Journal of Obstetrics and Gynaecology

ISSN: 0144-3615 (Print) 1364-6893 (Online) Journal homepage: http://www.tandfonline.com/loi/ijog20

Patient compliance with postnatal thromboprophylaxis: An observational study C. E. Hordern, C. W. Bircher, E. C. Prosser-Snelling, F. K. Fraser & R. P. Smith To cite this article: C. E. Hordern, C. W. Bircher, E. C. Prosser-Snelling, F. K. Fraser & R. P. Smith (2015) Patient compliance with postnatal thromboprophylaxis: An observational study, Journal of Obstetrics and Gynaecology, 35:8, 793-796, DOI: 10.3109/01443615.2015.1009878 To link to this article: http://dx.doi.org/10.3109/01443615.2015.1009878

Published online: 18 Feb 2015.

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Date: 05 November 2015, At: 07:36

Journal of Obstetrics and Gynaecology, November 2015; 35: 793–796 © 2015 Taylor & Francis Group, LLC ISSN 0144-3615 print/ISSN 1364-6893 online DOI: 10.3109/01443615.2015.1009878

OBSTETRICS

Patient compliance with postnatal thromboprophylaxis: An observational study C. E. Hordern, C. W. Bircher, E. C. Prosser-Snelling, F. K. Fraser & R. P. Smith

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Department of Obstetrics and Gynaecology, Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich, UK

Prescription of postnatal thromboprophylaxis has increased with the Royal College of Obstetricians and Gynaecologists and the National Institute for Health and Care Excellence guidance. Our study of postnatal women meeting the criteria for thromboprophylaxis aimed to ascertain compliance with low-molecular-weight heparin and barriers to completion of a full course. Women were recruited from the antenatal clinic or postnatal wards. Those who agreed were contacted by telephone 14 days after delivery and asked about their compliance with and experience of thromboprophylaxis. 111 women were followed up. We found reported compliance with postnatal thromboprophylaxis to be high (83% taking the full course); most women self-injected (54%) but a significant number relied on family members (39%). Most would be prepared to take the course in a future pregnancy (94%); however, some felt that they needed more information. Reported compliance with postnatal thromboprophylaxis is high. This may be down to the motivation of the new mother, appropriate information giving and access to health care professionals for advice. Keywords: Compliance, postnatal, pregnancy, thromboprophylaxis, thrombosis

Introduction Venous thromboembolism (VTE) remains one of the leading causes of direct maternal death in the UK, reported third, representing 18 women (0.79 per 100,000 maternities) in the most recent confidential enquiry into maternal deaths published by the Centre for Maternal and Child Enquiries in 2011. It was previously the leading cause and the reduction has been attributed, in part, to a greater use of thromboprophylaxis. Of those deaths reported, 16 out of 18 had identifiable risk factors and seven received inadequate thromboprophylaxis (Touqmatchi et al. 2012). In 2009 the Royal College of Obstetricians and Gynaecologists (RCOG) produced guidance recognising the increased risk of VTE in pregnant women and aiming to identify risk factors and provide adequate thromboprophylaxis to those at risk. The guideline estimates that it should be possible to reduce the risk of VTE in obstetric patients by two-thirds. The National Institute for Health and Care Excellence (NICE) also produced guidance in 2010 on reducing the risk of VTE in hospital patients (including some recommendations for pregnant women) and the Chief Medical Officer wrote to all trusts in England highlighting

