- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05974800
Potential Improvements in Emergency Department Care for Cancer Patients According to Clinical Staff (OVERSEE-II)
February 2, 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 - II Trial)
The goal of this Single center prospective cross-sectional study is to identify the facilitators and barriers among caregivers in the emergency department that influence disposition of patients with solid and hematology malignancies.
The main question it aims to answer is to categorize the facilitators and barriers identified by three groups of emergency department (ED) staff.
Participants will be asked for permission, afterwards a short interview will be held with the different ED caregivers (ED nurse, attending physician and supervising physician).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The goal of this to identify the facilitators and barriers among caregivers in the emergency department (ED) that influence disposition of patients with solid and hematology malignancies.
Participants will be asked for permission, afterwards a short interview will be held with the different caregivers (ED nurse, attending physician and supervising physician) in the ED.
The interviews will be held in the order of the ED care pathway, meaning ED nurse first, treating physician second and supervising physician at last.
The interviews will be conducted for every patient with each of the caregivers.
Each interview will be conducted after the caregiver has made the first examination of the patient.
The interview focuses on several parts of the emergency care process: The first part is regarding the actions that are executed during an ED visit.
We will establish which actions are executed and why.
The second part is regarding the suspected outcome for the patient.
The third part will be about any potential improvements to the emergency care process for the patient.
Study Type
Observational
Enrollment (Estimated)
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 Contact
- Name: Jason den Duijn
- Phone Number: +31107040704
- Email: j.denduijn@erasmusmc.nl
Study Locations
-
-
Zuid-Holland
-
Rotterdam, Zuid-Holland, Netherlands, 3015GD
- Recruiting
- Erasmus MC
-
Contact:
- Jason den Duijn
- Phone Number: +31107040704
- Email: j.denduijn@erasmusmc.nl
-
-
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 system 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 the same shift / day after presentation in the ED.
Exclusion Criteria:
- <18 years old.
- Only received a surgical intervention as cancer treatment.
- 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 that are admitted to the emergency department of the Erasmus medical center for the oncology, hematological, lung- and neuro-oncology medical unit are eligible for inclusion.
|
The interview focuses on several parts of the emergency care process: The first part is regarding the actions that are executed during an emergency department visit.
We will establish which actions are executed and why.
The second part is regarding the suspected outcome for the patient.
The third part will be about any potential improvements to the emergency care process for the patient.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clusters of facilitator and barriers identified by the emergency department (ED) nurse
Time Frame: Through study completion, an average of 6 months
|
(Sub)Clusters of facilitator and barriers identified by the ED nurse for the ED care of patients with cancer
|
Through study completion, an average of 6 months
|
Clusters of facilitator and barriers identified by the treating physician
Time Frame: Through study completion, an average of 6 months
|
(Sub)Clusters of facilitator and barriers identified by the treating physician for the ED care of patients with cancer
|
Through study completion, an average of 6 months
|
Clusters of facilitator and barriers identified by the supervising physician
Time Frame: Through study completion, an average of 6 months
|
(Sub)Clusters of facilitator and barriers identified by the supervising physician for the ED care of patients with cancer
|
Through study completion, an average of 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Emergency department (ED) length of stay (LOS)
Time Frame: Through study completion, an average of 6 months
|
Emergency department length of stay
|
Through study completion, an average of 6 months
|
Disposition
Time Frame: Through study completion, an average of 6 months
|
Outcome after ED admission, being home or admission
|
Through study completion, an average of 6 months
|
Correlation between ED-LOS and disposition
Time Frame: Through study completion, an average of 6 months
|
Correlation between ED-LOS and disposition
|
Through study completion, an average of 6 months
|
ED nurse agreement of disposition
Time Frame: Through study completion, an average of 6 months
|
Agreement between ED nurse expected disposition and the actual disposition
|
Through study completion, an average of 6 months
|
Attending physician agreement of disposition
Time Frame: Through study completion, an average of 6 months
|
Agreement between treating physician expected disposition and the actual disposition
|
Through study completion, an average of 6 months
|
Supervising physician agreement of disposition
Time Frame: Through study completion, an average of 6 months
|
Agreement between supervising physician expected disposition and the actual disposition
|
Through study completion, an average of 6 months
|
Time-to-disposition
Time Frame: Through study completion, an average of 6 months
|
The time between patient's arrival at the ED and the decision to disposition
|
Through study completion, an average of 6 months
|
Time-to-ward
Time Frame: Through study completion, an average of 6 months
|
The time between the decision to hospitalize and the arrival at the ward
|
Through study completion, an average of 6 months
|
Correlation between time-to-disposition and the ED-LOS
Time Frame: Through study completion, an average of 6 months
|
Correlation between time-to-disposition and the ED-LOS
|
Through study completion, an average of 6 months
|
Correlation between time-to-ward and the ED-LOS
Time Frame: Through study completion, an average of 6 months
|
Correlation between time-to-ward and the ED-LOS
|
Through study completion, an average of 6 months
|
Difference in categories
Time Frame: Through study completion, an average of 6 months
|
The difference in the percentages in categories between the different caregivers
|
Through study completion, an average of 6 months
|
ED nurse summary of actions
Time Frame: Through study completion, an average of 6 months
|
Summary of actions taken by ED nurse in the ED care for patients with cancer
|
Through study completion, an average of 6 months
|
Attending physician summary of actions
Time Frame: Through study completion, an average of 6 months
|
Summary of actions taken by attending physician in the ED care for patients with cancer
|
Through study completion, an average of 6 months
|
Supervising physician summary of actions
Time Frame: Through study completion, an average of 6 months
|
Summary of actions taken by supervising physician in the ED care for patients with cancer
|
Through study completion, an average of 6 months
|
Years of medical experience
Time Frame: Through study completion, an average of 6 months
|
Number of years a medical staffmember is working in health care
|
Through study completion, an average of 6 months
|
Need for imaging
Time Frame: Through study completion, an average of 6 months
|
Was imaging ordered during ED visit and which kind
|
Through study completion, an average of 6 months
|
ED crowding
Time Frame: Through study completion, an average of 6 months
|
Degree of crowding in the ED, consisting of number of patients in the ED and the ED crowding color code
|
Through study completion, an average of 6 months
|
Difference in clusters per group between day, evening and night
Time Frame: Through study completion, an average of 6 months
|
Difference in clusters per ED staff group between day, evening and night
|
Through study completion, an average of 6 months
|
Difference in clusters per group between weekdays and weekend
Time Frame: Through study completion, an average of 6 months
|
Difference in clusters per group between weekdays (Monday 08:00 till Friday 16:00) and weekend (Friday 16:01 till Monday 7:59)
|
Through study completion, an average of 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient characteristics
Time Frame: Through study completion, an average of 6 months
|
age, sex, type of cancer, type of treatment, main complaint, triage category, number of prior ED visits.
|
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)
February 2, 2024
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
July 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)
February 6, 2024
Last Update Submitted That Met QC Criteria
February 2, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10842
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
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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