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
 STUDY
DESIGN: Randomized controlled trial
Plan of work
RESEARCH VARIABLES
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. |
