<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/NCT04441567</url>
  </required_header>
  <id_info>
    <org_study_id>H-38859</org_study_id>
    <nct_id>NCT04441567</nct_id>
  </id_info>
  <brief_title>Right-Size Clinic Visits Using Memora Platform for PROMIS</brief_title>
  <official_title>Patient Reported Outcomes Measures Pilot Grant for Orthopedic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Medical Center</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>
      Developing novel methods of patient communication is crucial in providing value-based care to&#xD;
      orthopedic patients. Healthcare technology platforms have been developed to improve patient&#xD;
      communication methods particularly for the administration of patient-reported outcome&#xD;
      measures (PROMs). However, the majority of these interventions rely on web-based platforms&#xD;
      that require patients to have computer access. Among American households earning less than&#xD;
      $30,000 per year, only 59% have access to a desktop or laptop and just 47% have broadband&#xD;
      internet at home compared to mobile phone penetration which is estimated at 95% of which 93%&#xD;
      regularly use text messages. The use of phone messaging may be the most effective means to&#xD;
      have patients complete PROMs.&#xD;
&#xD;
      The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH-funded,&#xD;
      clinically validated method of tracking patient-reported outcomes to efficiently assess&#xD;
      patient health status. PROMIS utilizes Item Response Theory (IRT) and computerized adaptive&#xD;
      testing (CAT) to improve measurement precision and decrease survey time as compared to&#xD;
      traditional PROMs.&#xD;
&#xD;
      The purpose of this two-phase study is to utilize Memora Health's text-messaging platform to&#xD;
      collect web-based PROMIS CAT surveys from patients (Phase 1) and use this information to&#xD;
      right-size clinic visits (Phase 2).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase 1 will be a prospective evaluation of patients with the conditions listed. After&#xD;
      consent, participants will complete PROMIS CAT questionnaires on their mobile phones to&#xD;
      assess health status. During enrollment, participants will choose a method of completing the&#xD;
      surveys throughout the duration of the study. The participants will either 1) receive a short&#xD;
      message service(SMS) with a secure weblink to complete these PROMIS CAT questionnaires on a&#xD;
      secure website, or 2) engage in two-way SMS communication by answering the survey questions&#xD;
      individually by texting back their answers. The investigators will explain that the desired&#xD;
      method of participation is by weblink due to privacy issues associated with two-way texting.&#xD;
      The frequency at which the questionnaires will be sent is condition-specific. All patients&#xD;
      will be seen in clinic at standard follow up time-points and will be asked to complete PROMIS&#xD;
      questionnaires during each clinic visit, identical to the delivery of surveys while at home.&#xD;
      The PROMIS measures collected over a 1-year period will be used to develop patient-based&#xD;
      recovery curves.&#xD;
&#xD;
      Phase 2 will begin at the end of Phase 1 and compare each participant's recovery (based on&#xD;
      the PROMs) against the established recovery curve that was generated in Phase 1 for their&#xD;
      orthopedic condition. The investigators will right-size in-person clinic visits based on&#xD;
      individual recovery as compared with expected recovery. Earlier clinic appointments will be&#xD;
      given to participants at risk for a poor outcome (defined as any PROMIS score ≥1 standard&#xD;
      deviation below the mean). All other participants will receive a phone call to make sure that&#xD;
      participants feel they are doing well and to have any issues addressed. If it is felt that a&#xD;
      visit is warranted, it will be recommended, and if a subject wishes to have a visit it will&#xD;
      be scheduled. If the subject is happy with their progress, then that in-person clinic visit&#xD;
      will be deferred until the next standard follow-up visit and the same process will occur.&#xD;
      Some in-person visits will be mandatory when a physical exam or x-ray is required for optimal&#xD;
      care. These are condition specific. For all participants, a final in-person follow-up visit&#xD;
      will occur unless the subject is happy and does not want to be seen in person.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 10, 2021</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">June 2025</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>Sequential Assignment</intervention_model>
    <intervention_model_description>This is a two-phase pilot study recruiting approximately 1500 subjects in each of the two phases. Phase 1 - No intervention, create recovery curves only. Phase 2 - Adjust clinic follow-up based on patient responses in relation to recovery curves generated from Phase 1.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Right-size clinic visits for specific orthopedic conditions</measure>
    <time_frame>2 years</time_frame>
    <description>Right-size clinic visits for patients recovering at/better than expected while maintaining or improving overall patient-reported outcomes (PROMS) will be assessed by comparing to the mean condition-specific recovery curve from phase 1. Earlier clinic visits will be scheduled for those who are more than 1 standard deviation from the mean recovery at any time point and less frequent visits for all others to establish the right size clinic visits.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-based recovery curves for specific orthopedic conditions</measure>
