Construction, Validation and Evaluation of Simulation Scenario for parents on Management of Acute Exacerbation of Asthma in Children at Home Setting: Randomized Control Trial

AIM

This study aims to construct, validate and evaluate a simulation scenario for parents on management of acute exacerbation of asthma in children at home setting using a randomized controlled trial.

OBJECTIVES

Phase 1: Construction of the Simulation Scenario

1.1 To design simulation scenario for parents on management of acute exacerbation of asthma in children at home setting based on the findings from literature review and educational theories**.**

Phase 2: Validation of the Simulation Scenario

2.1 To investigate the validity of the simulation scenario for parents on management of acute exacerbation of asthma in children at home setting in terms of its content and in terms of its response process.

Phase 3: Evaluation of the Simulation Scenario

3.1 To evaluate the effectiveness of the simulation scenario for parents on management of acute exacerbation of asthma in children at home setting in terms of Knowledge, Skill, Confidence & Emergency Room Admission.

3.2 To identify the association and correlation of the knowledge, skill and confidence with demographic variables of parents.

 PROBLEM STATEMENT

A study to construct, validate and evaluate a simulation scenario for parents on management of acute exacerbation of asthma in children at home setting using a randomized controlled trial.

OPERATIONAL DEFINITION

Construct: It refers to the process of designing and developing the simulation scenario to manage the acute exacerbation of asthma in children at home setting.

Validate: It refers to the process of collecting validity evidence to evaluate the interpretations, uses and decisions based on assessment.

**Evaluate:**It refers to systematic assessment of the simulation scenario’s effectiveness in improving parents’ knowledge skills, and confidence in managing acute asthma exacerbations. This includes pre-and post-intervention questionnaires, observed performance during the simulation, and follow-up surveys at 6 months and 1 year to gauge long-term retention and application of skills.

Simulation Scenario: it refers to a detailed, interactive, and simulated experience designed to replicate the process of managing an acute asthma exacerbation in a child within home setting. This scenario will include scripted events, decision points and simulated patient responses to mimic real-life conditions as closely as possible. The scenario will be delivered through a combination of digital tools, role-playing, and instructional materials.

Parents: it refers to individuals who are the primary caregivers or guardians of children with asthma. In the context of this study, they are participants who will engage with the simulation scenario to learn and practice management strategies for acute asthma exacerbations.

Home Setting: It refers to the typical environment in which parents manage their child’s asthma, characterized by domestic conditions and resources. This setting is simulated to reflect real-life challenges and constraints, such as limited medical equipment and varying levels of support from other family members.

HYPOTHESIS

H1: The simulation scenario designed for parents on the management of acute exacerbation of asthma in children at home, based on findings from the literature review and educational theories, will be comprehensive and applicable to real-life situations faced by parents, effectively addressing key aspects of asthma management at home.

H2: The simulation scenario for parents on the management of acute exacerbation of asthma in children at home will be validated as effective in terms of content and responses process. Specifically, it will be found to accurately reflect best practices for asthma management and will receive positive feedback from participants regarding its relevance and practicality.

H3: There is a significant difference in parents’ knowledge, skill, confidence and emergency room admission regarding management of acute exacerbation of asthmatic children at home setting.

H4: There is a significant relationship between parents’ knowledge, skill, confidence and emergency room admission regarding management of acute exacerbation of asthmatic children at home setting

 ASSUMPTION:

Ø  Parents will be able to relate to and implement the scenario effectively in real-life situations based on the constructed simulation.

Ø  The simulation scenario will reflect real-life scenarios and adequately prepare parents for managing acute asthma exacerbations at home.

Ø  The simulation scenario will effectively improve parents’ knowledge, skills, and confidence, and reduce emergency room admissions as measured by the assessments and data collected.

Ø  Difference in demographic factors will influence parents’ initial knowledge, skills, and confidence levels and affect how these attributes change following the simulation.

