The 'Bekele Afessa Scan-Teach-Treat Approach'

Not Applicable

• Conditions: Infection; Sepsis
• Interventions: Behavioral: simple infection management protocol

• Registration Number: NCT02697513
• Lead Sponsor: University of Salzburg

Brief Summary

Infection and sepsis are among the leading causes of death worldwide, particularly in middle- and low-income countries.The Surviving Sepsis Campaign has launched an initiative to improve sepsis care in resource-limited settings by employing the 'Scan-Teach-Treat' Approach. In this prospective before-after study, three interventions will be performed: First four months period: collection of baseline data on the clinical management of patients with acute infection. Second four months period: During the first days, a 1.5-day focused training program will be performed (participants: health care workers of primary care facilities within the catchment area of the Gitwe hospital and health care workers of the Gitwe hospital). Then, a simple management protocol to care for patients with an acute infection will be implemented into clinical practice. During the third four months period, a 'Sepsis First Aid' kit containing essential resources to treat patients with an acute infection (antimicrobials, fluids, data documentation sheet) will be distributed to primary care facilities and the emergency department of the Gitwe hospital. During the 8 months following the focused training program (periods 2 and 3), data collection will continue. It is hypothesized that implementation of a simple clinical management protocol and exposure of health care workers in the Gitwe Hospital area to a focused training program on the management of acute infections will increase the rate of evidence-based interventions performed in patients with an acute infection during the first six hours after hospital admission (administration of oxygen and fluids whenever indicated, timely administration of antimicrobial drugs, source control measures).

Detailed Description

Infection and sepsis are among the leading causes of death worldwide. The annual burden of infectious diseases is particularly high in middle- and low-income countries. The Surviving Sepsis Campaign released guidelines for severe sepsis and septic shock management, whose implementation improved sepsis outcomes. Despite these benefits, the Surviving Sepsis Campaign cannot be implemented in middle- or low-income countries due to lack of training and resources. This leaves those clinicians caring for the worldwide majority of patients suffering from acute infection without standardized and adoptable guidance for sepsis. The Surviving Sepsis Campaign has launched an initiative to improve sepsis care in resource-limited settings by employing the 'Scan-Teach-Treat' Approach. This approach consists of the following three steps: Step 1 - scanning the region of interest for key elements of regional epidemiology of acute infectious diseases as well as elements of the teach and treat module; Step 2 - implementing a focused training program on the management of acute infectious diseases; Step 3 - implementing a 'Sepsis First Aid kit' into clinical practice.

In this prospective before-after study, this approach will be piloted at the Gitwe Distict Hospital in Gitwe, rural Rwanda. During three four month periods, three interventions are planned: First four months period: collection of baseline data on the clinical management of patients with acute infection. Second four months period: During the first days, a 1.5-day focused training program will be performed (participants: health care workers of primary care facilities within the catchment area of the Gitwe hospital and health care workers of the Gitwe hospital). Then, a simple management protocol to care for patients with an acute infection will be implemented into clinical practice. During the third four months period, a 'Sepsis First Aid' kit containing essential resources to treat patients with an acute infection (antimicrobials, fluids, data documentation sheet) will be distributed to primary care facilities and the emergency department of the Gitwe hospital. During the 8 months following the focused training program (periods 2 and 3), data collection will continue. It is hypothesized that implementation of a simple clinical management protocol and exposure of health care workers in the Gitwe Hospital area to a focused training program on the management of acute infections will increase the rate of evidence-based interventions performed in patients with an acute infection during the first six hours after hospital admission (administration of oxygen and fluids whenever indicated, timely administration of antimicrobial drugs, source control measures). In addition to the main analysis, study endpoints will be analyzed separately for the following á priori defined sub-groups: children (\<15 years); patients with malaria; patients positive for HIV; patients referred to from primary health care centers.

Study Timeline

• Study First Submitted: 2016-02-14
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-02
• Study First Posted: 2016-03-03
• Primary Completion: 2017-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-01
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1594

Inclusion Criteria

all patients admitted to Gitwe Hospital because of a suspected or confirmed acute infectious disease

Exclusion Criteria

• age <28 days of life
• known allergy to any study-related drug
• limited therapy due to terminal disease
• refusal of written informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
After Period	simple infection management protocol	Implementation of a simple infection management protocol as well as a 'Sepsis First Aid' kit to assist in the management of patients with acute infection

Primary Outcome Measures

Name	Time	Method
Rate of evidence-based interventions performed in study patients during six hours after hospital admission before and after the focused training program and implementation of the clinical management protocol.	Six hours after hospital admission	Evidenced based interventions are defined as initiation of antimicrobials, surgical source control (if applicable), oxygen administration (in case of respiratory distress) and fluid resuscitation (in case of tissue hypoperfusion)

Secondary Outcome Measures

Name	Time	Method
Prevalence of sepsis	72 hours after hospital admission
Rate of evidence-based interventions performed during the first 6 hours after hospital admission before and after the implementation of a 'Sepsis First Aid' kit	Six hours after hospital admission	Evidenced based interventions are defined as initiation of antimicrobials, surgical source control (if applicable), oxygen administration (in case of respiratory distress) and fluid resuscitation (in case of tissue hypoperfusion)
Time to initiation of evidence-based interventions after Hospital admission	Six hours after hospital admission	Evidenced based interventions are defined as initiation of antimicrobials, surgical source control (if applicable), oxygen administration (in case of respiratory distress) and fluid resuscitation (in case of tissue hypoperfusion)
Rate of pre-defined adverse events	Twenty-four hours after hospital admission
Hospital mortality	28 days after hospital admission or at hospital discharge
Rate of evidence-based interventions initiated before hospital admission in study patients referred to from regional dispensaries	baseline	Evidenced based interventions are defined as initiation of antimicrobials, surgical source control (if applicable), oxygen administration (in case of respiratory distress) and fluid resuscitation (in case of tissue hypoperfusion)
Rate of correct answers of a test on knowledge about acute infectious diseases before and after the focused educational training	1 hour before and 1 hour after the focused educational training course