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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Erasmus Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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