The 'Bekele Afessa Scan-Teach-Treat Approach'

Sepsis Clinical Trial

Official title:

The 'Bekele Afessa Scan-Teach-Treat Approach' to Improve Care of Patients With Acute Infection at the Gitwe Hospital in Gitwe/Rwanda

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02697513
• Other study ID #: V01
• Status: Active, not recruiting
• Phase: N/A
• First received: February 14, 2016
• Last updated: April 28, 2017
• Start date: March 2016
• Est. completion date: December 2017

Study information

• Verified date: April 2017
• Source: University of Salzburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1594
• Est. completion date: December 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Sepsis

Intervention

Behavioral:
• simple infection management protocol
Implementation of a simple management protocol to improve care of patients with acute infection. Implementation will be assisted by a 1.5-day focused training program.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
University of Salzburg	Gitwe Hospital and Gitwe School of Medicine, Mayo Clinic, Surviving Sepsis Campaign, University of Nebraska Medical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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)	Six hours after hospital admission
Secondary	Prevalence of sepsis		72 hours after hospital admission
Secondary	Hospital mortality		28 days after hospital admission or at hospital discharge
Secondary	Time to initiation of evidence-based interventions 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)	Six hours after hospital admission
Secondary	Rate of evidence-based interventions initiated before hospital admission in study patients referred to from regional dispensaries	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)	baseline
Secondary	Rate of pre-defined adverse events		Twenty-four hours after hospital admission
Secondary	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	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)	Six hours after hospital admission
Secondary	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