Innovation framework
In the present study, we use a framework based on several theories that have proven useful in the past for the introduction and evaluation of innovations – such as guidelines – in a wide range of settings in Dutch health care [25–30].
Figure 1 shows the four main stages in innovation processes. In the dissemination stage, the innovation should reach every professional. In the adoption stage, the professional develops positive or negative intentions about using the innovation. In the implementation stage, the professional tries to use the innovation in daily practice and finds out what working with the innovation actually means. In the final stage, the continuation stage, working with the innovation either becomes routine practice or not.
These four main stages in innovation processes can be thought of as success or failure points at which the desired change may, or may not, occur. The transition from one stage to the next can be affected, positively or negatively, by various determinants (see Figure 1). Determinants can be broken down depending on their association with:
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1.
The innovation (determinants such as complexity, relative advantage, compatibility),
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2.
The adopting person (determinants such as outcome expectations, self-efficacy, perceived patient cooperation),
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3.
The organisation (determinants such as staff turnover, financial resources, available time),
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4.
The socio-political context (determinants such as legislation) [23, 24].
A detailed understanding of determinants helps to design an innovation strategy that can achieve real change [23, 31–33]. A determinant analysis was performed in 2012 (see Background), resulting in a set of determinants that the present study will anticipate (see Activity 1).
The Dutch maternity care system
The Dutch EOGBS guideline targets obstetricians, midwives and paediatricians working in the Dutch maternity care system. This system is a stratified care model with different professional care providers at different risk levels. Midwives working in primary care are the main group of caregivers in low-risk pregnancies. Obstetricians and midwives working in hospitals take care of medium- or high-risk pregnancies and births. Care pathways are organised in Obstetric Collaboration Groups (OCGs). An OCG is organised around a hospital and consists of midwives (with independent practices and/or hospital-based), obstetricians and paediatricians. The OCGs make agreements about the regional organisation of maternity care and interdisciplinary collaboration.
Overview of project
This project comprises two main activities: 1). the development and application of innovation strategies to enhance the uptake of the three prevention strategies in three study regions and 2). the study of the effects of the implementation. Before the introduction of the three prevention strategies in August 2013, a pre-test will be conducted over a period of three months (March-May 2013). Then, over a period of two months, implementation activities will take place (June-July 2013). To assess the effect of the implementation, a post-test will be performed over a period of six months (August 2013-January 2014).
Activity 1: Development and application of innovation strategies
Participants
Three OCG regions will be recruited. Each OCG consists of one hospital working with three to five midwifery practices. The EOGBS prevention strategy to be implemented – the Dutch guideline, the risk-based strategy or the combination strategy – will be randomly allocated to each region.
All the respondents who participated in the previously performed determinant analysis (see Background) will be asked if their OCG is interested in participating in the study. All the care providers who respond positively will be approached. The chairpersons of the OCGs in the region will then be contacted. If participating members of the OCG express interest, the region will be informed about the study protocol in an OCG meeting. Inclusion criteria for participation are:
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a.
All OCG members have to participate in the study as the prevention strategy will be implemented in the entire region. If, for example, one member in the OCG does not initially support the allocated prevention strategy, this will have a direct effect on implementation and the cost-effectiveness.
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b.
The OCG must consist of one hospital and three to five midwifery practices in primary care in the vicinity. The number of care providers participating will be approximately ten midwives in primary care, five obstetricians, eight to ten hospital-based midwives and five paediatricians.
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c.
The OCG must consider collaboration between the professionals to be good.
Innovation strategies
1. Providing information (enhancing dissemination and adoption)
To enhance awareness of the allocated prevention strategy, all the care providers will receive a personal letter and the project will be discussed at several regular meetings of the OCG. Furthermore, a patient information brochure about the prevention strategy will be developed for distribution by all care providers to their clients.
2. Recruitment of coordinators (enhancing adoption, implementation and continuation)
Two implementation coordinators will be assigned to each participating OCG: a midwife and an obstetrician who introduce and guide, coordinate and monitor the implementation process for the allocated prevention strategy. The coordinators will receive coaching throughout the project from an implementation expert and the project group.
3. Training of professional care providers (enhancing adoption and implementation)
Before the introduction of the prevention strategy in August 2013, all care providers will receive training with the aim of optimising the implementation process. The training will be based on the determinants identified in the determinant analysis performed in the past. The training consists of three components:
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a.
General information will be provided about the theoretical background to EOGBS and its prevention. There will be a particular focus on correct culture-taking since considerable variation was found among care providers in the determinant analysis. The aim is to train all care providers to the same level.
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b.
