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/NCT06014931</url>
    </required_header>
    <id_info>
      <org_study_id>190790-Phase 2</org_study_id>
      <secondary_id>R01AG077644</secondary_id>
      <nct_id>NCT06014931</nct_id>
    </id_info>
    <brief_title>Telehealth-enhanced Patient-oriented Recovery Trajectory After Intensive Care</brief_title>
    <acronym>TelePORT</acronym>
    <official_title>Telehealth-enhanced Patient-oriented Recovery Trajectory After Intensive Care</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Vanderbilt University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Aging (NIA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>Ohio State University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Vanderbilt 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>
        Intact cognitive skills are necessary for independent living, going to work, and managing&#xD;
        finances, and any loss of cognitive skills places a burden on society akin to what is seen&#xD;
        with Alzheimer's Disease and Related Dementias. The TelePORT Study (Telehealth-Enhanced&#xD;
        Patient-Oriented Recovery Trajectories after Intensive Care) is the first post-intensive care&#xD;
        syndrome longitudinal long-term cognitive impairment intervention study. The societal effect&#xD;
        from long-term cognitive impairment after critical illness is great as many of these patients&#xD;
        are employable adults or functional retirees.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Up to 80% of Intensive Care Unit (ICU) survivors experience cognitive, physical, mental, and&#xD;
        socioeconomic impairments, known as Post-Intensive Care Syndrome (PICS), that can last months&#xD;
        to years following critical illness and lead to significant reductions in quality of life.&#xD;
        Among historical cohorts of acute respiratory distress syndrome and sepsis survivors, as many&#xD;
        as 80% demonstrate PICS-related acquired dementia. Likewise, in a broad group of ICU&#xD;
        survivors in all adult age groups, 33% to 50% have acquired dementia. ICU Recovery Clinics&#xD;
        (ICU-RC) are a feasible and promising intervention to address multifactorial PICS impairments&#xD;
        collaboratively, but in-person access is limited. There is an unmet need to study the&#xD;
        efficacy of clinics with large cohorts that apply alternative delivery strategies to enhance&#xD;
        availability and reach. Older adult (age &gt;=45) ICU survivor is at a combined risk for&#xD;
        long-term cognitive impairment (LTCI) among other PICS impairments, and the ideal population&#xD;
        to first address this knowledge gap. The investigators hypothesize that a collaborative&#xD;
        telemedicine-delivered interdisciplinary ICU-RC intervention effectively identifies and&#xD;
        improves LTCI, physical and mental health dysfunction, social integration, and&#xD;
        self-management behaviors vs. a control condition with follow-up chosen by the discharge&#xD;
        team. Therefore, in a sample of older septic shock and acute respiratory failure survivors,&#xD;
        the investigators aim to examine the efficacy of telemedicine ICU-RC services vs. control&#xD;
        follow-up chosen by the discharge team in identifying PICS impairments and improving&#xD;
        cognitive, physical, and mental health function; and social integration and self-management&#xD;
        behaviors at 6 months after hospital discharge. This willl be achieved via a randomized&#xD;
        controlled trial of 202 patients randomized 1:1 with age stratification to telemedicine&#xD;
        ICU-RC or control (101 per group). Telemedicine recipients will receive a minimum of 2 ICU-RC&#xD;
        visits within 3 months of hospital discharge or return to home if discharged to another&#xD;
        institution, with additional follow-up determined by the severity of PICS impairment.&#xD;
        Cognitive, mental health, and physical outcomes will be measured using the Long-term Core&#xD;
        Outcome Measurement Set for ICU survivors in addition to the Social Network Index and Patient&#xD;
        Activation Measure. Measures are timed to assess pre-hospital, 1-week post-discharge, and&#xD;
        6-month post-discharge functioning trajectories. This research will provide scientific&#xD;
        justification for the continued development, implementation, and scaling of ICU recovery care&#xD;
        programs. Ultimately, such knowledge can improve the quality of life for millions of ICU&#xD;
        survivors and their family members.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 15, 2024</start_date>
    <completion_date type="Anticipated">May 31, 2028</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2027</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cognitive function - MoCA</measure>
      <time_frame>6 months</time_frame>
