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The effect of patient-centered contraceptive counseling in women who undergo a voluntary termination of pregnancy
Patient Education and Counseling 65 (2007) 361–368 www.elsevier.com/locate/pateducou
The effect of patient-centered contraceptive counseling in women who undergo a voluntary termination of pregnancy§ Maria Patrizia Nobili a,*, Sabrina Piergrossi a, Valentina Brusati b, Egidio Aldo Moja a a
Institute of Medical Psychology, Faculty of Medicine, University of Milan, San Paolo Hospital, Via di Rudinı` 8, 20142 Milan, Italy b Obstetric-Gynaecology Clinic, University of Milan, Italy Received 14 March 2006; received in revised form 12 September 2006; accepted 20 September 2006
Abstract Objective: The aim of the study was to evaluate, by means of a randomized controlled trial, whether a patient-centered contraceptive counseling intervention increased the use of contraception, and the knowledge and positive attitudes towards contraception, in women who undergo a termination of pregnancy (TOP). Methods: The study was carried out at the San Paolo Hospital of Milan between the 1st of February and the 31st of May 2004. Participants (41 women; ages 20–44 years) were randomly divided into two groups: an experimental group (n = 20), who received patient-centered contraceptive counseling, and a control group (n = 21), who received the routine treatment in use at the San Paolo Hospital and were referred to the community health centers after the TOP. Both groups were administered a questionnaire at two points in time (before the counseling and 1 month later) which evaluated participants’ knowledge, attitudes and use of contraception (the latter was also followed up 3 months later). The counseling intervention lasted 30 min and was carried out by a psychologist and a gynaecologist. Results: It was found that knowledge, favorable attitudes and use of effective contraception increased significantly for the experimental group, whereas there was no significant change for the control group. Conclusion: The counseling intervention was therefore found to be efficacious in improving understanding and use of contraception in women who have undergone a TOP. The hope is that this will contribute to increased use of effective contraception in the future. Practice implications: Following the principles of patient-centered medicine, this study provides evidence for the importance of exploring woman’s feelings, beliefs, wishes and expectations regarding contraception within a contraceptive counseling intervention. # 2006 Elsevier Ireland Ltd. All rights reserved. Keywords: Patient-centered; Contraception; Counseling; Educational; Termination of pregnancy; Abortion; Compliance
1. Introduction Induced abortion was legalized in Italy in 1978. After an initial increase in the incidence, from 183,631 in 1979 to 234,801 in 1983 [1], induced abortion steadily decreased to 132,795 in 2003 of which 24% were repeated terminations of pregnancy (TOP). In the same year, 9–10/1000 women of childbearing age (15–49 years) underwent a TOP [2]. It has §
For more information on the Reflective Practice section please see: Hatem D, Rider EA. Sharing stories: narrative medicine in an evidencebased world. Patient Education and Counseling 2004;54:251–253. * Corresponding author. Tel.: +39 02 50323129; fax: +39 02 50323015. E-mail address: [email protected] (M.P. Nobili).
been suggested that lack of information about contraception is one of the main preventable causes of TOP in Italy and that 10–50% of induced abortions might be prevented through education and counselling [3]. In many countries, studies concerning voluntary TOPs and contraception reported that the prevalent use of relatively inadequate or ineffective methods of contraception (withdrawal, spermicides, douche), as well as the failure of effective contraceptive methods (inefficient use of the condom, diarrhoea or vomiting following oral contraceptive consumption) are significant factors contributing to the frequency of induced abortion. These studies underlined the usefulness of counseling and psycho-educational interventions aimed at increasing the use of effective
0738-3991/$ – see front matter # 2006 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.pec.2006.09.004
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contraceptive methods in women who voluntarily undergo a TOP. The ultimate aim of these interventions has been to reduce the incidence, for these women, of future TOPs [4–7]. However, controlled studies which have verified the effectiveness of such interventions are extremely rare. Among the few controlled studies, Fis¸ek and Su¨mbu¨log˘lu [8] measured the effects of an educational intervention on contraception, in rural Turkey. The effectiveness of the intervention was measured in terms of the percentage of effective contraceptive methods adopted following the intervention. Wang et al. [9] measured the effects of an educational intervention on contraception, in a district of Shanghai in China. The effectiveness of the intervention was measured in terms of the reduction in the number of undesired pregnancies and TOPs. In both studies the authors compared a control group (no psycho-educational intervention) with two experimental groups: one in which both the wives and husbands received the educational intervention and another group in which only the wives received the educational intervention. The results of these two studies were partially incongruent. The first study found a significant increase in the use of effective contraceptive methods in both experimental groups. The second study found that, in the experimental group made up of wives and husbands, the number of undesired pregnancies and TOPs diminished, but this change was not significant when compared to the control group. In the experimental group made up of women alone the number of undesired pregnancies and TOPs were higher than the control group, albeit not significantly. These results do not allow for any definitive conclusions on the effectiveness of psychoeducational interventions and of counseling in the field of contraception. Furthermore, in spite of the more or less unanimous opinion regarding the usefulness of counseling to facilitate the use of effective contraceptive methods, the literature does not specifically describe the ways in which these counseling interventions are carried out. For this reason the strategies which may be useful in order to enable behavior modification in this field are not very clear. We wished to verify, using a controlled clinical study, the effects of a patient-centered [10] contraceptive counseling intervention on the knowledge, attitudes and use of contraception in a group of Italian women, living in a large city in the north of Italy, who requested to undergo a TOP. We define patient-centered contraceptive counseling as an intervention in which, following the principles of patientcentered medicine, the woman’s ‘‘agenda’’ regarding contraception is explored, that is her feelings, beliefs, wishes and expectations regarding contraception as well as the environmental, cultural and experiential factors that influence these [10]. The theoretical assumption is that, by exploring each woman’s personal agenda regarding contraception, it is possible to understand the reason that contraception failed previously or was not used and to find
the method that can satisfy each woman’s needs. This should, in turn, increase compliance. Patient-centered counseling has been found to be efficacious in various clinical interventions, such as enhancing long-term dietary adherence [11], engaging patients in behavior change regarding physical activity [12], reducing alcohol consumption in high-risk drinkers [13] and modifying the lifestyles of patients with essential hypertension [14].
