<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/NCT04414787</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00101745</org_study_id>
    <secondary_id>R01AG058915</secondary_id>
    <nct_id>NCT04414787</nct_id>
  </id_info>
  <brief_title>A Needs-focused Palliative Care Intervention for Older Adults in ICUs</brief_title>
  <acronym>PCplanner</acronym>
  <official_title>Operationalizing PCplanner, a Needs-focused Palliative Care for Older Adults in Intensive Care Units: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke 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>
      The quality of intensive care unit (ICU)-based palliative care is highly variable,&#xD;
      particularly for the 2 million older adults admitted annually to ICUs. To address these care&#xD;
      delivery barriers among older ICU patients, a mobile app platform called PCplanner&#xD;
      (Palliative Care planner) was developed. PCplanner automates the identification of high-risk&#xD;
      patients (e.g., dementia, declining health status, poor functioning) by directly capturing&#xD;
      data from electronic health record (EHR) systems, cultivates family engagement with&#xD;
      supportive information and a digital system for self-report of actual needs, and facilitates&#xD;
      the delivery of care to those with a high burden of need by coordinating collaboration&#xD;
      between ICU teams and palliative care specialists.&#xD;
&#xD;
      150 patients, 150 family caregivers, and 75 physicians from academic and community settings&#xD;
      will be enrolled in a RCT designed to test the efficacy of PCplanner-augmented collaborative&#xD;
      palliative care vs usual care. Family caregiver and clinician experiences will be explored&#xD;
      using mixed methods to understand intervention mechanisms as well as implementation barriers&#xD;
      within diverse case contexts. The key hypothesis is that compared to usual care, PCplanner&#xD;
      will reduce family caregivers' unmet needs and psychological distress, increase the frequency&#xD;
      of goal concordant treatment among older adult patients, and reduce hospital length of stay.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The quality of intensive care unit (ICU)-based palliative care is highly variable,&#xD;
      particularly for the 2 million older adults admitted annually to ICUs. However, improving&#xD;
      care quality on a broad scale with the efficient delivery of patient-centered, need-targeted&#xD;
      palliative care is challenging because of logistical and technological barriers. To address&#xD;
      these care delivery barriers among older ICU patients, a mobile app platform called PCplanner&#xD;
      (Palliative Care planner) was developed. PCplanner automates the identification of high-risk&#xD;
      patients (e.g., dementia, declining health status, poor functioning) by directly capturing&#xD;
      data from electronic health record (EHR) systems, cultivates family engagement with&#xD;
      supportive information and a digital system for self-report of actual needs, and facilitates&#xD;
      the delivery of care to those with a high burden of need by coordinating collaboration&#xD;
      between ICU teams and palliative care specialists. In pilot comparison to a standard&#xD;
      palliative care control, the intervention reduced unmet needs, psychological distress, and&#xD;
      length of stay and increased goal concordant care, communication, and hospice utilization.&#xD;
&#xD;
      While these data are compelling, an efficacy evaluation of PCplanner is needed. Therefore,&#xD;
      150 patients, 150 family caregivers, and 75 physicians will be enrolled from academic and&#xD;
      community settings in a project with 2 key aims: (1) Test the efficacy of PCplanner-augmented&#xD;
      collaborative palliative care vs usual care in a randomized clinical trial (RCT) with 3-month&#xD;
      follow up, and (2) Explore family caregiver and clinician experiences using mixed methods to&#xD;
      understand intervention mechanisms as well as implementation barriers within diverse case&#xD;
      contexts. The key hypothesis is that compared to usual care, PCplanner will reduce family&#xD;
      caregivers' unmet needs and psychological distress, increase the frequency of goal concordant&#xD;
      treatment among older adult patients, and reduce hospital length of stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 22, 2021</start_date>
  <completion_date type="Anticipated">November 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 1, 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>Randomized clinical trial comparing intervention to usual care control.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>All masking done via differential user accesses allowed by a mobile app platform.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale total score</measure>
    <time_frame>Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization)</time_frame>
    <description>A palliative care needs instrument. Scores range from 0 (no needs) to 130 (higher needs)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire 9-Item scale (PHQ-9)</measure>
    <time_frame>Time 1 (baseline), Time 3 (target ~1 week post-randomization), and Time 4 (3 months post-randomization)</time_frame>
