<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/NCT03786874</url>
  </required_header>
  <id_info>
    <org_study_id>RC18_0047</org_study_id>
    <nct_id>NCT03786874</nct_id>
  </id_info>
  <brief_title>&quot;Impact of a Programme to Improve Interaction Among Professionals on the Management of Task Interruptions&quot;</brief_title>
  <acronym>IMPACTT</acronym>
  <official_title>&quot;Impact of a Programme to Improve Interaction Among Professionals on the Management of Task Interruptions&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</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>
      In 2017, all IMPACTT investigators experimented in coordinated manner on multifacet&#xD;
      intervention program, proposed by the present research protocol, with 2 teams from healthcare&#xD;
      units from the PDL region. This experiment followed collaborative work aiming to raise team&#xD;
      awareness on task interruptions. Given the existing data in the literature, the investigators&#xD;
      hypothesise that the implementation of a multifacet program focusing on interactions within a&#xD;
      team could enable the percentage of task interruptions linked to interactions between&#xD;
      coordination functions and healthcare provision activities to be decreased by 33%. This&#xD;
      decrease would concern task interruptions that are avoidable, in order to improve healthcare&#xD;
      safety and teamwork.&#xD;
&#xD;
      Also, the main objective of this project is to measure the impact of a program on the&#xD;
      evolution of the characteristics of avoidable task interruptions. The project combines&#xD;
      quantitative data (observations, questionnaire) and qualitative data (interviews).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research is a controlled, randomised, blind, pragmatic intervention study (36 months).&#xD;
      From the list of volunteering teams meeting inclusion criteria, a random selection will be&#xD;
      made. This will enable the formation of two groups of 20 teams each (control group and&#xD;
      experimental group). An observational method coupled with a validated questionnaire transfer&#xD;
      will allow teams to be questioned about their avoidable task interruptions (control group and&#xD;
      experimental group).&#xD;
&#xD;
      The multifacet intervention program is based the concept of teamwork implementation.&#xD;
      Targeting potential for improvement will be decided and implemented by each team&#xD;
      (experimental group).&#xD;
&#xD;
      Statistics analysis will be conducted on teams before and after the implementation of the&#xD;
      program. The assessment criteria will be: the evolution of characteristics of the task&#xD;
      interruptions observed (interactions between coordination functions and care delivery&#xD;
      functions, prevalence, avoidability, duration, resumption of tasks, social representations of&#xD;
      task interruptions).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Case group:&#xD;
Healthcare teams benefiting first the implementation of the coaching model other (centered round the following steps: identify, understand and act) : just after the first measure&#xD;
Control group:&#xD;
Healthcare teams benefiting first the implementation of the coaching model (centered round the following steps: identify, understand and act) : after the second measure (impact of the device on case group).</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>proportion of avoidable task interruptions</measure>
    <time_frame>1 year</time_frame>
    <description>Results from Dual Perspectives Method (DPM)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>sources and frequencies of task interruptions</measure>
    <time_frame>1 year</time_frame>
    <description>Results from Auto-administered questionnaire (TAA-KH-S)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>prevalence of task interruptions</measure>
    <time_frame>1 year</time_frame>
    <description>Time measurement of the duration of task interruption upon restart of work</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>20 teams the first year (G1)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>control group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>20 teams second year (G2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>case group with implementation of the multi-unit team accompaniment intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Identify work interruptions</intervention_name>
    <description>estimate baseline characteristics of the collaborative working model (proportion expressed as a percentage)</description>
    <arm_group_label>20 teams second year (G2)</arm_group_label>
    <arm_group_label>20 teams the first year (G1)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Understand work interruptions</intervention_name>
    <description>Team-review of the results of the task interruption and professional representations, identify activities to protect from task interruption</description>
    <arm_group_label>20 teams second year (G2)</arm_group_label>
    <arm_group_label>20 teams the first year (G1)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Act to limited work interruptions</intervention_name>
    <description>Adaptation of organizations; Awareness raising and Coaching for change</description>
    <arm_group_label>20 teams second year (G2)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  volunteering healthcare teams from healthcare centres in the PDL region,&#xD;
&#xD;
          -  public and private legal statuses;&#xD;
&#xD;
          -  with at least one activity in standard medical and/or surgical hospitalisation unit,&#xD;
&#xD;
          -  agreeing to take part in the project,&#xD;
&#xD;
          -  formalising their commitment to the multifacet program (see section 4),&#xD;
&#xD;
          -  including 50 professionals at the most,&#xD;
&#xD;
          -  including at least the following professional categories: medical, paramedical,&#xD;
             administrative, managerial and medical-technical/psycho-social.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Healthcare teams who do not belong to a healthcare unit in the PDL region&#xD;
&#xD;
          -  Healthcare teams who do not work in a medical and/or surgical hospitalisation unit.&#xD;
&#xD;
          -  Paediatric healthcare teams&#xD;
&#xD;
          -  Teams that have already been subjected to a methodological support program from one of&#xD;
             the co-investigating units on how to manage task interruptions,&#xD;
&#xD;
          -  Teams that do not meet the criteria for commitment to the multifacet program&#xD;
&#xD;
          -  Teams of more than 50 members&#xD;
&#xD;
          -  Teams who do not include the following professional categories: medical, paramedical,&#xD;
             administrative, managerial, medical-technical/psycho-social.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Risk management</keyword>
  <keyword>health &amp; safety</keyword>
  <keyword>task interruptions</keyword>
  <keyword>teamwork</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03786874
org study id: RC18_0047
nct id: NCT03786874
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In 2017, all IMPACTT investigators experimented in coordinated manner on multifacet
      intervention program, proposed by the present research protocol, with 2 teams from healthcare
      units from the PDL region. This experiment followed collaborative work aiming to raise team
      awareness on task interruptions. Given the existing data in the literature, the investigators
      hypothesise that the implementation of a multifacet program focusing on interactions within a
      team could enable the percentage of task interruptions linked to interactions between
      coordination functions and healthcare provision activities to be decreased by 33%. This
      decrease would concern task interruptions that are avoidable, in order to improve healthcare
      safety and teamwork.