2. Methods 2.1. Design This was a prospective randomized controlled trial. The independent variable was whether or not participants received the contraceptive counseling intervention. This variable had two levels, which corresponded to the two groups, experimental and control, into which participants were randomly divided. For every two women one was assigned to the experimental group and the next to the control group, in alternative order. The experimental group received a patient-centered counseling intervention, whereas the control group received treatment as usual. The dependent variable was the effects of the intervention, which were measured by a questionnaire with four areas, constructed by the experimenters and administered to both groups (see Section 2.3). Three areas of the questionnaire were administered at two points in time: at recruitment (Time 0) and 1 month after the TOP (Time 1). Due to the assumption that attitudes and knowledge precede behavior, only the last area of the questionnaire regarding contraceptive use was also administered at a third point in time, 3 months after the TOP (Time 2), in addition to Time 0 and Time 1. 2.2. Participants The present study was carried out at the San Paolo Hospital of Milan, a 600-bed public hospital which is also the site of part of the faculty of Medicine and Surgery at the University of Milan. All women who were over 18 years and of Italian nationality who requested a TOP between the 1st of February and the 31st of May 2004 were invited by the researchers to participate in the study at the time in which they came to the hospital to request the TOP. Women were not admitted to the study if any of the following criteria were present: psychiatric pathology, fetal malformations or insufficient address information for follow-up. Foreign women were also excluded from the study, due to the language and communication difficulties involved. In order to be included in the study all of the women were given detailed information and gave their written informed consent for their participation in the study. The study was approved by the Ethics Committee of the San Paolo Hospital.
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2.3. Materials The results of the study were measured by a questionnaire which was made up of four areas. The first area collected demographic data: date of birth, level of education, occupation, marital status and number of children. The second area was made up of 20 items regarding the knowledge of the use of the following effective contraceptive methods: condoms, contraceptive pill, intrauterine device (IUD), vaginal ring, contraceptive patch and emergency contraception (the morning after pill). The possible responses to these questions were true/false/I do not know. One score was calculated for each correct response. The maximum score which could be obtained was 20. This area of the questionnaire is shown in Appendix A. The third area consisted of 10 items regarding attitudes towards contraceptive methods. The responses to these items were measured on a four-point Likert scale (1 being very negative and 4 being very positive). The maximum score which could be obtained was 40. This area of the questionnaire is shown in Appendix B. The last area recorded the contraceptive method used at that time classifying it as either effective (such as the methods listed above) or ineffective (such as withdrawal or inappropriate natural methods). The full questionnaire was developed to specifically measure the effects of our intervention. It had not been used before nor was it validated, due to time restrictions. It was constructed by the researchers, partly by drawing on the relevant literature, as cited in Section 1. With regards to the second area, which focussed on contraceptive knowledge, we also consulted gynaecologists specializing in contraception regarding which contraceptive methods were to be considered effective or ineffective, which ones to focus on in the intervention, and in the construction of the items on contraceptive knowledge. The third area, regarding attitudes towards contraception, was also based on the theoretical assumptions of patient-centered medicine, which states that compliance and satisfaction increase when taking attitudes into account [10]. Our psycho-educational aim was to increase positive attitudes and correct false beliefs, so as to increase compliance. These items measure this potential change and improvement. The questionnaire was piloted with five women undergoing a TOP to determine its clarity, user-friendliness and face validity. It was then revised appropriately, following the women’s feedback. 2.4. Procedure Following their informed consent, the women were randomly allocated to either a control or to an experimental group. Immediately following their allocation, both groups were administered the four areas of the questionnaire by an interviewer who was ‘blind’ as to which group they were assigned to. The same interviewer administered the same
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questionnaire a second time over the telephone, after 1 month. The potential bias of repeated testing was controlled for by administering the same questionnaire to both the control and the experimental groups. A second telephone call, after 3 months, simply recorded the contraceptive method used. The control group received treatment as usual. This consists in encouraging the women to consult the community health centers after the TOP. No follow-up is carried out to check their actual use of this option. The experimental group took part in a personalized contraceptive counseling intervention of 30 min. This occurred during the week preceding the TOP, and after the first administration of the questionnaire. The counseling intervention was conducted by a psychologist and a gynaecologist and consisted of three phases: a. Patient-centered semi-structured interview (10 min) b. Offer of information and education (15 min) c. Choosing the contraceptive method and checking the understanding (5 min) a. Patient-centered semi-structured interview (10 min) This first part, conducted by the psychologist, aimed to explore the woman’s ‘‘agenda’’ regarding contraception, including her barriers to use, her perceptions of risk and her past and present experiences of contraception. b. Offer of information and education (15 min) This second phase was conducted by a gynecologist who presented the advantages and disadvantages of the available effective contraceptive methods (condom, pill, IUD, vaginal ring, contraceptive patch) as well as explaining how to use them. Information about how to obtain and use emergency contraception was also presented here. c. Choosing the contraceptive method and checking understanding (5 min) In the third phase, conducted by the psychologist, the woman decided which method was the most appropriate for her as a result of the exploration of her agenda and the information obtained in the previous stage. The psychologist and the gynaecologist could also answer any remaining doubts or questions, checking the woman’s understanding and satisfaction with the counseling intervention. 2.5. Analysis The data were analyzed through Statistical Package for Social Scientists (SPSS) 6.0 for Windows. A Mann– Whitney U-test was used to analyze the differences between the control group and the experimental group regarding the following variables: age, years of education, number of children, knowledge and attitudes regarding contraception at the time of recruitment. A Wilcoxon test was used to analyze the differences in the knowledge and attitudes regarding
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contraception both in the control and experimental groups between the time of recruitment and a month after the TOP. A Chi-square test was used to analyze the differences regarding marital status, occupation and use of contraception between the control and the experimental group at the time of recruitment. Finally, a McNemar test was used to analyze the differences between the type of contraceptive method used at recruitment and at 1 month and at 3 months after the TOP, both in the control and in the experimental groups.