Ø  Parents’ will provide honest and constructive feedback about the simulation scenario’s relevance and practicality.

DELIMITATION:

Ø  The design will be tailored specifically for parents of children with asthma and may not account for the needs of caregivers or other individuals involved in the child’s care.

Ø  The validation process will involve a selected group of experts in asthma management and simulation design. The feedback and validation will be limited to the perspectives of these experts, which may not capture all potential user experiences

Ø  The effectiveness will be evaluated over a defined period post-simulation, which may not capture long-term impacts or the sustainability of the improvements

Ø  The study will examine a limited range of demographic variables (e.g., age, education level, prior experience) and may not consider other factors such as socio-economic status, cultural background, or access to healthcare resources

                                    METHODOLOGY

Rectangle: Rounded Corners: Enrolment of parents of asthmatic childrenSTUDY DESIGN: Randomized controlled trial

Plan of work

RESEARCH VARIABLES

Rectangle: Rounded Corners: Data analysis

Independent Variable: simulation on Acute exacerbation management of asthma

Dependent/Outcome Variables**:** Knowledge, skill, confidence level of the caregivers /parents and reduction in Emergency Room admissions

Phases of the Study:

Phase I: Construction of the simulation Scenario:

Investigator will develop the simulation scenario based on evidence – based guidelines and best practices for managing acute asthma exacerbations in children at home, using structured model of simulation.

Phase II: Validation of the simulation scenario:

The scenario will undergo expert review by a panel of paediatric asthma specialists and simulation experts to assess its accuracy, realism and educational value. Remote validation of the simulated situation will take place. The experts will receive an email inviting them to judge the simulation scenario. TO meet the research scope, a convenient sample of judges will be recruited from the national and international simulation training centres. Also the snowball sampling method or snowball will be applied to find further experts. Experts shortlisted will recommend other possible judges to review the content.

Pilot testing with 10% of total sample will be conducted to refine the scenario. 8 parents on each arm will be tested for the feasibility of the study.

Phase III: Implementation and Evaluation:

Participants will be block randomized in to two groups:

·       Intervention group: parents will participate in the simulation scenario, followed by debriefing and educational sessions.

·       Control Group: Parents will receive standard asthma education materials.

Pre- and post- intervention assessments will be conducted to evaluate the effectiveness of the simulation scenario.

SETTING OF THE STUDY

The study will be conducted in All India Institute of Medical Sciences, Kalyani, West Bengal.

POPULATION:

The target population for the study included the parents of children with asthma. The accessible population consists of parents attending the outpatient department of pediatric unit, AIIMS, Kalyani.

SAMPLE:

Parents of asthma children attending the outpatient department of paediatric unit, AIIMS, Kalyani. and those who fulfill the inclusion and exclusion criteria during the period of enrolment will be selected as sample.

SAMPLE SIZE:

The sample size was calculated based on assumption, a mean difference of 3.4 in ACT score*, with 95 % confidence interval and 80%  power and 5% Alpha error the estimated sample size is 52. Accounting for a 10 % attrition rate. the minimum sample size required per group is 57 and the final estimated sample size is rounded off to 60 per group(26).

Where,

X) Standard deviation in group  I = 4.6               X) Standard deviation in group  II = 3.9

X) Mean difference  = 3.4                                  X) Effect size = 0.8

X) Alpha Error(%) = 0.5                                    X) Power(%)= 80

sided = 2

SAMPLING CRITERIA

Inclusion Criteria:

·       Care giver of the child who has clinical diagnosis of asthma

·       Children with a documented history of acute exacerbation of asthma leading to ER admissions

·       Caregivers with no prior experience in simulation-based training for managing acute exacerbation of asthma

Exclusion Criteria

·       Children with severe uncontrolled asthma requiring immediate ICU care

·       Caregivers with significant medical or psychological impairments

·       Children with other comorbidities along with asthma

·       Children in foster care or institutionalized care

SAMPLING TECHNIQUE AND RANDOMIZATION: Purposive selection and random allocation

MEASUREMENT OF INSTRUMENTS

Tools:

