<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/NCT03840564</url>
  </required_header>
  <id_info>
    <org_study_id>NI16022HLJ</org_study_id>
    <nct_id>NCT03840564</nct_id>
  </id_info>
  <brief_title>Impact of Biological Point of Care Devices Implementation on the Length of Stay of Patients in Emergency Room</brief_title>
  <acronym>SUPOC</acronym>
  <official_title>Impact of Biological Point of Care Devices Implementation on the Length of Stay of Patients in Emergency Room</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      &quot;Main objective: to demonstrate that the implementation of an extended panel solution for the&#xD;
      point of care analysis of biological parameters (point of care : POC) in an emergency&#xD;
      department (ED) reduces the length of stay (LOS) of patients Secondary objectives: to&#xD;
      demonstrate the feasibility of implementing an expanded panel of POC solutions in an ED and&#xD;
      the reduction of emergency overcrowding in the POC group.&#xD;
&#xD;
      To determine the medico-economic impact of the extended implementation of POC solutions&#xD;
      (cost-efficiency and health-economic study), to collect the satisfaction of medical&#xD;
      (emergency physicians, medical biologists) and paramedical personnel as well as the&#xD;
      satisfaction of patients.&#xD;
&#xD;
      Inclusion criteria: Any patient consulting in the emergency department during the study&#xD;
      period Non-inclusion criteria: Patients attending the emergency departments as part of&#xD;
      dressing or trauma follow-up consultations Main criteria of judgment: Time between&#xD;
      administrative registration and the patient's discharge or hospitalization decision, compared&#xD;
      between the control period and the intervention period (POC).&#xD;
&#xD;
      Design: Prospective, monocentric, controlled, cluster- randomized per week. Duration of&#xD;
      center preparation (technical preparation and training of laboratory staff): 4 weeks Duration&#xD;
      of inclusion period: 18 weeks Duration of patient participation: 1 day Total trial duration&#xD;
      time: 22 weeks&quot;&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      &quot;SUPOC is a monocentric, prospective, open-label, controlled study, randomized into one-week&#xD;
      inclusion periods, with 2 types of period: period POC (biological analysis performed as POC&#xD;
      in a dedicated emergency room implemented with POC devices) and period control (analysis&#xD;
      performed sent and processed in the central laboratory). Randomisation will be carried out by&#xD;
      periods of one week (periods of a whole week 24h/24 from Monday 8am to Sunday 8 pm: control&#xD;
      period or POC period, with a wash-out period between Sunday 08 pm and Monday 8am before each&#xD;
      change of period (in order to limit the patients overlap on 2 periods). The entire medical&#xD;
      care including the clinical examination, the prescriptions for additional radiological or&#xD;
      biological examinations, requests for specialist advice, as well as the conclusion of the&#xD;
      medical file will be left to the sole discretion of the emergency physician in charge of the&#xD;
      patient and dictated solely by the reason for consultation and the patient evolution. The&#xD;
      comparability of the POC and control periods will be verified, quantitatively (number of&#xD;
      patients, average number of paramedical personnel present, the number of medical personnel&#xD;
      being fixed) and qualitatively (triage scale applied by the triage nurses into 5 classes).&#xD;
&#xD;
      Despite the randomization of the two periods, the study type is best described as&#xD;
      &quot;Observational&quot; because there is no specific intervention or health outcome at the subject&#xD;
      level at all. The fact that blood samples are sent in the central laboratory or in the POC&#xD;
      platform are both considered as routine medical care. No investigator assigns a specific&#xD;
      intervention to the study participants; it is the emergency department itself which changes&#xD;
      its internal organization (the destination of the biologic samples) every week. In&#xD;
      conclusion, the purpose of the study is to examine the effect of a health provider&#xD;
      intervention (POC vs central laboratory use) on a health provider outcome (mean length of&#xD;
      stay according to the study period), and there is no health outcomes at the patient level.&#xD;
      According to the ICMJE guidelines, this type of study should not be considered as an&#xD;
      interventional clinical trial&#xD;
      (http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/).&#xD;
&#xD;
