The International Journal of the Addictions, 26(1), 107-1 19, 1991

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Research Note

The Effects of Counseling on Smoking Cessation Among Patients Hospitalized With Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial Linda L. Pedetson,* PhD Department of Epidemiology and Biostatistics Departments of Medicine, Victoria Hospital The University of Western Ontario

James M. Wanklin, PhD Department of Epidemiology and Biostatistics The University of Western Ontario

Neville M. Lefcoe, MD Departments of Medicine, Victoria Hospital The University of Western Ontario

Abstract

Seventy-four cigarette-smoking patients admitted with COPD to the Chest Unit of a 600-bedteachinghospital served as subjectsfor a random*To whom correspondenceand reprint requestsshould be addressed:Associate Professor, Department of Epidemiology and Biostatistics, Kresge Building, The University of Western Ontario, London, Ontario, Canada N6A 5C I. 107

Copyright @ 1991 by Marcel Dekker, Inc.

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PEDERSON,WANKLIN, AND LEFCOE

ized trial of smoking cessation counseling. All patients were advised to quit smoking and smoking in the unit was not allowed. One-half of the patients were, in addition, provided with a self-help manual and three to eight 15- to 20-min counseling sessions on alternate days while in hospital. Self-reports of smoking status were obtained at 3 and 6 months, a sample of which were validated with serum COHb. The results were disappointing. Differences between the counseled group and the controls both in rates of cessation at 6 months (33.3% vs 21.4%) and, for patients still smoking, reductions in amount smoked would have lacked practical significance even if statistical significance had been obtained. Some altemative treatment approaches are suggested for this group of patients. Key W o r k . Clinical trial; COPD patients; Smoking cessation

INTRODUCTION Evidence is continuing to accumulate that in groups of patients with severe respiratory disease, there is less rapid decline in lung function upon cessation of smoking (Buist et al., 1976, 1979; Kass et al., 1975; Rose et al., 1982; Tashkin et al., 1984; USDHHS, 1984). This is demonstrated by less nasal obstruction, cough, dyspnoea, and phlegm production, and significantly less decline in indices of small airways disease for quitters as compared to continuing smokers. In addition to favorable changes in morbidity, lower rates of mortality from lung cancer and coronary heart disease have been reported for quitters (USDHHS,1984). However, attempts to develop effective programs for these patients have met with only limited success. Routine physician advice on the importance of quitting smoking for the course of the disease has resulted in long-term cessation rates of approximately 20% (Pederson, 1982,1984). Even programs that have included information on exercise, behavior modification techniques and health motivation given by physicians, nurses, or psychologists have not markedly improved this general finding (British Thoracic Society, 1983; Campbell et al., 1986; Hall et al., 1983; Pederson et al., 1983; Raw and Friend, 1985; Rose et a]., 1982; Turner et al., 1985). In spite of an overall failure to develop effective cessation techniques for these patients, there continues to be information in the literature for physicians on ways to offer assistance such as active support, the provisions of educational material on smoking and health, and the use of nicotine chewing gum (American College of Chest Physicians, 1984; Ebert and McNabb, 1984; Francis et al., 1984; Sachs, l983,1984a, 1984b). While the suggested programs are based on techniques found to be effective for the general population smoker who wishes to quit, they appear to

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offer little to the individual who is experiencing, firsthand, the health effects of his or her habit. Both because of the demonstrated reduction in disease risk and because of the expressed desires of respiratory patients for assistance (Knudsen et al., 1985; Lefcoe et al., 1988), there is a need to continue the development and evaluation of programs for these patients. One lead comes from studies of patients who have experienced a myocardial infarction (MI-British Thoracic Society, 1984;Burling et al., 1982, 1984; Pederson, 1984; USDHHS,1983). Here, while the results vary, a substantial number of these patients have been found to quit smoking while in hospital and, especially in the face of a severe MI, maintain abstinence for periods of up to 5 years (Baile et al., 1982; Ockene et al., 1985; Rigotti and Tesar, 1985). Therefore, it was felt that patients with respiratory disease who were hospitalized because of acute exacerbations of their condition might be in a situation analogous to that of the post-MI patients, and be more amenable to quitting smoking. The purpose of this research was, then, to evaluate in a randomized clinical trial the effectiveness of repeated supportive counseling offered to hospitalized patients.