The allocated prevention strategy, and the study protocol, will be discussed in detail. Potential barriers to adherence will be discussed and particular attention will be paid to logistics. The aim is to clarify and standardise the allocated strategy for the EOGBS prevention.
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c.
There will be a particular focus on counselling for pregnant women, emphasising clear and unambiguous information about the screening procedure, the consequences, the administration of IAP and shared decision-making about treatment options.
Activity 2: Study of the effects of the implementation of each prevention strategy
Participants and study design
Before the actual introduction of the three prevention strategies in August 2013, a pre-test will be conducted over a period of three months to assess adherence to the current Dutch guideline. To determine the effects of the implementation of the three strategies, a post-test will be performed over a period of six months. During both the pre-test and post-test, all midwives and obstetricians will prospectively register all pregnant women from 30 weeks of gestational age onwards. All pregnant women will receive information about the EOGBS prevention strategy in their region and permission is acquired on the basis of opting out [34]. Women who decline to participate will be treated in accordance with the current Dutch guideline. However, pregnant women will be explicitly asked for permission to take cultures (see outcome measures) and for IAP in line with the usual professional standards. Therefore written informed consent will be obtained from all pregnant women.
Sample size
To determine adherence to each strategy with sufficient precision, 315 women are needed (in the case of 70% adherence, the 95% confidence interval will be 65-75%) since this number will ensure statistical significance at a variation in adherence of 10% between strategies (alpha = 0.05, power = 80%).
The pre-test must include 105 pregnant women per region: 315 in total for the three regions. The post-test must include 315 pregnant women per region: 945 in total for the three regions.
Adherence and determinants of adherence
Adherence
Throughout the study period, adherence to the key components of each prevention strategy will be measured for all care providers on the basis of the medical records of all the pregnant women. During the pre-test, adherence to the current Dutch guideline will be measured, and adherence to the allocated prevention strategy will be measured during the post-test. The key components are: assessment of the clinical risk factors for EOGBS, culture-taking during pregnancy and during labour, IAP during labour and treatment of the baby. In this way, the level of adherence will be measured as the proportion of all prescribed activities the professional has actually applied: “completeness of use”. The medical record search will be performed using standardised registration forms. Only the combination strategy requires a recto-vaginal culture to be taken from pregnant women between 35 and 37 weeks by their care provider. In all prevention strategies the care provider decides whether IAP is necessary or where there is a contra-indication for antibiotic prophylaxis.
Determinants
At the end of the pre-test (and therefore prior to the implementation of the innovation strategies) and at the end of the post-test, all care providers will receive a questionnaire about the – anticipated – determinants of adherence to the allocated prevention strategy. The Measuring Instrument for Determinants of Innovations will be used, which consists of 29 generic determinants that predict the actual use of innovations [24].
Outcomes in pregnant women and their babies
Throughout the study period, in the 35th week of pregnancy, all women will receive a questionnaire covering background characteristics, their worries in general and specifically their worries about EOGBS.
In the first week after birth, all women will receive a questionnaire covering actual care received and their satisfaction with received care during pregnancy, labour and the post-partum period.
GBS colonisation of the baby will be used as a proxy measurement for EOGBS. Cultures will be taken from 315 babies during the pre-test and from 945 babies during the post-test.
Clinical outcomes will also be obtained from the medical records: the established risk factors for EOGBS, outcomes of culture-taking during pregnancy and labour, IAP during labour, GBS colonisation of the baby, antibiotic treatment for the baby, length of hospital stay and level of hospital care (standard, medium, high). Standardised registration forms will be used to collect the medical data. Follow-up of the women and children will be one week after delivery.
Costs of the prevention strategies in relation to the effects
The decision analysis model of the 2005 study [20] comparing societal costs and the effects of different prevention strategies will be updated and validated using the empirical data from the present study. The costs of implementing the different strategies will also be incorporated. Sensitivity analyses will vary crucial model parameters to assess their influence on the cost-effectiveness ratio.
Analysis
Data will be analysed according to the intention to treat principle. OCGs will be analysed on the basis of the allocated strategy, regardless of whether the strategy is fully implemented in the OCG. Base characteristics will be described. The differences in the outcome percentages for the pre-test and the post-test will be calculated and included in the cost-effectiveness analysis. Descriptive and regression techniques will be used to evaluate the effect of the implementation.
Ethical consideration
This study is approved by the National Central Committee on Research involving Human Subjects (CCMO NL 41673.058.12) and by the ethics committee of the Leiden University Medical Centre (ref. no P12.184). The trial is registered in the Dutch Trial Register NTR 3965, http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3965).