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NCT Number: NCT07711535

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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 n sub-Saharan Africa, including physicians, nurses, researchers, and other healthcare professionals involved in acute care and quality assurance.

For the first Delphi round, we 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The degree of expert consensus on individual quality indicators

    Time frame: 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

  1. The final, agreed-upon set of quality indicators

    Time frame: Up to October 2026

    The final, agreed-upon set of quality indicators is developed during the project

  2. The agreed-upon structure of the STEPS survey instrument.

    Time frame: Up to October 2026

    The agreed-upon structure of the STEPS survey instrument.

  3. The agreed-upon content of the STEPS survey instrument.

    Time frame: Up to October 2026

    The agreed-upon content of the STEPS survey instrument.

Study contacts

Contact information is provided by the study sponsor or research team.

Claudia Spies, MD, Prof.

CONTACT

[email protected]

+49 30 450 55 11 02

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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