3. Results During the recruitment period, 186 women attended the TOP clinic at the San Paolo Hospital. Of these, 113 were foreign (61%) and 3 were below the age of 18 years. Of the 70 women eligible for the study, 43 women participated (61%). Of these, 21 women were assigned to the experimental group and 22 women to the control group. At the first telephone call, a month after the TOP, 20 women from the experimental group and 21 women from the control group answered. The same women answered at the second telephone call, 3 months after the TOP. Our results therefore refer to 20 women from the experimental group and to 21 women from the control group. The sociodemographic characteristics of the two samples are described in Table 1. The control and the experimental groups did not differ in terms of age distribution (U = 182.5; n.s.), years of education (U = 181; n.s.), number of children (U = 206.5; n.s.), marital status, (x2 = 1.46; d.f. = 3; n.s.) or occupation (x2 = 1.51; d.f. = 5; n.s.) (Table 1). At Time 0 (recruitment) there was no significant difference between the two groups in terms of knowledge (U = 193; n.s.) and attitudes (U = 169.5; n.s.) regarding contraception. The counseling intervention described above produced, 1 month later, a highly significant increase in the knowledge of
Table 1 Socio-demographic information for the control and experimental groups Variables
Control group
Experimental group
p-Value
7 12 2
6 13 1
n.s. a n.s. a n.s. a
8 8 5
9 9 2
n.s. a n.s. a n.s. a
Marital status Unmarried Married Separated Widowed
6 11 3 1
8 9 3 1
n.s. b n.s. b n.s. b n.s. b
Number of children 0 1–2 3–4
6 13 2
9 10 1
n.s. a n.s. a n.s. a
Occupation Student Housewife Commerce Office worker Private practice Domestic help
1 3 3 10 2 2
2 4 3 7 3 1
n.s. b n.s. b n.s. b n.s. b n.s. b n.s. b
Age 20–29 30–39 40–44 Years of education 8 9–13 14–18
N.B. The numbers refer to the number of women from each group who fit into a certain category. n.s.: not significant. a Mann–Whitney U-test. b Chi-square test.
contraception in the experimental group (Z = 3.91; p = 0.0001), compared to no significant change in the control group (Z = 1.78; n.s.). Knowledge of contraception was measured through a series of questionnaire items. The mean score for the experimental group increased from 9 to 18 on a scale with a maximum score of 20. The experimental group also showed a highly significant increase in positive
Fig. 1. Mean scores for the questionnaire items regarding knowledge and favorable attitudes towards contraception. These show a significant increase in knowledge and attitudes in the experimental group after 1 month ( p = 0.0001 Wilcoxon’s test). Time 0: at recruitment; Time 1: 1 month after TOP.
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Fig. 2. Number of women from both groups who switched from an effective to an ineffective contraceptive method (and vice versa), from Time 0 to Time 1, and from Time 1 to Time 2. The figure shows a significant increase in the number of women in the experimental group who switched to an effective method (Time 1: p = 0.004 McNemar’s test; Time 2: p = 0.0002 McNemar’s test).
attitudes towards contraception (Z = 3.81; p = 0.0001), compared to no significant change in the control group (Z = 0.83; n.s.). Attitudes towards contraception were measured through a series of questionnaire items. The mean score for the experimental group increased from 30 to 36 on a scale with a maximum score of 40 (Fig. 1). At Time 0, four women (19%) from the control group and four women (20%) from the experimental group were using an effective contraceptive method. At Time 1, 6 women (32%) from the control group and 13 women (65%) from the experimental group were using an effective method. At Time 2, 3 months later, 8 women (38%) from the control group and 16 women (80%) from the experimental group were using an effective method. The statistical analysis showed that the variation between Time 0 and Time 1 (McNemar p = n.s.) and the variation between Time 0 and Time 2 (McNemar p = n.s.) in the control group were not statistically significant. In the experimental group the variation was highly significant both between Time 0 and Time 1 (McNemar p = 0.004) and between Time 0 and Time 2 ( p = 0.0002). At the end of the study eight women from the control group switched from using an ineffective method to using an effective one whereas two switched from an effective to an ineffective one (see Fig. 2). In the experimental group 12 women switched from an ineffective method to an effective one while no woman abandoned an effective method for an ineffective one.
4. Discussion and conclusion 4.1. Discussion The aim of our study was to determine the effect of a patient-centered contraceptive counseling intervention on the knowledge, the attitudes and the use of contraception in Italian women who undergo a TOP.
The results of this study showed that such a counseling intervention produced a significant increase in the women’s knowledge and in their favorable attitudes towards contraception. Prior to the counseling intervention, the majority of women showed a scarce knowledge of the existing contraceptive methods and of their correct use. Such data are in accordance with the literature, which point out that often women do not know how to correctly use the contraceptive method in question or they are not aware of the behaviors that could compromise its efficacy [6]. Furthermore, some of the major problems regarding the use of contraception seem to be due to negative attitudes and false beliefs regarding the risks and benefits of effective contraceptive methods [15], even in women of a higher socio-cultural status [16]. For example, women tend to overestimate the possible health risks of contraception [17]. The increase in positive attitudes in the present study could be partly due to the increase in knowledge, acquired through the counseling intervention. It could also reflect the effect of a patient-centered intervention which, by exploring women’s feelings, attitudes and beliefs about contraception and addressing these cooperatively with each woman, might have enabled women to form more favorable attitudes towards contraception. The results of this study also showed an increase in the number of women who reportedly adopted an effective contraceptive method after the counseling intervention. Our data showed that 3 months after the TOP the percentage of women using an effective contraceptive method went from 20% to 80% in the experimental group, whereas it went from 19% to 38% in the control group. These data are in line with findings reported by the noncontrolled studies by Bulut [4] and Bianchi-Demicheli et al. [5] and by the controlled study by Fis¸ek and Su¨mbu¨log˘lu [8], who respectively found that 86%, 83% and 77% of women, following counseling, were using an effective contraceptive method. A percentage of around 80% of women who decide to use an effective method following a counseling