      Also, the main objective of this project is to measure the impact of a program on the
      evolution of the characteristics of avoidable task interruptions. The project combines
      quantitative data (observations, questionnaire) and qualitative data (interviews).
This research is a controlled, randomised, blind, pragmatic intervention study (36 months).
      From the list of volunteering teams meeting inclusion criteria, a random selection will be
      made. This will enable the formation of two groups of 20 teams each (control group and
      experimental group). An observational method coupled with a validated questionnaire transfer
      will allow teams to be questioned about their avoidable task interruptions (control group and
      experimental group).

      The multifacet intervention program is based the concept of teamwork implementation.
      Targeting potential for improvement will be decided and implemented by each team
      (experimental group).

      Statistics analysis will be conducted on teams before and after the implementation of the
      program. The assessment criteria will be: the evolution of characteristics of the task
      interruptions observed (interactions between coordination functions and care delivery
      functions, prevalence, avoidability, duration, resumption of tasks, social representations of
      task interruptions).
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Case group:
Healthcare teams benefiting first the implementation of the coaching model other (centered round the following steps: identify, understand and act) : just after the first measure
Control group:
Healthcare teams benefiting first the implementation of the coaching model (centered round the following steps: identify, understand and act) : after the second measure (impact of the device on case group).
primary purpose: Other
masking: None (Open Label)
measure: proportion of avoidable task interruptions
time frame: 1 year
description: Results from Dual Perspectives Method (DPM)
measure: sources and frequencies of task interruptions
time frame: 1 year
description: Results from Auto-administered questionnaire (TAA-KH-S)
measure: prevalence of task interruptions
time frame: 1 year
description: Time measurement of the duration of task interruption upon restart of work
arm group label: 20 teams the first year (G1)
arm group type: Active Comparator
description: control group
arm group label: 20 teams second year (G2)
arm group type: Experimental
description: case group with implementation of the multi-unit team accompaniment intervention.
intervention type: Other
intervention name: Identify work interruptions
description: estimate baseline characteristics of the collaborative working model (proportion expressed as a percentage)
arm group label: 20 teams second year (G2)
arm group label: 20 teams the first year (G1)
intervention type: Other
intervention name: Understand work interruptions
description: Team-review of the results of the task interruption and professional representations, identify activities to protect from task interruption
arm group label: 20 teams second year (G2)
arm group label: 20 teams the first year (G1)
intervention type: Other
intervention name: Act to limited work interruptions
description: Adaptation of organizations; Awareness raising and Coaching for change
arm group label: 20 teams second year (G2)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided