Heat Emergency Awareness and Treatment (HEAT)

Not Applicable

Completed

• Conditions: Heat Stroke; Heat Syncope, Sequela; Heat Illness; Heat Exhaustion; Heat Exposure; Heat Collapse; Heat; Heat Stroke and Sunstroke
• Interventions: Behavioral: Regular Community Healthcare provision; Behavioral: Implementation of Community-based Home Heat Bundle

• Registration Number: NCT03513315
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study Start: 2016-11-30
• Study First Submitted: 2018-04-12
• Study First Submitted QC: 2018-04-30
• Study First Posted: 2018-05-01
• Primary Completion: 2018-10-30
• Study Completion: 2018-10-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-07
• Last Update Posted: 2019-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16973

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Community Clusters	Regular Community Healthcare provision	Eight community clusters of 1000 population each where regular community-based healthcare services will be provided without focused interventions on identification and management of heat-related illnesses. These clusters will receive regular community healthcare provision.
Intervention Community Clusters	Implementation of Community-based Home Heat Bundle	For the community-based arm of the study, 16 clusters will be randomized into intervention and control groups. Those in the intervention group will receive implementation of community-based Home Heat Bundle. This Bundle includes education from community health workers on the signs and symptoms of heat-related illness, how to prevent the illness, and when to seek treatment. In addition, the intervention group will receive SMS messaging with information about heatwaves. The education and Short Message Service (SMS) messaging will occur in March and April via meetings in households and in public spaces. There will be a total of 40 activities, each lasting approximately two hours.

Primary Outcome Measures

Name	Time	Method
Emergency Department visits	3 months	Total number of individuals requiring visit to an emergency department during the study period

Secondary Outcome Measures

Name	Time	Method
Total number of deaths (due to any cause)	3 months	Total number of deaths in the community during the study period
Hospital admissions	3 months	Total number of hospital admissions due to any cause during the study period.

Trial Locations

Locations (2)

Aga Khan University; 🇵🇰 Karachi, Pakistan

The Aman Foundation; 🇵🇰 Karachi, Pakistan