·       Tool 1. Socio demographic data of the participants (Appendix -A)

·       Tool 2. Self-structured Knowledge Questionnaire on Acute management of Asthma in Children (Appendix B)

·       Tool 3. Skill test with a simulation Scenario (Appendix C)

·       Tool 4: Confidence Scale and open-ended feedback (Appendix D)

·       Tool 5: Asthma Control Test (Appendix E)

·       Follow Up of ER admissions for 6 months (Appendix F)

Intervention:

The intervention group will participate in the simulation scenario, which will involve a realistic representation of an acute asthma exacerbation situation in a home setting. Parents will be required to identify the signs and symptoms, initiate appropriate management steps, and demonstrate effective communication and decision – making skills. The simulation will be followed by a debriefing session and educational sessions facilitated by health care professionals.

Management of Acute exacerbation of asthma in children Module

Caring for a child with asthma involves unique challenges, particularly during acute exacerbations. As a caregiver, your role in the health and wellbeing of a child with asthma is pivotal, especially during exacerbations. This comprehensive training aims to empower you with the knowledge, skills, and confidence needed to effectively manage asthma exacerbations in the home environment.

This module recognizes the importance of the caregiver’s role as the first line of defense and aims to provide you with practical tools to navigate and respond to these critical situations effectively.

This module will cover Rescue inhaler administration, inhaler technique training, recognition of symptoms, asthma action plan implementation, monitoring and record keeping, importance of fluid, emergency response practice, communication skills follow-up, and recognition of improvement.

•        First Contact: After Enrolment and pre assessment, a training sessions will be given as day care basis in Seminar Room with simulator. A systematic way of capacity building will be done on Management of Acute Exacerbation of Asthma in children at home setting

•        At the beginning of session, the researcher will provide a hand holding practice using simulation training for 90 minutes in three sessions

•        Second Contact: Follow up will be done after 2 weeks in which caregivers will be reassessed for the management (Knowledge, Skill, Confidence, ACT score & Emergency Room Admission) of acute exacerbation of asthma in children at home setting using simulation.

•        Follow up: participants will be followed  over the phone for  a period of  6 months to assess ER admissions

Control

•        The participants of control group will be receiving standard teaching using flashcards and posters for 90 minutes. They will be provided with pamphlet on Management of Acute exacerbation of Asthma in children at home setting. They will not receive the hand holding practice with simulation training.

•        Hand holding practice will be given for the parents/caregivers of the child individually members of the family who are involved in the child’s care, or decision making.

 After completing the module, caregivers will be able to:

1.      Appreciate the early signs and symptoms of acute exacerbation of asthma in children

2.      Develop the competencies of the caregivers in the following areas:

a.      Administering the child’s rescue inhaler with a spacer

b.      Inhaler technique

c.      Development and implantation of the asthma action plan

d.      Demonstrate record-keeping in the asthma diary

3.      Demonstrate communication skills

The module is divided into 9 sections. The modules are as follows Section 1. How to recognize asthma?

Section 2: How to monitor asthma?

Section 3. How to identify severity?

Section 4: What are Quick relief medications?

Section 5: How to use inhaler with spacer?

Section 6: How to give nebulization (Optional if prescribed for the child)?

Section 7: How to implement Asthma Action Plan?

Section 8: How to maintain asthma diary for follow up visits?

Section 9: Reporting the event on calling for emergency help?

Simulation Scenario: Managing Acute Exacerbation of Asthma in a 6-year-old child

Background: You are a caregiver at a simulated home environment with a 6-year-old child named Alex. Alex has a history of asthma, and today, he is experiencing an acute exacerbation of symptoms.

The scenario aims to assess your ability to recognize and manage the situation effectively

Scenario Setting:

Environment: Simulated Home environment with a living room and a bedroom.