      For organizational reasons, 3 laboratory technicians will be recruited and trained&#xD;
      specifically for the study. They will be in charge of biological testing during POC periods.&#xD;
&#xD;
      Primary evaluation criteria: length of stay (LOS) of patients consulting the ED, defined by&#xD;
      the time between the administrative registration and the medical decision of discharge or&#xD;
      hospitalization of the patient. This LOS for each patient meeting the eligibility criteria&#xD;
      will be extracted by the hospital's informatic department from the emergency file database.&#xD;
      Secondary endpoints: - -the feasibility of an expanded POC menu in the ED will be assessed by&#xD;
      the &quot;&quot;converted&quot;&quot; analysis rate, i.e. the number of analyses sent to the central laboratory&#xD;
      in the POC period divided by the total number of analyses performed as POC during the period,&#xD;
      the rate of unavailability of each POC device for maintenance or breakdown, i.e. the&#xD;
      cumulative number of minutes of unavailability for all the POC equipment compared to the&#xD;
      total duration of the POC group's periods.&#xD;
&#xD;
      ED's crowding will be evaluated by: the waiting time in each period (time in minutes between&#xD;
      emergency registration and first medical contact), the occupancy rate defined by - at time t-&#xD;
      the number of patients present / ED's capacity. The capacity of the service is estimated on&#xD;
      the basis of the total number of boxes and beds, including short-term hospitalisation units.&#xD;
      An overcrowding is set to an occupancy rate&gt; 150%. In practice,it will be extracted by the&#xD;
      informatic department from emergency database every day of the study at 12pm, 6pm, 12am and&#xD;
      8am.&#xD;
&#xD;
      The time to results in each period and by biological parameter will be extracted from the&#xD;
      laboratory software.&#xD;
&#xD;
      The health-economic impact of the expanded implementation of POC will be assessed by the&#xD;
      average total cost of an ED's visit in each period. The costs and consequences of the&#xD;
      implementation of the POC will be estimated in a comparative way in the two periods, taking&#xD;
      into account on the one hand the point of view of the establishment and on the other hand&#xD;
      that of the healthcare system. The investigators will estimate an average cost per patient&#xD;
      and per emergency room visit.&#xD;
&#xD;
      The satisfaction of staff and patients will be evaluated by an anonymous questionnaire&#xD;
      including satisfaction scales on the overall quality of care in emergency department and on&#xD;
      the results of biological analyses, among patients (on a sample) and all staff (emergency&#xD;
      physicians and biologists, ED's nurses).&#xD;
&#xD;
      Sample size calculation: This is a one-week randomized cluster study. A preliminary study of&#xD;
      the first 6 months of 2016, using ED's software to extract data from emergency department&#xD;
      visits, estimated an average cluster size of 1100 patients, with a size variation coefficient&#xD;
      of 0.2, as well as a standard deviation of 2 hours and 20 minutes.&#xD;
&#xD;
      Assuming an average reduction of 20 minutes of the main judgement criterion, and an&#xD;
      intraclass correlation coefficient of 0.01, with a bilateral alpha equal to 5%, study will&#xD;
      have to include 9 clusters in each period to obtain a power of 80% - 18 weeks total duration&#xD;
      of inclusion.&#xD;
&#xD;
      For a monocentric study including all patients consulting in an adult emergency department&#xD;
      with a total of 60,000 visits per year, each month will allow the inclusion of at least 4,400&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 11, 2018</start_date>
  <completion_date type="Actual">December 21, 2018</completion_date>
  <primary_completion_date type="Actual">October 14, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>length of stay (LOS) of patients consulting the ED</measure>
    <time_frame>1 Week</time_frame>
    <description>length of stay (LOS) of patients consulting the ED For each patient the time frame of LOS is comprised between the admission schedule in the ED and the schedule of medical conclusion on the medical file of each patient consulting the emergency department</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence and duration of technical adverse events encountered with the POC platform</measure>
    <time_frame>through study completion (18 weeks)</time_frame>
