Health Care DeliveryNCT02979457
Degree of Worry as a Predictor for Utilization of Acute Health Care
A study testing Awareness of degree of worry in people with Health Care Delivery and Telephone Hotlines, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The overall aim of the study is to construct a scale that systematically incorporates the callers' perspective in a "degree of worry - scale" and to explore the consequences for the actors in the system - caller, call-handler, and health care system. This will be done through four independent studies. 1. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health Care Delivery, Telephone Hotlines, Patient Participation
- What is being tested?
- Awareness of degree of worry
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,340 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Jan 2017to 1 May 2018
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Callers to a Danish acute care hotline that are either patient self, close relative og friend of patient.
Who cannot join
- Non-close relation to patient
- Non-Danish speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Patient Involvement in Out-of-hours Health Care
The overall aim of the study is to construct a scale that systematically incorporates the callers' perspective in a "degree of worry - scale" and to explore the consequences for the actors in the system - caller, call-handler, and health care system.
This will be done through four independent studies.
- Is it possible to validate "the degree of worry" scale with the software system "Corti"?
- Does callers' degree of worry relieve after telephone consultation?
- Does call handlers' awareness of degree of worry affect triage outcome?
- Is callers' degree of worry a predictor of illness severity?
Read the detailed description
Does call-handlers awareness of caller Degree-Of-Worry affect triage outcome in telephone consultation? - a randomized trial.
Background When conducting a telephone consultation the call handler will make the decision of help needed on the basis of the dialog with the caller. The need of health care is difficult to estimate due to the lack of visual cues (Rothwell, Ellington, Planalp, \& Crouch, 2012) and might be complicated by factors related to the caller or the call handler herself (Lindström, Heikkilä, Bohm, Castrèn, \& Falk, 2014). Especially in cases of low-urgency and non-normative symptom description, as in the case of the majority of calls to the OOH, the call handlers' own health belief will have an impact on the triage outcome (Leprohon \& Patel, 1995; Ogden, 2011). Callers' Degree-Of-Worry (DOW) when contacting an Out-of-Hours service (OOH) has proven to be a valuable source of information of the callers' perception of the actual situation (not published). Call-handlers awareness of DOW can potentially increase the amount of telephone consultations terminated with advice of self-care or to seek General Practioner (GP) during office hours. Therefore, the present study seeks to investigate if call handlers' awareness of DOW affect triage outcome?
Aim: Does call-handlers awareness of caller Degree-Of-Worry affect triage outcome in telephone consultation
Methods Design The design of the study is a randomized controlled design blinding the call-handlers to callers' DOW in a computer assisted 1:1 ratio Eliglibility: all calls to hotline 1813 where informed consent is obtained. Intervention: blinding call-handlers to callers' DOW.
Setting The acute care system within the Capital Region of Denmark is divided into two facilities. The Medical Emergency Service and the Out-Of-Hours services (OOH) (hotline 1813) (Wadmann, Kjellberg, \& Kjellberg, 2015). All acute contact to the health care system within the region is pre-assessed and triaged. The OOH handles approx. 1 million calls per year of which approx. 40% are triaged to either self-care or consultation at their general practitioner (GP). The call handler is a nurse or physician, who triages the caller to either home visit, clinic consultation, self-care or GP. Triage and determination of urgency is guided by criterion based triage tools. The triage tool used in the OOH has been locally developed and has not been validated.
The present study is a part of a larger study which aims to construct a scale that systematically incorporates the callers' perspective in a "DOW" -scale" and to explore the consequences for the actors in the system - caller, call-handler, and health care system.
Data collection The research questions (see above) will be answered through the analysis of carefully collected data material incorporating the state of art set up at the hotline 1813 and the Danish health registers.
The data collection points are:
- Datapoint 1: After calling the hotline 1813 before reaching the call handler (caller delivers data).
- Datapoint 2: Right after call terminated (caller delivers data)
- Datapoint 3: 48 hours after initial contact to the medical hotline 1813 (Danish Registers delivers data)
Data will be collected at three different points during a call made to the hotline 1813. Participation in the study is voluntary. The data collection will be carried out as an automated telephone questionnaire. After the telephone consultation the caller will receive an automated call for further information. In case of non-response a text message will be sent after 30 and 60 minutes.