Manikin & set Up: Nebulizer, inhaler with spacer, emergency contact list, a mock asthma action plan, a stopwatch, and a simulated mobile phone.

Initial situation

Alex is playing in the living room when you notice him coughing persistently and appearing short of breath

Recognition:

Task: Recognize the early signs of an asthma exacerbation

Action

Managing Acute Exacerbation of Asthma at Home

|Manikin and set up: Simulated Home set up with a living room. Standard patient, nebulizer, inhaler with spacer, finger pulse oximetry, emergency contact list, a mock asthma action plan, a stop watch, and a simulated mobile phone

Embedded actor: ER Nurse who will join team in stage 2 if team is not able to proceed

Participants: child’s parents or caregiver (2 members for assessing and monitoring, medication administration and recording

|Case presentation to be read for the learners

|You are a caregiver at a simulated home environment with a 6-year-old child named Alex. Alex has a history of asthma, and today, he is experiencing an acute exacerbation of symptoms at home.

What’s available if asked:

Simulated emergency services (facilitator acting as dispatcher)

Simulated health care provider

Facilitator guidance for specific medications or treatment protocols

Bring all participants in. Introduce the child in healthy status, & equipment. Send outside the room.

Read out the case outside the room. Prepare by allocating roles first responder assessing and monitoring second rescuer medication administration and recording, if extra person event recorder

|Additional Background Information for facilitator

|Signs & Symptoms: Child can lie down, talks in sentences and gets agitated sometimes, has increased work of breathing RR > 30 bpm, not using accessary muscles or neck muscles, has end expiratory wheeze, pulse rate is <100bpm

Allergies: Pets and dust

Medications: child’s prescribed medication as regular medicine Past history: had one episode of moderate exacerbation and ER admission before 3 months. Last meal 6 hours’ back

Events: you noticed the child’s exacerbation is worsening

|Learning Objectives

|Recognize early signs and symptoms of an asthma exacerbation in a child

Effectively use inhaler with spacer and nebulizer (if prescribed) as per the asthma action plan

Demonstrate clear and concise communication with simulated emergency services

Demonstrate effective management of asthma exacerbation at home

|Equipment Needed

|Airway and Breathing: finger pulse oximeter, pillows to support the back inhaler with spacer, nebulizer if prescribed

Circulation: Drink milk/ juice/ warm water

Drugs: Prescribed MDI empty canister

Communication: Asthma Diary, mock Asthma Action Plan, simulated mobile Phone, Stop watch

All equipment and drugs are marked “FOR SIMULATION PURPOSE ONLY: NOT FOR HOSPITAL USE”

  |Debriefing

|Welcome and acknowledge participant’s efforts and summary, analyse with plus delta reflection and advocacy inquiry, personalize with take home message.

Discuss identification of acute exacerbation of asthma

Discuss on Quick relief medication administration with spacer (Spacer Technique), Effective administration of MDI.

Discuss on when to call for medical emergency and ER services

Discuss on events to be reported child’s name, symptoms presented, medication administered with spacer

|Progression of the case

|Stage

Child’s condition

Simulator Parameter

Expected Intervention

Faculty, actor Notes

|Stage 1

4-6 minutes

Gen: conscious,

Airway: increased work of breathing Child prefers sit up, talks in phrases and gets agitated some times

not using accessary muscles or neck muscles, has end expiratory wheeze, pulse rate is <100bpm

  HR: <100bpm

RR: >30bpm (i.e., Increased work of breathing, chest in drawing/ recessions, effortful breathing, noisy breathing)

SPO2: <= 92 %

 Identify the severity of the exacerbation as mild exacerbation

Calls for help

Positions the child to assume upright position with pillow support

Assess the respiration rate

Looks for the use of respiratory muscles

Listens for wheeze or musical respiratory sound

Monitors saturation with pulse oximeter

Gives prescribed quick relief inhaler with spacer

Primes the inhaler

Takes the cap off of the mouth piece. Puts the inhaler in the spacer

Shakes the inhaler for 5 seconds.

