NCT03513315

Heat Emergency Awareness and Treatment (HEAT)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16,973 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Heat Illness
• Heat Stroke
• Heat Exhaustion
• Heat Exposure
• Heat Syncope, Sequela
• Heat Collapse
• Heat
• Heat Stroke and Sunstroke

Interventions

Type	Name	Description
BEHAVIORAL	Implementation of Community-based Home Heat Bundle	This community-based intervention include a set of educational materials to increase awareness about heat-related illness and prevention with the intention of reducing the incidence of heat-related and reducing mortality associated with heat-related illness. Materials used in this intervention will include posters, brochures, in-person training, and SMS messaging.
BEHAVIORAL	Regular Community Healthcare provision	The community will get regular community health workers visit without the focus community mobilization and education on heat-related illnesses.

Timeline

• Start date: 2016-11-30
• Primary completion: 2018-10-30
• Completion: 2018-10-30
• First posted: 2018-05-01
• Last updated: 2019-01-09

Locations

2 sites across 1 country: Pakistan