<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/NCT03253640</url>
  </required_header>
  <id_info>
    <org_study_id>14-154</org_study_id>
    <secondary_id>IRAS Identifier</secondary_id>
    <nct_id>NCT03253640</nct_id>
  </id_info>
  <brief_title>Evaluation of Cost of Nosocomial Infection</brief_title>
  <acronym>ECONI</acronym>
  <official_title>Evaluation of Cost of Nosocomial Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Glasgow Caledonian University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Strathclyde</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nick Graves Independent Consultant</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>NHS Lothian</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>NHS Lanarkshire</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Glasgow Caledonian University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will investigate the cost and impact of Healthcare Associated Infection (HAI) to&#xD;
      patients, the health service and the wider community.&#xD;
&#xD;
      This is in order to develop a model to allow policy makers to compare the cost effectiveness&#xD;
      of Infection Prevention and Control measures in NHSScotland. The model will support policy&#xD;
      makers and clinical teams in building a patient centred, safe, effective and efficient&#xD;
      service.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Healthcare associated infection (HAI) also known as Nosocomial Infection (NI) is costly to&#xD;
      the NHS and distressing to patients. It leads to increased morbidity and mortality, increased&#xD;
      length of stay and often requires additional treatments. Information on the impact in terms&#xD;
      of additional cost of treatment, reduction in quality of life and cost to society is not&#xD;
      fully described. This study will collect epidemiological and economic data on patients with&#xD;
      and without HAI and develop a framework around which the cost effectiveness of a range of&#xD;
      Infection Prevention and Control (IPC) interventions can be assessed.&#xD;
&#xD;
      The study will be delivered as 4 distinct but overlapping work Phases Phase 1 will describe&#xD;
      the incidence of HAI (defined by ECDC case definitions) in an admission cohort. This phase is&#xD;
      a surveillance project.&#xD;
&#xD;
      Phase 2: Will describe the impact of HAI on care in hospital -as many patients as possible&#xD;
      who acquired HAI and twice as many non-HAI comparators will be recruited. Patients or their&#xD;
      guardians or nearest relative will be told about the study and asked if they are willing to&#xD;
      provide consent to complete a number of questionnaires. This phase will include case note&#xD;
      review by ECONI research nurses and a patient questionnaire.&#xD;
&#xD;
      Phase 3: Will investigate the impact of HAI on patient care post discharge (use of Health and&#xD;
      Social Care resources outside of Hospital), Quality of Life and personal expenses) -&#xD;
      questionnaire to patients to ask about impact on their overall health and wellbeing and&#xD;
      personal expenses. This will involve patients completing a paper questionnaire at one, three,&#xD;
      six and twelve months after they have been discharged from hospital. This phase will include&#xD;
      a nested qualitative study which will interview 20-30 patients who acquired HAI to further&#xD;
      investigate the impact of HAI on their lives and livelihoods Phase 4: This phase will not&#xD;
      involve any patient interaction. It will develop a framework to support modelling for&#xD;
      decision making for future investment in Infection Prevention and Control (IPC) based on data&#xD;
      collected within Phase one to three above. The information collected during the first three&#xD;
      phases will be used to model possible outcomes of infection prevention and control measures.&#xD;
      This will be a modelling exercise using data collected within Phase 1, 2 and 3 and the&#xD;
      protocol for this work will be described elsewhere.&#xD;
&#xD;
      Phase 2 and 3 will be a cohort of as many patients as possible with HAI and a sample of&#xD;
      non-HAI patients (twice the number of HAI patients) who consent to participate in the study&#xD;
      within the year of recruitment.&#xD;
&#xD;
      Modes of data collection&#xD;
&#xD;
        1. Research Nurse administered questionnaire on recruitment quality of life questionnaire&#xD;
           on recruitment&#xD;
&#xD;
        2. Day before discharge quality of life questionnaire&#xD;
&#xD;
        3. 1 month post discharge questionnaire&#xD;
&#xD;
        4. 3 month post discharge questionnaire&#xD;
&#xD;
        5. 6 month post discharge questionnaire&#xD;
&#xD;
        6. 12 month post discharge questionnaire&#xD;
&#xD;
        7. Record linkage - SMOR00, SMR01, PRISMA, District nursing&#xD;
&#xD;
        8. 1,500-3,000 patients recruited for follow up.&#xD;
&#xD;
        9. All admissions to study hospitals for record linkage. Follow up duration 1 year post&#xD;
           discharge from admission when patient was recruited.&#xD;
&#xD;
      Data will be collected using a Redcap database. Where possible controlled lists will be&#xD;
      included within the database to ensure consistency of reporting. Validation visits to study&#xD;
      sites will be undertaken throughout the study data collection period. Standard operating&#xD;
      procedures will be developed for the ECONI team to use during recruitment and data&#xD;
      collection. A data dictionary will be developed to record all data items recorded during the&#xD;
      study, where these data were sourced, the choices available and the field-names within the&#xD;
      data set. A publications and communication plan has been developed for the study and an&#xD;
      analysis plan will be developed linking each of the objectives to a peer reviewed&#xD;