STUDY METHODS Subjects

Subjects for the trial were cigarette-smoking patients admitted to the Chest Unit of a 600-bed teaching hospital. Criterion for selection was previously diagnosed COPD as defined by the ACCP-ATS Joint Committee on Pulmonary Nomenclature (American College of Chest Physicians and American Thoracic Society, 1975). They were admitted by one of three chest specialists who staffed the unit for exacerbation of their COPD and not for the purpose of participation in this study. They were, however, informed that, if they agreed, they would be randomized and possibly be visited by a counsellor who would try to help them quit smoking permanently. Suggestions of congestive heart failure and other acute disease were exclusion criteria. P C Owas ~ elevated (greater than 45 torr) on admission in 13.82, mean Po, was 65.40 torr (SD= 10.24), and mean FEVl.O/FVC was 0.52 (SD = 0.17). All were current smokers and, therefore, none were on home oxygen-not even oxygen concentrator. Sample-size requirements were set at comparison groups of 37 patients each, and 87 eligible patients had to be approached in order to obtain 74 who agreed to participate. Of the 74 patients, 43% were diagnosed as having chronic bronchitis, and the remaining 57% as having emphysema. Table 1 presents descriptive information on the smoking history and sociodemographic characteristics of the patients. The group consisted of 5 l males and 23 females, and ranged in age from 19 years to 78 years, with a mean age of 53.4 years (SD = 13.7). Sixty percent were currently married or living in a common-lawarrangement, and 33 Ihad completed

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Table 1 Sociodemographic Characteristics, Diagnosis, and Smoking History

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Sociodemographic Characteristics

Age in years Blishen SES Number of children Number of children at home

Mean

SD

53.4 36.2 2.3 0.5

13.7 11.2 1.8 0.9

Frequency

%

~~

Sex Male Female Education completed Elementary school Some high school Completed high school Trade school Some university University degree

51 23

68.9 31.1

23 26 9

31.5 35.6 12.3 9.6 8.2 2.7

7 6

2

Employment status Not employed outside home Employed outside home Retired Student Disabled Unemployed

11 27 17 2

10 4

Marital status MarriedJcommon-law Never married Widowed Divorced Separated

44 8

7 6 8

15.5 38.0 23.9 2.8 14.1 5.6 60.3 11.0 9.6 8.2 11.0

Primary Diagnosis Frequency Chronic bronchitis Emphysema Asthma

3 1 5

% 4.1 1.4 6.8

(continued)

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SMOKING CESSATION IN COPD PATIENTS Table 1 (continued)

Primary Diagnosis

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Frequency COPD-not specified Pneumonia & TB Miscellaneous respiratory disease.

15 8

42

I 20.3 10.8 56.8

Smoking History Frequency0 Years as a smoker Less than 5 years 5 to 19 years 20 to 39 years Over 40 years Amount smoked per day 1 to 10 11 to20 21 to40 Over 40

Main reason for smoking Enjoyment Relaxation Avoidance of withdrawal Habitual

%

3 13 29 27

4.2 18.1 40.3 37.5

5 31 33 2

7 .o 43.7 46.5 2.8

23 25 9 14

32.4 35.2 12.7 19.7

18 52

25.7 74.3

1 13 21 10 7 18

1.4 18.6 30 14.3 10.0 25.7

Previous quitting

No YeS

Longest time quit Less than 1 day 1 to 7 days > 1 week but c4 months 4 months to 1 year More than 1 year Did not try to quit

owhere the frequencies for a variable do not equal 74, it is because some items were not completed by the patients.

