Heat Clinical Trial
Official title:
Heat Emergency Awareness and Treatment (HEAT): A Cluster Randomized Trial to Assess the Impact of a Comprehensive Intervention to Mitigate Humanitarian Crisis Due to Extreme Heat in Karachi, Pakistan
Investigators propose an intervention trial of a comprehensive education and treatment bundle designed to reduce morbidity and mortality associated with heat-related illness for low resource settings. Two set of interventions will be developed each for emergency department and for community/home. These interventions will be developed by an internal expert group and will be customized and implemented at the home and emergency department (ED) levels, will include evidence-based educational training guidelines for ED health providers as well as educational messages targeting home and community in Karachi, Pakistan.
This study consists of a community-based and hospital-based components. The community-based
study is a prospective two-arm cluster randomized controlled trial and will be implemented in
16 clusters of 1000 people located in the most central neighborhood (called "mohalla") of a
Union Council. Minimum required sample size is 7120 in each group, which requires 890
subjects in each of the 16 clusters. Calculations are based on achieving 80% power to detect
a difference between the group proportions of 20% from the baseline.
For the hospital component, four major hospitals will be randomized to receive operations and
clinical capacity building on management of heat emergencies. The hospital sample size is
limited by the availability of hospitals and their uneven distribution which are not linked
to union councils in the district.
The primary outcome in the investigators' study is the frequency of emergency admissions to
the hospital with all-cause mortality as a secondary outcome.
A community-based and hospital-based protocols and training materials will be developed and
will serve as the intervention in this study. These will focus on education about recognizing
the signs of symptoms of heat-related illness and proper response and treatment based on
local resources.
Data collection will be done at baselines and post-intervention. In the community data on
demographics and household characteristics will be collected. Additionally, data on deaths in
households will be collected. Changes in knowledge, attitudes, and practices will be measured
using a Knowledge, Attitudes, and Practices (KAP) survey pre- and post-intervention.
In the hospital, data collection will focus on emergency department admissions, visits,
mortality, and heat index. Changes in physician knowledge will be measures with a KAP survey
pre- and post-intervention.
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