<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/NCT03762174</url>
  </required_header>
  <id_info>
    <org_study_id>147/17</org_study_id>
    <nct_id>NCT03762174</nct_id>
  </id_info>
  <brief_title>Characteristics of Back Pain Attendances at ED</brief_title>
  <official_title>An Investigation Into the Use of Emergency Medical Services by People Attending the Emergency Department With Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Matt Capsey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>County Durham and Darlington NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Teesside University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Back pain is experienced by approximately 80% of the population during their life. However,&#xD;
      only a small minority (&lt;1%) will have a medical condition (such as Cauda Equina Syndrome)&#xD;
      which requires immediate medical intervention.&#xD;
&#xD;
      Currently, it is not known how many people access Emergency Medical Services (EMS) in an&#xD;
      attempt to meet their needs for their back pain. The demand on EMS is increasing and many of&#xD;
      these patients could be better managed by other services. Additionally, little is known about&#xD;
      the characteristics of those accessing EMS due to back pain, or the nature of the contacts&#xD;
      regarding issues such as outcome of the patient contact. The aims of this study are:&#xD;
&#xD;
        1. to quantify the prevalence of people accessing EMS via attendance at an Emergency&#xD;
           Department (ED)&#xD;
&#xD;
        2. to describe the characteristics of people attending ED with non-traumatic back pain&#xD;
&#xD;
        3. to describe key characteristics of the contact between the service user and EMS&#xD;
&#xD;
        4. to compare the prevalence of attendance, patient characteristics and contact&#xD;
           characteristics between people with non-traumatic back pain and the general population&#xD;
           of those attending ED.&#xD;
&#xD;
      A secondary aim of the work is to explore what factors might predict patient outcomes such as&#xD;
      whether the patient self presents or is referred to ED by another service, whether the&#xD;
      patient receives analgesics, whether the patient receives a diagnostic scan and whether the&#xD;
      patient is admitted to hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose and Design&#xD;
&#xD;
      Back Pain is a common cause of pain and disability. The National Institute for Clinical&#xD;
      Excellent [NICE] (2016) identify back pain as affecting 1 in 10 people and causing more&#xD;
      disability than any other condition. In most people back pain resolves within a number of&#xD;
      weeks without any healthcare input. For those whose pain does not improve physical and&#xD;
      psychological treatments are recommended. These are provided by specialist services and are&#xD;
      not available in Emergency Departments or via Ambulance Services (collectively referred to as&#xD;
      Emergency Medical Services [EMS]). Thus, arguably only a very small minority of patients with&#xD;
      back pain, where a severe medical pathology is indicated (e.g. cauda equina syndrome) should&#xD;
      need to access EMS. However, anecdotally many people with back pain self-refer to EMS. The&#xD;
      prevalence of people self-referring and their characteristics are currently unknown as these&#xD;
      figures are not routinely reported although the information exists within the data collected&#xD;
      by many trusts.&#xD;
&#xD;
      This study aims to analyse anonymised data from the Darlington Memorial Hospital (DMH)&#xD;
      Emergency Department (ED) to establish the prevalence of those attending with back pain. The&#xD;
      characteristics of people presenting over a 12-month period with back pain, along with&#xD;
      characteristics of their contact (e.g.&#xD;
&#xD;
      administration of analgesia and the use of diagnostic imaging) will be described and compared&#xD;
      to the general characteristics of those attending ED.&#xD;
&#xD;
      These characteristics may help to inform healthcare service design, both EMS and non-EMS, to&#xD;
      better meet the needs of this patient group.&#xD;
&#xD;
      Research Methods&#xD;
&#xD;
      This study will be a secondary analysis of an existing NHS database. The study will request&#xD;
      anonymised data from DMH ED. The data will cover all adults who have accessed their services&#xD;
      in a 12-month period. The information requested will include data related to the attendance,&#xD;
      patient demographics/characteristics, geographical location and clinical data.&#xD;
&#xD;
      Recruitment&#xD;
&#xD;
      The data being used for this study is from a currently existing Trust database and therefore&#xD;
      there will be no recruitment of participants.&#xD;
&#xD;
      Inclusion/exclusion All individuals over the age of 16 will be included. Those aged under 16&#xD;
      will be excluded as they are not included in clinical guidelines.&#xD;
&#xD;
      Risks, Burdens and Benefits&#xD;
&#xD;
      The data has been collected for clinical care and not for research purposes. Therefore&#xD;
      patients will not have explicitly consented for their information to be used for research.&#xD;