    <description>A depression symptoms instrument. Scores range from 0 (no depression symptoms) to 27 (higher depression symptoms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generalized Anxiety Disorder 7-Item scale (GAD-7)</measure>
    <time_frame>Time 1 (baseline), Time 3 (target ~1 week post-randomization), and Time 4 (3 months post-randomization)</time_frame>
    <description>An anxiety symptoms instrument. Scores range from 0 (no anxiety symptoms) to 21 (higher anxiety symptoms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-Traumatic Stress Symptom (PTSS) inventory</measure>
    <time_frame>Time 1 (baseline) and Time 4 (3 months post-randomization)</time_frame>
    <description>A post-traumatic stress disorder symptom instrument. Scores range from 10 (low PTSD symptoms) to 70 (higher PTSD symptoms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Goal concordant care</measure>
    <time_frame>Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization)</time_frame>
    <description>A measure of hospital days after randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Perceived Patient-Centeredness (PPPC) scale</measure>
    <time_frame>Time 3 (target ~1 week post-randomization)</time_frame>
    <description>A measure of patient-centeredness with scores that range from 12 (higher patient-centeredness) to 48 (lower patient-centeredness)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-randomization intensive care unit length of stay</measure>
    <time_frame>Across the entire hospitalization after randomization (approximately 2 weeks)</time_frame>
    <description>A measure of intensive care unit days after randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-randomization hospital length of stay</measure>
    <time_frame>Across the entire hospitalization after randomization (approximately 2 weeks)</time_frame>
    <description>A measure of hospital days after randomization</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Palliative Care</condition>
  <condition>Critical Illness</condition>
  <condition>Aging</condition>
  <condition>Care Delivery Model</condition>
  <condition>Informal Caregivers</condition>
  <condition>Psychological Distress</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PCplanner intervention during hospitalization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PCplanner</intervention_name>
    <description>PCplanner-augmented care. The PCplanner mobile app will allow patients / family members to report their needs in a platform viewable by ICU physicians. Should the needs not improve over time, the palliative care team will be activated to contribute to care.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        PATIENTS&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥50 years of age&#xD;
&#xD;
          -  Receive care in a study ICU for ≥24 hours&#xD;
&#xD;
          -  Meets ≥1 of 9 high risk phenotypes a. Dementia (e.g., Alzheimer's, multi-infarct,&#xD;
             other dementia etiology) b. Declining health status defined by EITHER: i. ≥2 hospital&#xD;
             admissions in 3 months preceding current admission OR ii. &gt;1 ICU admission in 3 months&#xD;
             preceding current admission c. Poor functional status defined by EITHER: i. admit from&#xD;
             Skilled Nursing Facility (SNF) or Long-Term Acute Care (LTAC) facility OR ii. ≥3&#xD;
             activities of daily living (ADL) limitations at admission d. Severe acute illness&#xD;
             defined by EITHER: i. cardiac arrest OR ii. multisystem organ failure (≥3 of: lung,&#xD;
             kidney, hematological, brain, cardiac, liver) that has worsened over 48 hours (i.e.,&#xD;
             Sequential Organ Failure Assessment [SOFA] score increase) e. Severe acute stroke&#xD;
             (e.g., acute intracranial hemorrhage, ischemic stroke, or traumatic brain injury) f.&#xD;
             Acute respiratory failure (ventilation or high oxygen support for ≥24 hours) g. Acute&#xD;
             renal failure (new hemodialysis or continuous venovenous hemodiafiltration for ≥1&#xD;
             hour) h. Advanced cancer (Advanced / metastatic cancer diagnosis) i. Shock (use of&#xD;
             vasopressor or inotrope for ≥4 hours)&#xD;
&#xD;
        Exclusion Criteria (pre-consent):&#xD;
&#xD;
          -  Palliative care consultation performed during the hospitalization before eligibility&#xD;
             determination&#xD;
&#xD;
          -  Current admission to ICU at the index hospital ≥8 days&#xD;
&#xD;
          -  Imprisoned&#xD;
&#xD;
          -  No known family or surrogate decision maker&#xD;
&#xD;
          -  Death expected within 24 hours&#xD;
&#xD;
        Exclusion Criteria (post-consent):&#xD;
&#xD;
        - Patient dies before T2&#xD;
&#xD;
        FAMILY MEMBER&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years of age&#xD;
&#xD;
          -  Self-described as the individual (related or unrelated) who provides the most support&#xD;
             and with whom the patient has a significant relationship (per definition of 'family'&#xD;
             described in the Society of Critical Care Medicine 2016 Guidelines for Family-Centered&#xD;
             Care in the Neonatal, Pediatric, and Adult ICU)&#xD;
&#xD;
        Exclusion Criteria (pre-consent):&#xD;
&#xD;
          -  Lack a knowledge of English such that the potential participant is not confident that&#xD;
             they could complete study tasks (app viewing, surveys)&#xD;
&#xD;
          -  Imprisoned&#xD;
