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

NCT07711535 — Recruiting, 45 participants, Charite University, Berlin, Germany

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Registry	NCT07711535
Status	Recruiting
Study type	Observational
Enrollment	45 (Estimated)
Sponsor	Charite University, Berlin, Germany (Other)
Conditions	Sepsis
Dates	start 2026-09-01 (estimated), primary completion 2026-10-01 (estimated), completion 2026-10-01 (estimated), first posted 2026-07-17, last updated 2026-09-09
Locations	1 site in Ghana

-Summary

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.

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+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.

+Outcome measures

Primary outcomes

The degree of expert consensus on individual quality indicators [Up to October 2026]: The degree of expert consensus on individual quality indicators, measured on a 5-point Likert scale (median and interquartile range) .

Secondary outcomes

The final, agreed-upon set of quality indicators [Up to October 2026]: The final, agreed-upon set of quality indicators is developed during the project
The agreed-upon structure of the STEPS survey instrument. [Up to October 2026]: The agreed-upon structure of the STEPS survey instrument.
The agreed-upon content of the STEPS survey instrument. [Up to October 2026]: The agreed-upon content of the STEPS survey instrument.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
The Komfo Anokye teaching hospital	Kumasi	Ghana	Recruiting

+Investigators

Claudia Spies, MD, Prof., Study director, Charite University, Berlin, Germany