Health Education Research, Vol. 15, No. 4, 491-502,
August 2000
© 2000 Oxford University Press
A pilot study to establish a randomized trial methodology to test the efficacy of a behavioural intervention
1 Scottish Cot Death Trust, and
2 Paediatric Epidemiology and Community Health (PEACH) Unit, Department of Child Health, Royal Hospital for Sick Children, Yorkhill, Glasgow University, Glasgow G3 8SJ, UK,
3 Department of Obstetrics and Gynaecology, and
4 Haematology Department, Yorkhill NHS Trust, Yorkhill, Glasgow University, Glasgow G3 8SJ, UK,
5 No Smoking Day, Unit 203, 16 Baldwins Gardens, London EC1N 7RJ, UK,
6 Department of Public Health, Glasgow University, Glasgow G12 8QQ, UK,
7 Family Education Services, Christchurch, New Zealand and
8 Health Promotion Department, Greater Glasgow Health Board, Dalian House, PO Box 15328, 350 St Vincent Street, Glasgow G3 8YY, UK
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Abstract |
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How can pregnant women be helped to stop smoking? This was a pilot study of midwife home-based motivational interviewing. Clients were 100 consecutive self-reported smokers booking at clinics in Glasgow from March to May 1997. Smoking guidance is routinely given at booking. In addition, intervention clients received a median of four home-based motivational interviewing sessions from one specially trained midwife. All sessions (n = 171) were audio-taped and interviews (n = 49) from 13 randomly selected clients were transcribed for content analysis. Three `experts' assessed intervention quality using a recognized rating scale. Cotinine measurement on routine blood samples confirmed self-reported smoking change from late pregnancy telephone interview. Postnatal telephone questionnaire measured client satisfaction. Focus groups of routine midwives explored acceptability, problems and disruption of normal care. Fisher exact,
2 and Mann–Whitney tests compared enrolment characteristics. Two-sample t-tests assessed outcome between groups. Motivational interviewing was satisfactory in more than 75% of transcribed interviews. In this pilot study, self-reported smoking at booking (100 of 100 available) corroborated by cotinine (93 of 100) compared with late pregnancy self-reports (intervention 47 of 48; control 49 of 49) and cotinine (intervention 46 of 48; control 47 of 49) showed no significant difference between groups. Tools have been developed to answer the question: `Can proactive opportunistic home-based motivational interviewing help pregnant smokers reduce their habit?'. |
Introduction |
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Rationale
Smoking must be tackled to improve health in the UK (Bartecchi, 1994). A proactive therapeutic approach is required as most smokers never ask for help (DiClemente and Prochaska, 1998
). Opportunistic intervention during routine consultation can be cost-effective (Russell et al., 1979). Approximately one-third of pregnant women smoke (Royal College of Physicians, 1992); only one in four quit while pregnant (Owen et al., 1998). Two-thirds of quitters have done so by maternity booking and one-third [7.5% of pregnant smokers (NHS Centre for Reviews and Dissemination, 1998)] give up between booking and delivery. The prevalence of smoking and quitting is unchanged from 1992 to 1997, despite mass media campaigns (Owen et al., 1998).
How smokers quit
`Stages of Change' have been described where 40% of smokers are in the precontemplation stage (not thinking of making a change in the next 6 months), 40% in contemplation (seriously thinking of making a change in the next 6 months but not the next month) and 20% in preparation (considering change in the next month) (DiClemente and Prochaska, 1998). During action the behaviour change is made. If successful for 3–6 months, the individual moves into maintenance, where behaviour change is integrated into lifestyle. Once integrated, the individual can terminate the `process' and the change is said to be permanent. Often relapse takes place from any stage to an earlier stage. A common relapse is when a smoker who has quit for a month (action stage) starts again, moving back to contemplation. At least two attempts are usually made before a smoker quits permanently (DiClemente and Prochaska, 1982).
How to help
Interventions during pregnancy can reduce smoking and increase birthweight (Lumley et al., 1998). However, a number of questions still remain.
Is intensive intervention, i.e. repeated individual counselling (Sexton and Hebel, 1984), more cost-effective than minimal intervention, i.e. a letter from your obstetrician telling you to stop smoking (Burling et al., 1991), or an intermediate intervention, i.e. one 15 min counselling session at maternity booking (Windsor et al., 1985)? The present study elected to use intensive intervention as an application for a study of intermediate intervention failed because the funding committee felt it would not work.