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high school or beyond. Less than half of the patients were employed outside their homes (36.5%), and on average their socioeconomic status was middle class (Blishen Socioeconomic Index = 36.2, SD = 11.2-Blishen and McRoberts, 1976).Most (82.4%) had smoked for 20 years or more, and over 75% smoked 20 or more cigarettes a day. With regard to sample-size requirements, the results of earlier studies on outpatients with COPD who were advised to quit smoking had indicated that a cessation rate in the control group of about 15% could be anticipated (Pederson, 1984).It was felt that an improvementto at least 50%might be reasonable because this was the cessation rate commonly found in patients who had been hospitalized with an MI and advised to quit smoking (Burling et al., 1984; Pederson, 1984). With comparison groups of 37 subjects each, there would be an 80% chance of being able to establish such a difference at the 5% level of statistical significance (a= 0.05,l-p = 0.80).

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x

Procedures All patients were advised to quit smoking by their physicians prior to admission to the Chest Unit. Smoking was not permitted in the unit, and the patients were informed of this prior to admission. Informed consent for the study was obtained by the physician; random assignment and subsequent measurement and treatment followed admission. All patients who were asked to participate initially agreed to do so. However, 7 patients left hospital before the first treatment visit and 6 refused to participate once they were in hospital.An unknown number of patients was not asked to participate mainly because the consulting physician did not remember to request consent. While there was no evidence that requests to consent were in any way related to such things as the severity of the condition or the physician's perception of likelihood of success, selection bias of this kind cannot be completely ruled out. It is possible, therefore, that the sample of participants was not fully representative of all COPD patients who smoke and who are admitted to hospital because of their medical status. The treatment group was initially visited 48 hours after admission to hospital by an assistant who was not a trained health care or counselling professional, but who had been given specific training on how to handle cessation of smoking and withdrawal among patients with COPD. They were visited Gn alternate days for the duration of their hospital stay. During the first visit, they were provided with a selfhelp smoking cessation manual(Pomer1eau and Pomerleau, 1977)and instructed in its use. The manual provided information on reasons for smoking, techniques for gradual reduction, recordkeeping,coping with withdrawal symptoms, and what to do if recidivism occurred. The manual was written in easy to understand language and, in spite of the limited usefulness with COPD outpatients (Pederson et al.,

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1983), it was felt that inpatients might be more amenable to changing their smoking behavior. They were asked to fill out a questionnaire (see Note 1) on their smoking history, desire to quit smoking, health beliefs about smoking, preventive health practices, and sociodemographic characteristics. This questionnaire had been used in previous studies with COPD patients (Pederson et al., 1982,1984,1988’ Pederson and Baskerville, 1983). It took 10 to 15 min to complete and no problems with completion were noted. Pulmonary function tests were routinely done on all patients and blood was drawn for analysis of carboxyhemoglobin (COHb).COHb was used to validate smoking status rather than saliva thiocyanate or cotinine, both of which have a longer half-life, for reasons of cost (see Note 2) and because it was easier to camouflage the purpose of the test using a blood sample than asking for a saliva sample. Follow-up visits were used to offer support and encouragement, and to deal with any questions or concerns the patient might have about the manual and/or quitting smoking. There was no predetermined content for these visits. They were entirely responsive to the patients’ needs and questions. Questions were most often about the type and duration of withdrawal symptoms, and not about information contained in the manual. The number of 15- to 20-min visits varied from two to eight 3.0),and was dependent on the length of time the patient was hospitalized. Subjects assigned to the control group were visited once and were asked only to fill out the questionnaire. Physicians were blinded as to group membership. They provided information on diagnosis, a lileasure of the strength of their advice to the patient, and their prediction about whether the patient would be abstinent from cigarettes in 6 months. Self-reported smoking status was assessed at 3 and 6 months after admission to the study by means of a telephone interview. Follow-up of 6 months is recommended in evaluations of smoking cessation techniques (Schwartz, 1987),because most recidivism occurs in the first 3 to 6 months following treatment. Individuals reporting successful quitting were asked about how long they had been abstinent. Patients in the treatment group were questioned about their use of the self-help manual, and how helpful they felt it to be. The accuracy of reports of smoking status was assessed using COHb analysis from blood samples drawn at 6-month follow-up examinations at the hospital. Not all patients could be examined at the hospital because of geographic distance and degree of disability from their disease. Of those who could be examined, a random sample of 20 (13 reported smokers and 7 reported nonsmokers) was drawn for this assessment. Blood drawing occurred less than a week after contact and the patient was not informed as to its purpose-only that it was part of a routine follow-up.