      <description>The Montreal Cognitive Assessment-Blind is a 13-item widely used research measure for cognitive function that assesses memory, attention, language, recall, orientation, and abstraction. Test scores range from 0 (worst) to 22 (best) with a score below 18 being abnormal. Individual tasks on the MoCA-Blind are relatively difficult, reflecting less of a ceiling effect than comparable tools. Among widely used global screening measures, the MoCA has been consistently found to be the most sensitive in identifying even mild expressions of cognitive impairment.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive function - PROMIS</measure>
      <time_frame>6 months</time_frame>
      <description>The PROMIS Cognitive Function is an 8-item patient-reported outcome measure assessing patient-perceived changes in mental acuity, verbal/nonverbal memory, verbal fluency, and concentration. Raw scores are converted to a standardized T-score with a mean of 50. Higher T-scores indicates better cognitive function.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Physical function - ADL</measure>
      <time_frame>6 months</time_frame>
      <description>Katz's Activities of Daily Living (ADL) is a 6-item self-report of ability to perform ADLs (e.g., bathing, dressing) independently. Items are scored as 0 (dependent) or 1 (independence). Summary scores range from 0-6 with lower scores indicating greater dependence.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical function - IADL</measure>
      <time_frame>6 months</time_frame>
      <description>Lawton's Instrumental Activities of Daily Living (IADL) is an 8-item self-report of independence in performing IADLs (e.g., meal preparation, finance management). Items are scored as 0 (dependent) or 1 (independence). Summary scores range from 0-8 with lower scores indicating greater dependence.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical function - quality of life</measure>
      <time_frame>6 months</time_frame>
      <description>EuroQol-5D-5L is a 6-item self-report questionnaire of health status. Items are scored on 5 levels of severity ranging from 'no problems' to 'extreme problems' and higher scores indicating worse quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mental health - PTSD</measure>
      <time_frame>6 months</time_frame>
      <description>PTSD symptoms will be measured using the Impact of Events Scale-Revised (IES-R), a 22-item tool designed to measure the subjective distress caused by traumatic events. Subjects rate each item from 0 (not at all) to 4 (extremely) to indicate the degree to which they have been bothered by a particular symptom over the past week. Total score is obtained by calculating the mean of all items. Subscale scores can be calculated for avoidance, hyperarousal, and intrusion. Higher scores indicate more distress related to the specific event being evaluated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mental health - anxiety/depression</measure>
      <time_frame>6 months</time_frame>
      <description>Depression and Anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report. Subjects rate each item from 0 (absence) to 3 (extreme) to indicate the degree to which they have experienced the symptom in the past 7 days. The total possible score ranges from 0-21 per subscale with more than 11 being abnormal.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Social integration</measure>
      <time_frame>6 months</time_frame>
      <description>Berkman-Syme's Social Network Index measure of marital status, friends/family contact, church membership, and group membership. The index considers number and importance of social ties across categories using a summative measure (range: 0-4). For example, there is heavier weighting for intimate contacts (4x the weight of group membership) over church membership (2x the weight of group membership).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self management</measure>
      <time_frame>6 months</time_frame>
      <description>Patient Activation Measure, a 13-item survey quantifying how much someone is informed about and involved in their health care. The raw score is converted to an activation score (range: 0 [no activation] to 100 [high activation]). Domains assess importance of active role, confidence and knowledge to take action, taking action, and continuing healthy behaviors under stress.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Post-Traumatic Growth</measure>
      <time_frame>6 months</time_frame>
      <description>Post-Traumatic Growth Inventory, a 21-item scale with higher scores indicating greater post-traumatic growtth</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">202</enrollment>
    <condition>Post-intensive Care Syndrome</condition>
    <arm_group>
      <arm_group_label>Telemedicine ICU Recovery Clinic</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>scheduled telemedicine study visits 3 weeks and 3 months after hospital discharge or return-to-home if discharged to another facility</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard Recovery Conditions (i.e., Control)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Control group participants will proceed with follow-up as determined by the discharging hospital team and directed to use the provided PICS guide to connect with commonly used resources.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Telemedicine ICU Recovery Clinic Visit</intervention_name>