    <description>&quot;converted&quot; analysis rate, i.e. the number of analyses sent to the central laboratory in the intervention period divided by the total number of analyses performed as POC during the period, the rate of unavailability of each POC device for maintenance or breakdown, i.e. the cumulative number of minutes of unavailability for all the POC equipment compared to the total duration of the intervention group's periods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ED's crowding</measure>
    <time_frame>1 Week, i.e. the size of one cluster period of observation</time_frame>
    <description>Mean waiting time in each period defined by the time in minutes between the emergency admission registration schedule and the first medical contact)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time to results in each period and by biological parameter</measure>
    <time_frame>1 Week, i.e. the size of one cluster period of observation</time_frame>
    <description>The mean time elapsed between blood sampling an result availability for the physician</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>health-economic impact</measure>
    <time_frame>through study completion (18 Weeks)</time_frame>
    <description>Average total cost of an ED's visit in each period. The costs and consequences of the implementation of the POC will be estimated in a comparative way in the two periods, taking into account on the one hand the point of view of the establishment and on the other hand that of the healthcare system. We will estimate an average cost per patient and per emergency room visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>satisfaction of patients</measure>
    <time_frame>the last two weeks of the study: one week in the intervention period (POC) and one week in the control period (usual care)</time_frame>
    <description>anonymous questionnaire including satisfaction scales on the overall quality of care in emergency department and on the time to result of biological analyses, among patients (on a sample) For each of the satisfaction criteria studied, a numeric scale will be submitted to a sample of patients . The numeric scale ranges from 1 (very low satisfaction) to 10 (very high satisfaction).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>satisfaction of all staff</measure>
    <time_frame>the last two weeks of the study: one week in the intervention period (POC) and one week in the control period (usual care)</time_frame>
    <description>anonymous questionnaire including satisfaction scales on the overall quality of care in emergency department and on the time to result of biological analyses, satisfaction of all staff (emergency physicians and biologists, ED's nurses). For each of the satisfaction criteria studied, a numeric scale will be submitted to all the ED personnel . The numeric scale ranges from 1 (very low satisfaction) to 10 (very high satisfaction).</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">20000</enrollment>
  <condition>Emergencies</condition>
  <condition>Care</condition>
  <arm_group>
    <arm_group_label>Group point of care (POC)</arm_group_label>
    <description>All the analyzes will be done in delocalized</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>the analyzes will be done at the central laboratory</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Point of care (POC)</intervention_name>
    <description>All the analyzes will be done in delocalized</description>
    <arm_group_label>Group point of care (POC)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Any patient consulting in the emergency department&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient consulting in the emergency department during the study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients attending the emergency departments as part of dressing or trauma follow-up&#xD;
             consultations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>HAUSFATER Pierre, Pr, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pitie salpetriere hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pitié Salpetriere hospital</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>May 29, 2018</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 12, 2019</last_update_submitted>
  <last_update_submitted_qc>February 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <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/NCT03840564
org study id: NI16022HLJ
nct id: NCT03840564
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
"Main objective: to demonstrate that the implementation of an extended panel solution for the
      point of care analysis of biological parameters (point of care : POC) in an emergency
      department (ED) reduces the length of stay (LOS) of patients Secondary objectives: to
      demonstrate the feasibility of implementing an expanded panel of POC solutions in an ED and
      the reduction of emergency overcrowding in the POC group.

