Clinical trial NCT05455580: Nurses Taking On Readiness Measures - Mercer County, New Jersey
Official title: Nurses Taking On Readiness Measures - Mercer County, New Jersey
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disaster
Vulnerable Populations
Keywords: disabled persons
civil defense
hazard
emergency
preparedness
planning
readiness
kit
disaster planning
emergency preparedness
Lead sponsor: Hunter College of City University of New York
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a non-randomized, non-blinded, quasi-experimental, pre- and post-test phase I feasibility design pilot study.
Primary purpose: PREVENTION

Brief summary: Nurses Taking On Readiness Measures (N-TORM) is an innovative nurse-driven household emergency preparedness (HEP) intervention modeled after an existing community intervention provided by emergency management personnel. This phase I feasibility pilot study will describe the implementation and effectiveness of N-TORM in the community setting, but provided by nurses. The aims of this implementation study are to: (a) increase the reach of N-TORM to vulnerable populations; (b) evaluate the effectiveness of N-TORM for increasing HEP knowledge and behavior; (c) 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; (d) describe the factors necessary to maintain and expand N-TORM, and; (e) pilot test a new HEP instrument in order to perform psychometric testing on the instrument and generate reliability and validity data.

Detailed description: As more chronically ill people are living in the community and disasters are occurring frequently, the elderly and the medically frail vulnerable populations are experiencing significantly more disaster-related morbidity and mortality than the rest of the population. Lack of knowledge on how best to prepare for disasters and lack of means to purchase supplies are significant barriers to adequate household emergency preparedness (HEP). Community-based HEP interventions present a unique opportunity to address these barriers and disaster-related morbidity and mortality disparities in vulnerable populations. Modeled after a community intervention targeting healthy seniors (Golden, 2013) and residents (New York State, n.d.), Nurses Taking On Readiness Measures (N-TORM) is a nurse-driven HEP intervention that will be offered in the community to older adults, individuals with chronic illnesses, pregnant women, and caregivers of medically frail individuals. The Federal Emergency Management Agency (FEMA) Emergency Management Institute (2014) states that these individuals have access or functional needs during disasters and are considered vulnerable populations. The proposed study develops, tests, and evaluates the N-TORM intervention for the purpose of contributing to generalizable knowledge about the nurses' role in the HEP of vulnerable community members. The proposed phase I feasibility pilot study will specifically target independently living community members with access and functional needs. The N-TORM intervention will enable the household to meet the FEMA recommendations for HEP, to safely shelter in place, and evacuate quickly with their supplies if needed. Measurable outcomes of the proposed study include the nurse's impact on the participants' level of HEP post-intervention and participant satisfaction with the intervention. Multi-disciplinary collaboration with engagement of community and government organizations will be demonstrated by the proposed study. Community resources provided by the New Jersey Office of Emergency Management will be incorporated into N-TORM. It is plausible that the long-term impact of the N-TORM intervention would be lives saved and resources conserved. Because the N-TORM intervention uses an all-hazards approach, it is possible to replicate nationally and with different vulnerable populations.

* RQ 1: What is the baseline level of HEP of the participants?
* RQ 2: How much of the variance in HEP is explained by the Household Emergency Preparedness Instrument (HEPI)?
* RQ 3: Is there a significant difference in HEP level after receiving the N-TORM intervention?
* RQ 4: What are the facilitators and barriers of nurses delivering and participants receiving the N-TORM intervention? Finally, the proposed study will also pilot test a new household emergency preparedness instrument (Heagele et al., 2020) in order to perform psychometric testing on the instrument and generate reliability and validity data.

Potential Participants will be recruited from a private Facebook group called "Hamilton Twp. Mercer County NJ." The principal investigator will also utilize the Snowball Sampling technique where participants suggest other potential participants. The principal investigator will provide flyers to the participants with the hope that they will share them with other potential participants.

The principal investigator will then perform the online screening. The principal investigator will deliver the recruitment script to eligible participants.

Participants will be consented only once when they enroll in the study. The consent form will be provided during the online screening/recruitment for the potential participant to read. The consent form will be signed at the in-person meeting at a public place of the participant's choice within Mercer County, New Jersey, after the principal investigator has answered any questions that the participant has.