      <description>Multidisciplinary clinic visit that encompasses a medical examination, medication management, neuropsychological exam with focused psychotherapy, case management, and patient-centered consultation.</description>
      <arm_group_label>Telemedicine ICU Recovery Clinic</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults (age ≥45)&#xD;
  &#xD;
            -  Admitted to a medical or surgical ICU&#xD;
  &#xD;
            -  Treated for ARF (with mechanical ventilation) and/or septic shock (with vasopressors)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  hospice care at discharge or not expected to survive 6 months&#xD;
  &#xD;
            -  no access to a computer or electronic device (e.g., tablet, smart phone) with cellular&#xD;
               or WiFi connection for a telemedicine clinic visit&#xD;
  &#xD;
            -  substance abuse or psych disorder that prevents independent living&#xD;
  &#xD;
            -  inability to speak English&#xD;
  &#xD;
            -  severe dementia preventing independent living prior to index hospitalization&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Leanne M Boehm, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Vanderbilt University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Leanne M Boehm, PhD</last_name>
      <phone>615-343-1051</phone>
      <email>leanne.boehm@vanderbilt.edu</email>
    </overall_contact>
    <link>
      <url>https://nursing.vanderbilt.edu/people/bio/leanne-boehm</url>
      <description>PI profile</description>
    </link>
    <link>
      <url>https://www.icudelirium.org/the-icu-recovery-center-at-vanderbilt</url>
      <description>Vanderbilt ICU Recovery Center</description>
    </link>
    <reference>
      <citation>Boehm LM, Danesh V, Eaton TL, McPeake J, Pena MA, Bonnet KR, Stollings JL, Jones AC, Schlundt DG, Sevin CM. Multidisciplinary ICU Recovery Clinic Visits: A Qualitative Analysis of Patient-Provider Dialogues. Chest. 2023 Apr;163(4):843-854. doi: 10.1016/j.chest.2022.10.001. Epub 2022 Oct 13.</citation>
      <PMID>36243061</PMID>
    </reference>
    <reference>
      <citation>Boehm LM, Danesh V, LaNoue M, Trochez RJ, Jones AC, Kimpel CC, Sevin CM. Factors Influencing Engagement with in-Person Intensive Care Unit Recovery Clinic Services. J Intensive Care Med. 2023 Apr;38(4):375-381. doi: 10.1177/08850666221127154. Epub 2022 Sep 21.</citation>
      <PMID>36128790</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Vanderbilt University</investigator_affiliation>
      <investigator_full_name>Leanne M Boehm</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Sharing data generated by this project is an essential part of the proposed research. The investigators seek to make data available to the community of scientists interested in ICU recovery care, specifically related to older adults attending ICU-RCs. The TelePORT trial will yield longitudinal outcomes data from approximately 202 adults. The final data set will contain de-identified demographic information and patient outcome responses on PICS, social integration, self-management, and other exploratory outcomes. Data will be available for sharing after the publication date of the main results from the final dataset.</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_time_frame>after study completion</ipd_time_frame>
      <ipd_access_criteria>When approval is granted, data-sharing agreements that provide for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed will be instituted. Requests for data must be made in writing and must clearly state the intended use of the requested data and expected length of time for data analyses. This request must be sent directly to the study contact PI who will record all requests for NIH reporting and secure IRB involvement in the process.</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/NCT06014931
  org study id: 190790-Phase 2
  secondary id: R01AG077644
  nct id: NCT06014931
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Intact cognitive skills are necessary for independent living, going to work, and managing
        finances, and any loss of cognitive skills places a burden on society akin to what is seen
        with Alzheimer's Disease and Related Dementias. The TelePORT Study (Telehealth-Enhanced
        Patient-Oriented Recovery Trajectories after Intensive Care) is the first post-intensive care
        syndrome longitudinal long-term cognitive impairment intervention study. The societal effect
        from long-term cognitive impairment after critical illness is great as many of these patients
        are employable adults or functional retirees.
  Up to 80% of Intensive Care Unit (ICU) survivors experience cognitive, physical, mental, and
        socioeconomic impairments, known as Post-Intensive Care Syndrome (PICS), that can last months
        to years following critical illness and lead to significant reductions in quality of life.
