHC Systems, Inc A, 1218B, 1219 Agency: The Corporate Design Center, Inc. Dupont , 1195 Agency: Barnum Communications, Inc. Eckstein Brothers, Inc Harvard University Press Agency: Quinn and Johnson Innomed cover 3 Agency: Perter Forstenzer, Inc. Lea and Febiger Milner-Fenwick C. V. Mosby Agency: CVM Agency National Heart, Lung, and Blood Institute Agency: National Audiovisual Center Pfipharmecs , 1203 Agency: S. J. Weinstein Associates, Inc. Reed and Carnrick... cover 2, 1187 Agency: MED Communications Ross Laboratories Agency: Howard Swink Advertising Springer Publishing Agency: Henry E. Salloch Smith-Sternau Agency: Henry J. Kaufman & Associates, Inc. Texas Instruments Agency: The Corporate Design Center, Inc. Norcliff Thayer , 1211 Agency: Carrafiello, Diehl & Associates, Inc. Charles C Thomas Agency: Thomas Advertising Agency Welch Allyn.1204 Agency: WAC Advertising Ltd. Wyeth Laboratories..... cover 4 Agency: Kallir, Philips, Ross, Inc. Youngs Drug Agency: Poppe Tyson, Inc. AJPH November 1984, Vol. 74, No