Oncological diagnosis regardless of entity, severity, disease stage, recurrence status, or reason for contact
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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
Institut für Patientensicherheit, Universitätsklinikum Bonn