The randomization data is generated by reviling caller DOW to the call-handlers. DOW will be shown as a part of the medical history template, alongside civil registration number, address. In order to assure the DOW is seen by the call-handler this will be presented on the medical history template in red, size 14 numbers.
Triage outcome will be collected from the internal database at the hotline 1813.
The data analysis within the RCT will be limited to triage response given by call-handlers.
The plan of analysis is:
Primary outcome Does call-handlers awareness of caller Degree-Of-Worry affect triage outcome in telephone consultation
Chi2 test and OR of difference between intervention-and control group.
Log regression on outcome in exposure (little, medium and very much worry)
Sub-group of primary outcome (caller)
Eksplorative outcomes- DOW in three groups (little, some, much)
Is there a difference (intervention/control group) in triage outcome in the group of young children and old people, respectively?
Chi2 test of difference between intervention-and control group
Sub-group of primary outcome (call-handler)
Eksplorative outcomes - Is there a difference (intervention/control group) in triage outcome in call-handler gender, years of experience, waiting time?
Gender (chi2 test), Years of experience and waiting time
Non-response analysis Is there a difference between age, sex, triage-response, criteria, time of day and weekday? (participants/non-participants) age, sex, triage response, Criteria, Time of day, Weekday (Descriptive - mean and %)
- Being tested
- Awareness of degree of worry
- Keywords
- telephone consultation, patient involvement
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Awareness of degree of worryBehavioural
Also called DOW
degree of worry is a definition made for this project. It is roothed in coping psychology but has been influenced by the construct of self-rated health. Will blinding of DOW have an effect on triage outcome.
| Study group | Role | What they receive |
|---|---|---|
| no awareness of Degree of Worry | No intervention | Call handler is not made aware of caller's DOW on computer screen |
| awareness of Degree of Worry | Experimental | Call handler is made aware of caller's DOW on computer screen alongside patient information as address etc. Receives: Behavioral: Awareness of degree of worry |
What is being measured
The primary outcome is the main question the study is designed to answer.
call-handlers awareness of callers' DOW affects triage outcome
outcome measures = triage outcome Triage outcome is the triage response given to the caller: direct admission, out-of-hours clinic consultation, home visit, se GP during office hours advice on self-care
Measured: Call-handlers awareness of callers' DOW will be randomized during telephone consultation.
Secondary outcomes (1)
Does telephone consultation have a relieving effect on callers to a medical hotline?
Depending if the after DOW measurement is completed the caller (telephone call) the caller will be resent a text message with the same question (DOW) twice.
Measured: before and after measurement of DOW. After measurement is an computer assisted telephone datacollection 20 minutes and one hour after terminated call
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study start24 Jan 2017
- Primary completion15 May 2017
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Health Care DeliveryStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 11,340 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Emergency Medical Services, Capital Region, Denmark
- Responsible party
- Principal investigator, Hejdi Gamst-Jensen, University of Southern Denmark
- Investigators
- hejdi gamst-jensen, MSc, Principal investigator, Emergency Medical Services, Copenhagen Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979457
- Sponsor's protocol ID
- usoutherndenmark - hejdi
- Status last verified
- May 2018
- First submitted
- 21 Oct 2016
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gren C, Pedersen MK, Hasselager AB, Folke F, Ersboll AK, Cortes D, Egerod I, Gamst-Jensen H. How parents express their worry in calls to a medical helpline: a mixed methods study. BMC Prim Care. 2022 Apr 15;23(1):80. doi: 10.1186/s12875-022-01680-4.
PubMed 35421930Jensen AN, Kristiansen M, Tolstrup JS, Gamst-Jensen H. Associations between degree-of-worry, self-rated health and acute hospitalisation after contacting a medical helpline: a Danish prospective cohort study. BMJ Open. 2021 May 27;11(5):e042287. doi: 10.1136/bmjopen-2020-042287.
PubMed 34045212Gamst-Jensen H, Frishknecht Christensen E, Lippert F, Folke F, Egerod I, Brabrand M, Tolstrup JS, Thygesen LC, Huibers L. Impact of caller's degree-of-worry on triage response in out-of-hours telephone consultations: a randomized controlled trial. Scand J Trauma Resusc Emerg Med. 2019 Apr 11;27(1):44. doi: 10.1186/s13049-019-0618-2.
