Condition category
Not Applicable
Date applied
23/11/2020
Date assigned
09/12/2020
Last edited
08/01/2021
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Globally, midwives are the main providers of maternity care, providing 87 percent of essential care for women and newborns. Despite this, pre-service midwifery training is criticised for being largely theoretical. There is evidence that the pre-service education and training curriculum in low resource settings is deficient and graduates lack the requisite competencies needed to function adequately as skilled health personnel. The UK AID funded Maternal and Newborn Health programme has supported the regulatory Nursing Council of Kenya to review and integrate the competency-based emergency obstetrics and newborn care (EmONC) training in the diploma midwifery training syllabi so that it is in line with recent WHO definition and competencies for Skilled Health Personnel. This will be followed by training of the midwifery educators to deliver the new curriculum based on the updated syllabi. The objective of this study is to assess whether training, additional mentoring & provision of equipment improves the quality of teaching, knowledge and the confidence of the midwifery teachers in delivering the updated curriculum and student performance in the final Kenya national midwifery license examination.
Lessons learned from this implementation will inform relevant policy and training regulations change in the country for healthcare workers.

Who can participate?
20 colleges offering diploma midwifery training will be randomized to the intervention (12) and control (8) study sites. A total of 36 and 24 educators will participate in the intervention and control arms respectively.

What does the study involve?
The study will involve training, mentoring and replenishment of training equipment. Knowledge assessments will be conducted through online surveys at baseline and quarterly intervals using different sets of questions from a questions bank developed for this study for both intervention and control colleges. Teaching observations using a structured observation checklist will be monitored at baseline and every 3 months after the training for a period of 12 months. Mentoring of the educators in the intervention colleges will be conducted every 3 months after the training for 12 months. Experiences of educators implementing the updated curricula will be collected through key informant interviews and focus group discussions at 6 and 12 months following training.

What are the possible benefits and risks of participating?
The information obtained from this study including the barriers and experiences in implementing the updated curricula will be beneficial in understanding what works for the midwifery educators in the country. This will provide a platform on which support to the midwifery training programs in the country will be anchored, for the improvement of the teaching experiences. Personal interaction with the experienced trainers, through the observation and feedback sessions, will potentially improve the educator's teaching skills during delivery of the updated skills-based trainings. There are no anticipated risks for participating in the study. Study questions have been developed in such a way that they will not embarrass or force the participant to divulge information which could result in anxiety or fear.

Where is the study run from?
Kenya Medical Training College Headquarters

When is the study starting and how long is expected to run for?


Who is funding the study?
This work is not funded. It is within an existing Foreign, Commonwealth & Development Office (FCDO) funded 'Reducing Maternal and Perinatal Mortality in Kenya programme' of work led by Centre for Maternal and Newborn Health – Liverpool School of Tropical Medicine (CMNH-LSTM).

Who is the main contact?
Charles A. Ameh, charles.ameh@lstmed.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Charles Ameh

ORCID ID

http://orcid.org/0000-0002-2341-7605

Contact details

Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom
+44 (0)7714 75 3844
Charles.Ameh@lstmed.ac.uk

Type

Public

Additional contact

Mr Duncan Shikuku

ORCID ID

http://orcid.org/0000-0003-3580-7077

Contact details

P.O. BOX 24672
Nairobi
00100
Kenya
+254 725523716
duncan.shikuku@lstmed.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Protocol for evaluation of the implementation of the updated midwifery syllabi for pre-service training in Kenya: a randomized controlled study

Acronym

PRCT

Study hypothesis

Training, mentoring & provision of equipment (intervention) improves the quality of teaching, knowledge and the confidence of the midwifery lecturers to deliver an updated curriculum integrated with the competency-based emergency obstetrics and newborn care (EmONC)

Ethics approval

Approved 03/07/2020, Liverpool School of Tropical Medicine Research Ethics Committee (Pembroke Place, Liverpool, L3 5QA, UK; +44 (0)151 705 3100; lstmrec@lstmed.ac.uk), ref: 20-050

Study design

Multi-centre cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Pre-service training for midwives

Intervention

Randomisation
This will be a mixed methods study that involves a cluster randomized control study design and qualitative research methodology in 20 training institutions. Randomisation would be stratified by region (the eight former provinces will be used). Five pre-identified training hubs will receive the training equipment to support the trainings. Prior to commencing the trial the fifteen non-hub sites will be randomised, to study arm, with eight assigned to the control arm and seven to the intervention.
The proposed intervention is the training, provision of training equipment and regular mentoring on the quality of teaching and knowledge about the content of the new curricula 3-monthly (see below for details).

