xml: <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/NCT05972525</url>
    </required_header>
    <id_info>
      <org_study_id>S-20200137</org_study_id>
      <nct_id>NCT05972525</nct_id>
    </id_info>
    <brief_title>What Matters to Patients With Severe Hip or Knee Osteoarthritis?</brief_title>
    <acronym>PATI-Project</acronym>
    <official_title>What Matters to Patients With Severe Hip or Knee Osteoarthritis? Decisional Quality, Patient Involvement and Health Outcome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Vejle Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Odense University Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Vejle 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>
        This clinical trial aims to investigate if shared decision-making, and the use of an&#xD;
        in-consultation patient decision aid (PtDA), increases the decisional quality and therefore&#xD;
        treatment satisfaction and outcome of patients with severe hip or knee osteoarthritis.&#xD;
  &#xD;
        Finally, an evaluation will be conducted on patient-reported outcomes on pain, physical&#xD;
        function, quality of life (QoL), and patient satisfaction, up to one year after surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Osteoarthritis (OA) is the most common joint disease and a major cause of disability&#xD;
        worldwide. The condition typically affects the hip or knee, and as the condition progresses&#xD;
        it frequently causes debilitating pain and stiffness in the affected joints; thus impairing&#xD;
        mobility, and decreasing function and quality of life(QoL).&#xD;
  &#xD;
        Approximately 10,300 primary hip arthroplasties (THA) and 10,000 primary knee arthroplasties&#xD;
        (TKA/UKA) were performed in Denmark in 2021.&#xD;
  &#xD;
        For the majority of patients with severe osteoarthritis, evidence shows that joint&#xD;
        replacement surgery is life-changing. Despite this documented effect, not all patients&#xD;
        achieve optimal results. Patient dissatisfaction following THA and TKA has been reported as 7&#xD;
        % and 11-18%, respectively.&#xD;
  &#xD;
        It is hypothesized that a lack of adequate information and patient involvement in the&#xD;
        decision process might lead to the misalignment of patients' expectations and subsequent&#xD;
        dissatisfaction. Considerable evidence shows that patients prefer more information and&#xD;
        greater involvement. This strongly supports the concept that patients need to be actively&#xD;
        involved in treatment decisions.&#xD;
  &#xD;
        Accordingly, increasing patient involvement in healthcare decisions may be beneficial. Shared&#xD;
        decision-making (SDM) supports patients' active involvement in the process and improves the&#xD;
        quality of decisions. SDM can be facilitated using a PtDA, which has shown significant&#xD;
        benefits in a range of patient groups. However, research on SDM and PtDAs in patients with&#xD;
        severe hip or knee OA is lacking.&#xD;
  &#xD;
        The overall aim of this project is to investigate if an in-consultation PtDA increases the&#xD;
        decision quality for patients with severe OA of the hip or knee.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 11, 2023</start_date>
    <completion_date type="Anticipated">March 11, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 11, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>The group of hip and knee surgeons at Vejle, Odense, and Svendborg hospitals will be randomized 1:1 either to continue standard consultation or to practice SDM supported by the in-consultation PtDA.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The participant's decisional quality according to The Hip/Knee Osteoarthritis Decision Quality Instrument (HK-DQI).</measure>
      <time_frame>Within one week after inclusion in the consultation</time_frame>
      <description>Informed Patient-Centered (IPC) decision is calculated as the percentage of patients who are well-informed and received their preferred treatment.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Participant's engagement in the decision-making process as measured by the CollaboRATE questionnaire</measure>
      <time_frame>Within one week after inclusion in the consultation</time_frame>
      <description>Minimum value: 0. Maximum value: 100. The higher the value the more shared decision-making</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participant's involvement in the decision-making process as measured by the HK-DQI questionnaire</measure>
      <time_frame>Within one week after inclusion in the consultation</time_frame>
      <description>HK-DQI, section 3, decision-making process: Minimum value: 0. Maximum value: 100. The higher the value the more shared decision-making</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The participant's pain and physical function after undergoing hip replacement surgery as measured by the Oxford Hip Score (OHS) questionnaire</measure>
      <time_frame>Three months and one year following surgery</time_frame>
