MIDWIZE - Strengthening Midwives

Study Overview
=================
Brief Summary
-----------------
This PhD project aims to explore how midwives can take the lead in implementing and enhancing evidence-based quality improvement (QI) components within maternal and newborn health care in Uganda. The MIDWIZE conceptual framework will be used to understand the complexity of sustainably enhancing maternal and newborn healthcare. The project will start with a multisectoral co-creation process and subsequently involve online and onsite capacity building for midwives on selected evidence-based practices and implementation strategies. The project applies a mixed-method research approach, including focus groups discussions, interviews, quantitative data on health outcomes and a tool evaluating midwives' sense of power and autonomy.

Detailed Description
-----------------
MIDWIZE is a model based on multisectoral collaboration to enhance evidence-based practices through MLC and interdisciplinary teamwork. Focusing on midwives as the primary health care providers at all levels of a country's maternal and reproductive health care system is an elementary part of the MIDWIZE model. Utilising midwives' potential through MLC facilitates relational, safe, cost-effective, and patient-centred care. When additional support is required, the MLC needs to be provided in an environment that successfully takes advantage of different clinical professions' competencies. Working towards shared goals and having a clear understanding of each team member's responsibilities in an interdisciplinary team are central factors for utilising human and financial resources. At the heart of the MIDWIZE model is enhancing the use of evidence-based practices and international guidelines for maternal and newborn health care - focusing on a healthy mother, a healthy child, a positive birth experience, and respectful care. The Z in MIDWIZE stands for the importance of Zero separation between the mother/birthing parent/caregiver and newborn in the early postpartum period - an evidence-based practice enhancing neonatal health outcomes, breastfeeding, and the bonding between mother/birthing parent/caregiver and child. A prerequisite to sustainably implement or enhance these elements in a country's health system is to establish multisectoral collaborations between the four sectors (i) education, (ii) regulation, (iii) associations, and (iv) civil society. Also, the broader health system and its decision- and policymakers' readiness must be considered to create a sustainable system with continuous quality improvements within the education, regulation, and associations sectors. General objective This PhD project aims to explore if and how the MIDWIZE model can be implemented and sustained at one delivery ward in Uganda. (only Sub-study 2 is regarded a clinical trail, however substudy 1 and 3 are described in this text to explain the full scope of the study) Rationale, specific objectives and research questions Sub-study 1 - Co-creating and developing the intervention and the implementation Rationale: The involvement of stakeholders in the development of complex interventions is essential to ensure that the intervention and process are relevant, acceptable, and user friendly. Specific objective: To explore multisectoral stakeholders' perspectives and ideas on implementing the MIDWIZE model - with a particular focus on model adjustments and implementation strategies. Research Question: How do multisectoral stakeholders describe ways to implement the MIDWIZE model, how can the model be adapted to the local context and what strategies for implementation should be taken? (As the remaining parts of the intervention will be co-created, the following parts are preliminary) Sub-study 2 - Implementation and evaluating the sustainability of the implementation Rationale: This study will explore how midwives can take the lead in implementing or enhancing evidence-based practical components of maternal care. Long-term sustainability is vital in order to maximise the potential benefits of implementation. Therefore, this study will, apart from measuring the midwives' QI projects' during the implementation phase, also measure the long long-term impact six months after the project has ended. Three practical care components are suggested in the intervention prototype (i) dynamic birth positions, (ii) delayed cord clamping for a minimum of 3 min, and (iii) early and uninterrupted skin-to-skin care for a minimum of 90 minutes (i.e., Zero separation). The components are suggested based on a landscape and feasibility assessment in Uganda compiled by members of the research team. Specific objectives: To measure adherence to practical quality improvement components when midwives, working in interdisciplinary teams, take the lead in organising, providing, and enhancing intra- and postpartum care. To measure the long-term sustainability of the midwives' quality improvement projects. Research Questions: How has the midwives' implementation of QI components worked, and what can be improved for the future? What policy recommendations can be made? Has MLC and interdisciplinary teamwork been affected by the intervention? Sub-study 3 - Process evaluation Rationale: Identifying strengths and weaknesses in the program and the implementation is vital for future improvements of the model and the implementation plan. One focus of the process evaluation is exploring if and how the intervention has affected interdisciplinary teamwork and midwives' ability to lead, organise and provide maternal care. Specific objective: To evaluate the process of implementing the elements of the MIDWIZE model Research Questions: How has the implementation of the MIDWIZE model worked, and what can be improved for the future? Has MLC and interdisciplinary teamwork been affected by the intervention? Methodology Study Site Naguru maternity unit in Kampala, Uganda, is a public facility with 9000 births/year. Study design and data collection The overall study design is a longitudinal observational study. Sub-Study 1 An experience-Based Co-Design (EBCD) method will be used throughout the process. Focus Group Discussions (FGD) and workshops will be held in three steps: Clinical staff (e.g., midwives, nurses, obstetricians, and assistant nurses), stakeholders at professional associations, academia (e.g., midwife educators, researchers, and students), and decision-makers (e.g., staff at ministry of health and hospital managers) will be included (n=36, divided into six groups). Barriers and facilitators for multisectoral collaboration will be highlighted during the workshops. Members of the civil society (e.g., the projects main stakeholder - the childbearing women and their relatives) will be included in order to deliver an adequate and acceptable intervention (n=36, divided into six groups). Clinical staff and managers will be included to investigate the practical implementation aspects of the project and the birth unit's adherence to national policies and clinical guidelines (n=21, divided into three groups). Sub-Study 2 Quantitative data will be collected during and after implementing the quality improvement components. The post-measurement data will be collected on the chosen components six months after project implementation to measure if the midwife-led quality improvement project has been sustained. Data is suggested to be collected through the delivery unit's existing logbooks, a project logbook, and observations. However, how to best collect this data will be decided in co-creation with staff and managers at the clinic. Sub-study 3 Semi-structured interviews, FGD, and the Power as Knowing Participation in Change Tool (PKPCT). Clinical staff, managers, and women who have given birth during the intervention will be invited to join in FGD (n=36 divided into six groups). Key informants at the clinic will be asked to participate in interviews (n=7). Midwives at the clinic (n=30) will be asked to fill in the PKPCT tool on three occasions: before, during, and after implementation. Data collection for the process evaluation will occur continuously to detect any changes that need to be made during the project and to examine the entirety of the project implementation. Sample size Sub-Study 1 Part 1 - n=36 (Clinical staff, professional associations, academia, decision-makers) Part 2 - n=36 (childbearing women and their relatives) Part 3 - n=21 (clinical staff and managers) Sub-Study 2 As this is a quality improvement project, the number of participants depends on when the targeted goal is accomplished and the total number of participants can therefore not be decided on beforehand. The targeted goal for the specific unit will be decided in dialogue with staff and management. However, a preliminary calculation with an estimated increase of the components by 25% would suggest a minimum of 266 women during the intervention and 266 women six months after the intervention to measure the long term sustainability. Based on previous studies, the prevalence of the three components in connection with childbirth amounts to 50%. The size of the study population is based on a calculation with 80% strength and a 95% confidence interval. A clinically significant increase in the number of women giving birth with the three components of the intervention and who are satisfied with their delivery is estimated at 25%, i.e. from 50% of women to 75% of women. To achieve this level of strength, a study population of 242 women is required. With an estimated dropout rate of 10%, there will be a study population of 266 women. To study the project's long-term sustainability, a repeated measurement that includes 266 women six months after completing data collection 2 will be done. Measurement during the implementation phase - n=266 (birthing women) Post measurement - n=266 (birthing women) Sub-Study 3 Interviews - n=7 (key stakeholders at the hospital) FGD - n=36 (Clinical staff, clinical managers, and birthing women) PKPCT tool = n=30 (all midwives working at Naguru birth unit) Sampling procedure Sub-Study 1 Part 1 - A targeted selection process will be applied, and people will be included based on experience, knowledge and position in the care system (i.e. decision-makers at different levels). Part 2 - A random sampling will be made with stakeholders of the community (in this case, pregnant women or women who recently gave birth at the clinic) Part 3 - A targeted sampling with clinical staff and managers based on profession and experience Sub-Study 2 Sub-study 2 will include all women above the age of 18 with uncomplicated full-term pregnancies and births (i.e. between weeks 37 + 0 - 42 + 0). Sub-Study 3 In sub-study 3, all midwives at the clinic (n = 30) will be asked to participate in the evaluation with PKPCT. The selection of participants for FGD and interviews will be based on competence (i.e. midwives, nurses, doctors and assistants) and position in the care system (i.e. decision-makers, staff at the Ministry of Health and hospital managers). Pregnant and birthing women and any accompanying partner/relative who have been part of the intervention will be randomly sampled. Pre-testing No Pre-testing will be performed as this is a quality improvement project. The data collection for sub-study 2 will start when the implementation starts. The outcomes will be followed until sufficient data has been achieved. Field editing of data The research midwife of the day will fill in the data for sub-study 2 via excel, which will be sent to the PhD student. Missing data The research midwife of the day will fill in any missing data in dialogue with the clinical staff. Missing data will be continuedly monitored as the data sampling will be reported online (via a secured 2-step verification platform approved to share research data). Data Management Computer packages to use SPSS, NVivo Quality control In the qualitative parts of the project, the trustworthiness of the data will be ensured by recording interviews and FGD, transcribing verbatim, triangulation by including other researchers in the team in the analysis, regular discussions on the analysis to reach a common understanding within the team. The quantitative data quality will be checked by random control samples made by members of the research group. A statistician will be consulted during the analysis and an electronic logbook will be kept in order for external researchers to check the procedure. Data Analysis Presentation of data The findings will be published in peer-reviewed academic journals. Analysis Techniques Sub-Study 1 - Thematic analysis, according to Braun & Clark (2006) Sub-Study 2 - SPSS will be used for descriptive and comparative analysis of the data Sub-Study 3 - A process evaluation inspired by Moore et al. (2015).