      publication. A number of systematic reviews have be undertaken in the development of the&#xD;
      ECONI study protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">January 31, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</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>Acquisition of healthcare associated infection</measure>
    <time_frame>During hospital stay, within one year post discharge for two hospital sites</time_frame>
    <description>Number of patients who develop new HAI Defined using ECDC HAI case definitions, and including costs of care in hospital, post discharge and impact of usual activity, ability to work and social care.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Length of stay in hospital</measure>
    <time_frame>All patient stays during the study year</time_frame>
    <description>Date of admission to discharge</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Healthcare utilisation</measure>
    <time_frame>One year post discharge from hospital visit when recruited</time_frame>
    <description>Includes, specialty, antibiotic use, operations, post discharge health visits, community prescribing, out patient clinic attendance, re-admission to hospital</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>Utility score during hospital stay for HAI and non_HAI patients during hospital stay, one month post discharge and three months post discharge</time_frame>
    <description>Quality of life will be measured using SF-12 and EQ-5D validated questionnaires</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">123</enrollment>
  <condition>Crossing Infections</condition>
  <condition>Drug Resistance, Microbial</condition>
  <arm_group>
    <arm_group_label>Patients with HAI during hospital stay</arm_group_label>
    <description>Patients who meet the European Centre for Disease Control (ECDC) Healthcare Associated Infection (HAI) case definitions. Case note review will be undertaken during hospital stay. Questionnaire will be administered at recruitment, pre-discharge, one, three, six and twelve months post discharge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients without HAI during hospital stay</arm_group_label>
    <description>Patients who do not meet the European Centre for Disease Control (ECDC) Healthcare Associated Infection (HAI) case definitions. Case note review will be undertaken during hospital stay. Questionnaire will be administered at recruitment, pre-discharge, one, three, six and twelve months post discharge.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exposure</intervention_name>
    <description>Healthcare associated infection (HAI)</description>
    <arm_group_label>Patients with HAI during hospital stay</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients admitted to study hospitals over night during a one year study period&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Admitted to hospital for an overnight stay at study hospital&#xD;
&#xD;
          2. Subjects capable of giving informed consent, or if appropriate, subjects having an&#xD;
             acceptable individual capable of giving consent on the subject's behalf&#xD;
&#xD;
          3. Any sex&#xD;
&#xD;
          4. 18 years old and over&#xD;
&#xD;
          5. Patients without HAI will not be re-recruited into the study. Patients who have HAI on&#xD;
             a subsequent admission will not be re-recruited but will be asked to complete a&#xD;
             baseline data collection form (see below for discussion) NOTE: we do need to ensure&#xD;
             this is clear within the ethics application.&#xD;
&#xD;
          6. Good English language skills (sufficient to read and understand the participant&#xD;
             information sheet without help)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Admitted to hospital as a day case&#xD;
&#xD;
          2. Admitted to Hospitals other than the study hospitals&#xD;
&#xD;
          3. Under 18 years&#xD;
&#xD;
          4. Admitted to the study hospital during the study period and recruited to the study&#xD;
             during a previous stay. See below&#xD;
&#xD;
          5. Subjects not capable of giving informed consent unless legal representative or&#xD;
             relative can provide proxy consent&#xD;
&#xD;
          6. Patients who do not have English language skills to read and understand the&#xD;
             information sheet without help&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacqui M Reilly, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Glasgow Caledonian University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hairmyres Hospital</name>
      <address>
        <city>East Kilbride</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Edinburgh Royal Infirmary</name>
      <address>
        <city>Edinburgh</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>February 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>February 4, 2020</last_update_submitted>
  <last_update_submitted_qc>February 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Costs and Cost Analysis</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Length of Stay</keyword>
  <keyword>Cohort study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Cross Infection</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The study Steering Committee will review this at the end of the study. Data will be only be shared at an individual level if all identifiable information has been removed or categorised, individual records would be identified using a cypher code.</ipd_description>
  </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/NCT03253640
org study id: 14-154
secondary id: IRAS Identifier
nct id: NCT03253640
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This study will investigate the cost and impact of Healthcare Associated Infection (HAI) to
      patients, the health service and the wider community.

