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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03269240
Other study ID # IRB00007196
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 17, 2016
Est. completion date November 29, 2017

Study information

Verified date August 2018
Source Jhpiego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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:

1. Compare knowledge and skill learning outcomes between the two groups of birth attendants trained through the simulation-based LDHF/m-Mentoring versus group-based training approaches in Kogi and Ebonyi states over 12-months.

2. Assess the trainees' satisfaction with a simulation-based LDHF/m-Mentoring and group-based training approaches in improving skills of birth attendants in the selected facilities in Kogi and Ebonyi state over 12-months.

3. Determine the cost and cost-effectiveness of LDHF/m-Mentoring and group-based training approaches in improving skills of birth attendants in the selected facilities in Kogi and Ebonyi state over 12-months.


Description:

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).


Recruitment information / eligibility

Status Completed
Enrollment 299
Est. completion date November 29, 2017
Est. primary completion date March 24, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Must give informed consent to participate in the study;

2. Must have spent at least six months in maternal and/or newborn care services;

3. Must be providing services related to maternal and newborn health in selected health facilities at the time of the interview;

4. Must be available to participate in the training from the beginning to the end; and

5. Must have had pre-service training not incorporating simulation-based LDHF approach from accredited medical schools, schools of nursing/midwifery or health technology.

Exclusion Criteria:

1. Decides to opt out / declines to participate.

2. Has had prior training using the simulation-based LDHF approach.

3. Provides services related to maternal and newborn health more than one health facility selected as part of intervention or comparison group.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Acquisition of Knowledge and clinical skills
LDHF is a novel training approach that is being compared to the traditional training approach
Other:
Onsite training
Participants are training at their health facilities
Off-site training
Participants from different health facilities are gathered together in a central location for training, away from their workplaces

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Jhpiego

Outcome

Type Measure Description Time frame Safety issue
Primary 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 3 months
Secondary Comparison of retention of skills between the two study arms Proportion of service providers who retain clinical competency skills after 12 months 12 months
Secondary Level of satisfaction of service providers Proportion of service providers who are satisfied with the training approach 12 months
Secondary 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. 12 months
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