Clinical trial NCT03269240: Simulation-based Low-dose High Frequency (LDHF) Plus Mobile Mentoring (m-Mentoring) Study in Nigeria
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Training
Capacity Building
Satisfaction
Lead sponsor: Jhpiego
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized control trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Percent change in competency in basic obstetric and emergency care between the groups
timeFrame: 3 months
Secondary outcomes:
measure: Comparison of retention of skills between the two study arms
timeFrame: 12 months
measure: Level of satisfaction of service providers
timeFrame: 12 months
measure: Comparison of cost-effectiveness of the two approaches
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Jhpiego
name: Emmanuel Otolorin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ugwa E, Kabue M, Otolorin E, Yenokyan G, Oniyire A, Orji B, Okoli U, Enne J, Alobo G, Olisaekee G, Oluwatobi A, Oduenyi C, Aledare A, Onwe B, Ishola G. Simulation-based low-dose, high-frequency plus mobile mentoring versus traditional group-based trainings among health workers on day of birth care in Nigeria; a cluster randomized controlled trial. BMC Health Serv Res. 2020 Jun 26;20(1):586. doi: 10.1186/s12913-020-05450-9.
citation: Ugwa E, Otolorin E, Kabue M, Ishola G, Evans C, Oniyire A, Olisaekee G, Onwe B, LeFevre AE, Bluestone J, Orji B, Yenokyan G, Okoli U. Simulation-based low-dose, high-frequency plus mobile mentoring versus traditional group-based training approaches on day of birth care among maternal and newborn healthcare providers in Ebonyi and Kogi States, Nigeria; a randomized controlled trial. BMC Health Serv Res. 2018 Aug 13;18(1):630. doi: 10.1186/s12913-018-3405-2.