Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05544578 |
| Other study ID # |
2022-0542-Hunter |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 2022 |
| Est. completion date |
February 2024 |
Study information
| Verified date |
September 2022 |
| Source |
Hunter College of City University of New York |
| Contact |
Carolynn Julien, MS, CRA |
| Phone |
(212) 772-4020 |
| Email |
cjulien[@]hunter.cuny.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Nurses Taking on Readiness Measures (N-TORM) is an innovative nurse-driven household
emergency preparedness intervention modeled after an existing community intervention provided
by emergency management personnel. The proposed pilot studies will test the Korean
translation of the Household Emergency Preparedness Instrument (K-HEPI) and describe the
implementation and effectiveness of N-TORM in a community setting. The aims of this
instrument translation study and cluster randomized controlled trial are to (a) field and
pilot test the K-HEPI in order to perform psychometric testing on the instrument and generate
reliability and validity data, (b) increase the accessibility of N-TORM to vulnerable
populations, (c) evaluate the effectiveness of N-TORM to increase household emergency
preparedness knowledge and behavior, (d) implement N-TORM in a community located in an area
at increased risk for disasters, measuring consistency of delivery, time, and cost of N-TORM,
and (e) describe the factors most necessary to maintain and expand N-TORM.
Description:
The proposed instrument translation study will pilot test a Korean version of the Household
Emergency Preparedness Instrument (HEPI; Heagele et al., 2022a; Heagele et al., 2022b) to
perform psychometric testing on the instrument, generating reliability and validity data for
an examination of cross-cultural equivalence.
Following the instrument translation study, we will use the K-HEPI in a cRCT to measure the
level of household emergency preparedness of an at-risk population before and after receiving
the N-TORM intervention to measure intervention effectiveness and health impacts of an
extreme weather event. We will compare the intervention group's K-HEPI scores to the control
group's K-HEPI scores at baseline, one-month follow up, and after an extreme weather event.
Hypotheses (H):
H1: The level of household emergency preparedness, as measured by the K-HEPI, will increase
after an educational intervention.
H2: The K-HEPI will account for a significant proportion of the variance in emergency
preparedness among the sampled Korean households.
H3: Households who participate in the N-TORM educational intervention will show significantly
greater increases in household emergency preparedness, as measured by the K-HEPI, than
households that do not participate in the intervention.
H 4.1: Factors commonly found to be predictors of household emergency preparedness will be
significantly associated with post-test levels of household emergency preparedness both for
participants who do (experimental group) and do not (control group) complete the
intervention.
H 4.2: Factors commonly found to be predictors of household emergency preparedness will
significantly interact with whether or not participants complete the intervention, such that
barriers will affect those who do not complete the intervention more than they affect those
who do complete it.
H 5.1: The inter-item reliability of the K-HEPI will be similar to that of the English
version.
H 5.2: Confirmatory factor analysis will find a significant fit of the K-HEPI to the same
factor structure of the items that is found in the English version.
H 5.2.1: Model fit indices for the Korean version will be similar to those of the English
version.
Background:
Worldwide, extreme weather events and disasters continue to have devastating impacts on
households, communities, and nations with increased morbidity, mortality, and infrastructural
and economic devastation (Centre for Research on the Epidemiology of Disasters, United
Nations Office of Disaster Risk Reduction [CRED-UNDRR], 2020). Disasters are unforeseen
events that overwhelm local capacity, often resulting in a request at the national or
international level for external assistance (CRED-UNDRR, 2020). The Federal Emergency
Management Agency, Centers for Disease Control, American Red Cross, and local government
agencies have socially marketed the importance of household emergency preparedness for years,
yet the US public largely remains unprepared for disasters (United States Census Bureau,
2021a). Although household emergency preparedness has not been empirically demonstrated to
result in decreased disaster-related morbidity and mortality (Heagele, 2016), it is plausible
that self-sufficiency of households will result in disaster resilience. Families must prepare
for conditions that all disasters create, regardless of geographical area or type of
disaster, such as loss of electricity, water, and being unable to obtain supplies for several
days due to the need for sheltering in place or disruptions in the supply chain. A household
is considered prepared if members have created a family communication and evacuation plan and
assembled a disaster kit containing enough food and water to sustain each member for at least
one week (Heagele et al., 2022b).
In September 2021, due to Hurricane Ida flooding, at least 13 people died in New York City
(Kriegstein et al., 2021). Eleven died in their basement-level homes in Queens, and nearly
all the victims were residents of Asian descent who lived in low-income Asian immigrant
communities (Yam & Venkatraman, 2021). According to the 2020 Census data (US Census Bureau,
2021b), Asians represented about 14.3% of the population in New York City and 26% of Queens.
Asians in New York City are more likely to be foreign born immigrants than other major racial
groups. Undocumented immigrants are particularly vulnerable to social marginalization, low
socioeconomic status, lack of societal resources, and limited English proficiency, resulting
in difficulties seeking help during extreme weather events. However, Asian Americans'
emergency preparedness has rarely been measured in disaster research (Cong & Chen, 2022). As
a result of the experience of living through Hurricane Ida, members of the Asian immigrant
community requested household emergency preparedness education and community interventions
from members of the study team.