        Among historical cohorts of acute respiratory distress syndrome and sepsis survivors, as many
        as 80% demonstrate PICS-related acquired dementia. Likewise, in a broad group of ICU
        survivors in all adult age groups, 33% to 50% have acquired dementia. ICU Recovery Clinics
        (ICU-RC) are a feasible and promising intervention to address multifactorial PICS impairments
        collaboratively, but in-person access is limited. There is an unmet need to study the
        efficacy of clinics with large cohorts that apply alternative delivery strategies to enhance
        availability and reach. Older adult (age >=45) ICU survivor is at a combined risk for
        long-term cognitive impairment (LTCI) among other PICS impairments, and the ideal population
        to first address this knowledge gap. The investigators hypothesize that a collaborative
        telemedicine-delivered interdisciplinary ICU-RC intervention effectively identifies and
        improves LTCI, physical and mental health dysfunction, social integration, and
        self-management behaviors vs. a control condition with follow-up chosen by the discharge
        team. Therefore, in a sample of older septic shock and acute respiratory failure survivors,
        the investigators aim to examine the efficacy of telemedicine ICU-RC services vs. control
        follow-up chosen by the discharge team in identifying PICS impairments and improving
        cognitive, physical, and mental health function; and social integration and self-management
        behaviors at 6 months after hospital discharge. This willl be achieved via a randomized
        controlled trial of 202 patients randomized 1:1 with age stratification to telemedicine
        ICU-RC or control (101 per group). Telemedicine recipients will receive a minimum of 2 ICU-RC
        visits within 3 months of hospital discharge or return to home if discharged to another
        institution, with additional follow-up determined by the severity of PICS impairment.
        Cognitive, mental health, and physical outcomes will be measured using the Long-term Core
        Outcome Measurement Set for ICU survivors in addition to the Social Network Index and Patient
        Activation Measure. Measures are timed to assess pre-hospital, 1-week post-discharge, and
        6-month post-discharge functioning trajectories. This research will provide scientific
        justification for the continued development, implementation, and scaling of ICU recovery care
        programs. Ultimately, such knowledge can improve the quality of life for millions of ICU
        survivors and their family members.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Cognitive function - MoCA
  time frame: 6 months
  description: The Montreal Cognitive Assessment-Blind is a 13-item widely used research measure for cognitive function that assesses memory, attention, language, recall, orientation, and abstraction. Test scores range from 0 (worst) to 22 (best) with a score below 18 being abnormal. Individual tasks on the MoCA-Blind are relatively difficult, reflecting less of a ceiling effect than comparable tools. Among widely used global screening measures, the MoCA has been consistently found to be the most sensitive in identifying even mild expressions of cognitive impairment.
  measure: Cognitive function - PROMIS
  time frame: 6 months
  description: The PROMIS Cognitive Function is an 8-item patient-reported outcome measure assessing patient-perceived changes in mental acuity, verbal/nonverbal memory, verbal fluency, and concentration. Raw scores are converted to a standardized T-score with a mean of 50. Higher T-scores indicates better cognitive function.
  measure: Physical function - ADL
  time frame: 6 months
  description: Katz's Activities of Daily Living (ADL) is a 6-item self-report of ability to perform ADLs (e.g., bathing, dressing) independently. Items are scored as 0 (dependent) or 1 (independence). Summary scores range from 0-6 with lower scores indicating greater dependence.
  measure: Physical function - IADL
  time frame: 6 months
  description: Lawton's Instrumental Activities of Daily Living (IADL) is an 8-item self-report of independence in performing IADLs (e.g., meal preparation, finance management). Items are scored as 0 (dependent) or 1 (independence). Summary scores range from 0-8 with lower scores indicating greater dependence.
  measure: Physical function - quality of life
  time frame: 6 months
  description: EuroQol-5D-5L is a 6-item self-report questionnaire of health status. Items are scored on 5 levels of severity ranging from 'no problems' to 'extreme problems' and higher scores indicating worse quality of life.
  measure: Mental health - PTSD
  time frame: 6 months
  description: PTSD symptoms will be measured using the Impact of Events Scale-Revised (IES-R), a 22-item tool designed to measure the subjective distress caused by traumatic events. Subjects rate each item from 0 (not at all) to 4 (extremely) to indicate the degree to which they have been bothered by a particular symptom over the past week. Total score is obtained by calculating the mean of all items. Subscale scores can be calculated for avoidance, hyperarousal, and intrusion. Higher scores indicate more distress related to the specific event being evaluated.