    <time_frame>1 year</time_frame>
    <description>Each participant's recovery (based on the patient-reported outcome measures- PROMs) for their orthopedic condition will be assessed against the established recovery curve that was generated in phase one of the research for their condition.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average number of PROMs collected through SMS and weblink</measure>
    <time_frame>1 year</time_frame>
    <description>The number of PROMs collected through SMS and weblink will be assessed. PROMs are standardized, validated questionnaires completed by patients to measure their perception of their functional well-being and health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average number of PROMs collected during clinic visits</measure>
    <time_frame>1 year</time_frame>
    <description>The number of PROMs collected during clinic visits will be assessed. PROMs are standardized, validated questionnaires completed by patients to measure their perception of their functional well-being and health status.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Orthopedic Disorders</condition>
  <arm_group>
    <arm_group_label>Phase 1</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in phase 1 will be observed and data about their recovery time will be collected from which recovery curves will be calculated for Phase 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in Phase 2 will have their clinic visits potentially revised based on the phase 1 recovery curves which may increase or decrease the number of clinic visits they receive based on the PROMs reported.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Right-size clinic visits</intervention_name>
    <description>The curve created in Phase 1 will be used to guide the number of clinic visits based on PROMs reported by the participants in Phase 2.</description>
    <arm_group_label>Phase 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects that are classified by the Current Procedural Terminology/International&#xD;
             Classification of Diseases (CPT/ICD)-10 Diagnosis Codes, having sustained the injury&#xD;
             within 3 weeks of enrollment for non-operative treatment or will undergo surgery&#xD;
             during the enrollment period:&#xD;
&#xD;
          -  Ankle Fracture&#xD;
&#xD;
          -  Distal Radius Fracture&#xD;
&#xD;
          -  Tibial Plateau Open reduction internal fixation (ORIF)&#xD;
&#xD;
          -  Spine Operative&#xD;
&#xD;
               -  Anterior cervical discectomy with fusion (ACDF)&#xD;
&#xD;
               -  Cervical Laminectomy&#xD;
&#xD;
               -  Lumbar Fusion&#xD;
&#xD;
               -  Lumbar Decompression&#xD;
&#xD;
          -  Spine Non-operative&#xD;
&#xD;
               -  Lumbar Stenosis&#xD;
&#xD;
               -  Lumbar Degenerative Disc Disease&#xD;
&#xD;
          -  Rotator Cuff Repair&#xD;
&#xD;
          -  Anterior cruciate ligament (ACL) Reconstruction&#xD;
&#xD;
          -  Have personal use of cellular phone with access to the internet&#xD;
&#xD;
          -  Speak either English or English as a primary language:&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Limited and non-readers&#xD;
&#xD;
          -  Vulnerable populations - incarcerated patients&#xD;
&#xD;
          -  Patients with no cell phone to use for scoring&#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>Paul Tornetta III, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Paul Tornetta III, MD</last_name>
    <phone>617 414 5757</phone>
    <email>Paul.Tornetta@bmc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Katarzyna Wegrzyn, MD</last_name>
    <phone>617-414-5757</phone>
    <email>Katarzyna.Wegrzyn@bmc.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paul Tornetta III, MD</last_name>
      <phone>617-414-5757</phone>
      <email>Paul.Tornetta@bmc.org</email>
    </contact>
    <contact_backup>
      <last_name>Katarzyna Wegrzyn, MD</last_name>
      <phone>617-414-5757</phone>
      <email>Katarzyna.Wegrzyn@bmc.org</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>May 2, 2023</last_update_submitted>
  <last_update_submitted_qc>May 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PROM</keyword>
  <keyword>PROMIS</keyword>
  <keyword>Memora Health Text messaging platform</keyword>
  <keyword>SMS (Short Message Service)</keyword>
  <keyword>Orthopedic conditions</keyword>
  <keyword>Recovery curves</keyword>
  <keyword>Right-size clinic visits</keyword>
  <keyword>CAT</keyword>
  <keyword>SMS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Diseases</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/NCT04441567
org study id: H-38859
nct id: NCT04441567
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Developing novel methods of patient communication is crucial in providing value-based care to
      orthopedic patients. Healthcare technology platforms have been developed to improve patient
      communication methods particularly for the administration of patient-reported outcome
      measures (PROMs). However, the majority of these interventions rely on web-based platforms
      that require patients to have computer access. Among American households earning less than
      $30,000 per year, only 59% have access to a desktop or laptop and just 47% have broadband
      internet at home compared to mobile phone penetration which is estimated at 95% of which 93%
      regularly use text messages. The use of phone messaging may be the most effective means to
      have patients complete PROMs.

