Clinical trial NCT03513315: Heat Emergency Awareness and Treatment (HEAT)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heat Illness
Heat Stroke
Heat Exhaustion
Heat Exposure
Heat Syncope, Sequela
Heat Collapse
Heat
Heat Stroke and Sunstroke
Keywords: Heat-related illnesses
Heat Illnesses
Community based interventions
heatwave
Pakistan
emergency preparedness
emergency medicine
heat stroke
heat exhaustion
urban health
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Aga Khan University
name: Aman Foundation
First posted: 2018-05-01
Enrollment: 16973
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients presenting to the emergency departments in Karachi who present with suspected heat stroke/heat exhaustion and basic information about their presentation and treatment will be obtained in the ED for May-July.
* Community households in "Korangi District"
* Physicians/Nurses working in the emergency department of study hospital sites

Exclusion Criteria:

* When a family refused to participate in the study

Primary outcomes:
measure: Emergency Department visits
timeFrame: 3 months
Secondary outcomes:
measure: Total number of deaths (due to any cause)
timeFrame: 3 months
measure: Hospital admissions
timeFrame: 3 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
city: Karachi
country: Pakistan
facility: The Aman Foundation
Study officials:
affiliation: Johns Hopkins University
name: Junaid A Razzak, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Razzak JA, Agrawal P, Chand Z, Quraishy S, Ghaffar A, Hyder AA. Impact of community education on heat-related health outcomes and heat literacy among low-income communities in Karachi, Pakistan: a randomised controlled trial. BMJ Glob Health. 2022 Jan;7(1):e006845. doi: 10.1136/bmjgh-2021-006845.