scholarly journals Developing a complex intervention to support pregnant women with mild to moderate anxiety: application of the Medical Research Council framework

2020 ◽  
Author(s):  
Kerry Evans ◽  
Helen Spiby ◽  
Jane C Morrell

Abstract Background: To design and develop an intervention to support women with symptoms of mild to moderate anxiety in pregnancy.Methods: The development followed the MRC framework for complex interventions, utilising psychological theory, review level evidence and professional and public involvement. Two systematic reviews were completed which helped identify potentially beneficial intervention components. The theory underpinning the components was explored to consider the potential benefit for women with mild to moderate anxiety symptoms in pregnancy. Methods of delivering the intervention within maternity services were explored. The intervention comprised: group discussions, one to one support and assisted self-help resources. Midwives were identified as ideally placed to facilitate the intervention supported by midwifery support workers. A bespoke training package was provided by subject experts to prepare the facilitators.Results: The absence of established interventions and a paucity of evidence based approaches for pregnant women with symptoms of mild to moderate anxiety indicated the need for a rigorous and systematic approach to the intervention design. This approach led to the development of an intervention feasible for implementation in maternity care systems tailored to the needs of pregnant women. The involvement of a multi-professional advisory team and active engagement of service users helped to consider the acceptability of the intervention for women and the feasibility of delivering the intervention in the context of maternity care.Conclusion: The MRC Framework provided useful overarching guidance to develop a midwife facilitated intervention for women with symptoms of anxiety in pregnancy. The framework assisted the development of a robust rationale for each intervention component and considered the processes of evaluation and implementation into maternity care systems.

2020 ◽  
Author(s):  
Kerry Evans ◽  
Helen Spiby ◽  
Jane C Morrell

Abstract Aim: To design and develop an intervention to support women with symptoms of mild to moderate anxiety in pregnancy.Methods: The development followed the MRC framework for complex interventions, utilising psychological theory, review level evidence and professional and public involvement. Two systematic reviews were completed which helped identify potentially beneficial intervention components. The theory underpinning the components was explored to consider the potential benefit for women with mild to moderate anxiety symptoms in pregnancy. Methods of delivering the intervention within maternity services were explored. The intervention comprised: group discussions, one to one support and assisted self-help resources. Midwives were identified as ideally placed to facilitate the intervention supported by midwifery support workers. A bespoke training package was provided by subject experts to prepare the facilitators. Discussion: The absence of established interventions and a paucity of evidence based approaches for pregnant women with symptoms of mild to moderate anxiety indicated the need for a rigorous and systematic approach to the intervention design. This approach led to the development of an intervention feasible for implementation in maternity care systems tailored to the needs of pregnant women. The involvement of a multi-professional advisory team and active engagement of service users helped to consider the acceptability of the intervention for women and the feasibility of delivering the intervention in the context of maternity care. Conclusion: The MRC Framework provided useful overarching guidance to develop a midwife facilitated intervention for women with symptoms of anxiety in pregnancy. The framework assisted the development of a robust rationale for each intervention component and considered the processes of evaluation and implementation into maternity care systems.


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Kerry Evans ◽  
Helen Spiby ◽  
C. Jane Morrell

Abstract Background To design and develop an intervention to support women with symptoms of mild to moderate anxiety in pregnancy. Methods The development followed the MRC framework for complex interventions, utilising psychological theory, review level evidence and professional and public involvement. Two systematic reviews were completed which helped identify potentially beneficial intervention components. The theory underpinning the components was explored to consider the potential benefit for women with mild to moderate anxiety symptoms in pregnancy. Methods of delivering the intervention within maternity services were explored. The intervention comprised: group discussions, one to one support and assisted self-help resources. Midwives were identified as ideally placed to facilitate the intervention supported by midwifery support workers. A bespoke training package was provided by subject experts to prepare the facilitators. Results The absence of established interventions and a paucity of evidence based approaches for pregnant women with symptoms of mild to moderate anxiety indicated the need for a rigorous and systematic approach to the intervention design. This approach led to the development of an intervention feasible for implementation in maternity care systems tailored to the needs of pregnant women. The involvement of a multi-professional advisory team and active engagement of service users helped to consider the acceptability of the intervention for women and the feasibility of delivering the intervention in the context of maternity care. Conclusion The MRC Framework provided useful overarching guidance to develop a midwife facilitated intervention for women with symptoms of anxiety in pregnancy. The framework assisted the development of a robust rationale for each intervention component and considered the processes of evaluation and implementation into maternity care systems.