      To determine the medico-economic impact of the extended implementation of POC solutions
      (cost-efficiency and health-economic study), to collect the satisfaction of medical
      (emergency physicians, medical biologists) and paramedical personnel as well as the
      satisfaction of patients.

      Inclusion criteria: Any patient consulting in the emergency department during the study
      period Non-inclusion criteria: Patients attending the emergency departments as part of
      dressing or trauma follow-up consultations Main criteria of judgment: Time between
      administrative registration and the patient's discharge or hospitalization decision, compared
      between the control period and the intervention period (POC).

      Design: Prospective, monocentric, controlled, cluster- randomized per week. Duration of
      center preparation (technical preparation and training of laboratory staff): 4 weeks Duration
      of inclusion period: 18 weeks Duration of patient participation: 1 day Total trial duration
      time: 22 weeks"
"SUPOC is a monocentric, prospective, open-label, controlled study, randomized into one-week
      inclusion periods, with 2 types of period: period POC (biological analysis performed as POC
      in a dedicated emergency room implemented with POC devices) and period control (analysis
      performed sent and processed in the central laboratory). Randomisation will be carried out by
      periods of one week (periods of a whole week 24h/24 from Monday 8am to Sunday 8 pm: control
      period or POC period, with a wash-out period between Sunday 08 pm and Monday 8am before each
      change of period (in order to limit the patients overlap on 2 periods). The entire medical
      care including the clinical examination, the prescriptions for additional radiological or
      biological examinations, requests for specialist advice, as well as the conclusion of the
      medical file will be left to the sole discretion of the emergency physician in charge of the
      patient and dictated solely by the reason for consultation and the patient evolution. The
      comparability of the POC and control periods will be verified, quantitatively (number of
      patients, average number of paramedical personnel present, the number of medical personnel
      being fixed) and qualitatively (triage scale applied by the triage nurses into 5 classes).

      Despite the randomization of the two periods, the study type is best described as
      "Observational" because there is no specific intervention or health outcome at the subject
      level at all. The fact that blood samples are sent in the central laboratory or in the POC
      platform are both considered as routine medical care. No investigator assigns a specific
      intervention to the study participants; it is the emergency department itself which changes
      its internal organization (the destination of the biologic samples) every week. In
      conclusion, the purpose of the study is to examine the effect of a health provider
      intervention (POC vs central laboratory use) on a health provider outcome (mean length of
      stay according to the study period), and there is no health outcomes at the patient level.
      According to the ICMJE guidelines, this type of study should not be considered as an
      interventional clinical trial
      (http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/).

      For organizational reasons, 3 laboratory technicians will be recruited and trained
      specifically for the study. They will be in charge of biological testing during POC periods.

      Primary evaluation criteria: length of stay (LOS) of patients consulting the ED, defined by
      the time between the administrative registration and the medical decision of discharge or
      hospitalization of the patient. This LOS for each patient meeting the eligibility criteria
      will be extracted by the hospital's informatic department from the emergency file database.
      Secondary endpoints: - -the feasibility of an expanded POC menu in the ED will be assessed by
      the ""converted"" analysis rate, i.e. the number of analyses sent to the central laboratory
      in the POC period divided by the total number of analyses performed as POC during the period,
      the rate of unavailability of each POC device for maintenance or breakdown, i.e. the
      cumulative number of minutes of unavailability for all the POC equipment compared to the
      total duration of the POC group's periods.

      ED's crowding will be evaluated by: the waiting time in each period (time in minutes between
      emergency registration and first medical contact), the occupancy rate defined by - at time t-
      the number of patients present / ED's capacity. The capacity of the service is estimated on
      the basis of the total number of boxes and beds, including short-term hospitalisation units.
      An overcrowding is set to an occupancy rate> 150%. In practice,it will be extracted by the
      informatic department from emergency database every day of the study at 12pm, 6pm, 12am and
      8am.

      The time to results in each period and by biological parameter will be extracted from the
      laboratory software.

      The health-economic impact of the expanded implementation of POC will be assessed by the
      average total cost of an ED's visit in each period. The costs and consequences of the
      implementation of the POC will be estimated in a comparative way in the two periods, taking
      into account on the one hand the point of view of the establishment and on the other hand
      that of the healthcare system. The investigators will estimate an average cost per patient
      and per emergency room visit.

