The rationale of PCC and its delivery approaches

The rationale of PCC originates in the growing recognition that the embryonic development and placentation phase is critical for the outcome of the pregnancy.5 PCC is a set of interventions that aims to identify and modify biomedical, behavioural and social risks to a woman’s health or pregnancy outcome through prevention and management.6

The preconception period can be seen as the earliest link between maternal and newborn health. Therefore, it has been recognised as a pivot point which can be utilised to improve perinatal health.7–9 In the Netherlands, 85% of the perinatal mortality cases were preceded by small for gestational age (SGA), premature birth and congenital anomalies10 ,11 In theory, many risk factors for these problems are present and potentially detectable and treatable/manageable before conception.5 ,7 By the time a women enters antenatal care, a large part of organogenesis has taken place. PCC should therefore be regarded as a necessary additional component to the obstetric care system in the improvement of perinatal outcomes.

Key attributes of the study

The PCC study is designed as a community-based study with a high-risk approach in a primary care setting with tools to improve the uniformity of the health message.

This section describes the key concepts of the study:

• The high-risk approach: The Ministry of Health commissioned the HP4ALL study to target high-risk populations. After ranking the municipalities with the highest perinatal mortality and morbidity in the country, 14 municipalities were selected as candidates for participation (selection described elsewhere).4 The key approach of HP4ALL is to roll out the interventions in high-risk neighbourhoods—meaning neighbourhoods with rates of adverse perinatal outcomes above the average of the selected municipalities. It is presumed that women in these neighbourhoods can benefit the most from interventions in the HP4ALL study. Prevalence of risky lifestyle behaviours in the preconception phase is not exactly known as there is no surveillance among women contemplating pregnancy and risky behaviours tend to be under-reported during pregnancy. With regard to folic acid supplementation, a recent Dutch study conducted among a multiethnic population reported that 40% of pregnant women had used folic acid supplements before conception.21 A different study reported that of 7106 pregnant women, 8% smoked in the first trimester only and 17% continued smoking throughout pregnancy.22 In total, 35—50% of women are estimated to continue their alcohol consumption during pregnancy.23 The HP4ALL study will provide more information regarding risk behaviours before and in pregnancy in these high-risk neighbourhoods.

• The community-based approach: A community-based approach has advantages as it (1) reaches populations which are hard to reach by ensuring trust: collaboration with local health authorities in a community-based approach provides the opportunity that the target population is approached by professionals they know and mostly trust; (2) promotes collaboration and local support as it draws together the sectors necessary for optimal outreach.24

• A primary care approach: GPs and midwives practising in the high-risk neighbourhoods are recruited to deliver individual PCC consultations. They were selected because they can deliver the intervention in a responsive fashion, because they are familiar with the target population and by arranging them to provide the PCC consultations, accessibility of PCC is ensured.

• Tools for the consistency of health messages: PCC for the general population necessitates a thorough risk factor screening. Therefore, GPs and midwives are facilitated with tools and training to ensure consistency, which is important as different health messages reduce the effectiveness of interventions.14

Theoretical framework of the HP4ALL PCC substudy

The delivery of PCC in the PCC substudy is based on Andersen's model of healthcare Utilisation.25 Andersen defines the utilisation of a health service and other personal health behaviours as an outcome. These outcomes are a function of the predisposition (to utilise the healthcare service) and enabling or impeding factors (to utilise the healthcare service) and perceived and objective need (to utilise the healthcare service). This model has been used to understand utilisation of PCC services and other healthcare services (oral health services, mental health services, primary care).26 ,27 Figure 1 should be read from left to right: The PCC substudy intervenes in the environment in order to target the population to achieve the outcomes on the right.

• The environment: The study entails two organisational changes in the environment: First, individual PCC consultations are made available. Second, a strategy to recruit eligible women to utilise the PCC services is employed (see figure 2).

• The population: The study aims to target women of reproductive age (defined as 18 up to and including 41 years) living in municipalities with high perinatal mortality and morbidity rates with a specified recruitment strategy. Women will, however, decide individually, within their own context, whether they will use the healthcare service and/or change their health behaviours. We hypothesize this decision to be a function of:

  • Predisposing factors: In accordance with Andersen's model of healthcare utilisation, we contemplate that a woman's decision to utilise PCC will depend on a function of her health beliefs and attitude towards the preconception health service and a healthy pregnancy, social influences and demographic factors.

  • Enabling factors: The targeted woman can be stimulated to visit (or be impeded from visiting) the PCC health service by community factors (eg, a good infrastructure to attend a PCC consultation) or by individual factors (eg, speaking a different language than the PCC care provider can be a barrier to attending the PCC consultations).

  • Need: The targeted woman needs to feel a need to utilise the service. There are two kinds of need: (1) an objective need (the service is necessary in terms of medical risks) and (2) a perceived need (the service is perceived as necessary by the woman herself). Perceived need can be related to the objective need, but this is not necessarily the case. Factors from the literature or those which we hypothesised to influence the objective and/or perceived need for a PCC consultation are mentioned in figure 1. Need, as a resultant of a perceived need and objective need, is thought to be influenced by predisposing characteristics (eg, knowledge regarding risks, social network to point out the relevance of PCC for the individual).

