Clinical trial NCT06414629: An Implementation Research of Simulation Based Mentorship Program
Official title: Implementation and Evaluation of Simulation-Based Mentorship Program (SBMP) in Nepal Using the RE-AIM Framework
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Health
Neonatal Health
Keywords: Simulation
Mentorship
Capacity building
Lead sponsor: One Heart Worldwide
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 326
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study Birthing Centers were categorized into Intervention Birthing Center and Control Birthing Center
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this research was to evaluate the effectiveness and implementation outcomes of the Simulation Based Mentorship Program (SBMP) which was implemented in four districts of Nepal. The main questions it aims to answer are:

1. What is the reach of the Simulation Based Mentorship Program?
2. What is the effect of Simulation Based Based Mentorship Program on knowledge, clinical skills, and confidence of nurses working in Birthing Centers of four district of Nepal?
3. How was the program adopted by the Birthing Centers?
4. How was the program implemented?
5. What is the perception regarding the maintenance of the program?

The nurses working in the Birthing Centers were the study participants, and they received simulation-based monthly mentorship on following seven modules related to essential obstetric and newborn care every month:

1. Infection prevention
2. Antenatal care and counseling
3. Essential care of labor and birth
4. Helping babies breathe
5. Bleeding after birth
6. Pre-eclampsia and eclampsia management
7. Postnatal care and counseling

Detailed description: As the evidence showed gaps in the knowledge and skills of existing maternal and newborn health providers, we designed a Simulation-Based Mentorship Program (SBMP) to bridge the gaps. In this program, local-level mentors were developed to provide regular mentorship using a low-dose high-frequency approach in contrast to one-time coaching in a long gap. This program combined the existing package of the continuum of care along with Helping Babies Survive (HBS) \& Helping Mothers Survive (HMS) guidelines, adopting a simulation-based onsite mentoring and coaching approach.

The main aim of this mentorship program was to improve the quality of essential obstetric and newborn care provided by the nurses and Auxiliary Nurse Midwives (ANMs) irrespective of their pre-service and in-service training exposure by identifying gaps, providing regular technical support on the site, building close relationships between mentors and mentees, and increasing communication, backed up by regular practice in simulation labs to help in skill retention. In this mentorship program, mentorship was provided to both the Skilled Birth Assistants (SBAs) and non-Skilled Birth Attendants in their workstations to capacitate them in promoting mother and newborn health outcomes.

Reach, Effectiveness, Adoption, Implementation, and Maintenance (REAIM) Dimensions in the study were:

Reach

1. Number and percentage of Birthing centers intervened in the district
2. Number and percentage of nurses trained as district-level mentors
3. Number and percentage of nurses (and Auxiliary Nurse Midwives) receiving the intervention (simulation-based mentorship)
4. Perception regarding the representativeness of participants in the program

Effectiveness

1. Immediate change in knowledge, skills, and confidence (midline results)- compared with control group
2. Perceived reasons for program effectiveness

Adoption

1. Number and percentage of intervention sites completing all 6 monthly sessions
2. Number and percentage of mentees participating in all 6 monthly sessions
3. Number and percentage of mentees participating in weekly sessions
4. Reasons for participation/ non-participation

Implementation

1. Plan vs. actual implementation (duration between monthly sessions)
2. Perception regarding various components of the program (content, teaching and learning methods, mentors)
3. Challenges encountered during implementation, adaptations made/ mitigation measures adopted

Maintenance

1. Number and percentage of mentors and mentees remaining after 4 to 6 months of Simulation Based Mentorship Program (SBMP) implementation (end-line)
2. Retention of knowledge, skills, and confidence 4 to 6 months after completion of the intervention (end-line results) compared with the control group
3. Capital cost and recurrent cost required for continuation at government level
4. Application of learnings in a real setting (during and after the program implementation)
5. Willingness to implement the program in the health facilities of Simulation Based Mentorship Program (SBMP) implemented local levels after completion of the intervention
6. Continuation of mentoring/ learning in the simulation labs/ using manikins after completion of monthly sessions by mentors and mentees
7. Challenges and recommendations for continuation

Eligibility criteria: Inclusion Criteria:

* Nurses working in selected Birthing Centers during the baseline enrollment

Exclusion Criteria:

* Newly recruited nurses by the Birthing Centers

Primary outcomes:
measure: Knowledge, confidence and skills on seven modules
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: One Heart Worldwide
state: Bagmati
Study officials:
affiliation: One Heart Worldwide
name: Surya Bhatta, MHCDS
role: STUDY_DIRECTOR
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