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

NCT ID: NCT03269240

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 299 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-17
• Study Completion Date: 2017-11-29

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).

Conditions

Training; Capacity Building; Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

LDHF plus m-Mentoring

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.

Group Type: EXPERIMENTAL

Acquisition of Knowledge and clinical skills

Intervention Type: BEHAVIORAL

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

Onsite training

Intervention Type: OTHER

Participants are training at their health facilities

Traditional 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.

Group Type: ACTIVE_COMPARATOR

Acquisition of Knowledge and clinical skills

Intervention Type: BEHAVIORAL

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

Off-site training

Intervention Type: OTHER

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

Interventions

Acquisition of Knowledge and clinical skills

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

Intervention Type: BEHAVIORAL

Onsite training

Participants are training at their health facilities

Intervention Type: OTHER

Off-site training

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jhpiego

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuel Otolorin

Role: PRINCIPAL_INVESTIGATOR

Jhpiego

References

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.

Reference Type: DERIVED

PMID: 32590979 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30103761 (View on PubMed)

Other Identifiers

IRB00007196

Identifier Type: -

Identifier Source: org_study_id