  measure: Mental health - anxiety/depression
  time frame: 6 months
  description: Depression and Anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report. Subjects rate each item from 0 (absence) to 3 (extreme) to indicate the degree to which they have experienced the symptom in the past 7 days. The total possible score ranges from 0-21 per subscale with more than 11 being abnormal.
  measure: Social integration
  time frame: 6 months
  description: Berkman-Syme's Social Network Index measure of marital status, friends/family contact, church membership, and group membership. The index considers number and importance of social ties across categories using a summative measure (range: 0-4). For example, there is heavier weighting for intimate contacts (4x the weight of group membership) over church membership (2x the weight of group membership).
  measure: Self management
  time frame: 6 months
  description: Patient Activation Measure, a 13-item survey quantifying how much someone is informed about and involved in their health care. The raw score is converted to an activation score (range: 0 [no activation] to 100 [high activation]). Domains assess importance of active role, confidence and knowledge to take action, taking action, and continuing healthy behaviors under stress.
  measure: Post-Traumatic Growth
  time frame: 6 months
  description: Post-Traumatic Growth Inventory, a 21-item scale with higher scores indicating greater post-traumatic growtth
  arm group label: Telemedicine ICU Recovery Clinic
  arm group type: Experimental
  description: scheduled telemedicine study visits 3 weeks and 3 months after hospital discharge or return-to-home if discharged to another facility
  arm group label: Standard Recovery Conditions (i.e., Control)
  arm group type: No Intervention
  description: Control group participants will proceed with follow-up as determined by the discharging hospital team and directed to use the provided PICS guide to connect with commonly used resources.
  intervention type: Behavioral
  intervention name: Telemedicine ICU Recovery Clinic Visit
  description: Multidisciplinary clinic visit that encompasses a medical examination, medication management, neuropsychological exam with focused psychotherapy, case management, and patient-centered consultation.
  arm group label: Telemedicine ICU Recovery Clinic
  criteria: 
  gender: All
  minimum age: 45 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Leanne M Boehm, PhD
  role: Principal Investigator
  affiliation: Vanderbilt University
  last name: Leanne M Boehm, PhD
  phone: 615-343-1051
  email: leanne.boehm@vanderbilt.edu
  url: https://nursing.vanderbilt.edu/people/bio/leanne-boehm
  description: PI profile
  url: https://www.icudelirium.org/the-icu-recovery-center-at-vanderbilt
  description: Vanderbilt ICU Recovery Center
  citation: Boehm LM, Danesh V, Eaton TL, McPeake J, Pena MA, Bonnet KR, Stollings JL, Jones AC, Schlundt DG, Sevin CM. Multidisciplinary ICU Recovery Clinic Visits: A Qualitative Analysis of Patient-Provider Dialogues. Chest. 2023 Apr;163(4):843-854. doi: 10.1016/j.chest.2022.10.001. Epub 2022 Oct 13.
  PMID: 36243061
  citation: Boehm LM, Danesh V, LaNoue M, Trochez RJ, Jones AC, Kimpel CC, Sevin CM. Factors Influencing Engagement with in-Person Intensive Care Unit Recovery Clinic Services. J Intensive Care Med. 2023 Apr;38(4):375-381. doi: 10.1177/08850666221127154. Epub 2022 Sep 21.
  PMID: 36128790
  responsible party type: Principal Investigator
  investigator affiliation: Vanderbilt University
  investigator full name: Leanne M Boehm
  investigator title: Assistant Professor
  sharing ipd: Yes
  ipd description: Sharing data generated by this project is an essential part of the proposed research. The investigators seek to make data available to the community of scientists interested in ICU recovery care, specifically related to older adults attending ICU-RCs. The TelePORT trial will yield longitudinal outcomes data from approximately 202 adults. The final data set will contain de-identified demographic information and patient outcome responses on PICS, social integration, self-management, and other exploratory outcomes. Data will be available for sharing after the publication date of the main results from the final dataset.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: after study completion
  ipd access criteria: When approval is granted, data-sharing agreements that provide for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed will be instituted. Requests for data must be made in writing and must clearly state the intended use of the requested data and expected length of time for data analyses. This request must be sent directly to the study contact PI who will record all requests for NIH reporting and secure IRB involvement in the process.