An interventional study of Acquisition of Knowledge and clinical skills and Onsite training in Training, Capacity Building and Satisfaction, sponsored by Jhpiego. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-10.
Sponsored by Jhpiego · Not applicable, Interventional, and Health services research
The aim of this study is to compare the effectiveness and cost of a simulation-based low dose high frequency (LDHF) plus m-Mentoring training versus the traditional group-based training approaches in improving knowledge and skill in maternal and newborn care and to determine trainees' satisfaction with the approaches in Ebonyi and Kogi states.
The specific objectives are to:
Simulation-based low dose high frequency (LDHF) training has emerged as a new strategy for delivering key content and improving the competencies of health workers. In facility-based driven simulation-based LDHF trainings, providers are not removed from clinical practice for the extended periods of time, and a heavy emphasis is placed on simulation with practice and feedback.
The Maternal and Child Survival Program (MCSP) in Nigeria is working in selected health facilities in Ebonyi and Kogi States to improve the quality of care received by mothers and newborns on the day of birth using high-impact evidence-based lifesaving interventions. The simulation-based LDHF/m-Mentoring evaluation comparing it to the traditional group-based training will contribute to the body of knowledge on this approach.
The study design is cluster randomized control trial. Sixty (60) health facilities will be selected from the list of 120 facilities which are supported by MCSP and randomized to intervention and control group. Selection will be based on caseload, level of service delivery, and ownership. Thereafter, these will be randomly assigned to simulation-based LDHF/m-Mentoring Group (intervention arm) or Group-Based Training Group (control arm).
541 studies on the registry are indexed under Personal Satisfaction; 93 are open to participants now.
This study's enrollment of 299 is above the median of 93 across 416 interventional studies indexed under Personal Satisfaction.
Browse Personal Satisfaction studies →Jhpiego is the lead sponsor of 32 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will undergo pre-training assessment comprising multiple-choice questions and objective structured clinical examination (OSCE) using manikins. Training is divided into two 4-day "low-dose" sessions at the health facility or onsite training. Pre-training and immediate post-training assessments results will be compared. A score of ≥80% is acceptable competence (pass). During the one-month intervals between training sessions, participants practice using manikins to reinforce their competencies through simulation-based practices, facilitated by facility-based trained Peer Practice Coordinators (PPCs). The PPCs will also receive structured, monthly half-hour mentoring calls that will provide remote support, answering questions, providing guidance and reinforcing key messages. Acquisition of knowledge and clinical skills is measured.
Behavioral: Acquisition of Knowledge and clinical skills · Other: Onsite training
The health providers will receive the same content of training in eight days, Off-site training, the way it's currently done in Nigeria. Both theoretical and practical through use of manikins - simulation. No reinforcement and further practice will take place once the participants are back in their work stations. Acquisition of knowledge and clinical skills is measured.
Behavioral: Acquisition of Knowledge and clinical skills · Other: Off-site training
LDHF is a novel training approach that is being compared to the traditional training approach
Participants are training at their health facilities
Participants from different health facilities are gathered together in a central location for training, away from their workplaces
Percent change in competency in basic obstetric and emergency care between the groups
Proportion of competent providers who retain clinical competency skills 3 months post-training
Time frame: 3 months
Comparison of retention of skills between the two study arms
Proportion of service providers who retain clinical competency skills after 12 months
Time frame: 12 months
Level of satisfaction of service providers
Proportion of service providers who are satisfied with the training approach
Time frame: 12 months
Comparison of cost-effectiveness of the two approaches
Cost-effectiveness of LDHF/m-Mentoring compared to group-based training approaches in improving skills of birth attendants in the selected facilities in Kogi and Ebonyi states.
Time frame: 12 months
No study locations are listed for this record.
Plan to share: Undecided — The study protocol will be shared through publication in a peer-reviewed journal. De-identified participant data will be submitted to a data repository in accordance with the USAID policy where other researchers will have access.
Ran from Sep 2016 to primary completion in Mar 2017, 6 months.
Of 248 non-industry interventional studies with no phase under Personal Satisfaction, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 21. This study's 6 months is below that.
Counting every sponsor, half of 255 studies reached it within 9 months; a quarter within 3 and three quarters within 21.
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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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