<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02979457</url>
  </required_header>
  <id_info>
    <org_study_id>usoutherndenmark - hejdi</org_study_id>
    <nct_id>NCT02979457</nct_id>
  </id_info>
  <brief_title>Degree of Worry as a Predictor for Utilization of Acute Health Care</brief_title>
  <official_title>Early Patient Involvement in Out-of-hours Health Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Emergency Medical Services, Capital Region, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall aim of the study is to construct a scale that systematically incorporates the&#xD;
      callers' perspective in a &quot;degree of worry - scale&quot; and to explore the consequences for the&#xD;
      actors in the system - caller, call-handler, and health care system.&#xD;
&#xD;
      This will be done through four independent studies.&#xD;
&#xD;
        1. Is it possible to validate &quot;the degree of worry&quot; scale with the software system &quot;Corti&quot;?&#xD;
&#xD;
        2. Does callers' degree of worry relieve after telephone consultation?&#xD;
&#xD;
        3. Does call handlers' awareness of degree of worry affect triage outcome?&#xD;
&#xD;
        4. Is callers' degree of worry a predictor of illness severity?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Does call-handlers awareness of caller Degree-Of-Worry affect triage outcome in telephone&#xD;
      consultation? - a randomized trial.&#xD;
&#xD;
      Background When conducting a telephone consultation the call handler will make the decision&#xD;
      of help needed on the basis of the dialog with the caller. The need of health care is&#xD;
      difficult to estimate due to the lack of visual cues (Rothwell, Ellington, Planalp, &amp; Crouch,&#xD;
      2012) and might be complicated by factors related to the caller or the call handler herself&#xD;
      (Lindström, Heikkilä, Bohm, Castrèn, &amp; Falk, 2014). Especially in cases of low-urgency and&#xD;
      non-normative symptom description, as in the case of the majority of calls to the OOH, the&#xD;
      call handlers' own health belief will have an impact on the triage outcome (Leprohon &amp; Patel,&#xD;
      1995; Ogden, 2011). Callers' Degree-Of-Worry (DOW) when contacting an Out-of-Hours service&#xD;
      (OOH) has proven to be a valuable source of information of the callers' perception of the&#xD;
      actual situation (not published). Call-handlers awareness of DOW can potentially increase the&#xD;
      amount of telephone consultations terminated with advice of self-care or to seek General&#xD;
      Practioner (GP) during office hours. Therefore, the present study seeks to investigate if&#xD;
      call handlers' awareness of DOW affect triage outcome?&#xD;
&#xD;
      Aim: Does call-handlers awareness of caller Degree-Of-Worry affect triage outcome in&#xD;
      telephone consultation&#xD;
&#xD;
      Methods Design The design of the study is a randomized controlled design blinding the&#xD;
      call-handlers to callers' DOW in a computer assisted 1:1 ratio Eliglibility: all calls to&#xD;
      hotline 1813 where informed consent is obtained. Intervention: blinding call-handlers to&#xD;
      callers' DOW.&#xD;
&#xD;
      Setting The acute care system within the Capital Region of Denmark is divided into two&#xD;
      facilities. The Medical Emergency Service and the Out-Of-Hours services (OOH) (hotline 1813)&#xD;
      (Wadmann, Kjellberg, &amp; Kjellberg, 2015). All acute contact to the health care system within&#xD;
      the region is pre-assessed and triaged. The OOH handles approx. 1 million calls per year of&#xD;
      which approx. 40% are triaged to either self-care or consultation at their general&#xD;
      practitioner (GP). The call handler is a nurse or physician, who triages the caller to either&#xD;
      home visit, clinic consultation, self-care or GP. Triage and determination of urgency is&#xD;
      guided by criterion based triage tools. The triage tool used in the OOH has been locally&#xD;
      developed and has not been validated.&#xD;
&#xD;
      The present study is a part of a larger study which aims to construct a scale that&#xD;
      systematically incorporates the callers' perspective in a &quot;DOW&quot; -scale&quot; and to explore the&#xD;
      consequences for the actors in the system - caller, call-handler, and health care system.&#xD;
&#xD;
      Data collection The research questions (see above) will be answered through the analysis of&#xD;
      carefully collected data material incorporating the state of art set up at the hotline 1813&#xD;
      and the Danish health registers.&#xD;
&#xD;
      The data collection points are:&#xD;
&#xD;
        -  Datapoint 1: After calling the hotline 1813 before reaching the call handler (caller&#xD;
           delivers data).&#xD;
&#xD;
        -  Datapoint 2: Right after call terminated (caller delivers data)&#xD;
&#xD;
        -  Datapoint 3: 48 hours after initial contact to the medical hotline 1813 (Danish&#xD;
           Registers delivers data)&#xD;
&#xD;
      Data will be collected at three different points during a call made to the hotline 1813.&#xD;
      Participation in the study is voluntary. The data collection will be carried out as an&#xD;
      automated telephone questionnaire. After the telephone consultation the caller will receive&#xD;
      an automated call for further information. In case of non-response a text message will be&#xD;
      sent after 30 and 60 minutes.&#xD;
&#xD;
      The randomization data is generated by reviling caller DOW to the call-handlers. DOW will be&#xD;
      shown as a part of the medical history template, alongside civil registration number,&#xD;
      address. In order to assure the DOW is seen by the call-handler this will be presented on the&#xD;
      medical history template in red, size 14 numbers.&#xD;
