Evaluating the implementation of person-centred care - and simulation-based learning in a midwifery education programme in the Democratic Republic of Congo
| ISRCTN | ISRCTN10049855 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10049855 |
| Secondary identifying numbers | DRC2022 |
- Submission date
- 18/02/2024
- Registration date
- 23/02/2024
- Last edited
- 31/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
Professional midwives play a crucial role in enhancing the quality of maternal and newborn healthcare, particularly in low-income countries like those in the Central Africa Region. This stresses the importance of addressing the global shortage of adequately educated midwives to meet international standards, highlighting this as vital for achieving Sustainable Development Goals and improving maternal and newborn health outcomes.
In the Democratic Republic of Congo (DRC), the text details significant challenges in maternal and newborn healthcare, including high mortality rates and the impact of healthcare provider interactions on the quality of care. System deficiencies in resource-constrained settings like the DRC may lead to mistreatment and human rights violations.
The concept of person-centered care is a used to improve healthcare equity through mutual respect and collaboration between patients and providers. Implementing person-centered care has shown potential in reducing maternal and neonatal morbidity and mortality by involving patients as active partners in their care.
Simulation-based learning is a method to enhance clinical competence among healthcare providers, including midwives. This pedagogical approach uses simulated patient care scenarios to improve knowledge, skills, and patient safety. It is particularly noted for its cost-effectiveness and transformative potential in low-income settings.
Lastly, there are major knowledge gaps in midwifery education in the DRC, including deficiencies in the curriculum and a need for more simulation-based learning activities. As a response to these challenges, a midwifery education program at Evangelical University in Africa is focusing on person-centered care and simulation-based learning to meet international standards and improve the quality of care.
The overall aim of this research is to evaluate the implementation of person-centered approach and simulation-based learning in childbirth care as part of the midwifery education program at Evangelical University in Africa in the Democratic Republic of Congo.
The specific aims are to validate and culturally adapt the Swedish person-centered care course “Mutual meetings” and to determine the effectiveness of training midwives and gynecologists to function as facilitators in the implementation of person-centered care and the use of childbirth simulation-based learning activities at clinical practice sites for midwife students.
Who can participate?
All midwifery students in the first cohort of the bachelor level midwifery education programme at UEA.
All clinical preceptors in the five clinical practice sites educating the midwifery students during their clinical practice.
All trained facilitators in the testing of the person-centered care training programme "Mutual meetings" or the three simulation courses.
What does the study involve?
The study involves, besides the interventions, focus group interviews with the mentioned participants and a register study of the maternal and newborn register at the five selected implementation sites.
What are the possible benefits and risks of participating?
The benefits of participating are to contribute to generate new evidence which in turn can lead to improved quality in childbirth care. There are no evident risks for the participants.
Where is the study run from?
The Democratic Republic of Congo, South Kivu region.
When is the study starting and how long is it expected to run for?
February 2022 to January 2027.
Who is funding the study?
Gothenburg Center of Person-Centered care (Sweden), United Nations Population Fund DRC, Laerdal Global health and LM international.
Who is the main contact?
Frida Temple, frida.temple@gu.se
Contact information
Public, Scientific
Arwid Wallgrens backe, House 1
Gothenburg
413 46
Sweden
 ORCID ID |
0009-0001-2933-5280 |
|---|---|
| Phone | +250786900603 |
| frida.temple@gu.se |
Principal Investigator
Arwid Wallgrens backe, House 1
Gothenburg
413 46
Sweden
| ORCID ID |
0000-0003-2432-8097 |
|---|---|
| Phone | +46 738099508 |
| malin.bogren@gu.se |
Study information
| Study design | Exploratory design guided by the principles of an evaluation framework |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Training facility/simulation, University/medical school/dental school |
| Study type | Other |
| Participant information sheet | 45066 PIS.pdf |
| Scientific title | Evaluating the implementation of person-centred care - and simulation-based learning in a midwifery education programme in the Democratic Republic of Congo: a study protocol |
| Study hypothesis | Our hypothesis is that the implementation of both person-centered care and simulation-based learning in a midwifery education programme by educate facilitators will increase the quality of care in practice, and thereby improve maternal and neonatal outcomes. |
| Ethics approval(s) |
Approved 03/01/2024, National Ethical Committee of Public Health in the South Kivu Province (Av. du Boulevard Nr 2, Batiment de l'hygiene aux frontieres a Labotte, Bukavo, South Kivu, 22222, Congo, Democratic Republic; +243972214863; cnes.sudkivu@gmail.com), ref: CNES 001/DPSK/219PP/2024 |
| Condition | Effect of implementing Person-centered care and simulation-based learning in Midwifery education in the Democratic Republic of Congo (DRC). |
| Intervention | The intervention involves integrating two profiles into a midwifery education programme aligned with the national curriculum in DRC, namely person-centered care and simulation-based learning. The strategy used for the integration of the two profiles of person-centered care and simulation- based learning, is training facilitators from each clinical site to further ensure effective and sustained implementation. |
| Intervention type | Behavioural |
| Primary outcome measure | Maternal and Newborn health outcome measured using Birth registers from all five clinical practice sites during 01/01/2022 - 31/12/2022 and 01/01/2024 - 31/12/2024. |
| Secondary outcome measures | Effectiveness of the implemented intervention measured using focus Group Interviews with Midwifery students, Clinical Preceptors and Facilitators at each clinical practice sites. |
| Overall study start date | 01/02/2022 |
| Overall study end date | 01/01/2027 |
Eligibility
| Participant type(s) | Health professional, Learner/student, Service user |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Both |
| Target number of participants | 70 (for interviews). |
| Participant inclusion criteria | Study participants will include trained facilitators in Person-centered care and the simulation-based learning courses, clinical preceptors, and midwifery students at the Evangelical University of Africa in Bukavu, DRC. For the register data, all data on registered births at 5 clinical practice sites. |
| Participant exclusion criteria | Health care providers including trained facilitators and students involved in the midwifery education programme. |
| Recruitment start date | 15/09/2022 |
| Recruitment end date | 01/01/2026 |
Locations
Countries of recruitment
- Congo, Democratic Republic
Study participating centres
Bukavu
3323 Bukavu
Congo, Democratic Republic
Bukavu
3323 Bukavu
Congo, Democratic Republic
3324 Bukavu
Congo, Democratic Republic
Kasenga Uvira
22222 Uvira
Congo, Democratic Republic
Kyeshero
22222 Goma
Congo, Democratic Republic
3325 Bukavu
Congo, Democratic Republic
Sponsor information
University/education
Arvid Wallgrens Backe House 1
Gothenburg
41346
Sweden
| Phone | +46 738099508 |
|---|---|
| helena.wigert@fhs.gu.se | |
| Website | http://www.gu.se/english |
"ROR" |
https://ror.org/01tm6cn81 |
Funders
Funder type
Hospital/treatment centre
No information available
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 01/01/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Not expected to be made available |
| Publication and dissemination plan | Planned publications in a high impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to ethical approval not covering publicly sharing the data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 19/02/2024 | No | Yes | ||
| Protocol article | 31/12/2024 | 26/06/2024 | Yes | No |
Additional files
Editorial Notes
31/01/2025: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/01/2025 to 01/01/2026.
2. The overall end date was changed from 01/01/2025 to 01/01/2027.
3. The plain English summary was updated to reflect these changes.
26/06/2024: Publication reference added.
19/02/2024: Trial's existence confirmed by National Ethical Committee of Public Health in the South Kivu Province