      <description>Oxford Knee Score (OHS): Measuring function and pain with patients undergoing knee replacement surgery. Total scores range from 0 (poorest function) to 48 (maximal function).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The participant's pain and physical function after undergoing knee replacement surgery as measured by Oxford Knee Score (OKS) questionnaire</measure>
      <time_frame>Three months and one year following surgery</time_frame>
      <description>Oxford Knee Score (OKS): Measuring function and pain with patients undergoing knee replacement surgery. Total scores range from 0 (poorest function) to 48 (maximal function).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The participant's physical function after undergoing hip or knee replacement surgery as measured by Forgotten Joint Score (FJS) questionnaire</measure>
      <time_frame>Three months and one year following surgery.</time_frame>
      <description>Forgotten joint score (FJS): Measuring the participants' awareness of their artificial joint during ADL. Minimum value: 0. Maximum value: 100. The higher score, the less the patient is aware of their affected joint.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participant's Qol when undergoing hip or knee replacement surgery as measured by EuroQol (EQ-5D)</measure>
      <time_frame>Three months and one year following surgery.</time_frame>
      <description>QoL: EuroQol (EQ-5D): Measuring the health-related quality of life. Presenting in three levels; Level 1: Indicating no problem, to Level 3: Indicating extreme problems</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The duration of consultation when PtDA is used compared to standard consultation without the use of PtDA.</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>The time duration will be documented by the surgeons</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participant's regret of the treatment decision as measured by the Decision Regret Scale questionnaire.</measure>
      <time_frame>Three months and one year following surgery.</time_frame>
      <description>The Decision Regret Scale: Minimum value: 0. Maximum value: 100. The higher the value the more regret.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participant's satisfaction after undergoing hip or knee replacement surgery as measured by the patient satisfaction questionnaire (PSQ)</measure>
      <time_frame>Three months and one year following surgery.</time_frame>
      <description>The patient satisfaction questionnaire (PSQ): The higher the value the more satisfaction.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">551</enrollment>
    <condition>Hip Osteoarthritis</condition>
    <condition>Knee Osteoarthritis</condition>
    <arm_group>
      <arm_group_label>Shared decision-making (SDM)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will be informed by a nurse before being consulted by the surgeon randomized to SDM and use the in-consultation PtDA during the consultation on patients with severe hip or knee osteoarthritis</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual practice</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients will be informed by a nurse before being consulted by the surgeon randomized to usual practice during the consultation on patients with severe hip or knee osteoarthritis</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Shared decision-making supported by an in-consultation PtDA to patients with severe osteoarthritis in their hip or knee</intervention_name>
      <description>The intervention group has been involved in the development process of the PtDA. After receiving a training course in SDM and the use of a PtDA, the surgeons will practice SDM supported by an in-consultation PtDA during the consultations with the participant.</description>
      <arm_group_label>Shared decision-making (SDM)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Severe primary osteoarthritis eligible for primary total hip arthroplasty (THA) /&#xD;
               primary total knee arthroplasty (TKA) / primary partial knee arthroplasty (UKA)&#xD;
  &#xD;
            -  Able to understand and read Danish&#xD;
  &#xD;
            -  Informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previous THA, TKA, or UKA on the contralateral side&#xD;
  &#xD;
            -  Cognitive impairment&#xD;
  &#xD;
            -  Non-OA-related reason for the visit&#xD;
  &#xD;
            -  No digital mailbox (E-boks)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Trine Ahlmann, PhD stud</last_name>
      <role>Principal Investigator</role>
      <affiliation>Vejle Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Claus Varnum, Ass.Prof.MD</last_name>
      <role>Study Chair</role>
      <affiliation>Vejle Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Martin Lindberg-Larsen, Ass.Prof.MD.</last_name>
      <role>Study Chair</role>
      <affiliation>Odense University Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Charlotte Myhre Jensen, Ass.Prof.RN</last_name>
      <role>Study Chair</role>
      <affiliation>Odense University Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Karina Dahl Steffensen, Prof.MD.</last_name>
      <role>Study Chair</role>
      <affiliation>Vejle Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Trine Ahlmann, PhD stud</last_name>
      <phone>+4561164836</phone>
      <email>trine.alman.pedersen@rsyd.dk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Claus Varnum, Ass.Prof.MD</last_name>