      The satisfaction of staff and patients will be evaluated by an anonymous questionnaire
      including satisfaction scales on the overall quality of care in emergency department and on
      the results of biological analyses, among patients (on a sample) and all staff (emergency
      physicians and biologists, ED's nurses).

      Sample size calculation: This is a one-week randomized cluster study. A preliminary study of
      the first 6 months of 2016, using ED's software to extract data from emergency department
      visits, estimated an average cluster size of 1100 patients, with a size variation coefficient
      of 0.2, as well as a standard deviation of 2 hours and 20 minutes.

      Assuming an average reduction of 20 minutes of the main judgement criterion, and an
      intraclass correlation coefficient of 0.01, with a bilateral alpha equal to 5%, study will
      have to include 9 clusters in each period to obtain a power of 80% - 18 weeks total duration
      of inclusion.

      For a monocentric study including all patients consulting in an adult emergency department
      with a total of 60,000 visits per year, each month will allow the inclusion of at least 4,400
      patients.
observational model: Cohort
time perspective: Prospective
measure: length of stay (LOS) of patients consulting the ED
time frame: 1 Week
description: length of stay (LOS) of patients consulting the ED For each patient the time frame of LOS is comprised between the admission schedule in the ED and the schedule of medical conclusion on the medical file of each patient consulting the emergency department
measure: Incidence and duration of technical adverse events encountered with the POC platform
time frame: through study completion (18 weeks)
description: "converted" analysis rate, i.e. the number of analyses sent to the central laboratory in the intervention period divided by the total number of analyses performed as POC during the period, the rate of unavailability of each POC device for maintenance or breakdown, i.e. the cumulative number of minutes of unavailability for all the POC equipment compared to the total duration of the intervention group's periods
measure: ED's crowding
time frame: 1 Week, i.e. the size of one cluster period of observation
description: Mean waiting time in each period defined by the time in minutes between the emergency admission registration schedule and the first medical contact)
measure: The time to results in each period and by biological parameter
time frame: 1 Week, i.e. the size of one cluster period of observation
description: The mean time elapsed between blood sampling an result availability for the physician
measure: health-economic impact
time frame: through study completion (18 Weeks)
description: Average total cost of an ED's visit in each period. The costs and consequences of the implementation of the POC will be estimated in a comparative way in the two periods, taking into account on the one hand the point of view of the establishment and on the other hand that of the healthcare system. We will estimate an average cost per patient and per emergency room visit.
measure: satisfaction of patients
time frame: the last two weeks of the study: one week in the intervention period (POC) and one week in the control period (usual care)
description: anonymous questionnaire including satisfaction scales on the overall quality of care in emergency department and on the time to result of biological analyses, among patients (on a sample) For each of the satisfaction criteria studied, a numeric scale will be submitted to a sample of patients . The numeric scale ranges from 1 (very low satisfaction) to 10 (very high satisfaction).
measure: satisfaction of all staff
time frame: the last two weeks of the study: one week in the intervention period (POC) and one week in the control period (usual care)
description: anonymous questionnaire including satisfaction scales on the overall quality of care in emergency department and on the time to result of biological analyses, satisfaction of all staff (emergency physicians and biologists, ED's nurses). For each of the satisfaction criteria studied, a numeric scale will be submitted to all the ED personnel . The numeric scale ranges from 1 (very low satisfaction) to 10 (very high satisfaction).
arm group label: Group point of care (POC)
description: All the analyzes will be done in delocalized
arm group label: control group
description: the analyzes will be done at the central laboratory
intervention type: Other
intervention name: Point of care (POC)
description: All the analyzes will be done in delocalized
arm group label: Group point of care (POC)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: HAUSFATER Pierre, Pr, MD, PhD
role: Principal Investigator
affiliation: Pitie salpetriere hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Emergencies
sharing ipd: No