Decentralized antivenom therapy program for Indigenous communities in the Brazilian Amazon affected by snakebites. Injury, Occupational Diseases, Poisoning
Conditions
Interventions
The study will be conducted in seven Special Indigenous Health Districts (DSEIs) in the state of Amazonas, Brazil, covering about 250,000 people from approximately 100 ethnic groups, with a correspond
health professionals from the indigenous system
and local, state, and federal leaders of the indigenous health system, along with clinical experts and researchers in snakebite envenoming (SBEs). Phase III: Quantitative Implementation Targets: Aims
Sponsors
Fundação de Medicina Tropical Doutor Heitor Vieira Dourado
Liverpool School of Tropical Medicine
Duke University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Be 18 years of age or older. 2. Be Brazilian. 3. Seek initial care at one of the healthcare units participating in the study. 4. Present signs of local or systemic complications. 5. Have the cognitive capacity to consent, assessed by the attending physician based on clinical history and physical examination.
Exclusion criteria
Exclusion criteria: Be in critical condition or unable to communicate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baseline characteristics 1. Sociodemographic information is measured using a sociodemographic survey at baseline 2. Severity of SBE is measured using Snakebite Severity Score at baseline 3. Time to care is measured using time of SBE to health care encounter and final care at baseline Clinical care 4. Number of antivenom vials is measured using clinical report form at baseline 5. Time to achieve control is measured using clinical report form at baseline 6. Other medications are measured using clinical report form at baseline Implementation outcomes 7. Time from SBE to antivenom is measured using self-reported time from SBE to antivenom at baseline, T1, T2, T3, T4, T5 8. Protocol deviations are measured using AJURI Adherence Scale at T2 9. Penetration and adaptations are measured using qualitative interviews with healthcare providers at T2 10. Sustainability and maintenance are measured using patient records and qualiative interviews with healthcare providers at T2 Clinical effectiveness outcomes 11. Patient functionality is measured using Patient Specific Functionality Scale at baseline, T1, T2, T3, T4, T5 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. All-cause mortality is measured using clinical report form at baseline, T1, T2, T3, T4, T5 2. Presence of a long-term complication post-SBE is measured using a symptoms survey at baseline, T1, T2, T3, T4, T5 3. Proportion of patients with serum sickness is measured using clinical report form at baseline, T1, T2, T3, T4, T5 4. Disability is measured using WHO Disability Assessment Schedule 2.0 at T3 5. Functionality is measured using Functional Independence Measure (FIM) at T3 6. Upper limbs strength is measured using handgrip strength at T3 7. Lower limbs strength is measured using 1-Minute Sit-to-Stand Test at T3 8. Quality of life is measured using EQ-5D at T3 9. Proportion of major bleeding is measured using clinical report form at T1 10. Proportion of non-major bleeding is measured using clinical report form at T1 11. Proportion of patients requiring debridement, skin grafting or amputation is measured using clinical report form at T1, T2 12. Total surface area of full thickness skin necrosis is measured using clinical report form at T1, T3 | — |
Countries
Brazil
Contacts
Public ContactWuelton Monteiro
Outcome results
None listed