      <phone>+4579405779</phone>
      <email>Claus.Varnum@rsyd.dk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Odense University Hospital, OUH</name>
        <address>
          <city>Odense</city>
          <zip>5000</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <contact>
        <last_name>Trine Ahlmann, PhD student</last_name>
        <phone>+4561164836</phone>
        <email>Trine.Alman.Pedersen@rsyd.dk</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Odense University Hospital, OUH</name>
        <address>
          <city>Svendborg</city>
          <zip>5700</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <contact>
        <last_name>Trine Ahlmann, PhD student</last_name>
        <phone>+4561164836</phone>
        <email>Trine.Alman.Pedersen@rsyd.dk</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Lillebaelt Hospital - Vejle</name>
        <address>
          <city>Vejle</city>
          <zip>7100</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <contact>
        <last_name>Trine Ahlmann, PhD student</last_name>
        <phone>+4561164836</phone>
        <email>Trine.Alman.Pedersen@rsyd.dk</email>
      </contact>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 8, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Hip Osteoarthritis</keyword>
    <keyword>Knee Osteoarthritis</keyword>
    <keyword>Shared Decision Making</keyword>
    <keyword>Total knee arthroplasty</keyword>
    <keyword>Partiel knee arthroplasty</keyword>
    <keyword>Total hip arthroplasty</keyword>
    <keyword>Decision quality</keyword>
    <keyword>HK-DQI</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
      <mesh_term>Osteoarthritis, Knee</mesh_term>
      <mesh_term>Osteoarthritis, Hip</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All data of the outcome measures will be available in an anonymized form if required by the scientific journal, in which the results of the trial will be published.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Data will be available after the publication of the trial</ipd_time_frame>
      <ipd_access_criteria>Data access will be reviewed by the author's group</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05972525
  org study id: S-20200137
  nct id: NCT05972525
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This clinical trial aims to investigate if shared decision-making, and the use of an
        in-consultation patient decision aid (PtDA), increases the decisional quality and therefore
        treatment satisfaction and outcome of patients with severe hip or knee osteoarthritis.
  
        Finally, an evaluation will be conducted on patient-reported outcomes on pain, physical
        function, quality of life (QoL), and patient satisfaction, up to one year after surgery.
  Osteoarthritis (OA) is the most common joint disease and a major cause of disability
        worldwide. The condition typically affects the hip or knee, and as the condition progresses
        it frequently causes debilitating pain and stiffness in the affected joints; thus impairing
        mobility, and decreasing function and quality of life(QoL).
  
        Approximately 10,300 primary hip arthroplasties (THA) and 10,000 primary knee arthroplasties
        (TKA/UKA) were performed in Denmark in 2021.
  
        For the majority of patients with severe osteoarthritis, evidence shows that joint
        replacement surgery is life-changing. Despite this documented effect, not all patients
        achieve optimal results. Patient dissatisfaction following THA and TKA has been reported as 7
        % and 11-18%, respectively.
  
        It is hypothesized that a lack of adequate information and patient involvement in the
        decision process might lead to the misalignment of patients' expectations and subsequent
        dissatisfaction. Considerable evidence shows that patients prefer more information and
        greater involvement. This strongly supports the concept that patients need to be actively
        involved in treatment decisions.
  
        Accordingly, increasing patient involvement in healthcare decisions may be beneficial. Shared
        decision-making (SDM) supports patients' active involvement in the process and improves the
        quality of decisions. SDM can be facilitated using a PtDA, which has shown significant
        benefits in a range of patient groups. However, research on SDM and PtDAs in patients with
        severe hip or knee OA is lacking.
  
        The overall aim of this project is to investigate if an in-consultation PtDA increases the
        decision quality for patients with severe OA of the hip or knee.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The group of hip and knee surgeons at Vejle, Odense, and Svendborg hospitals will be randomized 1:1 either to continue standard consultation or to practice SDM supported by the in-consultation PtDA.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: The participant's decisional quality according to The Hip/Knee Osteoarthritis Decision Quality Instrument (HK-DQI).
  time frame: Within one week after inclusion in the consultation
  description: Informed Patient-Centered (IPC) decision is calculated as the percentage of patients who are well-informed and received their preferred treatment.
