Maternal HealthSBMPNCT06414629
An Implementation Research of Simulation Based Mentorship Program
A study testing Simulation Based Mentorship Program in people with Maternal Health and Neonatal Health, run by One Heart Worldwide at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Health, Neonatal Health
- What is being tested?
- Simulation Based Mentorship Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 1 siteNepal
- Study dates
- 1 Nov 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nurses working in selected Birthing Centers during the baseline enrollment
Who cannot join
- Newly recruited nurses by the Birthing Centers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation and Evaluation of Simulation-Based Mentorship Program (SBMP) in Nepal Using the RE-AIM Framework
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:
- What is the reach of the Simulation Based Mentorship Program?
- 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?
- How was the program adopted by the Birthing Centers?
- How was the program implemented?
- What is the perception regarding the maintenance of the program?
Read more
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:
- Infection prevention
- Antenatal care and counseling
- Essential care of labor and birth
- Helping babies breathe
- Bleeding after birth
- Pre-eclampsia and eclampsia management
- Postnatal care and counseling
Read the 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
- Number and percentage of Birthing centers intervened in the district
- Number and percentage of nurses trained as district-level mentors
- Number and percentage of nurses (and Auxiliary Nurse Midwives) receiving the intervention (simulation-based mentorship)
- Perception regarding the representativeness of participants in the program
Effectiveness
- Immediate change in knowledge, skills, and confidence (midline results)- compared with control group
- Perceived reasons for program effectiveness
Adoption
- Number and percentage of intervention sites completing all 6 monthly sessions
- Number and percentage of mentees participating in all 6 monthly sessions
- Number and percentage of mentees participating in weekly sessions
- Reasons for participation/ non-participation
Implementation
- Plan vs. actual implementation (duration between monthly sessions)
- Perception regarding various components of the program (content, teaching and learning methods, mentors)
- Challenges encountered during implementation, adaptations made/ mitigation measures adopted
Maintenance
- Number and percentage of mentors and mentees remaining after 4 to 6 months of Simulation Based Mentorship Program (SBMP) implementation (end-line)
- Retention of knowledge, skills, and confidence 4 to 6 months after completion of the intervention (end-line results) compared with the control group
- Capital cost and recurrent cost required for continuation at government level
- Application of learnings in a real setting (during and after the program implementation)
- Willingness to implement the program in the health facilities of Simulation Based Mentorship Program (SBMP) implemented local levels after completion of the intervention
- Continuation of mentoring/ learning in the simulation labs/ using manikins after completion of monthly sessions by mentors and mentees
- Challenges and recommendations for continuation
- Conditions
- Maternal Health, Neonatal Health
- Being tested
- Simulation Based Mentorship Program
- Keywords
- Simulation, Mentorship, Capacity building
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation Based Mentorship ProgramOther
Also called SBMP
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:
- Infection prevention
- Antenatal care and counseling
- Essential care of labor and birth
- Helping babies breathe
- Bleeding after birth
- Essential care of labor and birth
- Postnatal care and counseling
Every monthly session was followed by four weekly practice sessions. The nurses from intervention birthing centers were also called mentees.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group/ Intervention Birthing Center | Experimental | The nurses working in the Intervention Birthing Centers received the Simulation Based Mentorship Program. Receives: Other: Simulation Based Mentorship Program |
| Control Group/ Control Birthing Center | No intervention | The nurses working in the Intervention Birthing Centers did not receive the Simulation Based Mentorship Program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge, confidence and skills on seven modules
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Nov 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Maternal HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study Birthing Centers were categorized into Intervention Birthing Center and Control Birthing Center
- Masking
- None (open label)
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- One Heart Worldwide
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Surya Bhatta, MHCDS, Study director, One Heart Worldwide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414629
- Sponsor's protocol ID
- OHW1
- Acronym
- SBMP
- Status last verified
- May 2024
- First submitted
- 6 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Utz B, Siddiqui G, Adegoke A, van den Broek N. Definitions and roles of a skilled birth attendant: a mapping exercise from four South-Asian countries. Acta Obstet Gynecol Scand. 2013 Sep;92(9):1063-9. doi: 10.1111/aogs.12166. Epub 2013 Jun 15.
PubMed 23656549Olson 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.