The study data can build evidence for a promising individual and community household
emergency preparedness intervention. The effectiveness of N-TORM to increase household
emergency preparedness knowledge and behavior can be evaluated so that the intervention may
be revised and replicated within different populations. This intervention can also be used in
longitudinal studies to determine whether there is an association between being prepared for
a disaster and surviving the disaster without the need for rescue or outside assistance. For
medically frail community members, it can be determined whether there is an association
between being prepared for a disaster and surviving the disaster without an acute
exacerbation of a chronic illness and with no change in baseline functional status.
Study Design: K-HEPI Translation and Field Testing
The HEPI will be translated and field tested according to the recommended instrument
translation procedures of Feher Waltz et al., (2010, pp. 452-458) and Sperber (2004). The
English to Korean translation will follow a symmetrical translation, utilizing a decentered
process. This means both the source and target languages are considered equally important,
with both versions of the instrument remaining loyal to meanings and open to revision (Feher
Waltz et al., 2010). Investigators from two different cultures (US and South Korea) will
collaborate on the translation.
Study Design: K-HEPI Pilot Testing and N-TORM Intervention
Once the final version of the translated HEPI is achieved, the instrument will be used in a
cRCT study with the target population. The intervention versus control data collection sites
will be the unit of randomization.
Only approved research personnel will be involved in the research procedures. The
investigators are employed at Hunter College, the City University of New York, and their
duties in this study will be conducted under their role as employees of Hunter College. In
addition, Korean-speaking research assistants and community health workers will be hired and
trained to assist with study procedures.
The intervention group will receive two, 1-hour, in-person classes to help them develop their
family evacuation and communication plans, identify community resources, and assemble a
disaster supply kit. Trained study personnel will use a lecture and the Korean version of a
New York City community-specific booklet called Ready New York: My Emergency Plan (NYC
Emergency Management, n.d.) as a handout to educate the participants about the essentials of
household emergency preparedness. The control group will receive the Korean version of the
2-page Prepared New York: Disaster and Emergency Preparation pocket guide (NYC Emergency
Management, n.d.) after data collection.
Recruitment Procedures. Potential K-HEPI Pilot Testing / N-TORM participants will be
recruited from Korean Community Services of Metropolitan New York, Inc. (KCS).
Risks and Benefits. There is no more than minimal risk for participation in this study.
Little to no feelings of discomfort are expected. There are no direct benefits to
participating in this study. This research does not claim to present a therapeutic benefit to
the participants. Participants who successfully complete the N-TORM intervention may be
self-sufficient for up to 72-hours post-disaster, but the association between disaster
preparedness level and disaster resilience has not been empirically tested. It is anticipated
that this study will benefit society.
Intervention Fidelity. The principal investigator (PI) will educate the study team members on
how to deliver the N-TORM intervention. Each study team member who will serve as an N-TORM
instructor will demonstrate competency in intervention delivery by teaching back the
intervention to the PI. The PI and study team will evaluate the N-TORM intervention delivery
of each team member by providing praise and any necessary critique/corrective feedback after
the practice session. All instructors will use the same presentation and booklet and will
adhere to the study protocol methods. The PI or Site PI will observe at least one N-TORM
session by each instructor to monitor intervention fidelity. The investigators will keep a
record of how often the instructors met, what was covered, and length of time it took to
deliver the intervention.
The N-TORM intervention will take place at faith- and community-based organizations
affiliated with the Korean Community Services of Metropolitan New York, Inc. who agree to
recruit participants and host the N-TORM intervention at their site. The participants'
portion of the intervention will take place in their homes, between classes 1 and 2.
Data Analysis. Descriptive statistics of the sample will be reviewed prior to regression
analyses examining the associations between the study variables. Hierarchical linear
regression analyses with time nested in participants will be conducted. The change in the
level of household emergency preparedness will be evaluated with the pre- and
post-intervention scores on the K-HEPI. The improvement from pretest to posttest will be
analyzed through repeated measures ANOVAs; the main goal of these ANOVAs is to test the
effect of participation in the N-TORM intervention. However, one of the models will also
include demographics covariates and variables measuring common facilitators and barriers to
household emergency preparedness to test their effects on K-HEPI scores and the effectiveness
of the intervention considering them. In addition, the change in score will be evaluated with
a repeated measures matched pairs t-test. Finally, the mean household emergency preparedness
pretest score for all the participants will be compared to the mean posttest score with a
percentage change calculation.
The reliability of the HEPI will be measured by looking at the internal consistency of the
items (ordinal α coefficients and item-total correlations). Confirmatory factor analysis
using polychoric correlations will be used to examine the factor structure of the K-HEPI and
to compare it with that of the English version. Known-group validity of the K-HEPI will be
assessed by comparing the scores of the participants who self-reported that they were
unprepared for a disaster before and after the N-TORM intervention.
