## Protocol Section
### Identification Module
**NCT ID:** NCT06414629

**Acronym:** SBMP

**Brief Title:** 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

#### Organization Study ID Info
**ID:** OHW1
#### Organization
**Class:** OTHER
**Full Name:** One Heart Worldwide
### Status Module
#### Completion Date
**Date:** 2023-12-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2020-11-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** One Heart Worldwide

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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

### Conditions Module

**Conditions:**

- Maternal Health

- Neonatal Health

**Keywords:**

- Simulation

- Mentorship

- Capacity building

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** The study Birthing Centers were categorized into Intervention Birthing Center and Control Birthing Center

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 326

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The nurses working in the Intervention Birthing Centers received the Simulation Based Mentorship Program.

**Intervention Names:**

- Other: Simulation Based Mentorship Program

**Label:** Intervention Group/ Intervention Birthing Center

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The nurses working in the Intervention Birthing Centers did not receive the Simulation Based Mentorship Program.

**Label:** Control Group/ Control Birthing Center

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention Group/ Intervention Birthing Center

**Description:** In this program, local level mentors were developed to provide regular mentorship on 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 mentors provided monthly mentorship on following seven modules topics to the nurses of the intervention birthing centers:

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

Every monthly session was followed by four weekly practice sessions. The nurses from intervention birthing centers were also called mentees.

**Name:** Simulation Based Mentorship Program

**Other Names:**

- SBMP

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The knowledge and confidence scores of intervention and control group's nurses in all seven modules were compared before and after the study. However, skills scores of seven modules were measured only in intervention group's nurses. The overall maximum obtainable score was 127 points for knowledge assessment, 210 points for confidence assessment, and 340 points for skills assessment. The scores obtained by the participants were expressed as percentage, and a mean score was calculated for each module. A score of 80% or more was considered to be appropriate. High scores indicated better outcome, and low scores indicated poor outcome.

**Measure:** Knowledge, confidence and skills on seven modules

**Time Frame:** 1 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Nurses working in selected Birthing Centers during the baseline enrollment

Exclusion Criteria:

* Newly recruited nurses by the Birthing Centers

**Healthy Volunteers:** True

**Maximum Age:** 49 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Kathmandu

**Country:** Nepal

**Facility:** One Heart Worldwide

**State:** Bagmati

#### Overall Officials

**Official 1:**

**Affiliation:** One Heart Worldwide

**Name:** Surya Bhatta, MHCDS

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

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**PMID:** 23656549

**Citation:** Olson KR, Caldwell A, Sihombing M, Guarino AJ, Nelson BD, Petersen R. Assessing self-efficacy of frontline providers to perform newborn resuscitation in a low-resource setting. Resuscitation. 2015 Apr;89:58-63. doi: 10.1016/j.resuscitation.2015.01.008. Epub 2015 Jan 19.

**PMID:** 25613363

**Citation:** Alamrani MH, Alammar KA, Alqahtani SS, Salem OA. Comparing the Effects of Simulation-Based and Traditional Teaching Methods on the Critical Thinking Abilities and Self-Confidence of Nursing Students. J Nurs Res. 2018 Jun;26(3):152-157. doi: 10.1097/jnr.0000000000000231.

**PMID:** 29016466

**Citation:** Krielen P, Meeuwsen M, Tan ECTH, Schieving JH, Ruijs AJEM, Scherpbier ND. Interprofessional simulation of acute care for nursing and medical students: interprofessional competencies and transfer to the workplace. BMC Med Educ. 2023 Feb 11;23(1):105. doi: 10.1186/s12909-023-04053-2.

**PMID:** 36774481

**Citation:** Barre J, Michelet D, Truchot J, Cabon P, Tesniere A. Midwifery students' retention of learning after screen-based simulation training on neonatal resuscitation: a pilot study. BMJ Simul Technol Enhanc Learn. 2020 Apr 6;7(1):31-34. doi: 10.1136/bmjstel-2019-000525. eCollection 2021.

**PMID:** 35521074

**Citation:** Cant RP, Cooper SJ. Use of simulation-based learning in undergraduate nurse education: An umbrella systematic review. Nurse Educ Today. 2017 Feb;49:63-71. doi: 10.1016/j.nedt.2016.11.015. Epub 2016 Nov 22.

**PMID:** 27902949

**Citation:** Lee BO, Liang HF, Chu TP, Hung CC. Effects of simulation-based learning on nursing student competences and clinical performance. Nurse Educ Pract. 2019 Nov;41:102646. doi: 10.1016/j.nepr.2019.102646. Epub 2019 Oct 23.

**PMID:** 31698255

**Citation:** Hung CC, Kao HS, Liu HC, Liang HF, Chu TP, Lee BO. Effects of simulation-based learning on nursing students' perceived competence, self-efficacy, and learning satisfaction: A repeat measurement method. Nurse Educ Today. 2021 Feb;97:104725. doi: 10.1016/j.nedt.2020.104725. Epub 2020 Dec 16.

**PMID:** 33373813

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