Training
All midwifery educators (about 250) from all the 84 diploma training colleges will receive a 3-day training on mixed teaching methodologies integrated with feedback for delivery of the updated competency-based curricula and key life-saving emergency obstetrics and newborn care (EmONC) skills.This will involve return demonstrations, group discussions, role plays/scenarios in addition to the commonly utilized lectures. Key EmONC skills to be upskilled will include and not limited to breech birth, shoulder dystocia, vacuum extraction, episiotomy repair, manual removal of placenta, management of maternal shock, maternal/newborn resuscitation, use of the situation, background, assessment and recommendation (SBAR) communication tool in clinical practice, respectful maternity care and the WHO checklist. At the end of the training, each training institution will develop an action plan with a specific monitoring of implementation plan of activities that will focus on integrated teaching methodologies to promote learning, assessment tools, feedback mechanisms to promote teaching and learning (student-tutor and tutor-tutor), skills laboratory and teaching environment and update its specific training curricula from the prescribed syllabi by the NCK. These trainings are scheduled to be completed within the first 6 months of the intervention.

Mentoring
The mentoring of midwifery educators will be conducted by select experienced EmONC master trainers and lecturers and will focus on upskilling their teaching skills and reflective practice to promote learning among students especially on performance of critical life-saving EmONC skills. This will involve teaching of actual EmONC skills (including performance of complicated births – breech, shoulder dystocia, vacuum extraction and maternal/newborn resuscitation among others), use of simulations/scenarios, videos/films in teaching skills and evaluation of the skills. This will be conducted every 3 months for a duration of 12 months.

Equipment
The EmONC training equipment (aid in performance of the EmONC signal functions and skills) to be replenished include: obstetric phantom with fetal doll, uterine pelvic model (bony pelvis), Little Anne, kiwi omnicups, airway management trainer, instrumental birthing simulator & fetal head (Lucy & Mum), MVA syringe and cannula, retained knitted placenta models, resusci baby, episiotomy repair trainer, assorted forceps, ambubag and mask (adult and pediatric) and local consumables among others.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Measured at baseline, 3, 6, 9 and 12 months:
1. Knowledge of midwifery educators delivering the updated curricula measured using an online survey
2. Confidence of midwifery educators delivering the updated curricula measured using an online survey

Secondary outcome measures

1. Teaching style measured using direct observational checklists at baseline, 3 months and at 12 months
2. Experiences of midwifery educators implementing the updated curricula measured using qualitative key informant interviews and focused group discussions at 6 and 12 months
3. Final year midwifery students' performance measured at the end of the 3-year training using qualifying/licensure examination results

Overall trial start date

01/06/2020

Overall trial end date

30/12/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Midwifery training educators and clinical instructors offering the diploma midwifery training program

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

15/02/2021

Recruitment end date

30/06/2022

Locations

Countries of recruitment

Kenya

Trial participating centre

Kenya Medical Training College Headquarters
Off Ngong Road P.O. BOX 30195
Nairobi
00100
Kenya

Sponsor information

Organisation

Liverpool School of Tropical Medicine

Sponsor details

Pembroke Place
Liverpool
L3 5QA
Kenya
+44 (0)151 705 3100
lstmgov@lstmed.ac.uk

Sponsor type

University/education

Website

http://www.lstmed.ac.uk/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal; dissemination of results will be done to the Ministry of Health, Nursing Council of Kenya, Kenya Medical Training College Headquarters and the pre-service stakeholders.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from (Dr Charles Ameh, Charles.Ameh@lstmed.ac.uk) for deidentified quantitative and qualitative data. Data will become available after analysis is complete and published late 2022. In line with LSTM policy data will be available for 5 years type of data and will be shared for research purposes. All data is deidentified and participants will be consented for additional analysis using anonymised data.

Intention to publish date

31/12/2024

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

08/01/2021: The recruitment start date was changed from 11/01/2021 to 15/02/2021. 09/12/2020: Uploaded protocol (not peer reviewed) Version n/a, date not provided. 24/11/2020: Trial’s existence confirmed by Liverpool School of Tropical Medicine.