- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05974787
Potential Improvements in the Pre-emergency Department Care for Cancer Patients (OVERSEE-I)
October 14, 2024 updated by: Jason den Duijn, Erasmus Medical Center
Identification of Potential Improvements in the Acute Care Pathway for Cancer Patients in the Emergency Department (OVERSEE - I Trial)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
75
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zuid-Holland
-
Rotterdam, Zuid-Holland, Netherlands, 3015GD
- Erasmus MC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
In the emergency department (ED) of Erasmus medical center (MC) yearly around 1600 patients with cancer are presented to the ED.
Based on the study design we will conduct interviews with 75 to 100 patients with solid and hematologic malignancies, who are receiving systemic therapy or have received systemic therapy within the last 3 months and are admitted to the ED department of the Erasmus MC for the oncology, hematology, lung- and neuro-oncology medical unit.
If present, the interview will also be held with the family caregiver.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cancer patients
All adult patients with solid or hematological malignancies and receiving systemic therapy or having received systemic therapy within the last 3 months admitted to the emergency department of the Erasmus Medical Center for the oncology, hematology, lung- and neuro-oncology medical unit are eligible for inclusion.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clusters of facilitators experienced by cancer patients.
Time Frame: Through study completion, an average of 6 months
|
Different (sub)clusters of facilitators experienced by cancer patients visiting the emergency department (ED)
|
Through study completion, an average of 6 months
|
|
clusters of barriers experienced by cancer patients.
Time Frame: Through study completion, an average of 6 months
|
Different (sub)clusters of barriers experienced by cancer patients visiting the ED
|
Through study completion, an average of 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lag-time
Time Frame: Through study completion, an average of 6 months
|
The time between the first onset of symptoms and a visit to the ED.
|
Through study completion, an average of 6 months
|
|
Disposition
Time Frame: Through study completion, an average of 6 months
|
The outcome of a visit to the ED, being either admission or home
|
Through study completion, an average of 6 months
|
|
Patient characteristics
Time Frame: Through study completion, an average of 6 months
|
Age, sex, type of cancer, type of complaint, triage category, number of prior visits
|
Through study completion, an average of 6 months
|
|
Correlation between lag-time and ED-LOS
Time Frame: Through study completion, an average of 6 months
|
Correlation between lag-time and ED-LOS
|
Through study completion, an average of 6 months
|
|
Correlation between lag-time and disposition
Time Frame: Through study completion, an average of 6 months
|
Correlation between lag-time and disposition
|
Through study completion, an average of 6 months
|
|
Correlation between lag-time and patient characteristics
Time Frame: Through study completion, an average of 6 months
|
Correlation between lag-time and patient characteristics
|
Through study completion, an average of 6 months
|
|
Time-to-speak
Time Frame: Through study completion, an average of 6 months
|
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
|
|
Time-to-contact
Time Frame: Through study completion, an average of 6 months
|
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
|
|
Time-to-present
Time Frame: Through study completion, an average of 6 months
|
The time between the first contact with a healthcare professional and the presentation at the ED
|
Through study completion, an average of 6 months
|
|
Difference in group average lag-time between day, evening and night
Time Frame: Through study completion, an average of 6 months
|
Difference in group average lag-time between day, evening and night
|
Through study completion, an average of 6 months
|
|
Difference in group average lag-time between weekdays (Monday 08:00 till Friday 23:59) and weekend (Saturday 00:00 and Monday 7:59)
Time Frame: Through study completion, an average of 6 months
|
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
|
|
Correlation between number of contacted healthcare providers before presentation at the ED and the lag- time.
Time Frame: Through study completion, an average of 6 months
|
Correlation between number of contacted healthcare providers before presentation at the ED and the lag- time.
|
Through study completion, an average of 6 months
|
|
Willingness to participate
Time Frame: Through study completion, an average of 6 months
|
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
|
|
ED length of stay (LOS)
Time Frame: Through study completion, an average of 6 months
|
The time a patient spends in the ED
|
Through study completion, an average of 6 months
|
|
ED crowding
Time Frame: Through study completion, an average of 6 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jason den Duijn, Erasmus Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 29, 2024
Primary Completion (Actual)
September 1, 2024
Study Completion (Actual)
September 1, 2024
Study Registration Dates
First Submitted
July 18, 2023
First Submitted That Met QC Criteria
July 26, 2023
First Posted (Actual)
August 3, 2023
Study Record Updates
Last Update Posted (Actual)
October 15, 2024
Last Update Submitted That Met QC Criteria
October 14, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10841 (Fred Hutch/University of Washington Cancer Consortium)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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