PubMed 30975160
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Patient Involvement in Out-of-hours Health Care
- ClinicalTrials.gov ID
- NCT02979457
- Acronym / sponsor ID
- usoutherndenmark - hejdi
- Keywords
- telephone consultation, patient involvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11,340 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Emergency Medical Services, Capital Region, Denmark
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 1 Dec 2016 (estimated)
- 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.
The overall aim of the study is to construct a scale that systematically incorporates the callers' perspective in a "degree of worry - scale" and to explore the consequences for the actors in the system - caller, call-handler, and health care system.
This will be done through four independent studies.
- Is it possible to validate "the degree of worry" scale with the software system "Corti"?
- Does callers' degree of worry relieve after telephone consultation?
- Does call handlers' awareness of degree of worry affect triage outcome?
- Is callers' degree of worry a predictor of illness severity?
Detailed description
Does call-handlers awareness of caller Degree-Of-Worry affect triage outcome in telephone consultation? - a randomized trial.
Background When conducting a telephone consultation the call handler will make the decision of help needed on the basis of the dialog with the caller. The need of health care is difficult to estimate due to the lack of visual cues (Rothwell, Ellington, Planalp, \& Crouch, 2012) and might be complicated by factors related to the caller or the call handler herself (Lindström, Heikkilä, Bohm, Castrèn, \& Falk, 2014). Especially in cases of low-urgency and non-normative symptom description, as in the case of the majority of calls to the OOH, the call handlers' own health belief will have an impact on the triage outcome (Leprohon \& Patel, 1995; Ogden, 2011). Callers' Degree-Of-Worry (DOW) when contacting an Out-of-Hours service (OOH) has proven to be a valuable source of information of the callers' perception of the actual situation (not published). Call-handlers awareness of DOW can potentially increase the amount of telephone consultations terminated with advice of self-care or to seek General Practioner (GP) during office hours. Therefore, the present study seeks to investigate if call handlers' awareness of DOW affect triage outcome?
Aim: Does call-handlers awareness of caller Degree-Of-Worry affect triage outcome in telephone consultation
Methods Design The design of the study is a randomized controlled design blinding the call-handlers to callers' DOW in a computer assisted 1:1 ratio Eliglibility: all calls to hotline 1813 where informed consent is obtained. Intervention: blinding call-handlers to callers' DOW.
Setting The acute care system within the Capital Region of Denmark is divided into two facilities. The Medical Emergency Service and the Out-Of-Hours services (OOH) (hotline 1813) (Wadmann, Kjellberg, \& Kjellberg, 2015). All acute contact to the health care system within the region is pre-assessed and triaged. The OOH handles approx. 1 million calls per year of which approx. 40% are triaged to either self-care or consultation at their general practitioner (GP). The call handler is a nurse or physician, who triages the caller to either home visit, clinic consultation, self-care or GP. Triage and determination of urgency is guided by criterion based triage tools. The triage tool used in the OOH has been locally developed and has not been validated.
The present study is a part of a larger study which aims to construct a scale that systematically incorporates the callers' perspective in a "DOW" -scale" and to explore the consequences for the actors in the system - caller, call-handler, and health care system.
Data collection The research questions (see above) will be answered through the analysis of carefully collected data material incorporating the state of art set up at the hotline 1813 and the Danish health registers.
The data collection points are:
- Datapoint 1: After calling the hotline 1813 before reaching the call handler (caller delivers data).
- Datapoint 2: Right after call terminated (caller delivers data)
- Datapoint 3: 48 hours after initial contact to the medical hotline 1813 (Danish Registers delivers data)
Data will be collected at three different points during a call made to the hotline 1813. Participation in the study is voluntary. The data collection will be carried out as an automated telephone questionnaire. After the telephone consultation the caller will receive an automated call for further information. In case of non-response a text message will be sent after 30 and 60 minutes.
