Adaptation and implementation of a clinical protocol for pre-eclampsia with severe features and eclampsia in a teaching hospital in Ghana: a study protocol

1. INTRODUCTION 1.1 Background Pre-eclampsia is a multisystemic disorder characterised by varied degrees of placental malperfusion1. It is diagnosed when there is maternal hypertension coupled with new-onset proteinuria presenting on or after 20 weeks of gestation2. Pre-eclampsia is estimated to affect 3-5% of pregnancies globally3 accounts for up to 15% of maternal morbidity and mortality4. Incidence and associated morbidity and mortality is disproportionately higher in low and lower-middle-income countries affecting up to 151 in every 10,000 deliveries3. Preeclampsia is diagnosed by a constellation of signs and symptoms, and presents as a spectrum in severity. In its simplest presentation, it is diagnosed in the presence of maternal hypertension coupled with new-onset proteinuria presenting on or after 20 weeks of gestation2. ure being ≥160/110mmHg measured on two occasions at least 4 hours apart, the presence of thrombocytopenia (platelets less than 100,000/microlitre), severe persistent right upper quadrant or epigastric pain, abnormally elevated liver enzymes, progressive renal insufficiency, pulmonary oedema, and new-onset visual or cerebral disturbance2.At its most severe, eclampsia which is defined as the occurrence of one or more generalised tonic-clonic convulsions unrelated to other medical conditions in women with hypertensive disorder of pregnancy5. Pre-eclampsia is estimated to affect 3-5% of pregnancies globally3. In Ghana, the incidence estimates vary from 2.9% 5 to 9.9%6. The incidence and burden on poor outcomes are as a result of both population characteristics and quality of and access to maternal, antenatal and obstetric services in the country4. Potential solutions to improve outcomes in the presence of pre-eclampsia and eclampsia are increasingly focused on improving recognition, and timely and effective treatment, notably through the implementation and adoption of treatment guidelines and protocols7. A review of pregnancy-related deaths arising from pre-eclampsia/eclampsia recommended the need for hospitals and facilities to adopt and implement standard policies and protocols in the management of pre-eclampsia and eclampsia to improve outcomes8. Evaluations of existing care quality in relation to maternal management have established the poor uptake of scientific evidence of best practices in clinical care9. Effective methods to support implementation, and enhance adoption of evidence-based practices in daily care to improve patient outcomes are warrented10. Where implementation has been most successful, approaches have included, stakeholders’ participation, contextual adaptation to policies, and efforts to increase ownership from clinicians11. This protocol describes a proposed study aiming to evaluate a co-designed and stakeholder led implementation of an evidence-based protocol for the management of pre-eclampsia for patients presenting to ED- at a hospital in Ghana. Safety endpoints and clinical outcomes will also be pre-determined and evaluated. 1.2 Objectives First, this study will assess the feasibility and impact of implementing a clinician co-designed and context adapted protocol for managing patients with pre-eclampsia and eclampsia. Secondly, the study aims to evaluate the potential impact of the protocol on clinical care processes and outcomes (including safety endpoints). The study will identify barriers and facilitators for implementing a clinician co-designed, and setting adapted protocol for managing pre-eclampsia with severe features and eclampsia as reported by healthcare professionals (doctors, Nurses/Midwives, and pharmacists), and report adaptations to both the protocol design and implementation strategy made so as to overcome barriers to implementation. To achieve these aims the study combines MRC recommended guidance for stakeholder led protocol development, with an implementation evaluation tool the Reach, Effectiveness -Adoption Implementation and Maintenance framework ‘RE-AIM’12 2 METHODS 2.1 Ethical consideration The Institutional Review Board of the Komfo Anokye Teaching Hospital has approved this study as part of a set of quality improvement interventions to improve maternal outcomes. The interventions are intended to improve service delivery using already evidence based recommended practice, and successful implementation is determined by reach of the intervention; i.e. the greatest proportion of eligible patients receiving the intervention; therefore, no individual patient consent will be required. 2.2 Study design This will be an implementation-effectiveness study with the primary outcomes being determinants of implementation success. These are described below. 