After informed consent is obtained, the principal investigator will perform the study procedures with the participant:

1. administer the demographic data form to the participants.
2. administer the Household Emergency Preparedness Instrument (HEPI) to the participants before and after the intervention.
3. perform the N-TORM intervention.
4. administer the participant experience survey. The completed Family Disaster Plan booklets will not be copied, collected, stored, or used for research purposes. The booklets are for the participants to keep; they are the participants' household emergency preparedness plans and they will also serve as a community disaster resources information source. The participants will be provided with a disaster supply kit after successful completion of the booklet. The disaster supply kit, valued at $111.60 on September 18, 2020, is part of the intervention and is not considered compensation.

There is no need for follow-up with the participants after they have completed the intervention.

There is no more than minimal risk for participation in this study. Little to no feelings of discomfort are expected. When completing the HEPI and the Family Disaster Plan booklet, participants may experience unpleasant memories, anxiety, or respondent burden. To mitigate this risk, participants will be able to skip HEPI questions or stop the HEPI at any time if they become uncomfortable. Participants will also be able to stop filling out the Family Disaster Plan booklet at any time. In addition, the informed consent includes an assurance of the participant's right to choose not to participate or to terminate participation at any time during the intervention and states that, should the participant decide not to participate in this research study, his or her relationship with the study team will not change and he or she will not lose any benefits to which he or she is otherwise entitled.

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 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. The study data can build evidence for a promising individual and community HEP intervention. This HEP 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.

The participants will not incur any research-related costs. The participants will not be compensated for their participation.

The data from the HEPIs, demographic data forms, and surveys will be transcribed by the principal investigator into electronic documents. This deidentified data will be stored on a password-protected, encrypted server, which complies with the City University of New York's Computer Use and Internet-Based Research Policy, for three years after the study is completed and closed out with the IRB. After the three years are completed, the study data will be deleted. The paper copies of the HEPIs, demographic data forms, and surveys will be shredded after they are transcribed. The data will not be stored or distributed for future research studies.

The investigators will analyze the quantitative and qualitative data. A statistician will be utilized to assist with analyzing deidentified quantitative data. The reliability of the HEPI will be measured by looking at the internal consistency of the items. Polychoric correlations will be used to examine the factor structure of the HEPI. Known-group validity of the 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.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* English-speaking
* have access and functional needs during disasters or are caregivers of individuals with access and functional needs
* live independently within Mercer County, New Jersey (i.e., not in a rehabilitation facility, long-term care facility, halfway house, or prison)
* consent to participate

Exclusion Criteria:

* cognitive impairments
* less than 18 years of age
* Non-English speaking
* Non-English reading families

Primary outcomes:
measure: Household Emergency Preparedness Instrument (HEPI) Score
timeFrame: Baseline (Pre-test) and approximately 30 minutes (Post-test)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Hunter College, City University of New York
state: New York
Study officials:
affiliation: City University of New York, School of Public Health
name: Tara N Heagele, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Golden, S. (2013). STORM Seniors Taking on Readiness Measures: Family disaster plan. Freehold, NJ Monmouth County Sheriff's Office.
citation: Heagele TN, McNeill CC, Adams LM, Alfred DM. Household Emergency Preparedness Instrument Development: A Delphi Study. Disaster Med Public Health Prep. 2022 Apr;16(2):570-582. doi: 10.1017/dmp.2020.292. Epub 2020 Nov 20.
citation: Heagele TN, Nurse-Clarke NJ. A Nurse-Led Home Disaster Preparedness Intervention for New Parents. Neonatal Netw. 2022 Jan 1;41(1):5-10. doi: 10.1891/11-T-714.
citation: Heagele TN, Adams LM, McNeill CC, Alfred DM. Validation and Revision of the Household Emergency Preparedness Instrument (HEPI) by a Pilot Study in the City University of New York. Disaster Med Public Health Prep. 2022 Mar 25;17:e126. doi: 10.1017/dmp.2022.35.