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intervention, could possibly represent the most improvement one could realistically expect to achieve in educational interventions in this field. In our opinion, two factors contributed to the success of our counseling intervention: the importance of its timing and the attention given to its quality. The first factor consisted in making sure that the counseling happened at the optimal time. In this study the decision of carrying out the contraceptive counseling intervention before the TOP was supported by the observation that women appear to be more motivated to begin the use of a contraceptive method in the period of time which immediately follows the TOP [18] and by the fact that many patients do not attend the post-TOP control appointment with the medical professionals [19]. The second factor refers to the decision to carry out a ‘‘woman-centered’’ counseling intervention, with the assumption that the quality of counseling is a key point for its efficacy [19]. Indeed, a personalized counseling intervention significantly increases not only the use of contraception but also the women’s satisfaction and compliance [20]. Such an affirmation belongs to a cultural understanding which recognizes the central importance of the person in the face of medicine and which offers a patient-centered model of medicine, which is wider than the disease-centered model of medicine. In a patient-centered model of medicine communication and the relationship are tools which are indispensable in order to reach the aims of a clinical intervention [10]. There are a couple of possible limitations to take into account when considering the results of this study. One is the relatively small number of participants, partly due to the exclusion of foreign women from the study (see Section 2 for rationale for these exclusion criteria). Another regards the percentage of women of the experimental group who declared to be using an effective method during the follow-up. The numbers could be influenced by a ‘‘social desirability’’ effect [21] which could have caused women to report the behavior they perceived to be most positive and appreciated in a social context, or according to the answer they believed was most desirable according to the interviewer’s expectations. A further limitation could be due to the paucity of followups, which were carried out only after 1 and 3 months since the TOP. However, despite the few follow-ups, our preliminary findings were encouraging, in that there was a difference between the groups in the pattern of change of contraceptive use. In the control group the pattern appeared disordered and it did not seem to reflect an effective change of contraceptive use. In the experimental group, not only was there an increase in contraceptive use, but also a move away from the use of ineffective to effective contraceptive methods. The importance of carrying out follow-ups to increase women’s compliance with the chosen contraceptive method is underlined by the Royal College of Obstetrics and Gynaecologists [22] and mentioned in many studies [6,18]. The results of our 1- and 3-month follow-ups were promising, nevertheless it
would be useful to carry out more long-term follow-ups to verify and eventually support the continuity of the use of an effective contraceptive method. 4.2. Conclusion In a review of the evidence for the effectiveness of counseling to prevent unintended pregnancy from 1985 to 2000 [23], the authors concluded that all the studies addressing the effectiveness of counseling in changing knowledge, skills and attitudes about contraception and pregnancy did not provide definitive guidance about effective counseling strategies. The studies reviewed had poor internal validity, low response rates at follow-up and were extremely heterogeneous in terms of the sample studied. In the present study we presented a randomized controlled trial with a very high retention rate at follow-up and the inclusion of only women of Italian nationality. Moreover, Moos et al. [23] underlined how little is known about the determinants of contraceptive use because many factors influence contraceptive use and adherence. It may not be possible to control for the number and complexity of such factors. However, we found that a patient-centered contraceptive counseling intervention significantly increased women’s knowledge, favorable attitudes and reported use of contraception, compared to treatment as usual. Our data support the theoretical assumption that the collaborative approach offered by a patient-centered intervention improves compliance. The hope is that the intervention carried out in this study will reduce the incidence, for women who have undergone a TOP, of repeat TOPs in the future. Since 24% of induced abortions in 2003 were repeated TOPs [1], it is important to aim to reduce such repeat TOPs wherever possible. In conclusion, this study constitutes an initial investigation of the effectiveness of a patient-centered contraceptive counseling intervention. The results are promising, however more follow-ups are needed to evaluate the long-term effects of the intervention. 4.3. Practice implications This study offers evidence to suggest that a professional who provides informational/educational programs regarding contraception should consider the importance of exploring woman’s feelings, beliefs, wishes and expectations regarding contraception. The aim of a patient-centered counseling intervention of this kind is to actively involve the person in order to comprehend their needs, expectations and points of view, which affect their feelings and behaviors. The results of this study suggest that a patient-centered counseling intervention improves women’s contraceptive competence, in that it provides them with the knowledge and encourages attitudes that are purposefully based on each woman’s needs, and it increases their use of effective contraception.
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Appendix A
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3. Somewhat 4. Very much so
A.1. Specific knowledge Women are asked to answer ‘‘true’’ or ‘‘false’’, and in the case in which she does not know the contraceptive method in question, she may answer ‘‘I don’t know’’. The questions are the following: 1. The pill taken every day is effective even if you have vomited or had diarrhea after taking it. 2. The IUD can be kept inside for up to 5 years. 3. The vaginal ring must be taken out of the vagina after 21 days. 4. Condoms can be kept near sources of heat. 5. The contraceptive patch must be removed when taking a shower. 6. If you have forgotten the pill 1 day, you must take it within 12 h. 7. It is advisable to have a gynaecologist regularly check that the IUD is still in the correct position. 8. The morning after pill needs to be taken within 72 h from unprotected sexual intercourse. 9. No medication reduces the effectiveness of the vaginal ring. 10. If a condom breaks at any time during sexual intercourse, it is no longer effective. 11. Once having applied the contraceptive patch, you can move it as many times as you like. 12. A woman may insert an IUD by herself. 13. If you have vomited within 3 h of taking the morning after pill, you must take another one immediately. 14. The vaginal ring does not have an expiry date. 15. Condoms must be worn once erect, before any contact between the genitals. 16. The contraceptive patch is applied once a week, for 3 weeks in a row. 17. Some antibiotics reduce the pill’s contraceptive effectiveness. 18. It is advisable to take the morning after pill as soon as possible after unprotected sexual intercourse. 19. A new vaginal ring must be inserted in the vagina 7 days after having taken out the previous one. 20. Condoms do not have an expiry date.
Appendix B B.1. Attitudes The woman is told that she can choose from one of four possible responses: 1. Not at all 2. A little
The questions are the following: 1. Are you informed on the existing contraceptive methods? 2. Do you feel you need further information in order to choose the contraceptive method that is most suitable for you? 3. Do you believe contraceptive methods may be damaging to your health? 4. After unprotected sex, how likely would you be to take the morning after pill? 5. Do you believe that effective contraceptive methods exist? 6. Do you believe that the pill causes you to gain weight? 7. Is withdrawal an effective contraceptive method? 8. Do you believe the pill may cause tumors? 9. Do you believe there are some contraceptive methods which are more suitable for casual sex? 10. Do you believe it is important to keep updated regarding contraceptive methods?
