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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
Awareness of degree of worry
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.

Denmark1 site
  • Hejdi Gamst-Jensen

    Ballerup Municipality, 2750

Other trials in Denmark

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.

  1. Is it possible to validate "the degree of worry" scale with the software system "Corti"?
  2. Does callers' degree of worry relieve after telephone consultation?
  3. Does call handlers' awareness of degree of worry affect triage outcome?
  4. 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 groups in NCT02979457
Study groupRoleWhat they receive
no awareness of Degree of WorryNo interventionCall handler is not made aware of caller's DOW on computer screen
awareness of Degree of WorryExperimentalCall 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.

  1. 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)
  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.

  1. First posted1 Dec 2016 (estimated)
  2. Study start24 Jan 2017
  3. Primary completion15 May 2017
  4. Study completion1 May 2018

Resources

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)
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 35421930
  • Jensen 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 34045212
  • Gamst-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

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.

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