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Co-Producing Safety: Translation, Cultural Adaptation and Field Evaluation of a Patient-Incident Reporting Tool in Oncological Care Transitions

Co-Producing Safety: Translation, Cultural Adaptation and Field Evaluation of a Patient-Incident Reporting Tool in Oncological Care Transitions - PIRT OncoTransSafe

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00038941
Enrollment
199
Registered
2026-01-22
Start date
2026-03-11
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oncological diagnosis regardless of entity, severity, disease stage, recurrence status, or reason for contact

Interventions

Group 1: Study phase 1: Translation and adaptation of the Patient Incident Reporting Tool (PIRT) in accordance with established guidelines, including expert discussion (experts with professional or pe

Sponsors

Institut für Patientensicherheit
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Study population for study phase 2: - Adults capable of giving consent; - Presence of an oncological diagnosis (regardless of entity, severity, disease stage, recurrence status, or reason for contact); - The person is in, immediately before, or immediately after a clearly defined, circumscribed transition of care (i.e., inpatient to outpatient/discharge, active cancer therapy to follow-up care, change between forms of therapy). Study population for study phase 1: - Adults capable of giving informed consent; - Professional or personal experience in the care of cancer patients, especially at interfaces of care; - Belonging to one of the following groups: healthcare professionals (e.g., medicine, nursing), researcher, discharge management, patient representatives.

Exclusion criteria

Exclusion criteria: - Lack of sufficient German knowledge to participate in data collection (conducted in German); - Lack of capacity to give consent in accordance with ethical and legal requirements.

Design outcomes

Primary

MeasureTime frame
1. Validity of the German version of the Patient Incident Reporting Tool (PIRT): - Content validity: through expert evaluations and cognitive debriefings; - Construct validity: PIRT is assessed in parallel with two established instruments that measure related constructs (i.e. 1. quality and safety of care transitions, 2. preventable psychological harm, PPH). - Criterion validity: collection and analysis of demographic and context-specific data . Correlations between patient-reported safety events (PIRT) and external criteria (e.g. clinical characteristics, course and type of therapy) and their predictive power are investigated. 2. Safety-critical events - Prevalence (how many participants report at least one safety-related event) and volume (how many events are reported per person), - Types and context of safety-related events (classification, description, potential for harm, effects/consequences, care context, suspected cause, preventability)

Secondary

MeasureTime frame
The relationship between sociodemographic and contextual factors, data of a cancer registry, and forms of PPH with the safety events reported in the PIRT, and the extent to which these data can predict the occurrence of such events.

Countries

Germany

Contacts

Public ContactLarissa Brust

Institut für Patientensicherheit, Universitätsklinikum Bonn

Larissa.Brust@ukbonn.de+49 228 287-10536

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026