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The effect of patient-centered contraceptive counseling in women who undergo a voluntary termination of pregnancy§ Maria Patrizia Nobili a,*, Sabrina Piergrossi a, Valentina Brusati b, Egidio Aldo Moja a a
Institute of Medical Psychology, Faculty of Medicine, University of Milan, San Paolo Hospital, Via di Rudinı` 8, 20142 Milan, Italy b Obstetric-Gynaecology Clinic, University of Milan, Italy Received 14 March 2006; received in revised form 12 September 2006; accepted 20 September 2006
Abstract Objective: The aim of the study was to evaluate, by means of a randomized controlled trial, whether a patient-centered contraceptive counseling intervention increased the use of contraception, and the knowledge and positive attitudes towards contraception, in women who undergo a termination of pregnancy (TOP). Methods: The study was carried out at the San Paolo Hospital of Milan between the 1st of February and the 31st of May 2004. Participants (41 women; ages 20–44 years) were randomly divided into two groups: an experimental group (n = 20), who received patient-centered contraceptive counseling, and a control group (n = 21), who received the routine treatment in use at the San Paolo Hospital and were referred to the community health centers after the TOP. Both groups were administered a questionnaire at two points in time (before the counseling and 1 month later) which evaluated participants’ knowledge, attitudes and use of contraception (the latter was also followed up 3 months later). The counseling intervention lasted 30 min and was carried out by a psychologist and a gynaecologist. Results: It was found that knowledge, favorable attitudes and use of effective contraception increased significantly for the experimental group, whereas there was no significant change for the control group. Conclusion: The counseling intervention was therefore found to be efficacious in improving understanding and use of contraception in women who have undergone a TOP. The hope is that this will contribute to increased use of effective contraception in the future. Practice implications: Following the principles of patient-centered medicine, this study provides evidence for the importance of exploring woman’s feelings, beliefs, wishes and expectations regarding contraception within a contraceptive counseling intervention. # 2006 Elsevier Ireland Ltd. All rights reserved. Keywords: Patient-centered; Contraception; Counseling; Educational; Termination of pregnancy; Abortion; Compliance
1. Introduction Induced abortion was legalized in Italy in 1978. After an initial increase in the incidence, from 183,631 in 1979 to 234,801 in 1983 [1], induced abortion steadily decreased to 132,795 in 2003 of which 24% were repeated terminations of pregnancy (TOP). In the same year, 9–10/1000 women of childbearing age (15–49 years) underwent a TOP [2]. It has §
For more information on the Reflective Practice section please see: Hatem D, Rider EA. Sharing stories: narrative medicine in an evidencebased world. Patient Education and Counseling 2004;54:251–253. * Corresponding author. Tel.: +39 02 50323129; fax: +39 02 50323015. E-mail address: [email protected] (M.P. Nobili).
been suggested that lack of information about contraception is one of the main preventable causes of TOP in Italy and that 10–50% of induced abortions might be prevented through education and counselling [3]. In many countries, studies concerning voluntary TOPs and contraception reported that the prevalent use of relatively inadequate or ineffective methods of contraception (withdrawal, spermicides, douche), as well as the failure of effective contraceptive methods (inefficient use of the condom, diarrhoea or vomiting following oral contraceptive consumption) are significant factors contributing to the frequency of induced abortion. These studies underlined the usefulness of counseling and psycho-educational interventions aimed at increasing the use of effective
0738-3991/$ – see front matter # 2006 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.pec.2006.09.004
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contraceptive methods in women who voluntarily undergo a TOP. The ultimate aim of these interventions has been to reduce the incidence, for these women, of future TOPs [4–7]. However, controlled studies which have verified the effectiveness of such interventions are extremely rare. Among the few controlled studies, Fis¸ek and Su¨mbu¨log˘lu [8] measured the effects of an educational intervention on contraception, in rural Turkey. The effectiveness of the intervention was measured in terms of the percentage of effective contraceptive methods adopted following the intervention. Wang et al. [9] measured the effects of an educational intervention on contraception, in a district of Shanghai in China. The effectiveness of the intervention was measured in terms of the reduction in the number of undesired pregnancies and TOPs. In both studies the authors compared a control group (no psycho-educational intervention) with two experimental groups: one in which both the wives and husbands received the educational intervention and another group in which only the wives received the educational intervention. The results of these two studies were partially incongruent. The first study found a significant increase in the use of effective contraceptive methods in both experimental groups. The second study found that, in the experimental group made up of wives and husbands, the number of undesired pregnancies and TOPs diminished, but this change was not significant when compared to the control group. In the experimental group made up of women alone the number of undesired pregnancies and TOPs were higher than the control group, albeit not significantly. These results do not allow for any definitive conclusions on the effectiveness of psychoeducational interventions and of counseling in the field of contraception. Furthermore, in spite of the more or less unanimous opinion regarding the usefulness of counseling to facilitate the use of effective contraceptive methods, the literature does not specifically describe the ways in which these counseling interventions are carried out. For this reason the strategies which may be useful in order to enable behavior modification in this field are not very clear. We wished to verify, using a controlled clinical study, the effects of a patient-centered [10] contraceptive counseling intervention on the knowledge, attitudes and use of contraception in a group of Italian women, living in a large city in the north of Italy, who requested to undergo a TOP. We define patient-centered contraceptive counseling as an intervention in which, following the principles of patientcentered medicine, the woman’s ‘‘agenda’’ regarding contraception is explored, that is her feelings, beliefs, wishes and expectations regarding contraception as well as the environmental, cultural and experiential factors that influence these [10]. The theoretical assumption is that, by exploring each woman’s personal agenda regarding contraception, it is possible to understand the reason that contraception failed previously or was not used and to find
the method that can satisfy each woman’s needs. This should, in turn, increase compliance. Patient-centered counseling has been found to be efficacious in various clinical interventions, such as enhancing long-term dietary adherence [11], engaging patients in behavior change regarding physical activity [12], reducing alcohol consumption in high-risk drinkers [13] and modifying the lifestyles of patients with essential hypertension [14].
