| CTRI Number |
CTRI/2024/09/073367 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [educational ] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Effectiveness of Simulation based training on Emergency-care for Staff Nurses and Community Health Officers |
|
Scientific Title of Study
|
Effectiveness of simulation based training package on Emergency Care Practice among staff nurses of Primary Health Centers and Community Health Officers of Ayushman Arogya Mandir of Udupi District Karnataka |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sarah H |
| Designation |
PhD Scholar |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Manipal college of Nursing MAHE Manipal 576104
Manipal college of Nursing MAHE Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
09740555293 |
| Fax |
|
| Email |
sarahhulugoji@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sarah H |
| Designation |
PhD Scholar |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Manipal college of Nursing MAHE Manipal 576104
Manipal college of Nursing MAHE Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
09740555293 |
| Fax |
|
| Email |
sarahhulugoji@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sarah H |
| Designation |
PhD Scholar |
| Affiliation |
|
| Address |
Manipal college of Nursing MAHE Manipal 576104
Manipal college of Nursing MAHE Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
09740555293 |
| Fax |
|
| Email |
sarahhulugoji@gmail.com |
|
|
Source of Monetary or Material Support
|
| TMA Pai Scholarship, MAHE Manipal 576104, India |
|
|
Primary Sponsor
|
| Name |
Miss Sarah H |
| Address |
Manipal College of Nursing MAHE Manipal 576104 India |
| Type of Sponsor |
Other [Dr TMA Pai Scholarship MAHE Manipal] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Applied to ICMR |
New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rachana |
Primary Health Centers Health and Wellness Center |
Udupi District
Udupi
KARNATAKA |
9599460465
rachana.kmc@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individual working as a Staff Nurses and Community Health Officers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Information booklet on emergency care |
The control group will receive an information booklet on essential emergency care. This will includes topics such as trauma care, drowning, chest pain, animal bites, seizures, hypoglycemia, stroke, and obstetrical emergencies |
| Intervention |
Simulation based training on emergency care |
The intervention group will receive simulation-based training on essential emergency care topics such as trauma care, drowning, chest pain, animal bites, seizures, hypoglycemia, stroke, and obstetrical emergencies |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
58.00 Year(s) |
| Gender |
Both |
| Details |
willing to participate in the study
Who are working as Primary Health Care Officers (ANM), Staff Nurses, and Community Health Officers in Udupi District
|
|
| ExclusionCriteria |
| Details |
Who have received prior simulation training package on emergency care in past one year |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome of conducting this research would provide valuable insights into the distribution and severity of emergency cases handled at AAM(HWCs)/PHCs, along with the effectiveness of referral systems to higher-level centers. This data can aid in identifying areas for improvement in emergency care provision and staff training to enhance the overall healthcare delivery system |
post test will be collected at 1month, 3rd month and 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • The outcome of conducting this research would provide valuable insights into the distribution and severity of emergency cases handled at AAM(HWCs)/PHCs, along with the effectiveness of referral systems to higher-level centers. This data can aid in identifying areas for improvement in emergency care provision and staff training to enhance the overall healthcare delivery system |
Phase I of the study,
1 month, 3rd month and 6th months of post intervention of phase II of the study |
|
|
Target Sample Size
|
Total Sample Size="345"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study evaluates the impact of a simulation-based training package on emergency care practices among staff nurses at Primary Health Centers and Community Health Officers at Ayushman Arogya Mandir (Health and Wellness Centers) in Udupi district, Karnataka. The study has the following objectives. 1.To assess the knowledge and skill on emergency care among Primary Health Care Officers (ANM), Staff Nurses and Community Health Officers of Udupi District. 2. To assess the feasibility and facilities to provide emergency care at Primary Health Centers and Ayushman Arogya Mandir (Health and Wellness Centers). 3. To develop a comprehensive simulation-based training package for emergency care practice among Primary Health Care Officers (ANM), Staff Nurses and Community Health Officers of Udupi District. 4. To determine the effectiveness of simulation-based training package on knowledge and skills among Primary Health Care Officers (ANM)staff nurses and Community Health Officers on Emergency care. The study will be conducted in two phases. In Phase I, a descriptive survey will assess the baseline knowledge among 345 participants which includes staff nurses and Community Health Officers on Emergency care. Phase II will be implemented by adopting cluster randomization. We are planning to include 15 to 18 clusters comprised of 140 participants, divided equally into intervention and control groups. The intervention group will receive simulation-based training on essential emergency care topics such as trauma care, drowning, chest pain, animal bites, seizures, hypoglycemia, stroke, and obstetrical emergencies. The control group will receive an information booklet on these topics. Outcomes will be evaluated using structured knowledge and skill based questionnaires, and feedback. The follow-up and reinforcement will be done during first, third and sixth month of post intervention.
|