<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/NCT03788798</url>
  </required_header>
  <id_info>
    <org_study_id>104-8598B</org_study_id>
    <nct_id>NCT03788798</nct_id>
  </id_info>
  <brief_title>An Integrated Model of Intelligent Medical Service for Total Joint Replacement</brief_title>
  <official_title>An Integrated Model of Intelligent Medical Service for Total Joint Replacement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial 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>
      With the aging population, the needs for total joint replacement are increasing. A successful&#xD;
      recovery after joint replacement surgery depends on timely and active physical therapy in the&#xD;
      early postoperative period. To accomplish it, an integrated care model based on clinical&#xD;
      pathway has been implemented to secure the medical quality and patient safety. Recently, the&#xD;
      emerging technology of electronic medical record and medical informatics have made challenges&#xD;
      to the traditional health care models such as the clinical pathway. As a matter of fact, the&#xD;
      integration of informatics technology also provides an opportunity to modernize the clinical&#xD;
      pathway and make it smarter. By bridging the HIS system and the medical cloud of a virtual&#xD;
      platform of interactive clinical pathway, the quality of care and patient safety can be&#xD;
      better secured and the performance can be stored for analysis.&#xD;
&#xD;
      The project &quot; The effects of intelligent clinical pathway for total joint replacement&quot; is a&#xD;
      subproject of the integrated project &quot; An integrated model of intelligent medical service for&#xD;
      total joint replacement&quot;. It will be carried out in a facility built with intelligent&#xD;
      environment (Kaohsiung CGMH) and the data will be stored and computed in the medical care&#xD;
      cloud and specialist system server. Collaborating with subproject 2 and 4 (smart wearing&#xD;
      device) and subproject 3 (total nursing care), this project is intended to set the milestones&#xD;
      for the postoperative recovery after total joint replacement. Supplemented with the&#xD;
      specialist system and interactive programs, it will be implemented in total joint replacement&#xD;
      patients as an vehicle for perioperative assessment, follow-up, monitoring, and instruction.&#xD;
      The big data of the objective analytic results and feedback from the patients will be the&#xD;
      important reference for medical and health promotion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With the aging population, the needs for total joint replacement are increasing. On the basis&#xD;
      of 2000-to-2014 data from National Inpatient Sample (NIS), primary total knee arthroplasty&#xD;
      (TKA) is projected to grow by 85% to 1.26 million procedures in the United States by 2030. In&#xD;
      a 2012 report of Orthopaedic Industry, and the global sales of joint replacement products&#xD;
      exceeded $49.3 billion, with knees taking about half of them. The high financial burden of&#xD;
      joint replacement surgery on health care system highlights the importance of cost containment&#xD;
      without compromising the quality of patient care.&#xD;
&#xD;
      Clinical pathways for total joint arthroplasty can reduce care variability and improve the&#xD;
      quality of care. Taiwan's Bureau of National Health Insurance (BNHI) has initiated a&#xD;
      prospective payment system for TKA under diagnosis-related group (DRG) since 1997. It was&#xD;
      found the length of hospital stay, and the medical expenditure could be reduced because&#xD;
      standard clinical pathways were implemented in most hospitals. However, to optimize the&#xD;
      results and meet with patients' expectation are more challenging currently than before&#xD;
      because the length of hospitalization is markedly reduced and the standard care processes are&#xD;
      accelerated. The accelerated programs for total joint arthroplasty are revolutionizing the&#xD;
      standard clinical pathways. Patients can even be discharged from the hospital within one day&#xD;
      after the surgery. While a successful joint replacement surgery depends on well-practiced&#xD;
      clinical pathways delivered in a timely manner, patient's medical literacy should also have a&#xD;
      significant impact for his or her recovery. Unfortunately, patients may acquire incorrect&#xD;
      information from the internet or have unrealistic expectations before or during the&#xD;
      hospitalization that may compromise the decision making and clinical results.&#xD;
&#xD;
      Recently, the emerging technologies of the electronic medical record and medical informatics&#xD;
      have made challenges to the traditional healthcare models such as the clinical pathways. The&#xD;
      integration of informatics technology also provides an opportunity to modernize the clinical&#xD;
      pathways. But the effect of an interactive infotainment system on TKA is unknown. The purpose&#xD;
      of this study was to analyze whether the implementation of an interactive infotainment system&#xD;
      into a standard clinical pathway of TKA could influence the hospital course and the medical&#xD;
      quality in an arthroplasty specialty ward.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 8, 2016</start_date>
  <completion_date type="Actual">March 7, 2018</completion_date>
  <primary_completion_date type="Actual">July 19, 2017</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Length of stay</measure>
    <time_frame>up to 10 days</time_frame>
    <description>in hospital stay (days)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>30-day return to emergency room</measure>
