Potential Improvements in the Pre-emergency Department Care for Cancer Patients

Cancer Clinical Trial

— OVERSEE-I  

Official title:

Identification of Potential Improvements in the Acute Care Pathway for Cancer Patients in the Emergency Department (OVERSEE - I Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05974787
• Other study ID #: 10841
• Status: Recruiting
• Start date: January 29, 2024
• Est. completion date: July 1, 2024

Study information

• Verified date: February 2024
• Source: Erasmus Medical Center
• Contact: Jason den Duijn
• Phone: +31107040704
• Email: j.denduijn[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The goal of this single center prospective cross-sectional study is to identify the facilitators and barriers in the course of the disease that starts when symptoms first arise until patients with solid and hematologic malignancies arrive in the emergency department (ED). The main question it aims to answer are: Is there a potential relation between the lag-time and the ED length of stay (LOS) and the chance of admission. Participants will be asked to participate in a one-time interview, that focusses on the pre-admission process.

Description:

The goal of this single center prospective cross-sectional study is to identify the facilitators and barriers in the course of the disease that starts when symptoms first arise until patients with solid and hematologic malignancies arrive in the emergency department (ED). The main question it aims to answer are: Is there a potential relation between the lag-time and the emergency department length of stay and the chance of admission. Participants will be asked to participate in a one-time interview, that focusses on the pre-admission process. The interview focuses on several parts of the (pre-)admission process: The first part is regarding the timeline that led to an ED visit. The investigators will establish, when and which symptoms were first detected. The second part are regarding the number and type of health care workers that were contacted before visiting the ED. The third part will be about the actions that were taken before the ED visit.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: July 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patients with solid or hematological malignancies and receiving systemic therapy or having received systemic therapy within the last 3 months.
• Presented at or admitted from the emergency department for the oncology, hematology, neuro- or lung-oncology clinical unit.
• Awake and conscious.
• Possible to answer questions within 48 hours after presentation at the emergency department (ED).

Exclusion Criteria:

• <18 years old
• Only received a surgical intervention as cancer treatment
• Admitted to the ED for the surgical department
• Not willing or able to give written informed consent

Related Conditions & MeSH terms

• Cancer
• Emergencies

Intervention

Behavioral:
• Emergency department cancer patients interview
The interview focuses on several parts of the (pre-)admission process: The first part is regarding the barriers and facilitators encountered during the (pre-)admission process. The second part will focus on the timeline that led to an emergency department (ED) visit. It will be established when and which symptoms were first detected. The third part is regarding the number and type of health care workers that were contacted before visiting the ED. The fourth part will be about the actions and considerations taken before the ED visit.

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clusters of facilitators experienced by cancer patients.	Different (sub)clusters of facilitators experienced by cancer patients visiting the emergency department (ED)	Through study completion, an average of 6 months
Primary	clusters of barriers experienced by cancer patients.	Different (sub)clusters of barriers experienced by cancer patients visiting the ED	Through study completion, an average of 6 months
Secondary	Time-to-speak	The time between the first notice of symptoms and the first time these complaints were spoken out to the primary giver	Through study completion, an average of 6 months
Secondary	Time-to-contact	The time between the first time complaints are spoken out and contact is made with a healthcare professional	Through study completion, an average of 6 months
Secondary	Time-to-present	The time between the first contact with a healthcare professional and the presentation at the ED	Through study completion, an average of 6 months
Secondary	Difference in group average lag-time between day, evening and night	Difference in group average lag-time between day, evening and night	Through study completion, an average of 6 months
Secondary	Difference in group average lag-time between weekdays (Monday 08:00 till Friday 23:59) and weekend (Saturday 00:00 and Monday 7:59)	Difference in group average lag-time between weekdays (Monday 08:00 till Friday 23:59) and weekend (Saturday 00:00 and Monday 7:59)	Through study completion, an average of 6 months
Secondary	Correlation between number of contacted healthcare providers before presentation at the ED and the lag- time.	Correlation between number of contacted healthcare providers before presentation at the ED and the lag- time.	Through study completion, an average of 6 months
Secondary	Willingness to participate	the percentage of people that participated in this study in comparison to the people approached for this study.	Through study completion, an average of 6 months
Secondary	Lag-time	The time between the first onset of symptoms and a visit to the ED.	Through study completion, an average of 6 months
Secondary	ED length of stay (LOS)	The time a patient spends in the ED	Through study completion, an average of 6 months
Secondary	Disposition	The outcome of a visit to the ED, being either admission or home	Through study completion, an average of 6 months
Secondary	Patient characteristics	Age, sex, type of cancer, type of complaint, triage category, number of prior visits	Through study completion, an average of 6 months
Secondary	Correlation between lag-time and ED-LOS	Correlation between lag-time and ED-LOS	Through study completion, an average of 6 months
Secondary	Correlation between lag-time and disposition	Correlation between lag-time and disposition	Through study completion, an average of 6 months
Secondary	Correlation between lag-time and patient characteristics	Correlation between lag-time and patient characteristics	Through study completion, an average of 6 months
Secondary	ED crowding	Measure of business of the ED, composed of the number of patients in the ED and the color coding used for crowding	Through study completion, an average of 6 months