      The Information Governance Officer at DMH has confirmed that the data will be in&#xD;
      non-personally identifiable form when it is released to the research team and is compliant&#xD;
      with Section 33 of the Data Protection Act 1998.&#xD;
&#xD;
      The main risk to patients is that their clinical data is being used for research purposes.&#xD;
      However identifiable data will only be available to the usual clinical team. Anonymised&#xD;
      information will be extracted by a DMH member of staff before it is securely transferred to&#xD;
      the team at Teesside University where it will be analysed. Names and addresses will be&#xD;
      completely removed from the database before it leaves the NHS.&#xD;
&#xD;
      Some publications require raw data to be supplied. This would be supplied but it will be a&#xD;
      non-personally identifiable dataset.&#xD;
&#xD;
      Confidentiality&#xD;
&#xD;
      The Caldicott Principles will be followed:&#xD;
&#xD;
        1. Justify the purpose(s) of obtaining the information&#xD;
&#xD;
        2. Don't use person-identifiable information unless it is absolutely necessary&#xD;
&#xD;
        3. Use the minimum necessary person-identifiable information&#xD;
&#xD;
        4. Access to person-identifiable information should be on a strict need-to-know basis&#xD;
&#xD;
        5. Everyone with access to person-identifiable information should be aware of their&#xD;
           responsibilities&#xD;
&#xD;
        6. Understand and comply with the law&#xD;
&#xD;
      Problems arising from the processing of identifiable data and how they will be handled&#xD;
&#xD;
      The database contains socioeconomic data in the form of patients' postcodes. This&#xD;
      socioeconomic data is important as it has been linked to emergency medical service use. A&#xD;
      postcode is identifiable data. To overcome this DMH will supply only the first four digits&#xD;
      which covers a sufficiently large geographical area that this will no longer be identifiable&#xD;
      data. The first four digits will be sufficient to identify a Lower Layer Super Output Area&#xD;
      code (LSOA code) which is the equivalent index of socioeconomic status.&#xD;
&#xD;
      As the dataset will include all adults attending ED it will inevitably include members of&#xD;
      vulnerable groups or others who would usually require additional ethical approval for&#xD;
      inclusion in research (for example offenders) however this will not be known to the research&#xD;
      team or be apparent in the non-personally identifiable data requested.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2016</start_date>
  <completion_date type="Actual">July 31, 2017</completion_date>
  <primary_completion_date type="Actual">July 31, 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of people attending ED with back pain</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Age of people attending ED with back pain</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Gender of people attending ED with back pain</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Deprivation score of people attending ED with back pain</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of attendance of people attending ED with back pain</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Date of attendance of people attending ED with back pain</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of attendance of people attending ED with back pain</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Drugs given to people attending ED with back pain</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnostic tests used with people attending ED with back pain</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Disposal of people attending ED with back pain</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <enrollment type="Actual">62000</enrollment>
  <condition>Back Pain</condition>
  <eligibility>
    <study_pop>
      <textblock>
        People attending ED&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have attended Darlington Memorial Hospital between 01-08-2016 and&#xD;
             31-07-2017&#xD;
&#xD;
          -  Aged 16 or over&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Below the age of 16&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cormac Ryan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Teesside University</affiliation>
  </overall_official>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>November 30, 2018</last_update_submitted>
  <last_update_submitted_qc>November 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Teesside University</investigator_affiliation>
    <investigator_full_name>Matt Capsey</investigator_full_name>
    <investigator_title>Senior Lecturer in Paramedic Science</investigator_title>
  </responsible_party>
  <keyword>Emergency Medical Services</keyword>
  <keyword>Emergency Department</keyword>
  <keyword>Back Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</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/NCT03762174
org study id: 147/17
nct id: NCT03762174
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Back pain is experienced by approximately 80% of the population during their life. However,
      only a small minority (<1%) will have a medical condition (such as Cauda Equina Syndrome)
      which requires immediate medical intervention.