PubMed 25613363Alamrani 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.
PubMed 29016466Krielen 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.
PubMed 36774481Barre 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.
PubMed 35521074Cant 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.
PubMed 27902949Lee 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.
PubMed 31698255Hung 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.
PubMed 33373813
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of Simulation-Based Mentorship Program (SBMP) in Nepal Using the RE-AIM Framework
- ClinicalTrials.gov ID
- NCT06414629
- Acronym / sponsor ID
- SBMP / OHW1
- Conditions
- Maternal Health, Neonatal Health
- Keywords
- Simulation, Mentorship, Capacity building
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- One Heart WorldwideUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the reach of the Simulation Based Mentorship Program?
- 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?
- How was the program adopted by the Birthing Centers?
- How was the program implemented?
- 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:
- Infection prevention
- Antenatal care and counseling
- Essential care of labor and birth
- Helping babies breathe
- Bleeding after birth
- Pre-eclampsia and eclampsia management
- 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
- Number and percentage of Birthing centers intervened in the district
- Number and percentage of nurses trained as district-level mentors
- Number and percentage of nurses (and Auxiliary Nurse Midwives) receiving the intervention (simulation-based mentorship)
- Perception regarding the representativeness of participants in the program
Effectiveness
- Immediate change in knowledge, skills, and confidence (midline results)- compared with control group
- Perceived reasons for program effectiveness
Adoption
- Number and percentage of intervention sites completing all 6 monthly sessions
- Number and percentage of mentees participating in all 6 monthly sessions
- Number and percentage of mentees participating in weekly sessions
- Reasons for participation/ non-participation
Implementation
- Plan vs. actual implementation (duration between monthly sessions)
- Perception regarding various components of the program (content, teaching and learning methods, mentors)
- Challenges encountered during implementation, adaptations made/ mitigation measures adopted
Maintenance
- Number and percentage of mentors and mentees remaining after 4 to 6 months of Simulation Based Mentorship Program (SBMP) implementation (end-line)
- Retention of knowledge, skills, and confidence 4 to 6 months after completion of the intervention (end-line results) compared with the control group
- Capital cost and recurrent cost required for continuation at government level
- Application of learnings in a real setting (during and after the program implementation)
- Willingness to implement the program in the health facilities of Simulation Based Mentorship Program (SBMP) implemented local levels after completion of the intervention
- Continuation of mentoring/ learning in the simulation labs/ using manikins after completion of monthly sessions by mentors and mentees
- Challenges and recommendations for continuation
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study Birthing Centers were categorized into Intervention Birthing Center and Control Birthing Center
| Arm | Type | Receives |
|---|---|---|
| Intervention Group/ Intervention Birthing Center | Experimental | Other: Simulation Based Mentorship ProgramThe nurses working in the Intervention Birthing Centers received the Simulation Based Mentorship Program. |
| Control Group/ Control Birthing Center | No intervention | –The nurses working in the Intervention Birthing Centers did not receive the Simulation Based Mentorship Program. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Nurses working in selected Birthing Centers during the baseline enrollment
Key exclusion criteria (1 listed)
- Newly recruited nurses by the Birthing Centers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation Based Mentorship ProgramAlso: SBMPIn 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. | Other | Intervention Group/ Intervention Birthing Center |
Primary outcome
Knowledge, confidence and skills on seven modules
Time frame: 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Background: PubMed 23656549Utz B, Siddiqui G, Adegoke A, van den Broek N. Definitions and roles of a skilled birth attendant: a mapping exercise from four South-Asian countries. Acta Obstet Gynecol Scand. 2013 Sep;92(9):1063-9. doi: 10.1111/aogs.12166. Epub 2013 Jun 15.
- Background: PubMed 25613363Olson 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.
- Background: PubMed 29016466Alamrani 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.
- Background: PubMed 36774481Krielen 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.
- Background: PubMed 35521074Barre 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.
- Background: PubMed 27902949Cant 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.
- Background: PubMed 31698255Lee 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.
- Background: PubMed 33373813Hung 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Surya Bhatta, MHCDS study director
One Heart Worldwide
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation Based Mentorship Program in people with Maternal Health and Neonatal Health, run by One Heart Worldwide at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge, confidence and skills on seven modules (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06414629, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.