Degree-of-worry and Illness Perception in Patients Suffering From Acute Illness in the Emergency Department

May 11, 2023 updated by: Hejdi Gamst-Jensen, Hvidovre University Hospital
This study explores whether and how DOW, as a PRO marker, can contribute to triage in the Emergency Departments. The study is designed as a mixed-method study consisting of a survey among acutely ill patients and qualitative semi-structured interviews.

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

In Emergency Departments (ED) in Denmark and internationally, triage manuals are used to divide incoming patients according to their acute clinical severity, and thus assess who should be examined and treated first. However, the triage manuals are criticized for being imprecise in the intermediate categories. Furthermore, the triage manuals, nationally and internationally, are criticized for not adequately involving the patient's perspective and context. In addition, triage is not independent of personal factors and workload, which may contribute to interprofessional variation. Further, patients themselves express a desire to be even more involved. Also, the relationship between patient and healthcare professional has a direct impact on the quality of health services, however, there are divergent perceptions of what patient involvement entails. Patient-Reported Outcome (PRO) data is one way in which patient involvement can occur. PRO is data reported directly from the patient without interference from the healthcare professional and is thus self-reported data, typically generated through survey studies among patients. A strength of PRO data is that these are often more sensitive which may, for example, demonstrate a higher degree of severity of the patient's symptoms. Furthermore, it is considered a strength that PRO data can be used at both group level, for example in quality assurance, as well as at an individual level to support the decision making of healthcare professionals and thereby ensure efficient use of resources. Due to lack of evidence-based knowledge in the field and despite the potential of using PRO data, the information of patients and / or relatives is not used systematically in the Emergency Department. This also applies in the acute contact, where an imprecise initial evaluation of the patient's overall medical needs can cause both over- and under-triaging to the detriment of the overall patient course. The result is an inappropriate allocation of resources at the organizational level and a poorer quality in the treatment process. This points to the need to use relevant patient-reported measures (PROM), the tool for measuring PROs. One such instrument is Degree-of-Worry (DOW), which measures the patient's self-reported level of worry. DOW is a ten-point score of self-reported worry (from 1 = minimal concern to 10 = maximally concerned), reflecting the patient's own assessment of acute illness and own perception of concern. DOW has been scientifically tested in connection with telephone triage at the medical helpline 1813 (MH1813) as a five-point score. The patient's DOW, measured at the time the patient makes his first call to the MH1813, is strongly associated with the probability of acute hospitalization within 48 hours. However, a pilot test with DOW as a five-point score in the Emergency Department indicates a ceiling effect, by which DOW will be presented as a 10-point score in this setting. DOW has the potential to increase patient safety, create greater patient involvement and increase efficiency so that the lengths of stay reflects the triage level. A previous study suggests that DOW could also be used advantageously in other similar settings, such as Emergency Department, which, however, requires that potential implementation barriers is examined.

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.
944

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

  • Denmark
      • Hvidovre, Denmark, 2650
        • Copenhagen University Hospital, Hvidovre

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The survey: 1004 adults (≥18 years of age) who accept to participate in the study. The patients are at the Emergency Department due to acute illness.

The interviews: of the 1004 patients 10 (+/- 10 patients are invited to participate in a semi-structured interview. The recruitment is based on purposeful sampling with maximum variation.

Description

Inclusion Criteria:

  • ≥18 years of age
  • cognitively intact
  • consent to participation.

Exclusion Criteria:

  • patients arriving to the ED regarding injury
  • patient with the highest triage level
  • demented patients
  • intoxicated patients

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.
DOW and illness perception
Exploration of the association between DOW and illness perception
Behavioral: DOW and illness perception
Acutely ill patients are exposed to a survey regarding their degree of worry and illness perception

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
DOW and illness perception
Time Frame: 30 minutes
Self-reported degree-of-worry during acute illness scored on a 1-10 scale (1=minimal concern, 10=maximum concern) and illness perception measured using the Brief illness perception Questionnarie
30 minutes

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
DOW and re-presentation in the Emergency Department
Time Frame: 30 days
Self-reported degree-of-worry during acute illness scored on a 1-10 scale (1=minimal concern, 10=maximum concern) and representation in the Emergency Department during the following 30 days
30 days
DOW and patient barriers
Time Frame: 30 minutes
10 (+/- 10) semi-structured interviews to explore potential patient barriers to implement the DOW-scale in Emergency Departments
30 minutes

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.
Hvidovre University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Southern Denmark

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 13, 2020

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.
December 19, 2020

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.
December 19, 2020

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).
January 9, 2020

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.
January 9, 2020

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.
January 13, 2020

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.
May 12, 2023

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.
May 11, 2023

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.
May 1, 2023

More Information

Terms related to this study

Keywords

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.
  • HvidovreDOW1

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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