Acute IllnessNCT04226040
Degree-of-worry and Illness Perception in Patients Suffering From Acute Illness in the Emergency Department
An observational study of Acute Illness, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Illness
- What is being tested?
- DOW and illness perception
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 944 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Jan 2020to 19 Dec 2020
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- ≥18 years of age
- cognitively intact
- consent to participation.
Who cannot join
- patients arriving to the ED regarding injury
- patient with the highest triage level
- demented patients
- intoxicated patients
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Acute Illness
- Being tested
- DOW and illness perception
- Keywords
- degree-of-worry, illness perception, acute illness, emergency department
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOW and illness perceptionBehavioural
Acutely ill patients are exposed to a survey regarding their degree of worry and illness perception
| Study group | Role | What they receive |
|---|---|---|
| DOW and illness perception | Exploration of the association between DOW and illness perception Receives: Behavioral: DOW and illness perception |
What is being measured
The primary outcome is the main question the study is designed to answer.
DOW and illness perception
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
Measured: 30 minutes
Secondary outcomes (2)
DOW and re-presentation in the Emergency Department
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
Measured: 30 days
DOW and patient barriers
10 (+/- 10) semi-structured interviews to explore potential patient barriers to implement the DOW-scale in Emergency Departments
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start13 Jan 2020
- Primary completion19 Dec 2020
- Study completion19 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 944 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Principal investigator, Hejdi Gamst-Jensen, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226040
- Sponsor's protocol ID
- HvidovreDOW1
- Status last verified
- May 2023
- First submitted
- 9 Jan 2020
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jensen AN, Kallemose T, Frostholm L, Gamst-Jensen H. Correlation between illness perceptions and self-reported degree-of-worry in somatic ill patients in emergency care: a Danish cross-sectional study. BMJ Open. 2024 Nov 1;14(10):e089595. doi: 10.1136/bmjopen-2024-089595.
PubMed 39486818
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Degree-of-worry and Illness Perception in Patients Suffering From Acute Illness in the Emergency Department
- ClinicalTrials.gov ID
- NCT04226040
- Acronym / sponsor ID
- HvidovreDOW1
- Conditions
- Acute Illness
- Keywords
- degree-of-worry, illness perception, acute illness, emergency department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 944 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 19 Dec 2020 (actual)
- Study completion
- 19 Dec 2020 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DOW and illness perception | – | Behavioral: DOW and illness perceptionExploration of the association between DOW and illness perception |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- ≥18 years of age
- cognitively intact
- consent to participation.
Key exclusion criteria (4 listed)
- patients arriving to the ED regarding injury
- patient with the highest triage level
- demented patients
- intoxicated patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DOW and illness perceptionAcutely ill patients are exposed to a survey regarding their degree of worry and illness perception | Behavioural | DOW and illness perception |
Primary outcome
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
2 secondary outcomes
DOW and re-presentation in the Emergency Department
Time frame: 30 days
DOW and patient barriers
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Derived from this study: PubMed 39486818Jensen AN, Kallemose T, Frostholm L, Gamst-Jensen H. Correlation between illness perceptions and self-reported degree-of-worry in somatic ill patients in emergency care: a Danish cross-sectional study. BMJ Open. 2024 Nov 1;14(10):e089595. doi: 10.1136/bmjopen-2024-089595.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Illness, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DOW and illness perception (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04226040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.