Who should provide intervention, `a female with Bachelors Degree in Community Health Education' (Windsor et al., 1985), a trained lay person, (Gielen et al., 1997), a doctor (Secker-Walker et al., 1992) or a midwife also providing routine care (Kendrick et al., 1995)? The present study used a dedicated midwife in the client's home. Community midwives visit homes providing the opportunity for integration into routine care.
What counselling style should be used? Style is important to protect the patient–health care worker relationship (Butler et al., 1998). Authoritarian `active–passive' (parent–infant) style, typical of doctors and nurses (Burling et al., 1991), may evoke resistance which can be counterproductive (Miller and Sovereign, 1989). Resistance may mean an effective intervention (Russell et al., 1979) is not used. Working class women are more receptive to information sharing than being told what to do (Stott and Pill, 1990). Cognitive behaviour therapy or skills training (Rollnick et al., 1997) is only useful for preparation stage smokers who present for help (20%). The present study used motivational interviewing, which has strategies for every `Stage of Change', important for a proactive opportunistic intervention.
Motivational interviewing
Motivational interviewing, designed for addictive behaviours, is widely advocated building on Prochaska and DiClemente's `Stages of Change' (Miller and Rollnick, 1991). It may be more effective than authoritarian styles (Miller et al., 1993), being client-centred with `mutual participation' (Szasz and Hollender, 1956). Client's decisions about behaviour change are supported and guided by the therapist. Encouraging trials (Noonan and Moyers, 1997) have focused on alcohol addiction (Handmaker et al., 1999), with a psychologist providing intervention.
A psychologist may adapt to motivational methods, but doctors and nurses are traditionally authoritarian with little patient participation to limit the length of consultation. Changing style is difficult and may only be achieved during primary medical or nursing training. Motivational interviewing must first prove effective as a proactive opportunistic counselling style to negotiate behaviour change in various health care settings. Behavioural interventions are expensive and need randomized controlled trials (RCTs) to make sure they work (Stephenson and Imrie, 1998). The only trial of motivational interviewing with pregnant smokers was not completed (Gleeson et al., 1997) due to administrative problems with funding.
Documenting intervention process
Many smoking cessation studies have not documented process (Lumley et al., 1998), so poor implementation may explain why an intervention worked in some studies and not others. A primary care smoking cessation study (Scott Lennox et al., 1998) showed no effect from motivational interviewing. Poor implementation was blamed even though process was not documented. The same intervention is being disseminated in Glasgow. Documenting process for complex behavioural interventions is challenging. It is simple to measure the number and length of visits, but describing the content is difficult. Field notes can be used; however, bias is less likely by analysing the content of audio-taped interviews. A useful output from documenting process would be a manual to help others copy the intervention.
This study forms part of a programme to establish if proactive opportunistic home-based motivational interviewing by specially trained midwives will help pregnant smokers reduce their habit. This paper describes methods to document process and outcome and gives results of the pilot study.
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Method |
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Local ethics approval was granted.
The study design was a pilot RCT of motivational interviewing delivered in the clients' home by a specially trained midwife.
Funding was granted by the Scottish Cot Death Trust and the Chief Scientist Office.
Midwife training took place during 3 weeks in Christchurch, New Zealand working with S. C. and two lay workers, who have provided home-based motivational interviewing for pregnant smokers for 5 years (Cowan and Ford, 1996). Training involved observation and coaching using video-taped recordings of her own interactions with both acting and real clients.
The client sample was 100 smokers booked at one maternity hospital in Glasgow from March to May 1997 (Figure 1). A pregnant smoker ticked yes to being a smoker on the study information sheet given to all women at booking. The research midwife explained the study and gained written consent.
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Randomization.
The research midwife phoned W. H. G. who allocated to two equal groups using random numbers with stratification into six frames by telephone (yes or no) and deprivation (categories 1 and 2, 3–5 or 6 and 7) (Carstairs, 1991
). Table I gives the random allocation for determinants of smoking cessation.
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The intervention group received motivational interviewing at home with one research midwife. Five principles underlie motivational interviewing: expression of empathy, development of discrepancy, avoiding argumentation, rolling with resistance and supporting self-efficacy. Strategy is matched to `Stage of Change' to help the client move on. The goal negotiated could be to change perhaps smoking rate or to quit. Other antenatal problems were referred to the routine midwife. The control group received normal care. This should include information about smoking at maternity booking. Less than 20% of control or intervention clients recalled being given smoking information at maternity booking (Table I
).
