Potential Improvements in Emergency Department Care for Cancer Patients According to Clinical Staff (OVERSEE-II)

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 - 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

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 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

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.
59

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 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

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 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.
Behavioral: Emergency department caregivers interview
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

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 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

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
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

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.
February 2, 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.
October 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.
  • 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

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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