VTE prevention (including a Commissioning for Quality and Innovation target for risk assessment requiring 90% compliance) (Donaldson and Keogh 2010). Our unit previously performed a study (Revell and Smith 2011) to estimate what proportion of women would meet the criteria for thromboprophylaxis, and 41% of our population would have qualified for postnatal thromboprophylaxis. Using these data and the RCOG guidance (2009) our unit developed a guideline for risk assessment and prescription of thromboprophylaxis. Injectable medications are unpleasant to administer and can be technically challenging hence we might expect reduced compliance compared with oral medications. We might also expect reduced compliance as prophylactic medication does not address any particular symptoms. Although there have been studies looking at compliance with risk assessment and prescription of thromboprophylaxis (Tan and Wisdom 2006; Touqmatchi et al. 2012) and there are a few studies which directly assess patient compliance in orthopaedic patients (Colwell et al. 2005; Rübenacker et al. 2013) we could not find any which study the obstetric population. The postnatal period is a challenging time for new families, with sleep deprivation and increased stress; hence it is important to ascertain whether women assessed as requiring thromboprophylaxis and receiving the medication actually complete the course. Even if compliance by health care professionals with risk assessment and prescription is excellent, we cannot expect to see the estimated reduction in VTE events if women do not take the medication. Our study aimed to assess reported patient compliance with a standard course of postnatal thromboprophylaxis in the form of low-molecular-weight heparin (LMWH). Telephone interviews provided the opportunity to enquire about barriers to completing the course, the adequacy of information provided, who administered the injections and whether they would be prepared to accept thromboprophylaxis in the future.

Materials and methods Women were recruited in a consultant-led antenatal clinic and on the postnatal ward. They represented women booked at our unit, a university teaching hospital with approximately 6000 births per year. Those who agreed to take part were risk assessed using the hospital’s own Obstetric Thrombosis Risk Assessment Tool. This uses similar risk factors as the RCOG guideline and looks for multiple risk factors for VTE. If the woman scored two points she met the criteria for 7 days of

Correspondence: Richard Smith, Department of Obstetrics and Gynaecology, Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich, Colney Lane, Norwich, NR4 7UY, UK. E-mail: [email protected]

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postnatal thromboprophylaxis. These women were included in our study. Two points were scored for a previous provoked VTE, a known thrombophilia, a BMI greater than 40, a caesarean section or any medical co-morbidity that increases the risk of VTE. One point was scored for the following risk factors: family history of VTE under the age of 50 years; age greater than 35 years; BMI greater than 30; smoker; parity three or greater; multiple pregnancy; pre-eclampsia in current pregnancy; dehydration; labour greater than 24 h; rotational forceps delivery; postpartum haemorrhage greater than one litre; current systemic infection; immobility or a journey greater than 4 h. Three points were scored on the risk assessment tool if women had a history of recurrent VTE, unprovoked VTE or oestrogenrelated VTE. Higher risk women who scored three or more on the assessment tool, or those who required antenatal thromboprophylaxis, met the criteria for 6 weeks of postnatal thromboprophylaxis, and were therefore excluded from this study. At the time of the study, it was standard practice in the unit to include prescription of LMWH on the postnatal discharge letter which is sent to the community midwives and General Practitioner. The study group were contacted 2 weeks after delivery and a structured interview was undertaken. The interview consisted of eight questions ascertaining whether prescription of LMWH had been accepted; how long it was taken for; what were the reasons for stopping if less than the seven-day course was taken; whether the woman had received enough information regarding LMWH and who had been sources of additional information; who administered the injections and whether she would accept LMWH if indicated in a future pregnancy. The results of interviews were collected on a proforma and anonymised before being entered into an Excel spreadsheet for further analysis. Data on the postpartum VTE rate were not collected as part of this study as the study would be underpowered to detect a difference between rates in any subgroups. The study was approved by the National Research Ethics Service East of England Committee (10/H0306/78).

Results Data from 67 patients have previously been published in abstract form (Hordern et al. 2013). A total of 148 women consented to take part in the study and met the hospital criteria for 7 days of postnatal thromboprophylaxis. Eighty (54.1%) were recruited from the antenatal clinic and 68 (45.9%) from the postnatal ward. Thirty-seven were excluded; of those, four declined treatment; 31 were lost to follow-up because they failed to answer the telephone on three occasions; one woman had a baby which was stillborn so was not contacted; one woman withdrew consent. Therefore, results were available for 111 women. Ninety-three (83.3%) took the full 7-day course, including four patients who reported taking a course longer than 7 days (Figure 1). The most common reason given for not completing the full course was bruising or wound complications, with 3 patients stating this, followed by forgetting, fear or dislike of needles, or a feeling that the injections were not helping (Figure 2). Other reasons given included three who stopped on medical or midwifery advice, emotional reasons for stopping, one felt she was mobile and therefore did not require the medication and one cited possible complications as her reason for stopping.

