<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/NCT04482205</url>
  </required_header>
  <id_info>
    <org_study_id>akupde</org_study_id>
    <nct_id>NCT04482205</nct_id>
  </id_info>
  <brief_title>Covid -19 Pandemic: Economic Burden on Patients Operated for Traumatic Close Fractures</brief_title>
  <official_title>Covid -19 Pandemic: Economic Burden on Patients Operated for Traumatic Close Fractures in Musculoskeletal Service Line of a Tertiary Care Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aga Khan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aga Khan University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Covid-19 has adversely impacted the health care organizations by over burdening with Covid&#xD;
      patients and suspending the elective surgeries and clinics A single center retrospective&#xD;
      study was conducted to quantify losses due to postponement of elective surgeries and extra&#xD;
      cost for procurement of PPEs. The secondary objective was to see the effect of Covid -19 on&#xD;
      the total costs of inpatient care during Covid era.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Covid-19 has impacted adversely the economy of Pakistan that has already poor and challenged&#xD;
      socioeconomic conditions This is a single hospital retrospective cross sectional study&#xD;
      conducted to quantify losses due postponement of elective surgeries and procurement of PPEs&#xD;
      and see the effect of Covid -19 on the total costs of inpatient care during Covid era.&#xD;
&#xD;
      We included all the patients admitted in orthopedic section for operative intervention of&#xD;
      fractures and elective procedures from January 1, 2020 to May 31, 2020. We divided this&#xD;
      period into two halves; the first half was from January first to March 15 named as PreCovid&#xD;
      Era and second half was from March 16, to May 31, 2020, termed as Covid Era. The total number&#xD;
      of trauma procedures and elective procedures were compared in both eras. We compared six&#xD;
      procedures each from upper and lower limit for cost analysis and length of stay. We also&#xD;
      analyzed the extra cost for procurement of PPEs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 16, 2020</start_date>
  <completion_date type="Actual">May 31, 2020</completion_date>
  <primary_completion_date type="Actual">May 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>the effect of Covid -19 on the total costs of inpatient care</measure>
    <time_frame>5 months</time_frame>
    <description>the effect of Covid -19 on the total costs of inpatient care during Covid era</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>drop in the collective revenue generated in covid era</measure>
    <time_frame>5 months</time_frame>
    <description>to quantify drop in the collective revenue generated in covid era</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">840</enrollment>
  <condition>Economic Burden</condition>
  <arm_group>
    <arm_group_label>precovid group</arm_group_label>
    <description>those who were operated from fJanuary first to March 15</description>
  </arm_group>
  <arm_group>
    <arm_group_label>covid</arm_group_label>
    <description>those operated from March 16, to May 31, 2020</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        patients admitted for operative intervention of fractures management and elective&#xD;
        procedures for tumour, degenerative disease, sport related injuries&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All the patients admitted in orthopedic section for operative intervention of&#xD;
             fractures and elective procedures from January 1, 2020 to May 31, 2020.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients presenting with other bone morbidities that did not require surgical&#xD;
             interventions including rickets, osteomalacia, osteogenesis imperfecta, marble bone&#xD;
             disease (osteopetrosis), Paget disease of bone, and fibrous dysplasia, patients with&#xD;
             incomplete medical records were excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Pervaiz Hashmi, FCPS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aga Khan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aga Khan University Hospital</name>
      <address>
        <city>Karachi</city>
        <state>Sindh</state>
        <zip>74800</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aga Khan University</investigator_affiliation>
    <investigator_full_name>shah fahad</investigator_full_name>
    <investigator_title>Resident</investigator_title>
  </responsible_party>
  <keyword>economic burden, covid-19 pandemic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Financial Stress</mesh_term>
  </condition_browse>
  <!-- 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/NCT04482205
org study id: akupde
nct id: NCT04482205
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Covid-19 has adversely impacted the health care organizations by over burdening with Covid
      patients and suspending the elective surgeries and clinics A single center retrospective
      study was conducted to quantify losses due to postponement of elective surgeries and extra
      cost for procurement of PPEs. The secondary objective was to see the effect of Covid -19 on
      the total costs of inpatient care during Covid era.
Covid-19 has impacted adversely the economy of Pakistan that has already poor and challenged
      socioeconomic conditions This is a single hospital retrospective cross sectional study
      conducted to quantify losses due postponement of elective surgeries and procurement of PPEs
      and see the effect of Covid -19 on the total costs of inpatient care during Covid era.

      We included all the patients admitted in orthopedic section for operative intervention of
      fractures and elective procedures from January 1, 2020 to May 31, 2020. We divided this
      period into two halves; the first half was from January first to March 15 named as PreCovid
      Era and second half was from March 16, to May 31, 2020, termed as Covid Era. The total number
      of trauma procedures and elective procedures were compared in both eras. We compared six
      procedures each from upper and lower limit for cost analysis and length of stay. We also
      analyzed the extra cost for procurement of PPEs.
observational model: Other
time perspective: Retrospective
measure: the effect of Covid -19 on the total costs of inpatient care
time frame: 5 months
description: the effect of Covid -19 on the total costs of inpatient care during Covid era
measure: drop in the collective revenue generated in covid era
time frame: 5 months
description: to quantify drop in the collective revenue generated in covid era
arm group label: precovid group
description: those who were operated from fJanuary first to March 15
arm group label: covid
description: those operated from March 16, to May 31, 2020
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Pervaiz Hashmi, FCPS
role: Principal Investigator
affiliation: Aga Khan University
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Aga Khan University
investigator full name: shah fahad
investigator title: Resident
mesh term: Financial Stress