&#xD;
          -  Unable to complete surveys for any reason&#xD;
&#xD;
        Exclusion Criteria (post-consent):&#xD;
&#xD;
        - Low need burden (NEST score &lt;10) at baseline&#xD;
&#xD;
        ICU PHYSICIANS&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years of age&#xD;
&#xD;
          -  Attending or fellow physician in a study ICU&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christopher Cox, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Allie Frear</last_name>
    <phone>919-684-8914</phone>
    <email>allie.frear@duke.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Christopher Cox, MD</last_name>
    <phone>919-681-7232</phone>
    <email>Christopher.cox@duke.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Allie Frear</last_name>
      <phone>919-684-8914</phone>
      <email>allie.frear@duke.edu</email>
    </contact>
    <investigator>
      <last_name>Christopher Cox, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://pcplanner.duke.edu</url>
    <description>general trial information</description>
  </link>
  <reference>
    <citation>Cox CE, Jones DM, Reagan W, Key MD, Chow V, McFarlin J, Casarett D, Creutzfeldt CJ, Docherty SL. Palliative Care Planner: A Pilot Study to Evaluate Acceptability and Usability of an Electronic Health Records System-integrated, Needs-targeted App Platform. Ann Am Thorac Soc. 2018 Jan;15(1):59-68. doi: 10.1513/AnnalsATS.201706-500OC.</citation>
    <PMID>29121480</PMID>
  </reference>
  <reference>
    <citation>Cox CE, Olsen MK, Casarett D, Haines K, Al-Hegelan M, Bartz RR, Katz JN, Naglee C, Ashana D, Gilstrap D, Gu J, Parish A, Frear A, Krishnamaneni D, Corcoran A, Docherty SL. Operationalizing needs-focused palliative care for older adults in intensive care units: Design of and rationale for the PCplanner randomized clinical trial. Contemp Clin Trials. 2020 Nov;98:106163. doi: 10.1016/j.cct.2020.106163. Epub 2020 Sep 29.</citation>
    <PMID>33007442</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>January 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>palliative care</keyword>
  <keyword>Intensive Care Unit</keyword>
  <keyword>critical illness</keyword>
  <keyword>mobile app</keyword>
  <keyword>care delivery</keyword>
  <keyword>informal caregiver</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Per NIH and Duke University policies after trial and analyses completed.</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>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
  </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/NCT04414787
org study id: Pro00101745
secondary id: R01AG058915
nct id: NCT04414787
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The quality of intensive care unit (ICU)-based palliative care is highly variable,
      particularly for the 2 million older adults admitted annually to ICUs. To address these care
      delivery barriers among older ICU patients, a mobile app platform called PCplanner
      (Palliative Care planner) was developed. PCplanner automates the identification of high-risk
      patients (e.g., dementia, declining health status, poor functioning) by directly capturing
      data from electronic health record (EHR) systems, cultivates family engagement with
      supportive information and a digital system for self-report of actual needs, and facilitates
      the delivery of care to those with a high burden of need by coordinating collaboration
      between ICU teams and palliative care specialists.

      150 patients, 150 family caregivers, and 75 physicians from academic and community settings
      will be enrolled in a RCT designed to test the efficacy of PCplanner-augmented collaborative
      palliative care vs usual care. Family caregiver and clinician experiences will be explored
      using mixed methods to understand intervention mechanisms as well as implementation barriers
      within diverse case contexts. The key hypothesis is that compared to usual care, PCplanner
      will reduce family caregivers' unmet needs and psychological distress, increase the frequency
      of goal concordant treatment among older adult patients, and reduce hospital length of stay.
The quality of intensive care unit (ICU)-based palliative care is highly variable,
      particularly for the 2 million older adults admitted annually to ICUs. However, improving
      care quality on a broad scale with the efficient delivery of patient-centered, need-targeted
      palliative care is challenging because of logistical and technological barriers. To address
      these care delivery barriers among older ICU patients, a mobile app platform called PCplanner
      (Palliative Care planner) was developed. PCplanner automates the identification of high-risk
      patients (e.g., dementia, declining health status, poor functioning) by directly capturing
      data from electronic health record (EHR) systems, cultivates family engagement with
      supportive information and a digital system for self-report of actual needs, and facilitates
      the delivery of care to those with a high burden of need by coordinating collaboration
      between ICU teams and palliative care specialists. In pilot comparison to a standard
      palliative care control, the intervention reduced unmet needs, psychological distress, and
      length of stay and increased goal concordant care, communication, and hospice utilization.