The randomization data is generated by reviling caller DOW to the call-handlers. DOW will be shown as a part of the medical history template, alongside civil registration number, address. In order to assure the DOW is seen by the call-handler this will be presented on the medical history template in red, size 14 numbers.
Triage outcome will be collected from the internal database at the hotline 1813.
The data analysis within the RCT will be limited to triage response given by call-handlers.
The plan of analysis is:
Primary outcome Does call-handlers awareness of caller Degree-Of-Worry affect triage outcome in telephone consultation
Chi2 test and OR of difference between intervention-and control group.
Log regression on outcome in exposure (little, medium and very much worry)
Sub-group of primary outcome (caller)
Eksplorative outcomes- DOW in three groups (little, some, much)
Is there a difference (intervention/control group) in triage outcome in the group of young children and old people, respectively?
Chi2 test of difference between intervention-and control group
Sub-group of primary outcome (call-handler)
Eksplorative outcomes - Is there a difference (intervention/control group) in triage outcome in call-handler gender, years of experience, waiting time?
Gender (chi2 test), Years of experience and waiting time
Non-response analysis Is there a difference between age, sex, triage-response, criteria, time of day and weekday? (participants/non-participants) age, sex, triage response, Criteria, Time of day, Weekday (Descriptive - mean and %)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no awareness of Degree of Worry | No intervention | –Call handler is not made aware of caller's DOW on computer screen |
| awareness of Degree of Worry | Experimental | Behavioral: Awareness of degree of worryCall handler is made aware of caller's DOW on computer screen alongside patient information as address etc. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Callers to a Danish acute care hotline that are either patient self, close relative og friend of patient.
Key exclusion criteria (2 listed)
- Non-close relation to patient
- Non-Danish speaking
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 |
|---|---|---|
| Awareness of degree of worryAlso: DOWdegree of worry is a definition made for this project. It is roothed in coping psychology but has been influenced by the construct of self-rated health. Will blinding of DOW have an effect on triage outcome. | Behavioural | awareness of Degree of Worry |
Primary outcome
call-handlers awareness of callers' DOW affects triage outcome
Time frame: Call-handlers awareness of callers' DOW will be randomized during telephone consultation.
outcome measures = triage outcome Triage outcome is the triage response given to the caller: direct admission, out-of-hours clinic consultation, home visit, se GP during office hours advice on self-care
1 secondary outcome
Does telephone consultation have a relieving effect on callers to a medical hotline?
Time frame: before and after measurement of DOW. After measurement is an computer assisted telephone datacollection 20 minutes and one hour after terminated call
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 14 May 2018.
- Derived from this study: PubMed 35421930Gren C, Pedersen MK, Hasselager AB, Folke F, Ersboll AK, Cortes D, Egerod I, Gamst-Jensen H. How parents express their worry in calls to a medical helpline: a mixed methods study. BMC Prim Care. 2022 Apr 15;23(1):80. doi: 10.1186/s12875-022-01680-4.
- Derived from this study: PubMed 34045212Jensen AN, Kristiansen M, Tolstrup JS, Gamst-Jensen H. Associations between degree-of-worry, self-rated health and acute hospitalisation after contacting a medical helpline: a Danish prospective cohort study. BMJ Open. 2021 May 27;11(5):e042287. doi: 10.1136/bmjopen-2020-042287.
- Derived from this study: PubMed 30975160Gamst-Jensen H, Frishknecht Christensen E, Lippert F, Folke F, Egerod I, Brabrand M, Tolstrup JS, Thygesen LC, Huibers L. Impact of caller's degree-of-worry on triage response in out-of-hours telephone consultations: a randomized controlled trial. Scand J Trauma Resusc Emerg Med. 2019 Apr 11;27(1):44. doi: 10.1186/s13049-019-0618-2.
- 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.
hejdi gamst-jensen, MSc principal investigator
Emergency Medical Services, Copenhagen Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Awareness of degree of worry in people with Health Care Delivery and Telephone Hotlines, run by University of Southern Denmark 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 1 inclusion and 2 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 14 May 2018. 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?
call-handlers awareness of callers' DOW affects triage outcome (time frame: Call-handlers awareness of callers' DOW will be randomized during telephone consultation.). 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 NCT02979457, which also lists 3 linked publications.
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 14 May 2018.