    <time_frame>within 30 days after discharge</time_frame>
    <description>Patients who will return to the emergency room within 30 days after discharge</description>
  </primary_outcome>
  <primary_outcome>
    <measure>30-day readmission after discharge</measure>
    <time_frame>within 30 days after discharge</time_frame>
    <description>Patients who will readmit within 30 days after discharge</description>
  </primary_outcome>
  <primary_outcome>
    <measure>90-day return to emergency room</measure>
    <time_frame>within 90 days after discharge</time_frame>
    <description>Patients who will return to the emergency room within 90 days after discharge</description>
  </primary_outcome>
  <primary_outcome>
    <measure>90-day readmission after discharge</measure>
    <time_frame>within 90 days after discharge</time_frame>
    <description>Patients who will readmit within 90 days after discharge</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>medical expenditure</measure>
    <time_frame>up to 10 days</time_frame>
    <description>The total medical cost in the hospital</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Health Knowledge, Attitudes, Practice</condition>
  <arm_group>
    <arm_group_label>Standard clinical pathway</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>A standard clinical pathway for TKA has been compulsively implemented for medical cost containment and quality assurance to meet with the Taiwan Diagnosis-Related Groups (TW-DRGs) payment system since 1997. The clinical pathway for TKA undertakes with preadmissions, anesthetic, surgery, and physiotherapy assessment. Medical, nursing, and physiotherapy assessment were put down for each postadmission day. The time from admission to surgery, the use of intravenous antibiotics injection and intravenous fluid were all assessed. Discharge criteria were active knee flexion to 90 degrees, having the ability to walk with aids and clean wound condition with any infection sign. The pathway was initially set for a 6-day postoperative length of stay.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient Infotainment Terminal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who have additional access to an integrated infotainment system and are cared by a standard clinical pathway. The patient infotainment system is a quasi-interactive computer program connected to a server that pushes messages and educational programs ordered from the caring physicians or on-demand by the patients. The server has parallel data exchange gateways to the Hospital Information System (HIS), Picture Archiving Communication System (PACS), and can record the patients' responses to surveys and questionnaires.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Patient infotainment system</intervention_name>
    <description>The patient infotainment system is a quasi-interactive computer program connected to a server that pushes messages and educational programs ordered from the caring physicians or on-demand by the patients. The server has parallel data exchange gateways to the Hospital Information System (HIS), Picture Archiving Communication System (PACS), and can record the patients' responses to surveys and questionnaires.</description>
    <arm_group_label>Patient Infotainment Terminal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admission to the hospital, scheduled for total joint replacement surgery&#xD;
&#xD;
          -  Sign informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  In-patient, not scheduled for total joint replacement surgery&#xD;
&#xD;
          -  Any psychological condition or other condition that may influence the study result&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mel S Lee, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>83301</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>December 24, 2018</last_update_submitted>
  <last_update_submitted_qc>December 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03788798
org study id: 104-8598B
nct id: NCT03788798
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
With the aging population, the needs for total joint replacement are increasing. A successful
      recovery after joint replacement surgery depends on timely and active physical therapy in the
      early postoperative period. To accomplish it, an integrated care model based on clinical
      pathway has been implemented to secure the medical quality and patient safety. Recently, the
      emerging technology of electronic medical record and medical informatics have made challenges
      to the traditional health care models such as the clinical pathway. As a matter of fact, the
      integration of informatics technology also provides an opportunity to modernize the clinical
      pathway and make it smarter. By bridging the HIS system and the medical cloud of a virtual
      platform of interactive clinical pathway, the quality of care and patient safety can be
      better secured and the performance can be stored for analysis.

      The project " The effects of intelligent clinical pathway for total joint replacement" is a
      subproject of the integrated project " An integrated model of intelligent medical service for
      total joint replacement". It will be carried out in a facility built with intelligent
      environment (Kaohsiung CGMH) and the data will be stored and computed in the medical care
      cloud and specialist system server. Collaborating with subproject 2 and 4 (smart wearing
      device) and subproject 3 (total nursing care), this project is intended to set the milestones
      for the postoperative recovery after total joint replacement. Supplemented with the
      specialist system and interactive programs, it will be implemented in total joint replacement
      patients as an vehicle for perioperative assessment, follow-up, monitoring, and instruction.
