NCT03269240

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. 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. 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
299

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 17, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2017

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

6 months

First QC Date

August 24, 2017

Last Update Submit

August 8, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Comparison of retention of skills between the two study arms

    12 months

  • Level of satisfaction of service providers

    12 months

  • Comparison of cost-effectiveness of the two approaches

    12 months

Study Arms (2)

LDHF plus m-Mentoring

EXPERIMENTAL

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 skillsOther: Onsite training

Traditional training

ACTIVE COMPARATOR

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 skillsOther: Off-site training

Interventions

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

LDHF plus m-MentoringTraditional training

Participants are training at their health facilities

LDHF plus m-Mentoring

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

Traditional training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Personal Satisfaction

Interventions

Clinical Competence

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Quality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Emmanuel Otolorin

    Jhpiego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assessors will blinded with respect to which study arm the participants (health care workers) were assigned to.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Cluster randomized control trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2017

First Posted

August 31, 2017

Study Start

September 17, 2016

Primary Completion

March 24, 2017

Study Completion

November 29, 2017

Last Updated

August 10, 2018

Record last verified: 2018-08