Development of Context-Adapted Quality Indicators for Early Sepsis Care in Sub-Saharan Africa - A Modified Delphi Consensus Procedure

The research project is an anonymous, prospective, non-interventional consensus study in the form of a modified Delphi method, consisting of three online surveys and structured feedback meetings without recording. The goal is the structured evaluation and consolidation of expert assessments to develop context-adapted quality indicators and operationalize them for early sepsis care in Sub-Saharan Africa.

Study Overview

• Status: Recruiting
• Conditions: Sepsis

Detailed Description

The expert panel will be recruited through purposive sampling via existing national and international sepsis networks (including the Sub-Saharan African Consortium for the Advancement of Innovative Research and Care in Africa, "STAIRS"), scientific collaborations, and personal invitations from the study team in Berlin.

Invited are professionals with proven experience in sepsis care or sepsis research in sub-Saharan Africa, including physicians, nurses, researchers, and other healthcare professionals involved in acute care and quality assurance.

For the first Delphi round, the investigators plan to recruit approximately 10-15 experts. In a second recruitment phase, participants may nominate additional experts with relevant expertise (snowball sampling). The total number of panel members should not exceed 30-45.

• Study Type: Observational
• Enrollment (Estimated): 45

Contacts and Locations

• Study Contact: Name: Claudia Spies, MD, Prof.; Phone Number: +49 30 450 55 11 02; Email: claudia.spies@charite.de

Study Locations

• Ghana
  • Kumasi, Ghana
    • Recruiting
    • The Komfo Anokye teaching hospital
    • Contact: Phone Number: +233 593 830 400; Email: info@kath.gov.gh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Professionals with proven experience in sepsis care or sepsis research in low- and middle-income countries, particularly Sub-Saharan Africa, including physicians, nurses, researchers, and other healthcare professionals involved in early acute care and quality assurance.

Description

Inclusion Criteria:

• Professionals with proven experience in sepsis care or sepsis research in low- and middle-income countries, particularly Sub-Saharan Africa including physicians, nurses, researchers, and other healthcare professionals involved in early acute care and quality assurance
• Minimum age of 18
• Willingness to voluntarily participate in one or more Delphi rounds

Exclusion criteria:

• Lack of professional expertise in the field of sepsis care
• Refusal to consent to participation
• Withdrawal from participation at the participant's own request

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The degree of expert consensus on individual quality indicators	The degree of expert consensus on individual quality indicators, measured on a 5-point Likert scale (median and interquartile range) .	Up to October 2026

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The final, agreed-upon set of quality indicators	The final, agreed-upon set of quality indicators is developed during the project	Up to October 2026
The agreed-upon structure of the STEPS survey instrument.	The agreed-upon structure of the STEPS survey instrument.	Up to October 2026
The agreed-upon content of the STEPS survey instrument.	The agreed-upon content of the STEPS survey instrument.	Up to October 2026

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Study Director: Claudia Spies, MD, Prof., Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: July 14, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): August 28, 2026
• Last Update Submitted That Met QC Criteria: August 27, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis
• Other Study ID Numbers: Delphi-QI-Steps

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No