<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/NCT02258594</url>
  </required_header>
  <id_info>
    <org_study_id>2013P001966</org_study_id>
    <nct_id>NCT02258594</nct_id>
  </id_info>
  <brief_title>Promoting Respect and Ongoing Safety Through Patient-centeredness, Engagement, Communication and Technology</brief_title>
  <acronym>PROSPECT</acronym>
  <official_title>Transforming the Acute Care Environment: BWH PROSPECT Framework</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gordon and Betty Moore Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this project is to refine, implement, and evaluate a multi-component&#xD;
      intervention that achieves sustainable and meaningful impact on healthcare quality, safety,&#xD;
      and costs while ensuring dignity and respect for adult oncology and intensive care patients&#xD;
      and their care partners. The PROSPECT (Promoting Respect and Ongoing Safety through&#xD;
      Patient-centeredness, Engagement, Communication, and Technology) framework will achieve this&#xD;
      by enhancing the patient-provider relationship and introducing patient-centered approaches to&#xD;
      multi-disciplinary communication and patient education. The PROSPECT framework is based upon&#xD;
      a validated structured, team-work training model and novel web-based technology. The&#xD;
      overarching goals of this project are to achieve the following:&#xD;
&#xD;
        1. Optimize the overall experience of patients (including their family/care partners) by&#xD;
           promoting dignity/respect, encouraging engagement, improving care plan concordance, and&#xD;
           enhancing satisfaction.&#xD;
&#xD;
        2. Minimize preventable harms in two environments: intensive care and acute care oncology&#xD;
           units.&#xD;
&#xD;
        3. Reduce unnecessary healthcare resource utilization and associated costs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This overarching project aims are to refine, implement, and evaluate a multi-faceted&#xD;
      intervention composed of the Patient-SatisfActive® model, developed by Drs. Ronen Rozenblum&#xD;
      and David Bates at Brigham and Women's Hospital, and a web-based Patient-Centered Toolkit&#xD;
      (PCTK), developed by Drs. Dykes and Dalal, on quality, safety, and cost outcomes in the&#xD;
      intensive care and oncology units at Brigham and Women's Hospital. The specific aims of the&#xD;
      project are as follows:&#xD;
&#xD;
        -  Aim 1: To refine and implement the Patient-SatisfActive® model to promote respect,&#xD;
           dignity, and satisfaction of patients, care partners and staff on intensive care and&#xD;
           oncology units.&#xD;
&#xD;
        -  Aim 2: To refine and implement a web-based, Patient-Centered Toolkit (PCTK), comprised&#xD;
           of an electronic bedside communication center (eBCC) and a patient-centered microblog,&#xD;
           to promote tailored patient and care-partner education, communication, collaboration,&#xD;
           and engagement.&#xD;
&#xD;
        -  Aim 3: To evaluate the relative impact of this intervention compared to usual care on&#xD;
           patient reported outcome measures, adverse events (harms), post-discharge healthcare&#xD;
           utilization, concordance in understanding the care plan, and satisfaction among care&#xD;
           team members (patients/care partners, profession providers).&#xD;
&#xD;
        -  Aim 4: To identify the barriers and facilitators of implementing this intervention to&#xD;
           support dissemination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Preventable Harms (Adverse Events) in the Acute Care Setting</measure>
    <time_frame>Enrolled patients will be followed for the duration of hospital stay, typically ranging from 5 to 30 days.</time_frame>
    <description>Preventable adverse events in the acute care setting include medication errors, patient falls, veno-thromboembolism, hospital acquired infection, central line related bloodstream infection, ventilator associated pneumonia, catheter associated urinary tract infection, newly acquired physical harm/injury. We will measure the rate of adverse events acquired from the time of admission to study units through hospital discharge. Using an adaptation of the Institute for Healthcare Improvement (IHI) Global Trigger Tool, we will randomly sample charts of enrolled patients from intervention and control units during the pre-intervention and post-intervention periods to identify adverse events. The length of hospital stay for patients admitted to medical intensive care and oncology units at our institution is variable, typically ranging from 5 to 30 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Experience &amp; Satisfaction &amp; Engagement</measure>
    <time_frame>At time of transfer/discharger from study unit and up to 45-days post-hospitalization</time_frame>
    <description>Randomly selected patients transferred from the MICU units will receive FS-ICU survey, semi-structured interviews, and 45-day post-hospitalization phone survey&#xD;
Randomly selected patients discharged from Oncology units will receive semi-structured interviews and 45-day post-hospitalization phone survey. Data from national patient satisfaction survey, HCAHPS, will be collected and analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare Resource Utilization</measure>
    <time_frame>From time of hospital admission through 30-days post-discharge</time_frame>
    <description>Inpatient healthcare utilization measures: Total cost of hospitalization and hospital length of stay (total, ICU, and non-ICU) from administrative data for each enrolled patient.&#xD;
Post-discharge healthcare utilization measures: Rate of unscheduled utilization of health care resources (ambulatory/urgent care visits, emergency room visits, hospital readmissions) during the 30-day post-discharge period using the combination of administrative data and patient reports during their 30-day interview.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Care Plan Concordance</measure>
    <time_frame>Approximately 48-72 hours after admission to study unit</time_frame>
    <description>Structured interviews (9-question survey) with patient/care partners, a member of the inpatient medical team (attending, resident, or intern), inpatient nurses, and one additional care team member (e.g., PCP, ambulatory specialists) will be conducted after admission to MICU or Oncology units. Concordance for each item of survey will be rated on a 3-point scale (0, 1, 2) for each dyad. The scores of all dyads will be summed as a global concordance score for each patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceptions of Communication/Collaboration</measure>