      Currently, it is not known how many people access Emergency Medical Services (EMS) in an
      attempt to meet their needs for their back pain. The demand on EMS is increasing and many of
      these patients could be better managed by other services. Additionally, little is known about
      the characteristics of those accessing EMS due to back pain, or the nature of the contacts
      regarding issues such as outcome of the patient contact. The aims of this study are:

        1. to quantify the prevalence of people accessing EMS via attendance at an Emergency
           Department (ED)

        2. to describe the characteristics of people attending ED with non-traumatic back pain

        3. to describe key characteristics of the contact between the service user and EMS

        4. to compare the prevalence of attendance, patient characteristics and contact
           characteristics between people with non-traumatic back pain and the general population
           of those attending ED.

      A secondary aim of the work is to explore what factors might predict patient outcomes such as
      whether the patient self presents or is referred to ED by another service, whether the
      patient receives analgesics, whether the patient receives a diagnostic scan and whether the
      patient is admitted to hospital.
Purpose and Design

      Back Pain is a common cause of pain and disability. The National Institute for Clinical
      Excellent [NICE] (2016) identify back pain as affecting 1 in 10 people and causing more
      disability than any other condition. In most people back pain resolves within a number of
      weeks without any healthcare input. For those whose pain does not improve physical and
      psychological treatments are recommended. These are provided by specialist services and are
      not available in Emergency Departments or via Ambulance Services (collectively referred to as
      Emergency Medical Services [EMS]). Thus, arguably only a very small minority of patients with
      back pain, where a severe medical pathology is indicated (e.g. cauda equina syndrome) should
      need to access EMS. However, anecdotally many people with back pain self-refer to EMS. The
      prevalence of people self-referring and their characteristics are currently unknown as these
      figures are not routinely reported although the information exists within the data collected
      by many trusts.

      This study aims to analyse anonymised data from the Darlington Memorial Hospital (DMH)
      Emergency Department (ED) to establish the prevalence of those attending with back pain. The
      characteristics of people presenting over a 12-month period with back pain, along with
      characteristics of their contact (e.g.

      administration of analgesia and the use of diagnostic imaging) will be described and compared
      to the general characteristics of those attending ED.

      These characteristics may help to inform healthcare service design, both EMS and non-EMS, to
      better meet the needs of this patient group.

      Research Methods

      This study will be a secondary analysis of an existing NHS database. The study will request
      anonymised data from DMH ED. The data will cover all adults who have accessed their services
      in a 12-month period. The information requested will include data related to the attendance,
      patient demographics/characteristics, geographical location and clinical data.

      Recruitment

      The data being used for this study is from a currently existing Trust database and therefore
      there will be no recruitment of participants.

      Inclusion/exclusion All individuals over the age of 16 will be included. Those aged under 16
      will be excluded as they are not included in clinical guidelines.

      Risks, Burdens and Benefits

      The data has been collected for clinical care and not for research purposes. Therefore
      patients will not have explicitly consented for their information to be used for research.
      The Information Governance Officer at DMH has confirmed that the data will be in
      non-personally identifiable form when it is released to the research team and is compliant
      with Section 33 of the Data Protection Act 1998.

      The main risk to patients is that their clinical data is being used for research purposes.
      However identifiable data will only be available to the usual clinical team. Anonymised
      information will be extracted by a DMH member of staff before it is securely transferred to
      the team at Teesside University where it will be analysed. Names and addresses will be
      completely removed from the database before it leaves the NHS.

      Some publications require raw data to be supplied. This would be supplied but it will be a
      non-personally identifiable dataset.

      Confidentiality

      The Caldicott Principles will be followed:

        1. Justify the purpose(s) of obtaining the information

        2. Don't use person-identifiable information unless it is absolutely necessary

        3. Use the minimum necessary person-identifiable information

        4. Access to person-identifiable information should be on a strict need-to-know basis

        5. Everyone with access to person-identifiable information should be aware of their
           responsibilities

        6. Understand and comply with the law

      Problems arising from the processing of identifiable data and how they will be handled

      The database contains socioeconomic data in the form of patients' postcodes. This
      socioeconomic data is important as it has been linked to emergency medical service use. A
      postcode is identifiable data. To overcome this DMH will supply only the first four digits
      which covers a sufficiently large geographical area that this will no longer be identifiable
      data. The first four digits will be sufficient to identify a Lower Layer Super Output Area
      code (LSOA code) which is the equivalent index of socioeconomic status.

      As the dataset will include all adults attending ED it will inevitably include members of
      vulnerable groups or others who would usually require additional ethical approval for
      inclusion in research (for example offenders) however this will not be known to the research
      team or be apparent in the non-personally identifiable data requested.
observational model: Cohort
time perspective: Retrospective
measure: Number of people attending ED with back pain
time frame: 1 year
measure: Age of people attending ED with back pain
time frame: 1 year
measure: Gender of people attending ED with back pain
time frame: 1 year
measure: Deprivation score of people attending ED with back pain
time frame: 1 year
measure: Time of attendance of people attending ED with back pain
time frame: 1 year
measure: Date of attendance of people attending ED with back pain
time frame: 1 year
measure: Duration of attendance of people attending ED with back pain
time frame: 1 year
measure: Drugs given to people attending ED with back pain
time frame: 1 year
measure: Diagnostic tests used with people attending ED with back pain
time frame: 1 year
measure: Disposal of people attending ED with back pain
time frame: 1 year
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Cormac Ryan
role: Principal Investigator
affiliation: Teesside University
responsible party type: Sponsor-Investigator
investigator affiliation: Teesside University
investigator full name: Matt Capsey
investigator title: Senior Lecturer in Paramedic Science
mesh term: Back Pain
sharing ipd: No