Figure 1. Number of doses taken.

Ninety-three (83.8%) felt that they received enough information about thromboprophylaxis. However, they were not the same 93 women who completed the full course. Eight women reported receiving additional information from their midwife, four from their General Practitioner, one from family or friends and one from another (unidentified) source. The majority of patients self-administered the injections, although a significant number of women were administered the injections by family members (Figure 3). Two patients stated that they would have liked more information or training before leaving hospital. If thromboprophylaxis were indicated in a future pregnancy, 104 women (94.5%) would accept it.

Discussion Our data suggest that patient compliance with a 7-day course of postnatal thromboprophylaxis is high. Most women were willing to take the medication and the majority self-administered. A significant minority required others to help with the injections. The reasons for not completing the course included possible medical complications and factors related to an understanding of the purpose of the medication. A very small number honestly reported forgetting to take the medication. Postnatal thromboprophylaxis in women without traditional risk factors such as caesarean section is still a relatively new phenomenon and anecdotal evidence suggests that many women had not heard of the treatment during their pregnancy. However, the majority reported that they had received enough information about the treatment by the time of discharge. Of those who did seek additional information, midwives and General Practitioners proved to be the main sources. It is interesting to note that a large proportion reported that they would accept thromboprophylaxis in a future pregnancy, perhaps recognising the importance of the treatment despite its inconvenience and potential discomfort.

Figure 2. Reasons for not completing the full course.

Compliance with postnatal thromboprophylaxis 795

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Figure 3. Who administered the injections.

This study looked at a previously unstudied issue in an area of significant health risk. We were able to speak to a relatively large number of women and gain useful, quantitative information about their experience of taking thromboprophylaxis at this time in their lives. We could find no studies that directly addressed patient compliance with thromboprophylaxis in an obstetric population. However, our findings are comparable to a German study (Rübenacker et al. 2013) of surgical and orthopaedic patients who were prescribed 14 days of LMWH in which 92.5% of patients took the medication for the prescribed course. Reasons given for not completing the course appear similar to our study. Seventy-three per cent of patients in their study reported the administration of medication as simple. In a US study (Colwell et al. 2005) of orthopaedic patients 55% were compliant with a longer 21-day regime that required a dose change after 7 days. The high compliance in our study could be due to the relatively short course of injections. Another orthopaedic study (Spahn, 2002) reported that 77% of patients were prepared to self-inject with only 15% using family members to administer the medication. Self-injecting was higher than in our study, but perhaps this is accounted for by the difference of population and the greater availability of other families due to the presence of a new baby. The telephone interview presents opportunity for a structured conversation, but this is a weakness of the study, and may have led to over-reporting of compliance. Neither the RCOG guidelines (2009) nor NICE guidance (2010) provide specific information about the costs associated with VTE prophylaxis. Although it is clear that VTE events will be costly to treat, the numbers requiring prophylactic treatment to prevent a relatively small number of events are high. Revell and Smith (2011) note that it is not only the cost of the drug which needs to be considered, but also the associated costs such as staff education and patient counselling. Obstetric patients are not required to pay for this prescription directly in the UK, but the costs to the trust and taxpayer are not insignificant. It is therefore vital that we have an idea of the compliance of obstetric patients, and our data could help in this discussion. We recommend that specific costing studies are conducted to ascertain what it costs to prevent one event and what the average cost of thromboprophylaxis is per delivery.