• The outcomes: The primary outcomes of the PCC substudy are reduction of preconception risks by the (1) utilisation of PCC health services and (2) behavioural change regarding preconception risk behaviours. Reduction of preconception risk factors is thought to subsequently reduce (the risk for) perinatal morbidity and mortality.

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Figure 1

The Framework for the Healthy Pregnancy 4 All—Preconception Care substudy.

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Figure 2

The recruitment strategy of the Healthy Pregnancy 4 All—Preconception Care substudy.

The intervention

As displayed in figure 3, the PCC consultation consists of two visits to a participating GP or midwife in the course of 3 months. During the first consultation, systematic risk assessment is performed and a tailored management plan provided to address risk factors. Caregivers evaluate whether goals are reached or whether additional measures are necessary. Consultations are supported and archived with PCC tools (see box 1).28 ,29 The tool for risk assessment (Zwangerwijzer in Dutch) is a validated tool.30 When women participate in the cohort study as study participants, extra data are collected to assess the effectiveness of the care provided (see section on data collection).

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Figure 3

Flow chart for enrolment and intervention and data collection.

Study population

All women aged 18 up to and including 41 years (the adult reproductive lifespan) who make an appointment at the PCC health service are enrolled (registered in the database) to assess the effectiveness of the recruitment strategy. The additional criteria for inclusion in the cohort study to assess the effectiveness of PCC are: (1) a pregnancy wish (regardless of in which phase) and (2) voluntary participation. Exclusion criteria are: (1) no permission to be encountered about participation in the study (2) non-response to approach for inclusion (3) not speaking one of the following languages (Dutch, English, Turkish, Polish or Arabic) (4) cancellation/no-show at the appointment.

Recruitment and enrolment

The recruitment strategy consists of four components (see figure 2):

1. An invitational letter from the municipal public health service;

2. An invitational letter from participating general practices to their own patients;

3. Youth Health Care Physicians or nurses inform parents who visit the routine check-ups at the youth healthcare centre for their child with an information leaflet containing the names of the participating practices;

4. Referral by a preconception health educator after PCC education sessions. (A preconception health educator is a person from the peer group (the local community) who has completed certified training in health communication skills/preconception health). All female applicants for the PCC healthcare services are registered. These women are sent an information letter followed by a telephone call for individual counselling about participation in the study by the research team. Participants who agreed to take part in the study signed an informed consent form. Women receive the same PCC regardless of participation in the study; participation requires the participant to partake in data collection (questionnaires and laboratory tests) parallel to the care she receives.

Outcomes

The primary outcome regarding the effectiveness of the individual PCC consultations is behavioural change. Behavioural change is assessed for folic acid supplementation, smoking, alcohol consumption and illicit substance use. These four preconception health behaviours were chosen as primary outcomes due to their prevalence and their impact on the fetus and modifiability.31–36 Differences in these behaviours are assessed by premeasurement and postmeasurement by questionnaires (self-reported changes) and biomarkers (biochemical assessment of behavioural change). Biomarkers are used, as it is known that self-reported outcomes can show socially desirable answers. For example, in case of the use of folic acid supplements, a Dutch study found an over-report of 22% for self-reported folic acid supplement use.21

The primary outcome regarding the effectiveness of the recruitment strategy is the utilisation of the PCC services of the programme. This is measured quantitatively by the number of women who utilised the PCC programme (women successfully recruited) in relation to the number of women approached by the recruitment strategy. Second, the effectiveness of the recruitment strategy is assessed in terms of the outreach: by assessing characteristics of women reached. This includes basic demographics of women who were successfully recruited and identification of predisposing factors, need and enabling factors according to Andersen's model of healthcare utilisation among women included in the study. Data regarding the target group (all women aged 18 up to and including 41 years in the geographically targeted area) are obtained from municipal administrative records.

Outcomes, measures and data sources are presented in table 1.

Data collection and measurement

The process of data collection is illustrated in figure 3.

All women who make an appointment are registered in the Gemstracker (Generic Medical Survey Tracking system) database.37 The Gemstracker system first helps keep a log of all the consultations. Furthermore, the system assists in keeping a log of the inclusion process after which it organises data collection within a specific time track, by activating fields or questionnaires for respondents or PCC providers.

Data collection consists of a questionnaire (questionnaires 1 and 2, respectively), anthropometric measurements and laboratory tests, performed as a baseline measurement (before the first consultation) and follow-up measurement (around the second consultation).

• Questionnaires: Questionnaire 1 is filled in prior to the first PCC visit. This questionnaire assesses the characteristics of the study participant and health behaviours regarding the primary outcomes and other preconception risk factors. Questionnaire 2 is filled in after 3 months to assess changes in health behaviour regarding preconception risk factors. The questionnaires are filled in on paper or via the internet. Participants were reminded up to two times to fill in the questionnaire. The questionnaires were available in Dutch, English, Arabic, Turkish and Polish.

