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Completed

NCT Number: NCT03269240

Simulation-based Low-dose High Frequency (LDHF) Plus Mobile Mentoring (m-Mentoring) Study in Nigeria

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.

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Key information

Conditions

Training Behavior Capacity Building Personal Satisfaction Satisfaction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must give informed consent to participate in the study;
  • Must have spent at least six months in maternal and/or newborn care services;
  • Must be providing services related to maternal and newborn health in selected health facilities at the time of the interview;
  • Must be available to participate in the training from the beginning to the end; and
  • 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

  • Decides to opt out / declines to participate.
  • Has had prior training using the simulation-based LDHF approach.
  • Provides services related to maternal and newborn health more than one health facility selected as part of intervention or comparison group.

Treatment and study plan

Acquisition of Knowledge and clinical skills

Behavioral

LDHF is a novel training approach that is being compared to the traditional training approach

Onsite training

Other

Participants are training at their health facilities

Off-site training

Other

Participants from different health facilities are gathered together in a central location for training, away from their workplaces

Primary outcomes

  1. Percent change in competency in basic obstetric and emergency care between the groups

    Time frame: 3 months

    Proportion of competent providers who retain clinical competency skills 3 months post-training

Secondary outcomes

  1. Comparison of retention of skills between the two study arms

    Time frame: 12 months

    Proportion of service providers who retain clinical competency skills after 12 months

  2. Level of satisfaction of service providers

    Time frame: 12 months

    Proportion of service providers who are satisfied with the training approach

  3. Comparison of cost-effectiveness of the two approaches

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Jhpiego

Other

Registry information

Official study title

A Comparative Study of Simulation-based Low-dose High Frequency (LDHF) Plus Mobile Mentoring (m-Mentoring) Versus Traditional Group-based Training Approaches Among Maternal and Newborn Healthcare Providers in Ebonyi and Kogi States, Nigeria

Acronym: LDHF-Nigeria

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 31, 2017
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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