2. Methods 2.1. Design This was a prospective randomized controlled trial. The independent variable was whether or not participants received the contraceptive counseling intervention. This variable had two levels, which corresponded to the two groups, experimental and control, into which participants were randomly divided. For every two women one was assigned to the experimental group and the next to the control group, in alternative order. The experimental group received a patient-centered counseling intervention, whereas the control group received treatment as usual. The dependent variable was the effects of the intervention, which were measured by a questionnaire with four areas, constructed by the experimenters and administered to both groups (see Section 2.3). Three areas of the questionnaire were administered at two points in time: at recruitment (Time 0) and 1 month after the TOP (Time 1). Due to the assumption that attitudes and knowledge precede behavior, only the last area of the questionnaire regarding contraceptive use was also administered at a third point in time, 3 months after the TOP (Time 2), in addition to Time 0 and Time 1. 2.2. Participants The present study was carried out at the San Paolo Hospital of Milan, a 600-bed public hospital which is also the site of part of the faculty of Medicine and Surgery at the University of Milan. All women who were over 18 years and of Italian nationality who requested a TOP between the 1st of February and the 31st of May 2004 were invited by the researchers to participate in the study at the time in which they came to the hospital to request the TOP. Women were not admitted to the study if any of the following criteria were present: psychiatric pathology, fetal malformations or insufficient address information for follow-up. Foreign women were also excluded from the study, due to the language and communication difficulties involved. In order to be included in the study all of the women were given detailed information and gave their written informed consent for their participation in the study. The study was approved by the Ethics Committee of the San Paolo Hospital.
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2.3. Materials The results of the study were measured by a questionnaire which was made up of four areas. The first area collected demographic data: date of birth, level of education, occupation, marital status and number of children. The second area was made up of 20 items regarding the knowledge of the use of the following effective contraceptive methods: condoms, contraceptive pill, intrauterine device (IUD), vaginal ring, contraceptive patch and emergency contraception (the morning after pill). The possible responses to these questions were true/false/I do not know. One score was calculated for each correct response. The maximum score which could be obtained was 20. This area of the questionnaire is shown in Appendix A. The third area consisted of 10 items regarding attitudes towards contraceptive methods. The responses to these items were measured on a four-point Likert scale (1 being very negative and 4 being very positive). The maximum score which could be obtained was 40. This area of the questionnaire is shown in Appendix B. The last area recorded the contraceptive method used at that time classifying it as either effective (such as the methods listed above) or ineffective (such as withdrawal or inappropriate natural methods). The full questionnaire was developed to specifically measure the effects of our intervention. It had not been used before nor was it validated, due to time restrictions. It was constructed by the researchers, partly by drawing on the relevant literature, as cited in Section 1. With regards to the second area, which focussed on contraceptive knowledge, we also consulted gynaecologists specializing in contraception regarding which contraceptive methods were to be considered effective or ineffective, which ones to focus on in the intervention, and in the construction of the items on contraceptive knowledge. The third area, regarding attitudes towards contraception, was also based on the theoretical assumptions of patient-centered medicine, which states that compliance and satisfaction increase when taking attitudes into account [10]. Our psycho-educational aim was to increase positive attitudes and correct false beliefs, so as to increase compliance. These items measure this potential change and improvement. The questionnaire was piloted with five women undergoing a TOP to determine its clarity, user-friendliness and face validity. It was then revised appropriately, following the women’s feedback. 2.4. Procedure Following their informed consent, the women were randomly allocated to either a control or to an experimental group. Immediately following their allocation, both groups were administered the four areas of the questionnaire by an interviewer who was ‘blind’ as to which group they were assigned to. The same interviewer administered the same
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questionnaire a second time over the telephone, after 1 month. The potential bias of repeated testing was controlled for by administering the same questionnaire to both the control and the experimental groups. A second telephone call, after 3 months, simply recorded the contraceptive method used. The control group received treatment as usual. This consists in encouraging the women to consult the community health centers after the TOP. No follow-up is carried out to check their actual use of this option. The experimental group took part in a personalized contraceptive counseling intervention of 30 min. This occurred during the week preceding the TOP, and after the first administration of the questionnaire. The counseling intervention was conducted by a psychologist and a gynaecologist and consisted of three phases: a. Patient-centered semi-structured interview (10 min) b. Offer of information and education (15 min) c. Choosing the contraceptive method and checking the understanding (5 min) a. Patient-centered semi-structured interview (10 min) This first part, conducted by the psychologist, aimed to explore the woman’s ‘‘agenda’’ regarding contraception, including her barriers to use, her perceptions of risk and her past and present experiences of contraception. b. Offer of information and education (15 min) This second phase was conducted by a gynecologist who presented the advantages and disadvantages of the available effective contraceptive methods (condom, pill, IUD, vaginal ring, contraceptive patch) as well as explaining how to use them. Information about how to obtain and use emergency contraception was also presented here. c. Choosing the contraceptive method and checking understanding (5 min) In the third phase, conducted by the psychologist, the woman decided which method was the most appropriate for her as a result of the exploration of her agenda and the information obtained in the previous stage. The psychologist and the gynaecologist could also answer any remaining doubts or questions, checking the woman’s understanding and satisfaction with the counseling intervention. 2.5. Analysis The data were analyzed through Statistical Package for Social Scientists (SPSS) 6.0 for Windows. A Mann– Whitney U-test was used to analyze the differences between the control group and the experimental group regarding the following variables: age, years of education, number of children, knowledge and attitudes regarding contraception at the time of recruitment. A Wilcoxon test was used to analyze the differences in the knowledge and attitudes regarding
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contraception both in the control and experimental groups between the time of recruitment and a month after the TOP. A Chi-square test was used to analyze the differences regarding marital status, occupation and use of contraception between the control and the experimental group at the time of recruitment. Finally, a McNemar test was used to analyze the differences between the type of contraceptive method used at recruitment and at 1 month and at 3 months after the TOP, both in the control and in the experimental groups.