      This is in order to develop a model to allow policy makers to compare the cost effectiveness
      of Infection Prevention and Control measures in NHSScotland. The model will support policy
      makers and clinical teams in building a patient centred, safe, effective and efficient
      service.
Healthcare associated infection (HAI) also known as Nosocomial Infection (NI) is costly to
      the NHS and distressing to patients. It leads to increased morbidity and mortality, increased
      length of stay and often requires additional treatments. Information on the impact in terms
      of additional cost of treatment, reduction in quality of life and cost to society is not
      fully described. This study will collect epidemiological and economic data on patients with
      and without HAI and develop a framework around which the cost effectiveness of a range of
      Infection Prevention and Control (IPC) interventions can be assessed.

      The study will be delivered as 4 distinct but overlapping work Phases Phase 1 will describe
      the incidence of HAI (defined by ECDC case definitions) in an admission cohort. This phase is
      a surveillance project.

      Phase 2: Will describe the impact of HAI on care in hospital -as many patients as possible
      who acquired HAI and twice as many non-HAI comparators will be recruited. Patients or their
      guardians or nearest relative will be told about the study and asked if they are willing to
      provide consent to complete a number of questionnaires. This phase will include case note
      review by ECONI research nurses and a patient questionnaire.

      Phase 3: Will investigate the impact of HAI on patient care post discharge (use of Health and
      Social Care resources outside of Hospital), Quality of Life and personal expenses) -
      questionnaire to patients to ask about impact on their overall health and wellbeing and
      personal expenses. This will involve patients completing a paper questionnaire at one, three,
      six and twelve months after they have been discharged from hospital. This phase will include
      a nested qualitative study which will interview 20-30 patients who acquired HAI to further
      investigate the impact of HAI on their lives and livelihoods Phase 4: This phase will not
      involve any patient interaction. It will develop a framework to support modelling for
      decision making for future investment in Infection Prevention and Control (IPC) based on data
      collected within Phase one to three above. The information collected during the first three
      phases will be used to model possible outcomes of infection prevention and control measures.
      This will be a modelling exercise using data collected within Phase 1, 2 and 3 and the
      protocol for this work will be described elsewhere.

      Phase 2 and 3 will be a cohort of as many patients as possible with HAI and a sample of
      non-HAI patients (twice the number of HAI patients) who consent to participate in the study
      within the year of recruitment.

      Modes of data collection

        1. Research Nurse administered questionnaire on recruitment quality of life questionnaire
           on recruitment

        2. Day before discharge quality of life questionnaire

        3. 1 month post discharge questionnaire

        4. 3 month post discharge questionnaire

        5. 6 month post discharge questionnaire

        6. 12 month post discharge questionnaire

        7. Record linkage - SMOR00, SMR01, PRISMA, District nursing

        8. 1,500-3,000 patients recruited for follow up.

        9. All admissions to study hospitals for record linkage. Follow up duration 1 year post
           discharge from admission when patient was recruited.

      Data will be collected using a Redcap database. Where possible controlled lists will be
      included within the database to ensure consistency of reporting. Validation visits to study
      sites will be undertaken throughout the study data collection period. Standard operating
      procedures will be developed for the ECONI team to use during recruitment and data
      collection. A data dictionary will be developed to record all data items recorded during the
      study, where these data were sourced, the choices available and the field-names within the
      data set. A publications and communication plan has been developed for the study and an
      analysis plan will be developed linking each of the objectives to a peer reviewed
      publication. A number of systematic reviews have be undertaken in the development of the
      ECONI study protocol.
observational model: Cohort
time perspective: Prospective
measure: Acquisition of healthcare associated infection
time frame: During hospital stay, within one year post discharge for two hospital sites
description: Number of patients who develop new HAI Defined using ECDC HAI case definitions, and including costs of care in hospital, post discharge and impact of usual activity, ability to work and social care.
measure: Length of stay in hospital
time frame: All patient stays during the study year
description: Date of admission to discharge
measure: Healthcare utilisation
time frame: One year post discharge from hospital visit when recruited
description: Includes, specialty, antibiotic use, operations, post discharge health visits, community prescribing, out patient clinic attendance, re-admission to hospital
measure: Quality of Life
time frame: Utility score during hospital stay for HAI and non_HAI patients during hospital stay, one month post discharge and three months post discharge
description: Quality of life will be measured using SF-12 and EQ-5D validated questionnaires
arm group label: Patients with HAI during hospital stay
description: Patients who meet the European Centre for Disease Control (ECDC) Healthcare Associated Infection (HAI) case definitions. Case note review will be undertaken during hospital stay. Questionnaire will be administered at recruitment, pre-discharge, one, three, six and twelve months post discharge.
arm group label: Patients without HAI during hospital stay
description: Patients who do not meet the European Centre for Disease Control (ECDC) Healthcare Associated Infection (HAI) case definitions. Case note review will be undertaken during hospital stay. Questionnaire will be administered at recruitment, pre-discharge, one, three, six and twelve months post discharge.
intervention type: Other
intervention name: Exposure
description: Healthcare associated infection (HAI)
arm group label: Patients with HAI during hospital stay
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jacqui M Reilly, PhD
role: Study Director
affiliation: Glasgow Caledonian University
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Cross Infection
sharing ipd: Undecided
ipd description: The study Steering Committee will review this at the end of the study. Data will be only be shared at an individual level if all identifiable information has been removed or categorised, individual records would be identified using a cypher code.