The 'Bekele Afessa Scan-Teach-Treat Approach'

NCT ID: NCT02697513

Last Updated: 2017-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1594 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-12-31

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.

Conditions

Infection; Sepsis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Before Period

Collection of patient-related data without interventions being made

Group Type: NO_INTERVENTION

No interventions assigned to this group

After Period

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

Group Type: ACTIVE_COMPARATOR

simple infection management protocol

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 4 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gitwe Hospital and Gitwe School of Medicine

UNKNOWN

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: collaborator

Surviving Sepsis Campaign

UNKNOWN

Sponsor Role: collaborator

University of Nebraska Medical

UNKNOWN

Sponsor Role: collaborator

University of Salzburg

OTHER

Sponsor Role: lead

Responsible Party

Martin W Duenser, MD, DESA, EDIC

Lt. OA Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chris Farmer, MD

Role: STUDY_CHAIR

Mayo Clinic

References

Urayeneza O, Mujyarugamba P, Rukemba Z, Nyiringabo V, Ntihinyurwa P, Baelani JI, Kwizera A, Bagenda D, Mer M, Musa N, Hoffman JT, Mudgapalli A, Porter AM, Kissoon N, Ulmer H, Harmon LA, Farmer JC, Dunser MW, Patterson AJ; Sepsis in Resource-Limited Nations Workgroup of the Surviving Sepsis Campaign. Increasing Evidence-Based Interventions in Patients with Acute Infections in a Resource-Limited Setting: A Before-and-After Feasibility Trial in Gitwe, Rwanda. Crit Care Med. 2018 Aug;46(8):1357-1366. doi: 10.1097/CCM.0000000000003227.

Reference Type: DERIVED

PMID: 29957715 (View on PubMed)

Urayeneza O, Mujyarugamba P, Rukemba Z, Nyiringabo V, Ntihinyurwa P, Baelani JI, Kwizera A, Bagenda D, Mer M, Musa N, Hoffman JT, Mudgapalli A, Porter AM, Kissoon N, Ulmer H, Harmon LA, Farmer JC, Dunser MW, Patterson AJ; Sepsis in Resource-Limited Nations Workgroup of the Surviving Sepsis Campaign. Increasing evidence-based interventions in patients with acute infections in a resource-limited setting: a before-and-after feasibility trial in Gitwe, Rwanda. Intensive Care Med. 2018 Sep;44(9):1436-1446. doi: 10.1007/s00134-018-5266-x. Epub 2018 Jun 28.

Reference Type: DERIVED

PMID: 29955924 (View on PubMed)

Other Identifiers

V01

Identifier Type: -

Identifier Source: org_study_id