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

Chemokeyp: A Feasibility Study to Evaluate and Further Develop Patient Safety Software Enabling Efficient and Effective Information Exchange for Patients Undergoing Systemic Cancer Treatment Who Access Emergency or Unscheduled Care.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07592234

Enrollment

100

Registered

2026-05-18

Start date

2026-02-01

Completion date

2027-01-01

Last updated

2026-05-18

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

Conditions

Oncology, Patient Safety, Pharmacovigilance, Serious Adverse Events

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patient undergoing treatment for cancer at SVUH

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Time to awareness that a patient on systemic cancer therapy attends an Emergency Department	Reduce time to discovery that patient has accessed Emergency Unscheduled care to a maximum of 48 hours.	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.

Countries

Ireland

Contacts

CONTACTRosa F McNamara, FRCEM FRCPI

rosamcnamara@svhg.ie+353857111841

Outcome results