Conclusion Reported compliance with postnatal thromboprophylaxis is high. We have suggested reasons for this including the motivation of the new mother, appropriate antenatal and postnatal information giving, access to health care professionals during the medication

treatment period for advice and the potential for over-reporting by patients with a positive recall bias. It is reassuring that the treatment appears acceptable to this group of women and their families. There is the possibility for improvement in patient awareness of the potential need for, and benefits of, prescription of LMWH and this may improve understanding and hence compliance. We suggest a discussion with all women about risk factors during the antenatal period regarding the threshold and potential for LMWH. Posters in the antenatal clinic and wards could alert women to the dangers of VTE and the possible preventative measures which they might be offered. Leaflets with this information should be offered to all women and available in the community, clinic and ward areas. Women who stay as inpatients on the postnatal ward could attend informal teaching sessions on the administration of LMWH to which family members could be invited to attend. The group who are eligible for an accelerated discharge need particular attention to ensure good understanding of the need for and method of administration of LMWH. The community midwives and general practitioner need to be alerted to all women being discharged on LMWH to ensure there are no problems and that they understand why and how it is to be given. However, this group would not have had the same opportunity on the postnatal ward to ensure confidence with the medication hence they may need additional time and support during the early postnatal period. A larger study would be needed to reproduce these results in assessing whether patient compliance is as high as that reported in this study. However, it is difficult to envisage a design which excludes all recall bias. Even visiting individual women in the postnatal period would modify their behaviour, would be intrusive and would require significant funding to achieve. We have suggested several strategies to address some of the barriers to completing the full course of treatment through better education and awareness of staff and patients during the antenatal period and more dedicated input in the postnatal period.

Acknowledgements The authors would like to thank all the women who took part in the study. Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper. The study was supported by a grant from the Department of Health Flexibility and Sustainability Funding (FSF).

References Centre for Maternal and Child Enquiries . 2011. Savings Mothers’ Lives: reviewing maternal deaths to make motherhood safer: 2006–2008. The Eighth Report on Confidential Enquiries into Maternal Deaths in the United Kingdom. London: CMACE. Colwell CW Jr, Pulido P, Hardwick ME, Morris BA. 2005. Patient compliance with outpatient prophylaxis: an observational study. Orthopedics 28:143–147. Donaldson L, Keogh B. 2010. Letter to Medical Directors: Prevention of Venous Thromboembolism (VTE) in Hospitalised Patients. Department of Health. Hordern C, Bircher C, Prosser-Snelling E, Smith RP. 2013. PM.46 Reducing the Risk of Thrombosis and Embolism During the Puerperium: How Compliant Are Patients with Thromboprophylaxis Treatment? Archives of Disease in Childhood - Fetal and Neonatal Edition 98:A38. National Institute for Health and Care Excellence. 2008. Induction of Labour, Clinical Guideline 70. London: NICE.

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National Institute for Health and Care Excellence. 2010. Venous thromboembolism: reducing the risk: Reducing the risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in patients admitted to hospital, Clinical Guideline 92. London: NICE Royal College of Obstetricians and Gynaecologists. 2009. Green-Top Guideline No. 37a. Reducing the risk of thrombosis and embolism during pregnancy and the puerperium. London: RCOG. Revell BJ, Smith RP. 2011. Thrombosis and embolism in pregnancy and the puerperium, reducing the risk: what proportion of patients reach the threshold for thromboprophylaxis? Obstetric Medicine: The Medicine of Pregnancy 4:12–14.

Rübenacker S, Kaiser J, Guschmann M. 2013. Patientencompliance unter einer Thromboseprophylaxe mit Enoxaparin Die COMFORT-Studie. Der Chirurg 3:235–242. Spahn G. 2002. Compliance with Self-Administration of Heparin Injections in Outpatients. European Journal of Trauma 28:104–109. Tan EK, Wisdom SJ. 2006. Thromboprophylaxis post vaginal delivery: Are we forgetting it? Audit on thromboprophylaxis prescription post vaginal births. Journal of Obstetrics & Gynaecology 26:27–29. Touqmatchi D, Cotzias C, Girling J. 2012. Venous thromboprophylaxis in pregnancy: The implications of changing to the 2010 RCOG guidelines. Journal of Obstetrics & Gynaecology, 32:743–746.

Patient compliance with postnatal thromboprophylaxis: An observational study.

Prescription of postnatal thromboprophylaxis has increased with the Royal College of Obstetricians and Gynaecologists and the National Institute for H...
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