(x=

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RESULTS Response rates at follow-up were similar for the two groups. At 3 months, 2 patients in the treatment group had died, 1 from congestive heart failure and 1from cancer of the lung; and 3 were lost to follow-up. Three patients in the control group had died (1 from multiorgan failure and sepsis, and 2 from cancer of the lung), and 3 were lost to follow-up. At 6 months 2 additional treated patients were lost to follow-up and 3 control patients died from cancer of the lung. When comparisons were made between those who provided follow-up information and those who did not, only one statistically significant difference was found for the variables measured on the initial visit. Those who were followed at 6 months had more often expressed the belief that quitting smoking would lead to improvement in their health status (xi = 14.85, p < 0.05). Analyses were carried out in order to determine if there were any differences between the treatment and control groups on the variables measured at admission to the hospital. No differences of either practical or statistical significance were found. Abstainers in the two groups at 3 and 6 months posttreatment are shown in Table 2. Observed differences in rates of cessation were small, and chi-square tests revealed that none attained statistical significance. Only 38.5% of the treatment group reported using the manual at the 3-month follow-up and only 12% reported using it at the 6-month follow-up. There was, in addition, no evidencethat either the reported use or the perceived helpfulness of the manual, or the number of visits by the research assistant were in any way related to successful abstinence. In addition to questions on cessation of smoking, patients who were not abstinent were asked about amount smoked per day at follow-up. Most patients reported reduction of 20 or more cigarettes a day, but with reductions reported by 86.2% of the treated patients and 77.8% of the controls, the two groups again did not differ = 4.26, p > 0.05). significantly With one exception, the results of the COHb analyses were in agreement with the verbal reports. All of the 13 reported smokers, but only 1 of the 7 reported nonsmokers, had a COHb level over the 2.0% cutoff used to categorize a nonsmoker (Cohen and Bartsch, 1980). Mean COHb was 1.28 (SD= 1.47) for the entire group of 20 who were tested. Additional analyses were carried out in order to determine if any of the information provided on the initial questionnaire could be used to predict successful abstinence. Because no statistically significant differences had been found between the two groups, they were combined for these analyses. There was a tendency for the group of patients with initial Pco2 values of 46 torr or more to be more likely to quit smoking successfully than those with 45 torr

115

SMOKING CESSATION IN COPD PATIENTS Table 2

Abstention Rates for the Treatment and Control Groups at the 3- and 6-Month Follow-ups

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Treatment group

Still smoking Quit smoking less than 3 months Quit smoking more than 3 months but less than 6 months

3-month follow-up

6-month follow-up

%month follow-up

20 (62.5%)

20 (66.7%)

17 (54.8%)

19 (67.9%)

1

0

4 (12.9%)

(3.6%)

10 (32.2%)

2 (7.1%)

(3.1%) 11 (34.4%)

Quit smoking 6 months

Totals

Control Group

0

10

32 (100.0%)

-

6-month follow-up

1

6

A2Lm

-

-GU.&%d

30

31 (99.9%)

28 (100.0%)

(100.0%)

or less (x2 = 2.83,~ = -09).No such trend was observed for other initial pulmonary function measures. Successful quitters at 6 months tended to be older-than those who continued to smoke (Xage quitters = 58.2 years as compared to X age smokers = 51.5 years), although the difference failed to attain statistical significance (t * 1.76, DF = 56, 0.10> p > 0.05). Prediction by the patient about future smoking status, reported desire to quit, educational level, sex, socioeconomic status, and marital status were not related.