      The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH-funded,
      clinically validated method of tracking patient-reported outcomes to efficiently assess
      patient health status. PROMIS utilizes Item Response Theory (IRT) and computerized adaptive
      testing (CAT) to improve measurement precision and decrease survey time as compared to
      traditional PROMs.

      The purpose of this two-phase study is to utilize Memora Health's text-messaging platform to
      collect web-based PROMIS CAT surveys from patients (Phase 1) and use this information to
      right-size clinic visits (Phase 2).
Phase 1 will be a prospective evaluation of patients with the conditions listed. After
      consent, participants will complete PROMIS CAT questionnaires on their mobile phones to
      assess health status. During enrollment, participants will choose a method of completing the
      surveys throughout the duration of the study. The participants will either 1) receive a short
      message service(SMS) with a secure weblink to complete these PROMIS CAT questionnaires on a
      secure website, or 2) engage in two-way SMS communication by answering the survey questions
      individually by texting back their answers. The investigators will explain that the desired
      method of participation is by weblink due to privacy issues associated with two-way texting.
      The frequency at which the questionnaires will be sent is condition-specific. All patients
      will be seen in clinic at standard follow up time-points and will be asked to complete PROMIS
      questionnaires during each clinic visit, identical to the delivery of surveys while at home.
      The PROMIS measures collected over a 1-year period will be used to develop patient-based
      recovery curves.

      Phase 2 will begin at the end of Phase 1 and compare each participant's recovery (based on
      the PROMs) against the established recovery curve that was generated in Phase 1 for their
      orthopedic condition. The investigators will right-size in-person clinic visits based on
      individual recovery as compared with expected recovery. Earlier clinic appointments will be
      given to participants at risk for a poor outcome (defined as any PROMIS score ≥1 standard
      deviation below the mean). All other participants will receive a phone call to make sure that
      participants feel they are doing well and to have any issues addressed. If it is felt that a
      visit is warranted, it will be recommended, and if a subject wishes to have a visit it will
      be scheduled. If the subject is happy with their progress, then that in-person clinic visit
      will be deferred until the next standard follow-up visit and the same process will occur.
      Some in-person visits will be mandatory when a physical exam or x-ray is required for optimal
      care. These are condition specific. For all participants, a final in-person follow-up visit
      will occur unless the subject is happy and does not want to be seen in person.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: This is a two-phase pilot study recruiting approximately 1500 subjects in each of the two phases. Phase 1 - No intervention, create recovery curves only. Phase 2 - Adjust clinic follow-up based on patient responses in relation to recovery curves generated from Phase 1.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Right-size clinic visits for specific orthopedic conditions
time frame: 2 years
description: Right-size clinic visits for patients recovering at/better than expected while maintaining or improving overall patient-reported outcomes (PROMS) will be assessed by comparing to the mean condition-specific recovery curve from phase 1. Earlier clinic visits will be scheduled for those who are more than 1 standard deviation from the mean recovery at any time point and less frequent visits for all others to establish the right size clinic visits.
measure: Patient-based recovery curves for specific orthopedic conditions
time frame: 1 year
description: Each participant's recovery (based on the patient-reported outcome measures- PROMs) for their orthopedic condition will be assessed against the established recovery curve that was generated in phase one of the research for their condition.
measure: Average number of PROMs collected through SMS and weblink
time frame: 1 year
description: The number of PROMs collected through SMS and weblink will be assessed. PROMs are standardized, validated questionnaires completed by patients to measure their perception of their functional well-being and health status.
measure: Average number of PROMs collected during clinic visits
time frame: 1 year
description: The number of PROMs collected during clinic visits will be assessed. PROMs are standardized, validated questionnaires completed by patients to measure their perception of their functional well-being and health status.
arm group label: Phase 1
arm group type: No Intervention
description: Participants in phase 1 will be observed and data about their recovery time will be collected from which recovery curves will be calculated for Phase 2
arm group label: Phase 2
arm group type: Experimental
description: Participants in Phase 2 will have their clinic visits potentially revised based on the phase 1 recovery curves which may increase or decrease the number of clinic visits they receive based on the PROMs reported.
intervention type: Other
intervention name: Right-size clinic visits
description: The curve created in Phase 1 will be used to guide the number of clinic visits based on PROMs reported by the participants in Phase 2.
arm group label: Phase 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul Tornetta III, MD
role: Principal Investigator
affiliation: Boston Medical Center
last name: Paul Tornetta III, MD
phone: 617 414 5757
email: Paul.Tornetta@bmc.org
last name: Katarzyna Wegrzyn, MD
phone: 617-414-5757
email: Katarzyna.Wegrzyn@bmc.org
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Musculoskeletal Diseases
sharing ipd: No