      While these data are compelling, an efficacy evaluation of PCplanner is needed. Therefore,
      150 patients, 150 family caregivers, and 75 physicians will be enrolled from academic and
      community settings in a project with 2 key aims: (1) Test the efficacy of PCplanner-augmented
      collaborative palliative care vs usual care in a randomized clinical trial (RCT) with 3-month
      follow up, and (2) Explore family caregiver and clinician experiences using mixed methods to
      understand intervention mechanisms as well as implementation barriers within diverse case
      contexts. The key hypothesis is that compared to usual care, PCplanner will reduce family
      caregivers' unmet needs and psychological distress, increase the frequency of goal concordant
      treatment among older adult patients, and reduce hospital length of stay.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized clinical trial comparing intervention to usual care control.
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
masking description: All masking done via differential user accesses allowed by a mobile app platform.
measure: Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale total score
time frame: Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization)
description: A palliative care needs instrument. Scores range from 0 (no needs) to 130 (higher needs)
measure: Patient Health Questionnaire 9-Item scale (PHQ-9)
time frame: Time 1 (baseline), Time 3 (target ~1 week post-randomization), and Time 4 (3 months post-randomization)
description: A depression symptoms instrument. Scores range from 0 (no depression symptoms) to 27 (higher depression symptoms)
measure: Generalized Anxiety Disorder 7-Item scale (GAD-7)
time frame: Time 1 (baseline), Time 3 (target ~1 week post-randomization), and Time 4 (3 months post-randomization)
description: An anxiety symptoms instrument. Scores range from 0 (no anxiety symptoms) to 21 (higher anxiety symptoms)
measure: Post-Traumatic Stress Symptom (PTSS) inventory
time frame: Time 1 (baseline) and Time 4 (3 months post-randomization)
description: A post-traumatic stress disorder symptom instrument. Scores range from 10 (low PTSD symptoms) to 70 (higher PTSD symptoms)
measure: Goal concordant care
time frame: Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization)
description: A measure of hospital days after randomization
measure: Patient-Perceived Patient-Centeredness (PPPC) scale
time frame: Time 3 (target ~1 week post-randomization)
description: A measure of patient-centeredness with scores that range from 12 (higher patient-centeredness) to 48 (lower patient-centeredness)
measure: Post-randomization intensive care unit length of stay
time frame: Across the entire hospitalization after randomization (approximately 2 weeks)
description: A measure of intensive care unit days after randomization
measure: Post-randomization hospital length of stay
time frame: Across the entire hospitalization after randomization (approximately 2 weeks)
description: A measure of hospital days after randomization
arm group label: Intervention
arm group type: Active Comparator
description: PCplanner intervention during hospitalization
arm group label: Usual care control
arm group type: No Intervention
description: Usual care
intervention type: Behavioral
intervention name: PCplanner
description: PCplanner-augmented care. The PCplanner mobile app will allow patients / family members to report their needs in a platform viewable by ICU physicians. Should the needs not improve over time, the palliative care team will be activated to contribute to care.
arm group label: Intervention
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Christopher Cox, MD
role: Principal Investigator
affiliation: Duke University
last name: Allie Frear
phone: 919-684-8914
email: allie.frear@duke.edu
last name: Christopher Cox, MD
phone: 919-681-7232
email: Christopher.cox@duke.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: http://pcplanner.duke.edu
description: general trial information
citation: Cox CE, Jones DM, Reagan W, Key MD, Chow V, McFarlin J, Casarett D, Creutzfeldt CJ, Docherty SL. Palliative Care Planner: A Pilot Study to Evaluate Acceptability and Usability of an Electronic Health Records System-integrated, Needs-targeted App Platform. Ann Am Thorac Soc. 2018 Jan;15(1):59-68. doi: 10.1513/AnnalsATS.201706-500OC.
PMID: 29121480
citation: Cox CE, Olsen MK, Casarett D, Haines K, Al-Hegelan M, Bartz RR, Katz JN, Naglee C, Ashana D, Gilstrap D, Gu J, Parish A, Frear A, Krishnamaneni D, Corcoran A, Docherty SL. Operationalizing needs-focused palliative care for older adults in intensive care units: Design of and rationale for the PCplanner randomized clinical trial. Contemp Clin Trials. 2020 Nov;98:106163. doi: 10.1016/j.cct.2020.106163. Epub 2020 Sep 29.
PMID: 33007442
responsible party type: Sponsor
mesh term: Critical Illness
sharing ipd: Yes
ipd description: Per NIH and Duke University policies after trial and analyses completed.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code