• Anthropometric measurements: PCC providers measure the following anthropometric measurements at both PCC visits: blood pressure (mm Hg), length (cm), weight (kg), hip and waist circumference (cm). These measurements were performed according to a predefined protocol.

• Laboratory tests: Data from the questionnaires regarding the primary outcomes of behavioural change are verified with biomarkers. Folic acid supplementation is assessed by measuring red cell folate in the serum.31 Smoking cessation is assessed by serum cotinine levels.38 ,39 Applying biomarkers for alcohol consumption is challenging because diagnostic accuracy is generally moderate and diagnostic properties differ over different alcohol consumption quantities and patterns. Ideally, one would match a biomarker to the presumed alcohol consumption (quantitatively in time) of the study population. However, the prevalence of alcohol consumption is difficult to predict as there is a lack of consensus regarding the classification of alcohol consumption.40 Numbers in the general population and in cohorts of pregnant women vary.35 As there is no consensus regarding safety of alcohol consumption in the preconception phase, the recommendation is to not consume alcohol in the preconception phase. Thus, we will be interested in biomarkers for any level of alcohol consumption. To detect alcohol drinking in the heavy end of the spectrum, we chose to use carbohydrate deficient transferrin (CDT%).41 As a biomarker to assess the mild–moderate drinking spectrum, we will explore the availability of ethylgluconeride (EtG) or a serum test of phosphatidylethanol (PEth) for the mild–moderate drinking spectrum.42 Illicit substance use will be tested with conventional urinary drug tests (assessing amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opioids (codeine, morphine, heroin, oxycodone, etc), phencyclidine, propoxyphene, synthetic cannabinoids). Providers are blinded to data from questionnaires and from the mentioned biomarkers.

‘In case of no-show at either consultation, PCC providers are encouraged to provide a new appointment for the consultation. If the woman does not attend the first PCC consultation, she will be included for the analysis of the recruitment strategy. However, she will be excluded from the PCC cohort. If a woman does not attend the second PCC consultation, she will be asked to complete her second questionnaire and where it is logistically opportune, she will be asked to undergo a second laboratory assessment. She will be included in the outcome assessment of the effectiveness trial in that case.

Data analysis and sample size calculation

Organisation and time schedule

Municipalities were encountered for participation from June 2011 to November 2013. General practices and midwife practices were encountered for participation from November 2011 to July 2013. They were prepared to deliver PCC in the PCC substudy after a one-on-one training to deliver PCC according to the study protocol. They received a self-study e-learning course and study material about PCC in general and about risk factors. Practices were provided with information leaflets, posters and kits to hand out for the laboratory tests. Recruitment strategies were rolled out when practices were ready to receive participants for the study. Data collection is performed in close collaboration with the practices by means of the Gemstracker system. In order to promote the readiness of study participants to provide blood and urine samples and to ensure timely handling of the samples, all laboratory sampling and processing are performed at neighbourhood health centres or local laboratories in the participating municipalities. Finally, to reduce bias, the non-time critical laboratory tests are performed at one central laboratory (the trial laboratory of the Erasmus Medical Center of Rotterdam, the Netherlands). After each PCC consultation study, participants receive a preassembled laboratory kit from their PCC provider. This kit includes 1 mL freezer capsules, a urine container and an application form to process the material according to the standard operating procedure of our study. All local laboratories were accredited by CCKL (in Dutch: Coördinatie Commissie ter bevordering van de Kwaliteitsbeheersing op het gebied van Laboratoriumonderzoek in de Gezondheidszorg or the organisation that audits laboratories in the healthcare system in the Netherlands).44 Blood samples are collected in EDTA, SST or sodium fluoride vacutainers (in size and numbers as routine to the local laboratories). Local laboratories perform tests which have to be performed within 1 h (eg, glucose) or before refrigeration (haemoglobin, haematocrit, mean corpuscular volume, red blood cell count) directly after blood sampling. Two mL of whole blood is then pipetted and stored and the remainder is centrifuged (depending on local equipment: ±2000 g/10 min). Approximately 2 mL of plasma and 7 mL of serum is pipetted into 1 mL freezer capsules. Urine is centrifuged (depending on local equipment: ±2000 g/10 min) after which 4 mL is stored. Whole blood is stored at −20°C; plasma/serum fraction and urine at −70 or 80°C (depending on local equipment). All laboratories closely monitor their storing protocol and are able to provide a report of the storing conditions at request. At set times, all samples are distributed to the central trial laboratory. The first municipality started enrolment in February 2013 and the last municipality started inclusion in February 2014. Enrolment is ongoing until the time period: April 2014 or until the calculated sample size of included participants has been reached to meet current research goals. As the sample size has not been reached as yet, the inclusion period is currently planned until December 2014.

Ethical considerations

The HP4ALL PCC substudy has been approved by the Medical Ethical Committee of the Erasmus Medical Center of Rotterdam (MEC 2012-425). In line with regulations, an independent physician is available for consultation by the (eligible) study population.