- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04226040
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
Completed
Conditions
Intervention / Treatment
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
Observational
Enrollment (Actual)
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 Locations
-
-
-
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
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 |
Intervention / Treatment |
---|---|
DOW and illness perception
Exploration of the association between 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
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
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
Collaborators
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 13, 2020
Primary Completion (Actual)
December 19, 2020
Study Completion (Actual)
December 19, 2020
Study Registration Dates
First Submitted
January 9, 2020
First Submitted That Met QC Criteria
January 9, 2020
First Posted (Actual)
January 13, 2020
Study Record Updates
Last Update Posted (Actual)
May 12, 2023
Last Update Submitted That Met QC Criteria
May 11, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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