    <time_frame>Once during baseline (pre-intervention) and post-intervention periods, approximately 12 months</time_frame>
    <description>Overall perception of collaboration and satisfaction with communication among the various members of the care team will be measured on a 5-point Likert scale via surveys administered during the baseline and intervention periods. Scores will be dichotomized.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Safety Climate</measure>
    <time_frame>Once during baseline (pre-intervention) and post-intervention periods, approximately 12 months</time_frame>
    <description>The AHRQ Patient Safety Culture (PSC) survey will be used to control for differences across units and facilities that may impact incidence of adverse events (communication, leadership, teamwork, frequency of reporting, perceived patient safety score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dignity and Respect</measure>
    <time_frame>At time of transfer/discharger from study unit and up to 45-days post-hospitalization</time_frame>
    <description>Randomly selected patients transferred from the MICU will receive the FS-ICU survey, which contains several questions related to dignity and respect. Randomly selected patients will also receive semi-structured interviews to enhance understanding of dignity and respect.&#xD;
Randomly selected patients discharged from Oncology units will receive semi-structured interviews regarding perceptions of dignity and respect and a 45-day post-hospitalization phone survey. Relevant data from national patient satisfaction survey, HCAHPS, will be collected and analyzed.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">4368</enrollment>
  <condition>Medical Intensive Care Unit (MICU) Patients</condition>
  <condition>Oncology Unit Patients</condition>
  <arm_group>
    <arm_group_label>Baseline - Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual Care on two Medical Intensive Care Units units&#xD;
Usual Care on four Oncology units</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-Implementation - Intervention Units</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PROSPECT Intervention (Web-Based Patient Centered Toolkit (PCTK) + The Patient-SatisfActive® Model) on two MICU units&#xD;
PROSPECT Intervention (Web-Based Patient Centered Toolkit (PCTK) + The Patient-SatisfActive® Model) on two Oncology units</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-Implementation - Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual Care on two Oncology Units</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Web-Based Patient Centered Toolkit (PCTK)</intervention_name>
    <description>The PCTK provides patients/care partners tailored health information regarding conditions, test results, and medications presented at a consumer health literacy level, and the ability to communicate with care team members via &quot;patient-facing&quot; tools accessible from bedside tablet computers. The PCTK allows patients to post questions to their care team members via a patient-centered microblog. The microblog facilitates development of a collaborative patient plan of care. The &quot;provider-facing&quot; PCTK includes tools that engage care team members in 1) completing a safety checklist and viewing a safety dashboard; 2) viewing patient-inputted information (goals, preferences, concerns) regarding the plan of care; 3) identifying clinical problems, care team goals, and patient schedules for education and multidisciplinary communication; 4) messaging patients on the &quot;patient thread&quot;; and 5) discussing patient's plan of care with other providers via the &quot;provider thread&quot;.</description>
    <arm_group_label>Post-Implementation - Intervention Units</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The Patient-SatisfActive® Model</intervention_name>
    <description>The Patient-SatisfActive Model is a structured, pro-active, patient-centered care model that aims at improving patient satisfaction by enhancing the degree to which patients' needs, concerns and expectations are met and by preserving dignity and respect. The model comprises steps that enhance interpersonal communication between clinicians and patients, incorporates clinicians' efforts to ascertain, address and document patients' needs, concerns, expectations and perceptions throughout hospitalization, and includes elements that empower and engage patients in their care.</description>
    <arm_group_label>Post-Implementation - Intervention Units</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18&#xD;
&#xD;
          -  Any patient admitted or transferred to designated care units&#xD;
&#xD;
          -  Admitted or transferred to a MICU or Oncology service&#xD;
&#xD;
          -  On the designated unit for at least 24 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18&#xD;
&#xD;
          -  Any patient admitted or transferred to designated care unit but NOT on a MICU or&#xD;
             Oncology service&#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>David W Bates, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Patricia Dykes, RN, DNSc</last_name>
    <role>Study Director</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>February 28, 2022</last_update_submitted>
  <last_update_submitted_qc>February 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>David W. Bates, MD, MSc</investigator_full_name>
    <investigator_title>Chief, Division of General Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02258594
org study id: 2013P001966
nct id: NCT02258594
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this project is to refine, implement, and evaluate a multi-component
      intervention that achieves sustainable and meaningful impact on healthcare quality, safety,
      and costs while ensuring dignity and respect for adult oncology and intensive care patients
      and their care partners. The PROSPECT (Promoting Respect and Ongoing Safety through
      Patient-centeredness, Engagement, Communication, and Technology) framework will achieve this
      by enhancing the patient-provider relationship and introducing patient-centered approaches to
      multi-disciplinary communication and patient education. The PROSPECT framework is based upon
      a validated structured, team-work training model and novel web-based technology. The
      overarching goals of this project are to achieve the following:

        1. Optimize the overall experience of patients (including their family/care partners) by
           promoting dignity/respect, encouraging engagement, improving care plan concordance, and
           enhancing satisfaction.

        2. Minimize preventable harms in two environments: intensive care and acute care oncology
           units.

        3. Reduce unnecessary healthcare resource utilization and associated costs.
This overarching project aims are to refine, implement, and evaluate a multi-faceted
      intervention composed of the Patient-SatisfActive® model, developed by Drs. Ronen Rozenblum
      and David Bates at Brigham and Women's Hospital, and a web-based Patient-Centered Toolkit
      (PCTK), developed by Drs. Dykes and Dalal, on quality, safety, and cost outcomes in the
      intensive care and oncology units at Brigham and Women's Hospital. The specific aims of the
      project are as follows:

        -  Aim 1: To refine and implement the Patient-SatisfActive® model to promote respect,
           dignity, and satisfaction of patients, care partners and staff on intensive care and
           oncology units.

        -  Aim 2: To refine and implement a web-based, Patient-Centered Toolkit (PCTK), comprised
           of an electronic bedside communication center (eBCC) and a patient-centered microblog,
           to promote tailored patient and care-partner education, communication, collaboration,
           and engagement.

        -  Aim 3: To evaluate the relative impact of this intervention compared to usual care on
           patient reported outcome measures, adverse events (harms), post-discharge healthcare
           utilization, concordance in understanding the care plan, and satisfaction among care
           team members (patients/care partners, profession providers).

