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Feasibility Study to Evaluate the Use of Patient Reported Complications After Digital Consent

Study acronym: PRC
StatusRecruiting
PhaseNot specified
Started2024-03-07
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 24 months later Oct 31, 2025 → Oct 31, 2027
See other at-risk trials from Portsmouth Hospitals NHS Trust

Amendment history

2026-09-16
Primary completion pushed: 2025-10-31 → 2027-10-31
Completion pushed: 2025-10-31 → 2027-10-31
2025-07-14
Study Identification, Study Status, Oversight v3
Primary completion date2025-04-30→2025-10-31
Completion date2025-04-30→2025-10-31
2024-11-06
Study Identification, Study Status, Oversight v2
Primary completion date2024-09-19→2025-04-30
Completion date2024-10-31→2025-04-30
2024-04-08
Study Identification, Study Status, Study Description, Outcome Measures, Eligibility v1
Eligibility criteria-71 characters
[...] consent for participation in the study. Exclusion Criteria: The participant may not enter the study if ANY of the following apply: Unable to consent for themselves or do not wish to participate. Patients who need an interpreter.
Secondary endpoints6 entries, revised
Frequency of PRC and CRCs (Consent Form Reported Complications)
Study description+26 characters
[...] perative patient complications is important and it is an NHS (National Health Service) requirement that complications are discussed within regular [...]
Study title-6 characters
Feasibility Study to Evaluate the Use of (P)AtientPatient (R)EportedReported (C)OmplicationsComplications After Digital Consent
2024-04-02
Original filing
Patient report complication data to our best knowledge has not been studied yet in electronic consent. This study is a feasibility study to assess whether patients will reliably report their complications, the quality of this reporting and whether the information provided in the consent form matches up to their experience. This data will then be used to improve the consent process and evaluate whether the Patient Initiated Follow Up (PIFU) model is effective or if it leads to underreporting of problems.
Trial Details
NCT Number NCT06351865
Lead Sponsor Portsmouth Hospitals NHS Trust
Collaborators: University of East Anglia
Conditions Breast Cancer, Complication of Surgical Procedure
Enrollment 50 participants
Start Date 2024-03-07
Primary Completion 2027-10-31 (estimated)
Study Completion 2027-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-15