2.3 Study site The study will be conducted at the Obstetric Emergency Unit of the Komfo Anokye Teaching Hospital. The Directorate of Obstetrics and Gynaecology of the Komfo Anokye Teaching Hospital in Ghana. Komfo Anokye Teaching Hospital is a 1500-bed facility in the Northern half of Ghana. The Directorate of Obstetrics and Gynaecology is a 250-bed department with a 35-bed Emergency Unit. The annual deliveries conducted in the hospital average 4500 -5000. There is currently no protocol for managing these emergency cases, leading to variations in clinical care. 2.4 Study participants The study will include all patients who present at the obstetric emergency with the clinical assessment of pre-eclampsia with severe features or eclampsia. Severe features are defined as the presence of one of the following; platelets,100 x109, severe persistent right upper quadrant pain, renal insufficiency (serum creatinine > 1.1 mg/dL or doubling of serum creatinine in the absence of renal disease), pulmonary oedema, visual disturbance, unexplained new-onset headache unresponsive to medication and HELLP syndrome (haemolysis, elevated liver enzymes, low platelets)13. Patients who present dead on arrival to the emergency unit will be excluded. There are a few patients who will not present to the emergency department with pre-eclampsia/eclampsia but may develop the condition days later during a hospital admission for another pregnancy related condition. These patients will also be excluded, given the variation in their journey through the hospital, and the likely limited number of affected patients. 2.5 Study Procedure The study will employ the principles of co-design in all phases of the study from clinical protocol for managing pre-eclampsia with severe features and eclampsia through implementation, adaptations and dissemination and learning following evaluation. Co-design is a collaborative methodology that actively engages a broad range of people or professionals in designing and implementing interventions14. It has benefits such as improving creativity and idea generation, improvement in cooperation, loyalty to organizations and care processes, and better satisfaction and outcomes13. These benefits are observed because co-design goes beyond just a participatory approach to empower stakeholders to the level of collaborators and decision-makers thus improving ownership of a process, research, or an intervention15. Study timeline. There will be a three-month period of pre-implementation data collection to established baseline assessment of processes of care, population characteristics and clinical outcomes. Active implementation will occur over a * week period, during which the research team will meet with the clinical stakeholders weekly to identify potential barriers to implementation, and seek solutions, including adaptations to the protocol, and the implementation strategies. After which time, the research team will step back from weekly meetings, with only data collection by trained data collectors so as to evaluate the study outcomes. Data collection The study data required to evaluate this study requires data collected from across the patient continuum through the hospital, from the emergency unit, through acute care, to wards and ICU. Given the need for process (timeseries data) alongside one off information such as patient characteristics and clinical outcomes, the potential for burden of data collection is high. To help mitigate this, existing data sources where possible will be utilised. In the emergency unit, a recently established HER and triage scoring system will be leveraged to help identify data pertaining to presentation, case mix, cohort identification and risk assessment. Similarly, an existing digital ICU registry established in both adult and neonatal ICU in the year 2022 will provide data on case mix, care processes and risk adjusted outcomes for the study cohort. Study specific measures for implementation and care processes will be measured using a pre-determined E-CRF built using REDcap16. The E-CRF, will be developed together with stakeholders and piloted for feasibility prior to use. The study team. A purposively recruited stakeholder team will be convened to guide co-design, and adaptation and ratification of the clinical protocol. The team will include representation from trained specialist Obstetricians, Nurses/Midwives, Anesthesiologists critical care intensivists and a patient/patient relative. The research and implementation team is led by a trained intensivist working in the setting, with a special interest in maternal and obstetric emergency and critical care. He oversees a team of trained research assistants and a study coordinator, who will lead implementation and data collection. Methodological support for the design and evaluation lysis for the study is supported by the lead intensivist’s PhD supervisory team, who bring expertise in implementation science, stakeholder consultation methods, critical care and statistical analysis. 2.5.1 Protocol selection and adaptation The process will involve three (3) stages; protocol selection and adaptation, implementation of the clinical protocol and evaluation of the process. First the stakeholder team, will draft, discuss, and critically review a setting adapted protocol for managing pre-eclampsia with severe features and eclampsia. The drafting of the protocol will be guided by the process prescribed by the ADAPTE Collaboration Network titled “Guideline Adaptation: A Resource Toolkit”17 as used by Salarvand et al18, which involves 3 phases; set up, adaptation, and feedback. In the set-up phase, the scope of work to be done will be defined by the team. This will be followed by the Adaptation phase, which will involve an extensive systematic search of the literature to identify published guidelines (WHO, Cochrane review, systematic reviews, RCT, and guidelines by reputable societies) for adoption or adaptation. The guidelines will then be adapted/ revised to reflect current evidence, and address the barriers to implementation and use by the clinical teams identified during the scope. In the final phase, feedback will be obtained from wider stakeholders responsible for the management of patients with severe pre-eclampsia and eclampsia, so as to ensure likely acceptability, and identify potential barriers to implementation. Wider engagement at this stage of the design will be critical in engaging the clinical team, generating tension for change, and for identifying and garnering buy-in from potential early adopters. 