&#xD;
      Triage outcome will be collected from the internal database at the hotline 1813.&#xD;
&#xD;
      The data analysis within the RCT will be limited to triage response given by call-handlers.&#xD;
&#xD;
      The plan of analysis is:&#xD;
&#xD;
      Primary outcome Does call-handlers awareness of caller Degree-Of-Worry affect triage outcome&#xD;
      in telephone consultation&#xD;
&#xD;
      Chi2 test and OR of difference between intervention-and control group.&#xD;
&#xD;
      Log regression on outcome in exposure (little, medium and very much worry)&#xD;
&#xD;
      Sub-group of primary outcome (caller)&#xD;
&#xD;
      Eksplorative outcomes- DOW in three groups (little, some, much)&#xD;
&#xD;
      Is there a difference (intervention/control group) in triage outcome in the group of young&#xD;
      children and old people, respectively?&#xD;
&#xD;
      Chi2 test of difference between intervention-and control group&#xD;
&#xD;
      Sub-group of primary outcome (call-handler)&#xD;
&#xD;
      Eksplorative outcomes - Is there a difference (intervention/control group) in triage outcome&#xD;
      in call-handler gender, years of experience, waiting time?&#xD;
&#xD;
      Gender (chi2 test), Years of experience and waiting time&#xD;
&#xD;
      Non-response analysis Is there a difference between age, sex, triage-response, criteria, time&#xD;
      of day and weekday? (participants/non-participants) age, sex, triage response, Criteria, Time&#xD;
      of day, Weekday (Descriptive - mean and %)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 24, 2017</start_date>
  <completion_date type="Actual">May 1, 2018</completion_date>
  <primary_completion_date type="Actual">May 15, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>call-handlers awareness of callers' DOW affects triage outcome</measure>
    <time_frame>Call-handlers awareness of callers' DOW will be randomized during telephone consultation.</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Does telephone consultation have a relieving effect on callers to a medical hotline?</measure>
    <time_frame>before and after measurement of DOW. After measurement is an computer assisted telephone datacollection 20 minutes and one hour after terminated call</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11340</enrollment>
  <condition>Health Care Delivery</condition>
  <condition>Telephone Hotlines</condition>
  <condition>Patient Participation</condition>
  <arm_group>
    <arm_group_label>no awareness of Degree of Worry</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Call handler is not made aware of caller's DOW on computer screen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>awareness of Degree of Worry</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Call handler is made aware of caller's DOW on computer screen alongside patient information as address etc.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Awareness of degree of worry</intervention_name>
    <description>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.</description>
    <arm_group_label>awareness of Degree of Worry</arm_group_label>
    <other_name>DOW</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Callers to a Danish acute care hotline that are either patient self, close relative og&#xD;
             friend of patient.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-close relation to patient&#xD;
&#xD;
          -  Non-Danish speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>hejdi gamst-jensen, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emergency Medical Services, Copenhagen Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hejdi Gamst-Jensen</name>
      <address>
        <city>Ballerup</city>
        <zip>2750</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>October 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>May 11, 2018</last_update_submitted>
  <last_update_submitted_qc>May 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern Denmark</investigator_affiliation>
    <investigator_full_name>Hejdi Gamst-Jensen</investigator_full_name>
    <investigator_title>M.Sc. health science</investigator_title>
  </responsible_party>
  <keyword>telephone consultation, patient involvement</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02979457
org study id: usoutherndenmark - hejdi
nct id: NCT02979457
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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?
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 %)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Care Provider)
measure: call-handlers awareness of callers' DOW affects triage outcome
time frame: Call-handlers awareness of callers' DOW will be randomized during telephone consultation.
description: 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
measure: 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
description: 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.
arm group label: no awareness of Degree of Worry
arm group type: No Intervention
description: Call handler is not made aware of caller's DOW on computer screen
arm group label: awareness of Degree of Worry
arm group type: Experimental
description: Call handler is made aware of caller's DOW on computer screen alongside patient information as address etc.
intervention type: Behavioral
intervention name: Awareness of degree of worry
description: 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.
arm group label: awareness of Degree of Worry
other name: DOW
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: hejdi gamst-jensen, MSc
role: Principal Investigator
affiliation: Emergency Medical Services, Copenhagen Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Southern Denmark
investigator full name: Hejdi Gamst-Jensen
investigator title: M.Sc. health science
sharing ipd: No