Official Title
-----------------
MIDWIZE - Strengthening Midwives to Implement and Sustain Quality Improvements to Optimise Maternity Care: A Longitudinal Observational Study in Uganda

Conditions
-----------------
Midwifery

Intervention / Treatment
-----------------
* Other: The MIDWIZE model


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People above the age of 18 with uncomplicated full-term pregnancies and births (i.e. between weeks 37 + 0 - 42 + 0). Exclusion Criteria: People under the age of 18, people with complications in pregnancy or with a planned c-section.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The MIDWIZE model<br>Pregnant women giving birth during at Naguru maternity ward during the intervention period It's only Sub/study 2 in this PhD project which is a clinical trial and which is described onwards. Sub-study 2 will include all women above the age of 18 with uncomplicated full-term pregnancies and births (i.e. between weeks 37 + 0 - 42 + 0) giving birth at the delivery ward during the implementation phase. Data will be collected during the implementation of the quality improvement components. | Other: The MIDWIZE model<br>* So-called MIDWIZE ambassadors are planned to be appointed to lead the clinical implementation of the quality improvement components. Initial training workshops will be held with the ambassadors on practical aspects of the chosen components and how to explain their benefits to the units' staff. Training will also be provided on how to enhance interdisciplinary teamwork and coordinate quality improvements. The workshops will be held onsite at Naguru hospital and online via the project's MIDWIZE virtual platform. The ambassadors will themselves hold training workshops to support midwives and other healthcare providers at the clinics during the implementation of the quality improvements components. The virtual MIDWIZE platform will contain videos, posters, presentations, and other training material that the ambassadors can utilise to enhance the units' capacity and engage their colleagues.<br>|
| The MIDWIZE model - postintervention<br>Pregnant women giving birth at Naguru maternity ward 6 months post intervention period. Sub-study 2 will include all women above the age of 18 with uncomplicated full-term pregnancies and births (i.e. between weeks 37 + 0 - 42 + 0) giving birth at the delivery ward 6months after the implementation phase. Data will be collected after implementing the quality improvement components. The post-measurement data will be collected on the chosen components six months after project implementation to measure if the midwife-led quality improvement project has been sustained. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The uptake of the midwives quality improvments | Three practical care components are suggested in the intervention prototype (i) dynamic birth positions, (ii) delayed cord clamping, for a minimum of 3 min, and (iii) early and uninterrupted skin-to-skin care for a minimum of 90 minutes (i.e., Zero separation). As this project will be co-created with relevant stakeholders these are however only preliminary suggestions. Number of minutes of unbroken skin to skin contact between newborn/mother/another caregiver Number of minutes until the umbilical cord is cut Birth position | Through study completion, an average of 6 months and a follow up period (1 week) after 6months after implementation phase is completed. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mothers age | Mothers age | Through study completion, an average of 6 months and a follow up period (1 week) after 6months after implementation phase is completed. | 
| Level of education | Level of education for mothers giving birth during the intervention. | Through study completion, an average of 6 months and a follow up period (1 week) after 6months after implementation phase is completed. | 
| Marital status | Marital status | Through study completion, an average of 6 months and a follow up period (1 week) after 6months after implementation phase is completed. | 
| Area of living | Area of living | Through study completion, an average of 6 months and a follow up period (1 week) after 6months after implementation phase is completed. | 
| Employment | Employment | Through study completion, an average of 6 months and a follow up period (1 week) after 6months after implementation phase is completed. | 
| Obstetric background | Obstetric background | Through study completion, an average of 6 months and a follow up period (1 week) after 6months after implementation phase is completed. | 
| Gestation week | Gestation week | Through study completion, an average of 6 months and a follow up period (1 week) after 6months after implementation phase is completed. | 
| Mode of delivery | Mode of delivery | Through study completion, an average of 6 months and a follow up period (1 week) after 6months after implementation phase is completed. | 
| Length of second stage of labour | Length of second stage of labour | Through study completion, an average of 6 months and a follow up period (1 week) after 6months after implementation phase is completed. | 
| Apgar score | Apgar score | Through study completion, an average of 6 months and a follow up period (1 week) after 6months after implementation phase is completed. | 
| Birth weight | Birth weight | Through study completion, an average of 6 months and a follow up period (1 week) after 6months after implementation phase is completed. | 
| Head circumference | Head circumference | Through study completion, an average of 6 months and a follow up period (1 week) after 6months after implementation phase is completed. | 
| Transfer to a neonatal unit | Transfer to a neonatal unit | Through study completion, an average of 6 months and a follow up period (1 week) after 6months after implementation phase is completed. | 
| Perineal tear, grade I-IV | Perineal tear, grade I-IV | Through study completion, an average of 6 months and a follow up period (1 week) after 6months after implementation phase is completed. | 
| Postpartum haemorrhage | Postpartum haemorrhage | Through study completion, an average of 6 months and a follow up period (1 week) after 6months after implementation phase is completed. | 
| Neonatal and maternal deaths | Neonatal and maternal deaths | Through study completion, an average of 6 months and a follow up period (1 week) after 6months after implementation phase is completed. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Midwifery, Midwife Led Care, MIDWIZE