19 After drafting the protocol, a list of key processes will be identified as critical to likely implementation success. These processed will be used to refine and improve a logic model from with implementation outcomes will be measured. The logic framework will be guided by the Implementation Research Logic Model (IRLM) as depicted below in the figure below. Figure 2: Logic model for implementation 2.5.2 Implementation of the clinical protocol/guidelines Once developed, the clinical protocol for the management of pre-eclampsia with severe features and eclampsia will be implemented in the clinical setting. To improve the chances of implementation success, a combination of implementation strategies have been selected, given their superior effect in combination, when compared to the use of a single strategy20. Strategies will include, education, audit and feedback and the use of local champions to guide implementation, adaption and tailoring. These strategies have been demonstrated to be feasible, and effective in Lower and Middle-income countries but have not been evaluated in the context of emergency obstetric and maternal care in Ghana21. A stakeholder is defined as any group or individual who is responsible for or affected by health and healthcare -related decisions that can be informed by research evidence22.In this study, the key stakeholders will be management members and clinicians (Obstetricians, Nurse/midwives and Pharmacists). Extensive stakeholder engagement before an intervention can lead to a better appreciation of barriers and local needs which ultimately improves the chances of successful implementation and adoption23. The stakeholders will be informed about and educated on the project, its objectives, and the implementation plan. Education: Education in implementation science ensures that key stakeholders have adequate knowledge and information on an intervention and this improves uptake24. The newly adapted clinical protocol for the management of Pre-eclampsia with severe features and eclampsia will be shared with all clinical professionals (Nurses/Midwives, Doctors, and Pharmacists) in the Directorate of Obstetrics and Gynaecology of the Komfo Anokye Teaching Hospital to study. Subsequently, training will be organized for all clinical professionals directly involved in the care of these patient cohort in groups of 20-30. During the training, participants will be taken through the objectives and benefits of the protocol, their roles and the implementation process. The training will be completed a week before the start of the protocol implementation. Audit and feedback: Audit and feedback is an implementation strategy that is known to affect the behavior of clinicians25 with wide application in clinical care26, 27,28. A Cochrane review determined that it is an effective implementation strategy that enhances the adoption of interventions29. During the implementation period, clinicians and stakeholders will receive selected clinical data periodically (every two weeks) to assess the progress of the implementation. The data will be presented in the form of a report, developed from the study and registry data and made available directly to the clinical team. The report will combine existing data reported monthly on case mix, and clinical outcomes, with study specific data pertaining to implementation and care processes identified below. Implementation champion Champions are individuals or healthcare providers who volunteer to promote the uptake or implementation of an intervention30,31. Champions will be identified and utilised because it has been found that their involvement facilitates the implementation of interventions32. A nurse or midwife and a doctor will be identified as champions to facilitate the implementation. They will be tasked to encourage their colleagues to adhere to the protocol and continuously explain the benefits to them. They will also take note of any challenges that are encountered by their colleagues and report them to the implementation committee. 2.5.3 Evaluation of implementation success/failure and impacts on clinical outcomes The RE-AIM framework will be used to evaluate the implementation of the protocol intervention. RE-AIM framework offers a systematic evaluation of the effectiveness and impact of healthcare interventions, and is increasingly used both in Hybrid trials, and to support implementation evaluations alongside more classical RCTs12. In addition, interviews with stakeholders will be conducted prior to and following implementation. The interviews will seek to explore stakeholder perceptions to the protocolized care, and identify behavioral factors which may influence implementation success. Interviews will be conducted by the research team, online, and de-identified, and transcribed prior to analysis. 2.5.4 Primary outcome The primary outcome will be implementation success, which will be assessed using three (3) components of the RE-AIM framework (Fidelity, Reach, and Adoption). For each component of the framework, a threshold of 80% compliance combined for all three components will be considered as success. This threshold is based on similar used in other studies, and the understanding that for policy implementation to have meaningful impact on clinical outcomes, and be sustainable as a long-term practice change, its adoption should be achieved in the greatest number of eligible patients as possible33. 