Documenting intervention process.
All home-based interviews (n = 171) were audio-taped using a standard hand-held Grundig Stenocassette 30, and sessions (n = 49) from 13 randomly selected clients were transcribed and read to assess conversation about smoking. Intervention quality was measured using a rating scale developed by Miller (Miller and Rollnick, 1991). Raters listened three times (three passes). Pass 1 (global assessment measured on a seven-point Likert scale) and pass 2 (detailed categorization of each therapist and client utterance) were performed by three raters: a psychiatric nurse (F. Cu.) trained in cognitive-behavioural therapy and two Senior Health Promotion Officers (D. M. and F. Cr.) who teach motivational interviewing. Pass 3 (percent therapist talk time) was measured by D. M. T. using a stop watch. Dr S Rollnick (Miller and Rollnick, 1991) oversaw application of Miller's rating scale. F. Cu., D. M. and F. Cr. used some interviews to learn the rating scale, then independently assessed 32 interviews/transcripts to document reproducibility. Use and reproducibility of the rating scale is the subject of a further article (Tappin et al., 2000). The research midwife telephoned intervention mothers postnatally for their views using a structured interview. Questions were: `How has the programme been for you?', `What have been the good things about the programme for you?', `What have been the not so good things about the programme for you?', `Would you recommend it to others?', `What would you suggest to improve the programme?'. Focus groups of routine community midwives discussed the programme.
Impact was defined as movement from booking (face-to-face), to late pregnancy (telephone) in `Readiness to change' for both intervention and control clients.
Assessment by the client of readiness to change:
- Not ready to change anything.
- Not sure what I am ready for.
- Ready to make changes but not quit.
- Ready to quit.
- (quit) Late pregnancy only.
This impact evaluation was flawed, so five intervention and five control clients were used to develop another late telephone questionnaire (Figure 2).
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Outcome evaluation.
Face-to-face interview at booking (median 14 weeks gestation) and telephone interview in late pregnancy (median 36 weeks gestation) used the same question (`How many cigarettes did you smoke yesterday?') to measure self-reported change in smoking habit. The timing of the late pregnancy interview depended on the availability of a routine pregnancy blood sample and one `late' pregnancy telephone interview was performed in the second trimester at 20 weeks gestation, the rest were performed in the third trimester at greater than 27 weeks gestation. The time between the blood sample and telephone interview was a median of 1 day, upper quartile 6 days, lower quartile 1 day. R. W. set up a computer tag on all 100 enrolees. When a sample arrived (routinely a Group & Coombs test in late pregnancy) it was put aside for cotinine testing. Residual samples were stored frozen at –10°C prior to cotinine analysis using gas–liquid chromatography at ABS Laboratories Medical Toxicology Unit (London, UK) (Feyerabend and Russell, 1990
). Cotinine, a nicotine metabolite with a 20 h half-life, remains in the bloodstream for 3–4 days after the last cigarette. A quit self-report was corroborated by a cotinine level below 15 ng/ml (Cummings and Richard, 1988).
Analysis was performed on an intention to treat basis. Changes in the self-reported cigarettes smoked and the cotinine level from booking to late pregnancy were compared between intervention and control groups using two-sample t-tests. Fisher exact, 2, Mann–Whitney and two-sample t-tests were used elsewhere as appropriate.
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Results |
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Process evaluation
One control and one intervention client moved away. Another intervention client was lost (Figure 1
) to miscarriage. Two others had no visits, both had phones but were not contactable after repeated calls and visits. A median of four counselling sessions were given to each intervention client, depending on needs and availability (Figure 3a). Total counselling time had a median of 2.5 h (Figure 3b). Nearly all transcribed interview text was about smoking, lower quartile of 97.5%.