3. Results During the recruitment period, 186 women attended the TOP clinic at the San Paolo Hospital. Of these, 113 were foreign (61%) and 3 were below the age of 18 years. Of the 70 women eligible for the study, 43 women participated (61%). Of these, 21 women were assigned to the experimental group and 22 women to the control group. At the first telephone call, a month after the TOP, 20 women from the experimental group and 21 women from the control group answered. The same women answered at the second telephone call, 3 months after the TOP. Our results therefore refer to 20 women from the experimental group and to 21 women from the control group. The sociodemographic characteristics of the two samples are described in Table 1. The control and the experimental groups did not differ in terms of age distribution (U = 182.5; n.s.), years of education (U = 181; n.s.), number of children (U = 206.5; n.s.), marital status, (x2 = 1.46; d.f. = 3; n.s.) or occupation (x2 = 1.51; d.f. = 5; n.s.) (Table 1). At Time 0 (recruitment) there was no significant difference between the two groups in terms of knowledge (U = 193; n.s.) and attitudes (U = 169.5; n.s.) regarding contraception. The counseling intervention described above produced, 1 month later, a highly significant increase in the knowledge of
Table 1 Socio-demographic information for the control and experimental groups Variables
Control group
Experimental group
p-Value
7 12 2
6 13 1
n.s. a n.s. a n.s. a
8 8 5
9 9 2
n.s. a n.s. a n.s. a
Marital status Unmarried Married Separated Widowed
6 11 3 1
8 9 3 1
n.s. b n.s. b n.s. b n.s. b
Number of children 0 1–2 3–4
6 13 2
9 10 1
n.s. a n.s. a n.s. a
Occupation Student Housewife Commerce Office worker Private practice Domestic help
1 3 3 10 2 2
2 4 3 7 3 1
n.s. b n.s. b n.s. b n.s. b n.s. b n.s. b
Age 20–29 30–39 40–44 Years of education 8 9–13 14–18
N.B. The numbers refer to the number of women from each group who fit into a certain category. n.s.: not significant. a Mann–Whitney U-test. b Chi-square test.
contraception in the experimental group (Z = 3.91; p = 0.0001), compared to no significant change in the control group (Z = 1.78; n.s.). Knowledge of contraception was measured through a series of questionnaire items. The mean score for the experimental group increased from 9 to 18 on a scale with a maximum score of 20. The experimental group also showed a highly significant increase in positive
Fig. 1. Mean scores for the questionnaire items regarding knowledge and favorable attitudes towards contraception. These show a significant increase in knowledge and attitudes in the experimental group after 1 month ( p = 0.0001 Wilcoxon’s test). Time 0: at recruitment; Time 1: 1 month after TOP.
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Fig. 2. Number of women from both groups who switched from an effective to an ineffective contraceptive method (and vice versa), from Time 0 to Time 1, and from Time 1 to Time 2. The figure shows a significant increase in the number of women in the experimental group who switched to an effective method (Time 1: p = 0.004 McNemar’s test; Time 2: p = 0.0002 McNemar’s test).
attitudes towards contraception (Z = 3.81; p = 0.0001), compared to no significant change in the control group (Z = 0.83; n.s.). Attitudes towards contraception were measured through a series of questionnaire items. The mean score for the experimental group increased from 30 to 36 on a scale with a maximum score of 40 (Fig. 1). At Time 0, four women (19%) from the control group and four women (20%) from the experimental group were using an effective contraceptive method. At Time 1, 6 women (32%) from the control group and 13 women (65%) from the experimental group were using an effective method. At Time 2, 3 months later, 8 women (38%) from the control group and 16 women (80%) from the experimental group were using an effective method. The statistical analysis showed that the variation between Time 0 and Time 1 (McNemar p = n.s.) and the variation between Time 0 and Time 2 (McNemar p = n.s.) in the control group were not statistically significant. In the experimental group the variation was highly significant both between Time 0 and Time 1 (McNemar p = 0.004) and between Time 0 and Time 2 ( p = 0.0002). At the end of the study eight women from the control group switched from using an ineffective method to using an effective one whereas two switched from an effective to an ineffective one (see Fig. 2). In the experimental group 12 women switched from an ineffective method to an effective one while no woman abandoned an effective method for an ineffective one.
4. Discussion and conclusion 4.1. Discussion The aim of our study was to determine the effect of a patient-centered contraceptive counseling intervention on the knowledge, the attitudes and the use of contraception in Italian women who undergo a TOP.
The results of this study showed that such a counseling intervention produced a significant increase in the women’s knowledge and in their favorable attitudes towards contraception. Prior to the counseling intervention, the majority of women showed a scarce knowledge of the existing contraceptive methods and of their correct use. Such data are in accordance with the literature, which point out that often women do not know how to correctly use the contraceptive method in question or they are not aware of the behaviors that could compromise its efficacy [6]. Furthermore, some of the major problems regarding the use of contraception seem to be due to negative attitudes and false beliefs regarding the risks and benefits of effective contraceptive methods [15], even in women of a higher socio-cultural status [16]. For example, women tend to overestimate the possible health risks of contraception [17]. The increase in positive attitudes in the present study could be partly due to the increase in knowledge, acquired through the counseling intervention. It could also reflect the effect of a patient-centered intervention which, by exploring women’s feelings, attitudes and beliefs about contraception and addressing these cooperatively with each woman, might have enabled women to form more favorable attitudes towards contraception. The results of this study also showed an increase in the number of women who reportedly adopted an effective contraceptive method after the counseling intervention. Our data showed that 3 months after the TOP the percentage of women using an effective contraceptive method went from 20% to 80% in the experimental group, whereas it went from 19% to 38% in the control group. These data are in line with findings reported by the noncontrolled studies by Bulut [4] and Bianchi-Demicheli et al. [5] and by the controlled study by Fis¸ek and Su¨mbu¨log˘lu [8], who respectively found that 86%, 83% and 77% of women, following counseling, were using an effective contraceptive method. A percentage of around 80% of women who decide to use an effective method following a counseling
