Overview of Research Design
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Home Safety Practices for Prevention of Poisoning in Young Children
Phase 0: Validation of Home Safety Device
In order to ensure that the home safety device used in this study works effectively, the researchers performed a sub-study to test the efficacy of two different children
home safety devices prior to its implementation in the study. The most efficacious device was then chosen.
In this sub-study, 100 children and 100 adult parentscaregivers accompanying the child to attend the MOH health clinics were recruited to test the home safety devices.
Parentscaregivers accompanying a child aged between 12 to 60 months to a MOH clinic were approached about the study and a written consent was obtained if he
or she agreed to be involved. 100 children and 100 of their parentscaregivers were asked to test on Device A and Device B.
The inclusion criteria for the children recruited for the study were: i
Seeking treatment at MOH health clinic. ii
Aged 12-60 months. The exclusion criteria for the children recruited for the study was:
i Suffering from any physical or mental disabilities.
The inclusion criteria for the adults recruited for the study were: i
Parentcaregiver for the child recruited for the study. ii
Ability to communicate in English or Malay. The exclusion criteria for the adults recruited for the study were:
i Suffering from any physical or mental disabilities.
There were three activities in the study: i
The first activity involved the child operating Device A or Device B without guidance. The child was given 5 minutes to operate the device. The method
used by the children to successfully operate the device was documented.
ii The second activity phase involved the child operating Device A or Device B
without guidance, following a demonstration by a researcher. The child was given 5 minutes to operate the device. The method used by the children to
successfully operate the device was documented.
iii The third activity involved the accompanying parentcaregiver operating
Device A or Device B without guidance, following a demonstration by a researcher. The adult were given 5 minutes to operate the device.
Table 4 describes the criteria to determine the efficacy of the home safety device. The results were analysed to decide on the most efficacious device to be utilized
in the study.
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Home Safety Practices for Prevention of Poisoning in Young Children
Table 4. Criteria for efficacy of home safety device Activity
Criteria for Efficacy Activity 1
Child operates device without guidance At least 85 of the children must fail to
operate the device within 5 minutes of attempting
Activity 2 Child operates device without guidance,
following a demonstration by a researcher
At least 80 of the children must fail to operate the device within 5 minutes of
attempting
Activity 3 Adult operates device without guidance,
following a demonstration by a researcher
At least 85 of adults must be able to successfully operate the device within 5
minutes of attempting
Phase 1: Identification, Baseline Audit and Intervention
Phase 1 involved the identification of households with children aged 1-4 years, a baseline audit of the households and the implementation of an intervention package
which include an immediate post audit feedback, an educational pamphlet and a home safety device.
The samples were randomly chosen from the Birth Registration Book from Year 2004 till Year 2007. The homes identified were sampled into two intervention arms.
Caregivers in Group 1 received intervention package which consists of an immediate post audit feedback, an educational pamphlet and a home safety device while
caregivers in Group 2 received intervention package which consists of an immediate post audit feedback and an educational pamphlet.
Public health nurses from district health clinics were identified as research assistants as they are well versed with the demographics of the study areas. They were trained
to administer a knowledge questionnaire refer to Appendix A, to conduct a home safety audit using a checklist refer to Appendix B, to give immediate feedback,
recommendations to caregivers after the audit, to explain an educational material refer to Appendix D and to explain the use of a home safety device to caregivers
based on an instruction leaflet refer to Appendix E.
During the first audit, public health nurses visited the homes identified, administered the knowledge questionnaire to caregivers; conducted a home safety audit using
a checklist and gave immediate feedback to caregivers after the audit. A copy of the audit checklist signed by the respondent and public health nurse include the
nurse’s phone number for respondent to call if there is any problem were given
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Home Safety Practices for Prevention of Poisoning in Young Children
Figure 2: Flow chart of study design
Inclusion criteria: 1.
All households with children aged 1-4
2. Respondents consented
to participate 3.
Respondents able to converse in English or
Malay
Exclusion criteria: 1. Households where only the
maid and children are present during the visit
Identification of households with children age 1 -4 n = 300 Group 2 Manjung n=150
Households to receive intervention package 2
1. Immediate post audit
feedback Education
Group 1 Kinta n=150
Households to receive intervention package 1
1. Immediate post
audit feedback Education
2. Home safety device
Training of public health
Audit 1 Nurses administered questionnaire,
carried out 1
st
audit and implemented intervention package 1.
Audit 1 Nurses administered questionnaire,
carried out 1
st
audit and implemented intervention package
Evaluation of the effectiveness of intervention package in terms of
1. Safe storage
2. Home safety device
3. New changes by parents eg
use child resistant device Evaluation of the effectiveness of
intervention package in terms of 1.
Safe storage 2.
New changes by parents eg use child resistant device
Nurses administered questionnaire
Evaluation of the effectiveness of intervention package in terms of
1. Safe storage
2. New changes by parents Evaluation of the effectiveness of the intervention
package in terms of 1.
Safe storage 2.
New changes by parents 3. Home safety device
Phase 0: Sub-study to validate the home safety device
Two home safety devices will be tested on children and adults. The most cost-efficient and effective device was chosen based on the following criteria:
i At least 85 of children fail to operate the device after 5 minutes without guidance
ii At least 80 of children fail to operate the device after 5 minutes without guidance, following
demonstration by the researcher iii
At least 85 of adults successfully operate the device after 5 minutes without guidance, following demonstration by the researcher
The most cost-efficient and effective home safety device was chosen and used for the study
Phase 1: Identification of households, baseline audit and intervention implementation
Nurses administered questionnaire
Phase 2: 3 months post intervention audit
Phase 3: 6 months post intervention
Figure 2. Flow chart of study design
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Home Safety Practices for Prevention of Poisoning in Young Children
to the respondent. An educational material were provided to both intervention groups but the home safety device with instruction leaflet and demonstration of
the device by the nurse were provided only to homes in Group 1.
Phase 2
The second audit was conducted after 3 months from the first audit. The same tools as in the first audit were used. Improvements in home poison safety practices
were evaluated in both intervention arms. Additional changes made by parents to improve home poison safety practices were assessed in both intervention arms.
Phase 3
The third audit was conducted after 6 months from the first audit. The same tools as in the first audit were used. Improvements in home poison safety practices were
evaluated in both intervention arms. Additional changes made by parents to improve home poison safety practices were also assessed in both intervention arms.
Fidelity testing was also done for the audit to monitor the quality of the intervention implementation. This was carried out by telephone calls to the audited respondents
based on a Fidelity Test Form Appendix C. In both intervention arms of each audit, 30 different samples were chosen for fidelity testing each time.