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Raters scored more than 75% of interviews consistent with motivational interviewing (global first pass score 5 or greater) (Table II
). For the second pass analysis, three analysts used 49 interviews from 13 randomly selected clients—a total of 128 interview scores were made. Each utterance by client and midwife was categorized. Table III gives scores per interview for therapist and client behaviours consistent and not consistent with motivational interviewing. Therapist utterances were generally consistent with motivational interviewing—in particular there were very few episodes of warning or confrontation recorded. Client utterances were also consistent, with three times as many self motivational as resistant statements. Pass 3 (percent therapist talk time) was normally distributed with a median of 54% (lower quartile 42, upper quartile 64) and a wide range of 30–84%. The study midwife contacted 37 of 48 intervention mothers postnatally by telephone. No attempts were made to contact seven who gave birth at the end of the study and time ran out. Four could not be contacted. Clients views were positive, 36 of 37 would recommend the programme to friends. Good things were: encouragement (n = 11 clients), not being made to feel guilty (n = 7), home visits (n = 6), being given help (n = 6) and being given information (n = 4). Not so good things were: audio-taping (n = 5), guilt at not reaching their target (n = 3) and staying at home for intervention (n = 3). Suggested improvements were: more visits (4), additional telephone and clinic contact (n = 3), no audio-taping (n = 1), more literature (n = 1) and nicotine patches (n = 1). One client was very intimidating and verbally aggressive to the research midwife. Routine midwives supported the programme, but would have liked more involvement. Control clients had no complaints about not receiving intervention. Routine antenatal care was not disrupted.
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Impact evaluation
Table IV
describes movement, in the clients own assessment of their `readiness to change' smoking habit, between booking and late pregnancy. There was no difference in impact between intervention and control groups. It is interesting to note that readiness to change deteriorated in both intervention and control groups. Perhaps clients at the start were optimistic about their ability to change. Once attempts were made, they became more realistic.
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Outcome evaluation
This showed a greater self-reported reduction in the intervention group (–3.4 cigarettes/day) than the control group (–1.5) which did not reach statistical significance using a two-sample t-test (P = 0.3, 95% CI –1.7/5.6). Residual routine pregnancy samples were available from 45 of 50 intervention clients at booking (mean 136 ng/ml) and 48 of 50 control clients (mean 126 ng/ml). After intervention, samples were available on 46 of 48 intervention clients (mean 122 ng/ml) and 47 of 49 controls (mean 115 ng/ml). For intervention the mean reduction in cotinine from booking to late pregnancy was 8 ng/ml, compared with 19 ng/ml for controls (95% CI –35/12). Table IV
describes the changes. One control client had a cotinine level of 21 ng/ml on the same day as the late pregnancy interview self-report indicated quit. Two intervention clients also had high cotinine (53 and 90 ng/ml) levels with self-report of quit. Overall two of 48 intervention clients quit smoking (cotinine below 15 ng/ml) compared with four of 49 controls (P = 0.67). There was no significant difference in mean birthweight between intervention (3206 g) and control (3271 g) groups (P = 0.55). Five intervention and four control infants were born prematurely (under 37 weeks). One intervention baby was born dead at 27 weeks gestation. |
Discussion |
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This study aimed to pilot a RCT to answer the question `Does motivational interviewing work in this setting?' and to establish a practical tool to answer the question `Did motivational interviewing take place as planned?'.
For tuition in motivational interviewing, the research midwife was sent to New Zealand for 3 weeks to work with a group who provide help for pregnant smokers (Cowan and Ford, 1996). For a future full randomized trial, she will complete a trainers course to teach other midwives motivational interviewing.
Seventy-five percent of self-reported smokers were prepared to take part and clinics were not disrupted. It may be difficult to establish the true smoking rate without performing a biochemically verified prevalence study (Ford et al., 1997). One trial asked all women to blow into a carbon monoxide meter (Burling et al., 1991). In the present pilot study 34% of bookers (133 of 393) classified themselves as smokers. Twenty-five percent of women who gave birth in the same hospital classified themselves as smokers at 10 days postnatal age (Information and Statistics Department, Greater Glasgow Health Board), providing some evidence that pregnant smokers were not missed. A future trial would use a multiple choice approach to maximize disclosure (Dolan Mullen et al., 1991).
Randomization established equal groups (Table I) except for `no support at home'. One variable from 20 is likely to show a significant difference at the 5% level by chance alone. Most clients were severely deprived, categories 6 and 7 (76%), which was thought to affect quit rate (Frost et al., 1994). Telephone (85%) was thought important to arrange home visits.
Two intervention clients were not contactable after repeated appointments and visits, and may have changed their minds about the study. Often with other clients the research midwife made appointments and found nobody in. Eventually most contacts were made by knocking on doors without appointment. This had already turned out to be the most efficient contact method for community midwives in deprived areas of Glasgow.