  measure: Participant's engagement in the decision-making process as measured by the CollaboRATE questionnaire
  time frame: Within one week after inclusion in the consultation
  description: Minimum value: 0. Maximum value: 100. The higher the value the more shared decision-making
  measure: Participant's involvement in the decision-making process as measured by the HK-DQI questionnaire
  time frame: Within one week after inclusion in the consultation
  description: HK-DQI, section 3, decision-making process: Minimum value: 0. Maximum value: 100. The higher the value the more shared decision-making
  measure: The participant's pain and physical function after undergoing hip replacement surgery as measured by the Oxford Hip Score (OHS) questionnaire
  time frame: Three months and one year following surgery
  description: Oxford Knee Score (OHS): Measuring function and pain with patients undergoing knee replacement surgery. Total scores range from 0 (poorest function) to 48 (maximal function).
  measure: The participant's pain and physical function after undergoing knee replacement surgery as measured by Oxford Knee Score (OKS) questionnaire
  time frame: Three months and one year following surgery
  description: Oxford Knee Score (OKS): Measuring function and pain with patients undergoing knee replacement surgery. Total scores range from 0 (poorest function) to 48 (maximal function).
  measure: The participant's physical function after undergoing hip or knee replacement surgery as measured by Forgotten Joint Score (FJS) questionnaire
  time frame: Three months and one year following surgery.
  description: Forgotten joint score (FJS): Measuring the participants' awareness of their artificial joint during ADL. Minimum value: 0. Maximum value: 100. The higher score, the less the patient is aware of their affected joint.
  measure: Participant's Qol when undergoing hip or knee replacement surgery as measured by EuroQol (EQ-5D)
  time frame: Three months and one year following surgery.
  description: QoL: EuroQol (EQ-5D): Measuring the health-related quality of life. Presenting in three levels; Level 1: Indicating no problem, to Level 3: Indicating extreme problems
  measure: The duration of consultation when PtDA is used compared to standard consultation without the use of PtDA.
  time frame: Through study completion, an average of 1 year
  description: The time duration will be documented by the surgeons
  measure: Participant's regret of the treatment decision as measured by the Decision Regret Scale questionnaire.
  time frame: Three months and one year following surgery.
  description: The Decision Regret Scale: Minimum value: 0. Maximum value: 100. The higher the value the more regret.
  measure: Participant's satisfaction after undergoing hip or knee replacement surgery as measured by the patient satisfaction questionnaire (PSQ)
  time frame: Three months and one year following surgery.
  description: The patient satisfaction questionnaire (PSQ): The higher the value the more satisfaction.
  arm group label: Shared decision-making (SDM)
  arm group type: Experimental
  description: Patients will be informed by a nurse before being consulted by the surgeon randomized to SDM and use the in-consultation PtDA during the consultation on patients with severe hip or knee osteoarthritis
  arm group label: Usual practice
  arm group type: No Intervention
  description: Patients will be informed by a nurse before being consulted by the surgeon randomized to usual practice during the consultation on patients with severe hip or knee osteoarthritis
  intervention type: Behavioral
  intervention name: Shared decision-making supported by an in-consultation PtDA to patients with severe osteoarthritis in their hip or knee
  description: The intervention group has been involved in the development process of the PtDA. After receiving a training course in SDM and the use of a PtDA, the surgeons will practice SDM supported by an in-consultation PtDA during the consultations with the participant.
  arm group label: Shared decision-making (SDM)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Trine Ahlmann, PhD stud
  role: Principal Investigator
  affiliation: Vejle Hospital
  last name: Claus Varnum, Ass.Prof.MD
  role: Study Chair
  affiliation: Vejle Hospital
  last name: Martin Lindberg-Larsen, Ass.Prof.MD.
  role: Study Chair
  affiliation: Odense University Hospital
  last name: Charlotte Myhre Jensen, Ass.Prof.RN
  role: Study Chair
  affiliation: Odense University Hospital
  last name: Karina Dahl Steffensen, Prof.MD.
  role: Study Chair
  affiliation: Vejle Hospital
  last name: Trine Ahlmann, PhD stud
  phone: +4561164836
  email: trine.alman.pedersen@rsyd.dk
  last name: Claus Varnum, Ass.Prof.MD
  phone: +4579405779
  email: Claus.Varnum@rsyd.dk
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  country: Denmark
  responsible party type: Sponsor
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee
  mesh term: Osteoarthritis, Hip
  sharing ipd: Yes
  ipd description: All data of the outcome measures will be available in an anonymized form if required by the scientific journal, in which the results of the trial will be published.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Analytic Code
  ipd time frame: Data will be available after the publication of the trial
  ipd access criteria: Data access will be reviewed by the author's group