2020 ◽  
Author(s):  
Kerry Evans ◽  
Helen Spiby ◽  
Jane C Morrell

Abstract Aim: To design and develop an intervention to support women with symptoms of mild to moderate anxiety in pregnancy.Methods: The development followed the MRC framework for complex interventions, utilising psychological theory, review level evidence and professional and public involvement. Two systematic reviews were completed which helped identify potentially beneficial intervention components. The theory underpinning the components was explored to consider the potential benefit for women with mild to moderate anxiety symptoms in pregnancy. Methods of delivering the intervention within maternity services were explored. The intervention comprised: group discussions, one to one support and assisted self-help resources. Midwives were identified as ideally placed to facilitate the intervention supported by midwifery support workers. A bespoke training package was provided by subject experts to prepare the facilitators. Discussion: The absence of established interventions and a paucity of evidence based approaches for pregnant women with symptoms of mild to moderate anxiety indicated the need for a rigorous and systematic approach to the intervention design. This approach led to the development of an intervention feasible for implementation in maternity care systems tailored to the needs of pregnant women. The involvement of a multi-professional advisory team and active engagement of service users helped to consider the acceptability of the intervention for women and the feasibility of delivering the intervention in the context of maternity care.Conclusion: The MRC Framework provided useful overarching guidance to develop a midwife facilitated intervention for women with symptoms of anxiety in pregnancy. The framework assisted the development of a robust rationale for each intervention component and considered the processes of evaluation and implementation into maternity care systems.


2020 ◽  
Author(s):  
Kerry Evans ◽  
Helen Spiby ◽  
Jane C Morrell

Abstract Background: To design and develop an intervention to support women with symptoms of mild to moderate anxiety in pregnancy. Methods: The development followed the MRC framework for complex interventions, utilising psychological theory, review level evidence and professional and public involvement. Two systematic reviews were completed which helped identify potentially beneficial intervention components. The theory underpinning the components was explored to consider the potential benefit for women with mild to moderate anxiety symptoms in pregnancy. Methods of delivering the intervention within maternity services were explored. The intervention comprised: group discussions, one to one support and assisted self-help resources. Midwives were identified as ideally placed to facilitate the intervention supported by midwifery support workers. A bespoke training package was provided by subject experts to prepare the facilitators. Results: The absence of established interventions and a paucity of evidence based approaches for pregnant women with symptoms of mild to moderate anxiety indicated the need for a rigorous and systematic approach to the intervention design. This approach led to the development of an intervention feasible for implementation in maternity care systems tailored to the needs of pregnant women. The involvement of a multi-professional advisory team and active engagement of service users helped to consider the acceptability of the intervention for women and the feasibility of delivering the intervention in the context of maternity care. Conclusion: The MRC Framework provided useful overarching guidance to develop a midwife facilitated intervention for women with symptoms of anxiety in pregnancy. The framework assisted the development of a robust rationale for each intervention component and considered the processes of evaluation and implementation into maternity care systems.


2020 ◽  
Author(s):  
Kerry Evans ◽  
Helen Spiby ◽  
Jane C Morrell

Abstract Background: To design and develop an intervention to support women with symptoms of mild to moderate anxiety in pregnancy.Methods: The development followed the MRC framework for complex interventions, utilising psychological theory, review level evidence and professional and public involvement. Two systematic reviews were completed which helped identify potentially beneficial intervention components. The theory underpinning the components was explored to consider the potential benefit for women with mild to moderate anxiety symptoms in pregnancy. Methods of delivering the intervention within maternity services were explored. The intervention comprised: group discussions, one to one support and assisted self-help resources. Midwives were identified as ideally placed to facilitate the intervention supported by midwifery support workers. A bespoke training package was provided by subject experts to prepare the facilitators. Discussion: The absence of established interventions and a paucity of evidence based approaches for pregnant women with symptoms of mild to moderate anxiety indicated the need for a rigorous and systematic approach to the intervention design. This approach led to the development of an intervention feasible for implementation in maternity care systems tailored to the needs of pregnant women. The involvement of a multi-professional advisory team and active engagement of service users helped to consider the acceptability of the intervention for women and the feasibility of delivering the intervention in the context of maternity care. Conclusion: The MRC Framework provided useful overarching guidance to develop a midwife facilitated intervention for women with symptoms of anxiety in pregnancy. The framework assisted the development of a robust rationale for each intervention component and considered the processes of evaluation and implementation into maternity care systems.


BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e037874
Author(s):  
Lisa Hinton ◽  
James Hodgkinson ◽  
Katherine L Tucker ◽  
Linda Rozmovits ◽  
Lucy Chappell ◽  
...  

ObjectiveOne in 20 women are affected by pre-eclampsia, a major cause of maternal and perinatal morbidity, death and premature birth worldwide. Diagnosis is made from monitoring blood pressure (BP) and urine and symptoms at antenatal visits after 20 weeks of pregnancy. There are no randomised data from contemporary trials to guide the efficacy of self-monitoring of BP (SMBP) in pregnancy. We explored the perspectives of maternity staff to understand the context and health system challenges to introducing and implementing SMBP in maternity care, ahead of undertaking a trial.DesignExploratory study using a qualitative approach.SettingEight hospitals, English National Health Service.ParticipantsObstetricians, community and hospital midwives, pharmacists, trainee doctors (n=147).MethodsSemi-structured interviews with site research team members and clinicians, interviews and focus group discussions. Rapid content and thematic analysis undertaken.ResultsThe main themes to emerge around SMBP include (1) different BP changes in pregnancy, (2) reliability and accuracy of BP monitoring, (3) anticipated impact of SMBP on women, (4) anticipated impact of SMBP on the antenatal care system, (5) caution, uncertainty and evidence, (6) concerns over action/inaction and patient safety.ConclusionsThe potential impact of SMBP on maternity services is profound although nuanced. While introducing SMBP does not reduce the responsibility clinicians have for women’s health, it may enhance the responsibilities and agency of pregnant women, and introduces a new set of relationships into maternity care. This is a new space for reconfiguration of roles, mutual expectations and the relationships between and responsibilities of healthcare providers and women.Trial registration numberNCT03334149.


2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  

Abstract Over recent years, immigration to Europe has risen significantly. This development has led to increasing birth rates by non-Western immigrant women. Maternity care systems are not yet adapted to this increased diversity of women. In Denmark, 13 % of all children are currently born by women originating from non-Western countries. Despite a publically funded antenatal care, non-Western immigrant women have lower utilization of Danish antenatal care compared to other women giving birth. Many non-Western immigrant women have an increased prevalence of severe maternal morbidity and higher risks of maternal death, stillbirth and infant death compared to the majority populations. Poor health status at birth can impair the cognitive, sensory and motor development and lead to learning disabilities during school age, and thus reduce equality in life chances. Suboptimal care is a contributing factor to these ethnic disparities. Provision of appropriate antenatal care is pivotal to reduce these serious disparities and challenges to public health, however little is known about models of care, which can overcome these barriers. The MAMAACT intervention was developed to increase response to symptoms of pregnancy complications among maternity care providers as well as non-Western immigrant women. The intervention consisted of postgraduate training of midwives in intercultural communication and health education materials (leaflet and an app) for non-Western immigrant women describing how to respond to warning signs during pregnancy in six different languages, The intervention was implemented at 10 out of 20 Danish maternity wards as part of a national trial from the year 2018 to 2019, potentially reaching 25.000 pregnant women, including 2500 of non-Western origin. This workshop shares insight into innovative ways of providing antenatal care for non-Western immigrant women and will focus on methodological aspects of scientific evaluation of complex interventions for vulnerable populations. The workshop includes an introduction, three presentations, and a discussion with the audience. Using quantitative data, the first presentation will give an overview of ethnic disparities in stillbirth and infant death in Denmark. The second presentation will present qualitative data from the implementation evaluation of the MAMAACT intervention with a focus on the interventions program theory, methodological considerations and evaluation results. Finally, the third presentation will illuminate how the concepts of Health Literacy and cultural health capital contribute to an understanding of mechanisms leading to ethnic disparities and how they can be used for evaluating the impact of the MAMAACT intervention. The final discussion will stimulate knowledge sharing between the participants on how to combine quantitative and qualitative insights in trials, how to build partnerships and recruit vulnerable populations in evaluations, and how to use sociological theory in evaluations. Key messages Reducing ethnic disparity in reproductive health requires maternity care systems to rethink their antenatal care services so they are better equipped to support non-Western immigrant women’s needs. Sharing knowledge on the use of mixed methods, recruitment of vulnerable populations, and the use of sociological theory can contribute to future approaches to evaluate complex interventions.


