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Not yet recruiting NCT07711535

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

Observational Sepsis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Sepsis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Primary outcome measures

  • The degree of expert consensus on individual quality indicators [Time frame: Up to October 2026]
Secondary outcome measures (3)
  • The final, agreed-upon set of quality indicators [Time frame: Up to October 2026]
  • The agreed-upon structure of the STEPS survey instrument. [Time frame: Up to October 2026]
  • The agreed-upon content of the STEPS survey instrument. [Time frame: Up to October 2026]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07711535 · Delphi-QI-Steps

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