The 'Bekele Afessa Scan-Teach-Treat Approach'

NCT02697513 | Unknown DMC

• 1 other identifier: V01
• Study Type: interventional
• Target: 1,594
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Infection; Sepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Prevalence of sepsis

  72 hours after hospital admission

• Hospital mortality

  28 days after hospital admission or at hospital discharge

• Time to initiation of evidence-based interventions after Hospital admission

  Six hours after hospital admission

• Rate of evidence-based interventions initiated before hospital admission in study patients referred to from regional dispensaries

  baseline

• Rate of pre-defined adverse events

  Twenty-four hours after hospital admission

Study Arms (2)

Before Period

NO INTERVENTION

Collection of patient-related data without interventions being made

After Period

ACTIVE COMPARATOR

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

Behavioral: simple infection management protocol

Interventions

simple infection management protocol 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.

After Period

Eligibility Criteria

• Age: 4 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Salzburg: lead
• Gitwe Hospital and Gitwe School of Medicine: collaborator
• Mayo Clinic: collaborator
• Surviving Sepsis Campaign: collaborator
• University of Nebraska Medical: collaborator

Related Publications (2)

• 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.

  PMID: 29957715 DERIVED

• 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.

  PMID: 29955924 DERIVED

MeSH Terms

Conditions

Infections; Sepsis

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chris Farmer, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lt. OA Dr.

Study Record Dates

• First Submitted: February 14, 2016
• First Posted: March 3, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 1, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share