DISCUSSION Variables such as patient prediction, socioeconomic status, and sex have been found to be related in previous research on similar patients (Campbell, 1985; Daughton et al., 1980;Dudley et al., 1975;Pederson et al., 1982,1983,1984,1988; Pederson and Baskerville, 1983).This failure to find similar relationships may be due, in part, to a lack of power because of the small sample size and, in part, to some fundamental differences between the participants in this and earlier studies. Individuals in the present study tended to be older and more incapacitated by their ill-

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PEDERSON,WANKLIN, AND LEFCOE

nesses, as evidenced by the fact that they were hospitalized as opposed to being treated on an outpatient basis. While evidence indicates that patients hospitalized following a severe myocardial infarction achieve successful long-term abstinence from smoking (British Thoracic Society, 1984; Burling et al., 1982, 1984; Pederson, 1984; USDHHS, 1983), patients with COPD hospitalized because of acute exacerbations of their disease do not appear as likely to benefit from the active intervention employed in this study. Among the explanations that come to mind are the possibilities that COPD patients do not perceive their disease as life threatening, as do post-MI patients, or that the quit-smoking advice given to the COPD patients is somehow different both qualitatively and quantitatively from that given to the post-MI patient. A third possibility is that hospitalized COPD patients represent a particularly difficult group with which to work. Unlike patients hospitalized with an MI for whom onset usually is sudden, COPD patients still smoking at the time of hospitalization have obviously continued to smoke in spite of experiencing some pulmonary distress and may, therefore, differ from MI patients in terms of their reasons for smoking. Clearly the observed difference in long-term cessation rates between treated patients and their controls (33.3% vs 21.4%) fell far short of statistical significance, and far short of the 35 percentage points taken as the criterion for clinical significance. On the other hand, it will be recalled that sample-size requirements were not fully met, and in fact the upper limit of a 95 Iconfidence interval approximates 35 percentage points. Thus, while the results were less than encouraging, they were, at the same time, somewhat equivocal. Perhaps a different type of intervention would have been more effective. A more intense program could have included group counseling and an exercise regimen which continued after discharge from the hospital. It could also have added support from significant others who had been trained in smoking cessation techniques and/or who had entered into a contract with the patient about their role in the process. In addition, it may be that a self-help manual specifically designed for the patient with COPD with advice and information relevant to this group would have been more useful. Such a manual could provide a rationale for self-help techniques by explaining that the patient is responsible for hisher behavior and by providing skills to deal with recidivism. This would prepare the individual for continuing with the process after leaving the hospital. Also, other techniques such as rapid smoking and/or nicotine gum have been shown to be effective with cardiopulmonary patients (Hall et al., 1984) and could be incorporated into interventions with patients with COPD. Questions of cost and feasibility should, of course, be kept in mind when more ambitious interventions such as these are considered.

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Finally, any such evaluation should seek to identify the kinds of COPD patients for whom a particular intervention works best. The objective would be the ability to direct patients to the intervention most likely to result in success.

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ACKNOWLEDGMENTS The writers thank Mrs. Gloria Murphy for visiting the patients in the hospital and providing them with support and information, for carrying out the follow-ups, and for coding the data for analysis.

NOTES 1.

Questionnaires are available from the f m t author upon request.

2.

This research was carried out without having applied for research funding.

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The effects of counseling on smoking cessation among patients hospitalized with chronic obstructive pulmonary disease: a randomized clinical trial.

Seventy-four cigarette-smoking patients admitted with COPD to the Chest Unit of a 600-bed teaching hospital served as subjects for a randomized trial ...
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