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Laura Goodwin ◽  
Magdalena Skrybant ◽  
Sara Kenyon

Abstract Background Meaningful public involvement in maternity research remains challenging, partly due to the transient nature of pregnancy. This paper reflects on the development, implementation and simple evaluation of an innovative and inclusive approach to engaging and involving pregnant and early postnatal women in research. Methods Between January and February 2018, a Research Fellow in Maternity Care, a Professor of Evidence Based Maternity Care, and a Patient and Public Involvement Lead convened for a number of meetings to discuss how public involvement and engagement might be improved for pregnancy-related research. A stakeholder group was created, including a local community matron, a community engagement officer at a local children’s centre, public contributors, and senior members of the Maternal and Child Health theme of the West Midlands Collaboration for Leadership in Applied Health Research and Care (CLAHRC WM). The team worked together to develop a format for Yoga for Bump sessions: a free 90-min session, offered weekly, which included research involvement/engagement, pregnancy yoga, and a ‘question and answer’ session with a midwife. Results A total of 67 women from two local communities in Birmingham attended Yoga for Bump sessions, which ran between May and December of 2018. Evaluation of the sessions suggested benefits to both women and researchers: it created mutually beneficial relationships between contributors and researchers, provided opportunities for women to engage and get involved in research that was directly relevant to them, and provided a convenient and efficient way for researchers to involve and engage pregnant women from diverse backgrounds in their research. Unintended benefits included self-reported improvements in women’s health and wellbeing. Conclusions Yoga for Bump demonstrates an innovative approach to engaging and involving pregnant and early postnatal women; combining a free exercise class with healthcare advice and opportunities to engage with and be involved in research, and demonstrating mutual benefits for those involved. This model has the potential to be replicated elsewhere to support inclusive public involvement in pregnancy-related research. Further work is needed to design and evaluate similar approaches to involvement/engagement and explore potential funding avenues to enhance sustainability.


2020 ◽  
Author(s):  
Niamh Keating ◽  
Brendan Dempsey ◽  
Siobhan Corcoran ◽  
Joan Lalor ◽  
Mary Higgins

Abstract BACKGROUND: The COVID-19 pandemic has changed how maternity care services are provided worldwide. In an effort to contain the virus many providers have reduced the number of face-to-face visits for women. In addition, partner attendance is now prohibited in many circumstances in order to protect staff, and other service users, from potential infection. METHODS: A qualitative study with 14 women was conducted using a grounded theory approach. Data were collected between April to June 2020 and in-depth interviews were conducted either in pregnancy or in the first 12 weeks after the birth. RESULTS: Six categories emerged: loss of normality, navigating "new" maternity care systems, partners as bystanders, balancing information, uncertainty and unexpected benefits of pregnancy during the pandemic. Women described the challenges they faced with accessing information of the risk of COVID-19 in pregnancy and how to navigate the new hospital and community restrictions. For the most part women accepted many of the restrictions as they understood as being in place to keep them safe. They perceived themselves as vulnerable group despite apparent available evidence to the contrary. The loss of the partner as an advocate, particularly at the anomaly scan and in the neonatal intensive care, was a source of anxiety. Social media was the main source of information for many in place of traditional sources such as healthcare providers. Some unexpected benefits of restrictions included working from home which allowed women to manage normal pregnancy symptoms such as fatigue at home. CONCLUSION: The pandemic caused anxiety for pregnant women. This is exacerbated by uncertainty about the effects of COVID-19 on pregnancy and unclear messaging about restrictions. Pregnancy has a significant temporal component and so maternity services need to respond to women’s needs for information and support rapidly and effectively, with more interactive and personalised communication to support them to cope with uncertainty. The birth partner is an important role as an advocate for women. Containment strategies for the pandemic should be developed with this in mind and attempt to view the family as a unit rather than the woman in isolation.


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