      The big data of the objective analytic results and feedback from the patients will be the
      important reference for medical and health promotion.
With the aging population, the needs for total joint replacement are increasing. On the basis
      of 2000-to-2014 data from National Inpatient Sample (NIS), primary total knee arthroplasty
      (TKA) is projected to grow by 85% to 1.26 million procedures in the United States by 2030. In
      a 2012 report of Orthopaedic Industry, and the global sales of joint replacement products
      exceeded $49.3 billion, with knees taking about half of them. The high financial burden of
      joint replacement surgery on health care system highlights the importance of cost containment
      without compromising the quality of patient care.

      Clinical pathways for total joint arthroplasty can reduce care variability and improve the
      quality of care. Taiwan's Bureau of National Health Insurance (BNHI) has initiated a
      prospective payment system for TKA under diagnosis-related group (DRG) since 1997. It was
      found the length of hospital stay, and the medical expenditure could be reduced because
      standard clinical pathways were implemented in most hospitals. However, to optimize the
      results and meet with patients' expectation are more challenging currently than before
      because the length of hospitalization is markedly reduced and the standard care processes are
      accelerated. The accelerated programs for total joint arthroplasty are revolutionizing the
      standard clinical pathways. Patients can even be discharged from the hospital within one day
      after the surgery. While a successful joint replacement surgery depends on well-practiced
      clinical pathways delivered in a timely manner, patient's medical literacy should also have a
      significant impact for his or her recovery. Unfortunately, patients may acquire incorrect
      information from the internet or have unrealistic expectations before or during the
      hospitalization that may compromise the decision making and clinical results.

      Recently, the emerging technologies of the electronic medical record and medical informatics
      have made challenges to the traditional healthcare models such as the clinical pathways. The
      integration of informatics technology also provides an opportunity to modernize the clinical
      pathways. But the effect of an interactive infotainment system on TKA is unknown. The purpose
      of this study was to analyze whether the implementation of an interactive infotainment system
      into a standard clinical pathway of TKA could influence the hospital course and the medical
      quality in an arthroplasty specialty ward.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Length of stay
time frame: up to 10 days
description: in hospital stay (days)
measure: 30-day return to emergency room
time frame: within 30 days after discharge
description: Patients who will return to the emergency room within 30 days after discharge
measure: 30-day readmission after discharge
time frame: within 30 days after discharge
description: Patients who will readmit within 30 days after discharge
measure: 90-day return to emergency room
time frame: within 90 days after discharge
description: Patients who will return to the emergency room within 90 days after discharge
measure: 90-day readmission after discharge
time frame: within 90 days after discharge
description: Patients who will readmit within 90 days after discharge
measure: medical expenditure
time frame: up to 10 days
description: The total medical cost in the hospital
arm group label: Standard clinical pathway
arm group type: No Intervention
description: A standard clinical pathway for TKA has been compulsively implemented for medical cost containment and quality assurance to meet with the Taiwan Diagnosis-Related Groups (TW-DRGs) payment system since 1997. The clinical pathway for TKA undertakes with preadmissions, anesthetic, surgery, and physiotherapy assessment. Medical, nursing, and physiotherapy assessment were put down for each postadmission day. The time from admission to surgery, the use of intravenous antibiotics injection and intravenous fluid were all assessed. Discharge criteria were active knee flexion to 90 degrees, having the ability to walk with aids and clean wound condition with any infection sign. The pathway was initially set for a 6-day postoperative length of stay.
arm group label: Patient Infotainment Terminal
arm group type: Experimental
description: Patients who have additional access to an integrated infotainment system and are cared by a standard clinical pathway. The patient infotainment system is a quasi-interactive computer program connected to a server that pushes messages and educational programs ordered from the caring physicians or on-demand by the patients. The server has parallel data exchange gateways to the Hospital Information System (HIS), Picture Archiving Communication System (PACS), and can record the patients' responses to surveys and questionnaires.
intervention type: Device
intervention name: Patient infotainment system
description: The patient infotainment system is a quasi-interactive computer program connected to a server that pushes messages and educational programs ordered from the caring physicians or on-demand by the patients. The server has parallel data exchange gateways to the Hospital Information System (HIS), Picture Archiving Communication System (PACS), and can record the patients' responses to surveys and questionnaires.
arm group label: Patient Infotainment Terminal
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Mel S Lee, MD,PhD
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
sharing ipd: No