Chemokeyp: A Feasibility Study for Realtime Safety Data-Capture for Potential Serious Adverse Drug Events

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSt Vincent's University Hospital, Ireland

About this trial

Chemokeyp is a feasibility study testing a secure ED-Oncology interface for patients receiving chemotherapy who may present to unscheduled care with possible treatment-related complications.

Participants are enrolled through Oncology and issued a medical-alert-style wristband with a QR code. If they attend the Emergency Department, staff can scan the QR code, access a generic study landing page, and, after SVUH authentication, complete a short structured checklist about possible serious adverse events such as infection, chest pain, vomiting, syncope, or other red-flag symptoms.

The platform is designed as a secure research data-capture portal, not an electronic health record or clinical documentation system. It does not read from or write to the hospital EHR, does not provide clinical decision support, and does not change usual clinical care. Data entered by ED clinicians are limited to predefined structured fields for research and safety-signal feasibility purposes.

The study will assess whether ED clinicians can complete the checklist in real time, whether the information can support earlier notification to the research/trial team, and whether this data accurately corresponds with verified serious adverse events. If feasible, Chemokeyp could help improve communication between Oncology, Emergency Medicine, and trial teams, supporting safer care for patients on chemotherapy and informing future development of ED-oncology digital safety tools.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient undergoing treatment for cancer at SVUH

Disqualifiers

Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation (inability to give informed consent)

Trial population

Patients of SVUH undergoing systemic anti-cancer therapy who may require emergent care during their cancer treatment and who consent to participate.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: Patients receiving systemic anti-cancer therapy enrolled in the Chemokeyp feasibility study

Trial outcomes

Primary outcomes

1

Time to awareness that a patient on systemic cancer therapy attends an Emergency Department

The goal is to see if this intervention reduces the awareness of potential serious adverse drug reactions by alerting specialist teams if someone presents to any Emergency Department for emergency care.

Time frame
Reduce time to discovery that patient has accessed Emergency Unscheduled care to a maximum of 48 hours.

Secondary outcomes

Other outcomes

Sponsors and contacts

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