        -  Aim 4: To identify the barriers and facilitators of implementing this intervention to
           support dissemination.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Preventable Harms (Adverse Events) in the Acute Care Setting
time frame: Enrolled patients will be followed for the duration of hospital stay, typically ranging from 5 to 30 days.
description: Preventable adverse events in the acute care setting include medication errors, patient falls, veno-thromboembolism, hospital acquired infection, central line related bloodstream infection, ventilator associated pneumonia, catheter associated urinary tract infection, newly acquired physical harm/injury. We will measure the rate of adverse events acquired from the time of admission to study units through hospital discharge. Using an adaptation of the Institute for Healthcare Improvement (IHI) Global Trigger Tool, we will randomly sample charts of enrolled patients from intervention and control units during the pre-intervention and post-intervention periods to identify adverse events. The length of hospital stay for patients admitted to medical intensive care and oncology units at our institution is variable, typically ranging from 5 to 30 days.
measure: Patient Experience & Satisfaction & Engagement
time frame: At time of transfer/discharger from study unit and up to 45-days post-hospitalization
description: Randomly selected patients transferred from the MICU units will receive FS-ICU survey, semi-structured interviews, and 45-day post-hospitalization phone survey
Randomly selected patients discharged from Oncology units will receive semi-structured interviews and 45-day post-hospitalization phone survey. Data from national patient satisfaction survey, HCAHPS, will be collected and analyzed.
measure: Healthcare Resource Utilization
time frame: From time of hospital admission through 30-days post-discharge
description: Inpatient healthcare utilization measures: Total cost of hospitalization and hospital length of stay (total, ICU, and non-ICU) from administrative data for each enrolled patient.
Post-discharge healthcare utilization measures: Rate of unscheduled utilization of health care resources (ambulatory/urgent care visits, emergency room visits, hospital readmissions) during the 30-day post-discharge period using the combination of administrative data and patient reports during their 30-day interview.
measure: Care Plan Concordance
time frame: Approximately 48-72 hours after admission to study unit
description: Structured interviews (9-question survey) with patient/care partners, a member of the inpatient medical team (attending, resident, or intern), inpatient nurses, and one additional care team member (e.g., PCP, ambulatory specialists) will be conducted after admission to MICU or Oncology units. Concordance for each item of survey will be rated on a 3-point scale (0, 1, 2) for each dyad. The scores of all dyads will be summed as a global concordance score for each patient.
measure: Perceptions of Communication/Collaboration
time frame: Once during baseline (pre-intervention) and post-intervention periods, approximately 12 months
description: Overall perception of collaboration and satisfaction with communication among the various members of the care team will be measured on a 5-point Likert scale via surveys administered during the baseline and intervention periods. Scores will be dichotomized.
measure: Patient Safety Climate
time frame: Once during baseline (pre-intervention) and post-intervention periods, approximately 12 months
description: The AHRQ Patient Safety Culture (PSC) survey will be used to control for differences across units and facilities that may impact incidence of adverse events (communication, leadership, teamwork, frequency of reporting, perceived patient safety score).
measure: Dignity and Respect
time frame: At time of transfer/discharger from study unit and up to 45-days post-hospitalization
description: Randomly selected patients transferred from the MICU will receive the FS-ICU survey, which contains several questions related to dignity and respect. Randomly selected patients will also receive semi-structured interviews to enhance understanding of dignity and respect.
Randomly selected patients discharged from Oncology units will receive semi-structured interviews regarding perceptions of dignity and respect and a 45-day post-hospitalization phone survey. Relevant data from national patient satisfaction survey, HCAHPS, will be collected and analyzed.
arm group label: Baseline - Usual Care
arm group type: No Intervention
description: Usual Care on two Medical Intensive Care Units units
Usual Care on four Oncology units
arm group label: Post-Implementation - Intervention Units
arm group type: Experimental
description: PROSPECT Intervention (Web-Based Patient Centered Toolkit (PCTK) + The Patient-SatisfActive® Model) on two MICU units
PROSPECT Intervention (Web-Based Patient Centered Toolkit (PCTK) + The Patient-SatisfActive® Model) on two Oncology units
arm group label: Post-Implementation - Usual Care
arm group type: No Intervention
description: Usual Care on two Oncology Units
intervention type: Other
intervention name: Web-Based Patient Centered Toolkit (PCTK)
description: The PCTK provides patients/care partners tailored health information regarding conditions, test results, and medications presented at a consumer health literacy level, and the ability to communicate with care team members via "patient-facing" tools accessible from bedside tablet computers. The PCTK allows patients to post questions to their care team members via a patient-centered microblog. The microblog facilitates development of a collaborative patient plan of care. The "provider-facing" PCTK includes tools that engage care team members in 1) completing a safety checklist and viewing a safety dashboard; 2) viewing patient-inputted information (goals, preferences, concerns) regarding the plan of care; 3) identifying clinical problems, care team goals, and patient schedules for education and multidisciplinary communication; 4) messaging patients on the "patient thread"; and 5) discussing patient's plan of care with other providers via the "provider thread".
arm group label: Post-Implementation - Intervention Units
intervention type: Behavioral
intervention name: The Patient-SatisfActive® Model
description: The Patient-SatisfActive Model is a structured, pro-active, patient-centered care model that aims at improving patient satisfaction by enhancing the degree to which patients' needs, concerns and expectations are met and by preserving dignity and respect. The model comprises steps that enhance interpersonal communication between clinicians and patients, incorporates clinicians' efforts to ascertain, address and document patients' needs, concerns, expectations and perceptions throughout hospitalization, and includes elements that empower and engage patients in their care.
arm group label: Post-Implementation - Intervention Units
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David W Bates, MD, MSc
role: Principal Investigator
affiliation: Brigham and Women's Hospital
last name: Patricia Dykes, RN, DNSc
role: Study Director
affiliation: Brigham and Women's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: David W. Bates, MD, MSc
investigator title: Chief, Division of General Medicine
mesh term: Neoplasms