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intervention, could possibly represent the most improvement one could realistically expect to achieve in educational interventions in this field. In our opinion, two factors contributed to the success of our counseling intervention: the importance of its timing and the attention given to its quality. The first factor consisted in making sure that the counseling happened at the optimal time. In this study the decision of carrying out the contraceptive counseling intervention before the TOP was supported by the observation that women appear to be more motivated to begin the use of a contraceptive method in the period of time which immediately follows the TOP [18] and by the fact that many patients do not attend the post-TOP control appointment with the medical professionals [19]. The second factor refers to the decision to carry out a ‘‘woman-centered’’ counseling intervention, with the assumption that the quality of counseling is a key point for its efficacy [19]. Indeed, a personalized counseling intervention significantly increases not only the use of contraception but also the women’s satisfaction and compliance [20]. Such an affirmation belongs to a cultural understanding which recognizes the central importance of the person in the face of medicine and which offers a patient-centered model of medicine, which is wider than the disease-centered model of medicine. In a patient-centered model of medicine communication and the relationship are tools which are indispensable in order to reach the aims of a clinical intervention [10]. There are a couple of possible limitations to take into account when considering the results of this study. One is the relatively small number of participants, partly due to the exclusion of foreign women from the study (see Section 2 for rationale for these exclusion criteria). Another regards the percentage of women of the experimental group who declared to be using an effective method during the follow-up. The numbers could be influenced by a ‘‘social desirability’’ effect [21] which could have caused women to report the behavior they perceived to be most positive and appreciated in a social context, or according to the answer they believed was most desirable according to the interviewer’s expectations. A further limitation could be due to the paucity of followups, which were carried out only after 1 and 3 months since the TOP. However, despite the few follow-ups, our preliminary findings were encouraging, in that there was a difference between the groups in the pattern of change of contraceptive use. In the control group the pattern appeared disordered and it did not seem to reflect an effective change of contraceptive use. In the experimental group, not only was there an increase in contraceptive use, but also a move away from the use of ineffective to effective contraceptive methods. The importance of carrying out follow-ups to increase women’s compliance with the chosen contraceptive method is underlined by the Royal College of Obstetrics and Gynaecologists [22] and mentioned in many studies [6,18]. The results of our 1- and 3-month follow-ups were promising, nevertheless it
would be useful to carry out more long-term follow-ups to verify and eventually support the continuity of the use of an effective contraceptive method. 4.2. Conclusion In a review of the evidence for the effectiveness of counseling to prevent unintended pregnancy from 1985 to 2000 [23], the authors concluded that all the studies addressing the effectiveness of counseling in changing knowledge, skills and attitudes about contraception and pregnancy did not provide definitive guidance about effective counseling strategies. The studies reviewed had poor internal validity, low response rates at follow-up and were extremely heterogeneous in terms of the sample studied. In the present study we presented a randomized controlled trial with a very high retention rate at follow-up and the inclusion of only women of Italian nationality. Moreover, Moos et al. [23] underlined how little is known about the determinants of contraceptive use because many factors influence contraceptive use and adherence. It may not be possible to control for the number and complexity of such factors. However, we found that a patient-centered contraceptive counseling intervention significantly increased women’s knowledge, favorable attitudes and reported use of contraception, compared to treatment as usual. Our data support the theoretical assumption that the collaborative approach offered by a patient-centered intervention improves compliance. The hope is that the intervention carried out in this study will reduce the incidence, for women who have undergone a TOP, of repeat TOPs in the future. Since 24% of induced abortions in 2003 were repeated TOPs [1], it is important to aim to reduce such repeat TOPs wherever possible. In conclusion, this study constitutes an initial investigation of the effectiveness of a patient-centered contraceptive counseling intervention. The results are promising, however more follow-ups are needed to evaluate the long-term effects of the intervention. 4.3. Practice implications This study offers evidence to suggest that a professional who provides informational/educational programs regarding contraception should consider the importance of exploring woman’s feelings, beliefs, wishes and expectations regarding contraception. The aim of a patient-centered counseling intervention of this kind is to actively involve the person in order to comprehend their needs, expectations and points of view, which affect their feelings and behaviors. The results of this study suggest that a patient-centered counseling intervention improves women’s contraceptive competence, in that it provides them with the knowledge and encourages attitudes that are purposefully based on each woman’s needs, and it increases their use of effective contraception.
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Appendix A
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3. Somewhat 4. Very much so
A.1. Specific knowledge Women are asked to answer ‘‘true’’ or ‘‘false’’, and in the case in which she does not know the contraceptive method in question, she may answer ‘‘I don’t know’’. The questions are the following: 1. The pill taken every day is effective even if you have vomited or had diarrhea after taking it. 2. The IUD can be kept inside for up to 5 years. 3. The vaginal ring must be taken out of the vagina after 21 days. 4. Condoms can be kept near sources of heat. 5. The contraceptive patch must be removed when taking a shower. 6. If you have forgotten the pill 1 day, you must take it within 12 h. 7. It is advisable to have a gynaecologist regularly check that the IUD is still in the correct position. 8. The morning after pill needs to be taken within 72 h from unprotected sexual intercourse. 9. No medication reduces the effectiveness of the vaginal ring. 10. If a condom breaks at any time during sexual intercourse, it is no longer effective. 11. Once having applied the contraceptive patch, you can move it as many times as you like. 12. A woman may insert an IUD by herself. 13. If you have vomited within 3 h of taking the morning after pill, you must take another one immediately. 14. The vaginal ring does not have an expiry date. 15. Condoms must be worn once erect, before any contact between the genitals. 16. The contraceptive patch is applied once a week, for 3 weeks in a row. 17. Some antibiotics reduce the pill’s contraceptive effectiveness. 18. It is advisable to take the morning after pill as soon as possible after unprotected sexual intercourse. 19. A new vaginal ring must be inserted in the vagina 7 days after having taken out the previous one. 20. Condoms do not have an expiry date.
Appendix B B.1. Attitudes The woman is told that she can choose from one of four possible responses: 1. Not at all 2. A little
The questions are the following: 1. Are you informed on the existing contraceptive methods? 2. Do you feel you need further information in order to choose the contraceptive method that is most suitable for you? 3. Do you believe contraceptive methods may be damaging to your health? 4. After unprotected sex, how likely would you be to take the morning after pill? 5. Do you believe that effective contraceptive methods exist? 6. Do you believe that the pill causes you to gain weight? 7. Is withdrawal an effective contraceptive method? 8. Do you believe the pill may cause tumors? 9. Do you believe there are some contraceptive methods which are more suitable for casual sex? 10. Do you believe it is important to keep updated regarding contraceptive methods?
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