Holds the inhaler upright with 1 finger on the top of the canister, and thumb on the bottom of the inhaler, and other hand holding the spacer.

Asks the child breathe out normally

Asks the child to close his lips around the mouthy piece of the spacer.

Presses down the canister

Asks the child to take a deep, slow breath in, then hold it for 5 to 10 seconds.

Asks the child to wait for 15 to 30 seconds before giving the second puff. (If prescribed)

Removes the inhaler from the spacer and puts the cap back on the mouth piece

If the inhaler is a steroid medicine (Glucocorticoid), asks the child to rinse out his mouth, gargle and spit out the water.

Removes the canister and cap from the mouth piece. Do not washes the canister or put the canister under water.

Runs warm water through the mouth piece for 30 to 60 seconds.

Shakes the water off of the mouthpiece & Lets it for air dry.

If they do not assess the respiratory rate and monitors SPO2, then pause and debrief

If right roles are not followed, then pause and debrief

If they do not use quick relief medication as prescribed beta antagonists, then pause and debrief

If they do not use spacer for the MDI, then pause and debrief

 If any of the steps of the MDI administration using spacer is not performed or performed inappropriately then pause and debrief.

  |Stage 2

4-6 minutes

Gen Condition: Agitated

Sits up right

Talks in words

Uses accessory muscles and neck muscles

Has loud inhalational and exhalation wheeze

RR > 40bpm

HR>120 bpm

SPO2 <92

Contacts clinician urgently for further instruction through the simulated mobile phone

Informs the child identity address, symptoms and drugs administered with current status

Administers third dose of beta agonist and mobilizes to ER If advised by physician

Reports to ER nurse child’s identity symptoms, medications given and past history

 Initiates the call to the treating physician through simulated mobile phone, if not done then pause and debrief

Encourage to use Mock Asthma Action plan

Introduce ER nurse to look for communication in ER by the caregiver

|

Notes for embedded actor ER nurse:

Take handover summary SBAR format, ask care giver for suggestions

Encourage to monitor SPO2, RR

Encourage to use Asthma Action Plan & Asthma Diary

Remind learners to use spacer while using MDIs

Emphasize to call for help to the treating clinician

Consort Diagram

Fig.1 Consort Diagram of the research study

 DATA COLLECTION: The period of data collection is from 2024-2025. As per the sample size calculation, the Total samples are 120, in that 60 will be in the intervention group and 60 will be in the control group. The researcher initially establishes a rapport with study participants. The purpose of the study will be explained, written and oral consent will be obtained from study participants prior to the data collection and they will be randomly allotted in intervention and control group accordingly. Parents of asthmatic children will be assessed for background variables, Asthma Control Test, using interview technique. Each subject will be interview separately, which will last for 10-15 minutes.  Then researcher or the research assistant will provide the simulation exercise and practice to the parent over a period of 90 miniutes, with demonstrations and hands on sessions. Reaasessment will be done after 7 days from training session, 6 weeks of training, knowledge and ER admissions will be followed at 6 months of training and 12 months of training.

Data analysis :

Statistical analysis will be performed using r software. Scores of Pre and Post Simulation Knowledge Questionnaire, Simulation Scenario Skill Test and Confidence Scale will be summarized by descriptive statistics Frequency, Mean, and Standard Deviation. Comparison of the outcome variables before and after intervention within the group will be summarized by paired ‘t’ test and between the groups will be summarized by student ‘t’ test. Association between the selected background variables with the selected outcome variables will be summarized by Chi-square. Relationship between the clinical and behavioural outcome will be summarized by Pearson’s correlation test. ANOVA will be done to summarize the association between the selected variables.

Ethics committee where approval will be sought: Ethical approval will be obtained from the ethical committee AIIMS, Kalyani, CTRI & also from SRIHER

Collaboration with other institutions: nil

Source of funding of the Ph.D. Project: planning to apply for ICMR funding.