2.5.6 Secondary outcome The secondary outcome will be intervention effect on clinical care processes and outcomes associated with care of patients with pre-eclampsia and eclampsia. These are based on a-priori understanding of existing policies, and some published eclampsia research34 such as the PHOENIX trial35. Selected clinical care processes and outcomes are; blood pressure monitoring, request of relevant laboratory investigations, time to administration of antihypertensives, time to intravenous, antihypertensive administration (in minutes) and magnesium sulphate, volume of fluid administration, and the use of intravenous antihypertensives. In addition outcomes for both the foetus35 (NICU admission, preterm birth, APGAR score, placental abruption IUFD, IUGR, mortality) and the mother34 (ICU admission, length of hospital stay, mortality, and neurological deficit) will also be assessed. 3.0 ANALYSIS PLAN Patient demographics and patient characteristics Descriptive statistics, mean/median, will be used to describe the baseline patient characteristics of age, gravidity, parity, and blood pressure. The patient categories of antepartum and postpartum will be reported as percentage. The presenting diagnosis of the patients will also be reported as a percentage. Primary outcome The individual components of Reach, Fidelity, and Adoption of the RE-AIM framework will be computed individually as a percentage, as shown in Table 1. To assess fidelity, a checklist of key clinical interventions will be developed from the protocol and compared to the care delivered. This will include the frequency of blood pressure monitoring, the threshold for administering intravenous antihypertensives, and the timeliness of the administration of magnesium sulphate. Fidelity, reach, and adoption will be equally weighted, so a composite computation will be done using the mean. A threshold of 80% in each of the three domains will define success. Qualitative analysis Perceptions as to individual and behaviour factors influencing implementation of the protocol will be analysed thematically from the interview transcriptions. Ten clinicians (Obstetricians, Anaesthesiologists, Intensivists, Midwives, Critical care Nurses) who are involved in the care of this cohort of patients will be interviewed before and after the implementation of the protocol. Barriers and facilitators will be analysed using the Consolidated Framework for Implementation Research (CFIR 2)36. The CFIR 2 is ideally suited to facilitating identification, coding and synthesis of context specific behaviors, perceptions and beliefs that may influence implementation. To ensure reliability, transcripts will be analysed by two researchers independently under the direct supervision of researchers AB and RH who have extensive experience as researchers. The transcripts will first be reviewed line by line to generate open codes. The codes will then analysed to create categories of related codes. Further analysis of the categories will generate themes that will be mapped to the CFIR 2 framework. These themes would then be used as part of a complementary analysis in understanding the quantitative RE-AIM findings after analysis. Secondary outcomes The secondary outcome variables will be measured in the pre-implementation, peri and post implementation periods. The details of the outcome variables have been listed in table 1. Changes in measure (i.e. time, therapy, event rate) will be reported descriptively. The study is not powered to detect significant change associated with the intervention; rather, these clinical process and outcome measures will provide a signal for safety and provide important feasibility information to inform future scalable studies if the protocol and co-design approach to implementation is found to be effective. 4.0 DISCUSSION Pre-eclampsia and eclampsia are part of the top 5 causes of maternal mortality in Sub-Saharan Africa37. In Ghana, it is one of the top two causes of maternal mortality38. Given its significant contribution to maternal mortality, any intervention that improves maternal outcomes in that cohort of patients will considerably impact overall maternal outcomes. Standardized policies and protocols for clinical care have been shown to improve outcomes39 but the generally poor uptake requires the use of systematic processes that overcome the barriers to the implementation process and identify potential facilitators of implementation. Studies have identified barriers which are attributed to inhibiting the adoption of evidence-based into maternal and obstetric practice. These include: staffing, gaps in clinical knowledge, lack of resources, lack of organisational and management support, alongside behaviors and beliefs which may mean guidelines are perceived to compete with other clinical priorities, or be in conflict with clinician autonomy1 , 2. Furthermore, a lack of buy-in from medical staff, inadequate needs assessment with stakeholders, may also limit implementation and adoption40. This study is designed to assess the effectiveness of implementation strategies and stakeholder co-design to improve management of pre-eclampsia and eclampsia. Improving management and outcomes for this population requires healthcare teams from different specialities to work collaboratively, often rapidly (i.e., within