All intervention interviews were audio-taped and for a random sample of 13 clients interviews were transcribed for process analysis. The identity of these clients was unknown to the therapist, so bias was unlikely. Initially the midwife felt threatened by `experts' listening to audio-taped sessions. Later she felt her standard of motivational interviewing remained high because of audio-taping. The application of Millers' rating tool was overseen by Rollnick (Miller and Rollnick, 1991). The first pass global scale confirmed overall proficiency and more than 75% of interviews had scores 5 or above on a seven-point Likert scale. The second pass looked at individual statements confirming lack of therapist confrontation or warning, and many self motivational statements and little resistance in client responses. It is difficult to know the ideal percent therapist talk time (third pass). The client should lead the interaction in preparation and action stages, but in pre-contemplation and contemplation, the therapist may talk more to move the interaction along. It was clear when listening that it took at least one session for the client to trust the midwife. Constructive work is unlikely until this is achieved, so in Glasgow a single 15 min interview may not be effective. Only one study (Walsh et al., 1997) in the review (Lumley et al., 1998) audio-taped interviews. Length of counselling was reported but quality was not. Miller's rating scale (Tappin et al., 2000) was detailed, having been designed for feedback to student psychologists. It took 160 min to analyse one 30 min interview. The present form of the rating scale would be unworkable to provide quality control for integration into normal practice. Further development is required.
All except one client felt the programme worthwhile. Most thought support and encouragement was important, and that the research midwife had not made them feel guilty. One client who found the intervention difficult would be managed by withdrawing and leaving a contact telephone number, rather than continuing with intervention.
The research midwife reported that clients generally started by changing their smoking habit—delaying the first cigarette in the morning or making the bedroom smoke-free. If successful, this was followed by cutting down and the perhaps quitting. Most intervention clients attempted a number of changes and some made quit attempts. Table IV shows that clients were unable to sustain their initial `Readiness to change' by late pregnancy. Another explanation was that clients moved through all stages and relapsed to behind where they started. `Readiness to change' could not show this important movement. Another late pregnancy telephone interview was developed with the help of five intervention and five control clients (Figure 2). This will provide a better measure of impact, with quit and cut down attempts and movement in `Stage of Change'. The anomaly of staging a first time changer in stage 3, who has never made a quit or cut down attempt, as stage 2, accepts the fact that first time changers often overestimate their abilities.
Enrolled clients were flagged on the laboratory computer and the research midwife was informed when samples reached the laboratory. She then initiated late pregnancy self-report by telephone and quit was verified by a serum cotinine below 15 ng/ml. It is unfortunate that cotinine measurement is necessary (Lumley et al., 1998), but we found three self-reported quitters with cotinine above 15 ng/ml. Lumley (Lumley et al., 1998) suggested the importance of verifying cut down. A crude measure may be a late pregnancy cotinine below half the booking level (Windsor et al., 1993).
Motivational interviewing is becoming part of established practice without adequate evaluation. It is expensive and time consuming, but potential benefits are considerable. Many health care workers are being taught motivational interviewing to help smokers quit. In this study, a midwife provided satisfactory motivational interviewing for pregnant smokers in their homes, within the constraints of a RCT. Procedures for enrolment, randomization, follow-up including late pregnancy residual routine blood samples and assessment of client satisfaction were established. A rating scale to document the process of motivational interviewing has been used successfully. The control quit rate was 8% (n = 4), compared with 4% (n = 2) with intervention. This pilot study had only 14% power to establish an increase in quit rate from 7.5 to 15% (NHS Centre for Reviews and Dissemination, 1998). We cannot conclude that motivational interviewing is not effective in this setting, but a definitive study with sufficient power is needed to show that this widely advocated behavioural intervention actually works in this setting (Stephenson and Imrie, 1998). If no effect is seen in the best of circumstances with plenty of resources, then proactive opportunistic motivational interviewing can be abandoned in this setting and another intervention tried.
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Acknowledgments |
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We would like to thank Professor W. Miller (Departments of Psychology and Psychiatry University of New Mexico) who provided the analysis tool; Steven Rollnick (Senior Lecturer in Psychology University of Wales), Dr Margaret Reid (Reader Department of Public Health Medicine), Professor McEwen (Henry Mechan Chair of Public Health Glasgow University), Dr Rodney Ford (Consultant Community Paediatrician Christchurch New Zealand), The Scottish Cot Death Trust, The Chief Scientist Office, The Yorkhill NHS Trust and all the women who took part.
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Received on October 16, 1999; accepted on February 2, 2000
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