the first hour of admission) and support ongoing management often during the transfer of patients between emergency units, operating theatres and sometimes intensive care41. The complexity of this patient care pathway means it is critical to identify, and hopefully mitigate potential barriers to policy adoption and practice change prior to wider scaled implementation. Furthermore, this patient population is vulnerable, and both mother and baby are exposed to significant risk of morbidity and mortality if the condition is not optimally managed42 This study will generate new information regarding the effect of these strategies in the emergency, obstetrics and maternal care population, drawing on perceptions and experiences from a diverse healthcare team. carefully designed with the active participation of stakeholders to overcome known barriers in implementation science. Stakeholder engagements before the implementation of a protocol enables the identification of context-specific barriers and gives a sense of ownership by clinicians, which improves the chances of success23. Some Doctors and Nurses will be identified as champions to leverage their influence in the department to enhance implementation as documented in literatutre31. Throughout the implementation period, periodic auditing of the progress will be conducted through analysis of the data to provide feedback to clinicians because audit and feedback positively influences the attitude of clinicians towards the implementation2. The strategies to enhance implementation (education, stakeholder engagements, use of champions, audit, and feedback) will be employed over six weeks of active implementation. Their eventual withdrawal may pose a challenge to sustainability, but it is expected that the potential benefits in clinical outcomes and systems improvement would drive sustainability. The success of these implementation strategies will be evaluated using 3 domains (fidelity, reach and adoption) of the RE-AIM framework. The RE-AIM framework is an effective evaluation tool for the systematic evaluation of healthcare interventions32. Despite this study purposefully selecting strategies to support context adaptation, and engagement from clinical stakeholders, there is no assurance of success. The findings of the study will determine the ease of adoption and implementation of this clinical protocol, identify barriers and facilitators of the implementation process, and assess the impact on maternal outcomes specific both to the hospital, and potentially relevant to the wider Ghanaian healthcare system. Though a single centre study, the findings may still serve as a guide for future policy implementation more widely. REFERENCES 1. Chappell LC, Cluver CA, Kingdom J, Tong S. Pre-eclampsia. The Lancet. 2021 Jul 24;398(10297):341–54. 2. Ajah LO, Ozonu NC, Ezeonu PO, Lawani LO, Obuna JA, Onwe EO. The Feto-Maternal Outcome of Preeclampsia with Severe Features and Eclampsia in Abakaliki, South-East Nigeria. J Clin Diagn Res JCDR. 2016 Sep;10(9):QC18–21. 3. Fishel Bartal M, Sibai BM. Eclampsia in the 21st century. 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Table 1: Primary and Secondary outcome variables OUTCOME MEASURE AND REPORTING Implementation (primary outcome) Fidelity: Proportion of patients who are correctly managed with the protocol Numerator: Number of patients who are correctly managed with the protocol Denominator: Number of patients diagnosed with pre-eclampsia with severe features and eclampsia Reach: The proportion of patients who get managed with the protocol Numerator: Number of patients who get managed with the protocol Denominator: Number of obstetric emergency patients who presented at the Emergency Unit with the diagnosis of pre-eclampsia with severe features and eclampsia. Adoption: Proportion of patients who get managed with the protocol 6 months after the implementation. Numerator: Number of patients who get who get managed with the protocol in the 6th month of implementation Denominator: Number of eligible patients who present to the Emergency Unit Intervention effect and patient safety. (secondary outcomes) Maternal Hospital length of stay (in days) ICU referral and admission (expressed as a %) Hospital mortality (expressed as a %) ICU mortality (expressed as a %) Time to antihypertensive administration (in minutes) (defined as the time between admission at the Emergency department and the time of first administration of antihypertensive) Time to intravenous antihypertensive administration (in minutes) (defined as the time between the first recorded BP ≥180/110mmHg and the time of first administration of intravenous antihypertensive) Daily volume of fluid administration (expressed in ml/day) Time to magnesium sulphate administration (in minutes) (defined as the time between admission at the Emergency department and the time of first administration of magnesium sulphate) Foestal NICU admission (expressed as a %) [Numerator = number of babies admitted to NICU, Denominator =number of babies delivered] Preterm birth (expressed as a %) [Numerator = number of preterm deliveries, Denominator =number of babies delivered] Placental abruption ((expressed as a %) [Numerator = number of placental abruption, Denominator =number of babies delivered] IUFD (expressed as a %) [Numerator = number of preterm intrauterine foetal deaths, Denominator =number of babies delivered] IUGR (expressed as a %) [Numerator = number of IUGR, Denominator =number of babies delivered] Average APGAR score at 1 and 5 minutes