<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/NCT02969343</url>
  </required_header>
  <id_info>
    <org_study_id>5P30HS023535</org_study_id>
    <nct_id>NCT02969343</nct_id>
  </id_info>
  <brief_title>Patient Safety Learning Laboratory: Making Acute Care More Patient-Centered</brief_title>
  <acronym>PSLL</acronym>
  <official_title>Patient Safety Learning Laboratory: Making Acute Care More Patient-Centered</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Northeastern University</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 Brigham and Women's Hospital (BWH) Patient Safety Learning Laboratory (PSLL) focuses on&#xD;
      developing health information technology (HIT) tools to engage patients, family, and&#xD;
      professional care team members in reliable identification, assessment, and reduction of&#xD;
      patient safety threats in real-time, before they manifest in actual harm.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Brigham and Women's Hospital (BWH) Patient Safety Learning Laboratory (PSLL) will develop&#xD;
      systems approaches to integrating health information technology (HIT), stakeholder engagement&#xD;
      mechanisms, and process design/engineering methods focused on patient safety, development and&#xD;
      enhancement of tools, health care system interventions, and translation into practice. The&#xD;
      three technological toolkits to be developed as part of the Patient Safety Learning&#xD;
      Laboratory (PSLL) are:1) Patient-centered Fall Prevention Toolkit which aims to engage&#xD;
      patients and their family caregivers in the design of HIT tools to prevent patient falls and&#xD;
      related injuries during an acute hospitalization; 2) Patient Safety Checklist Tool to improve&#xD;
      patient safety and quality outcomes, provider efficiency, and team communication; and 3)&#xD;
      MySafeCare Patient Safety Reporting System which aims to iteratively develop and evaluate the&#xD;
      impact of a patient safety reporting system on patient safety and fosters a health system&#xD;
      focused on collaborative learning. The Brigham and Women's Patient Safety Learning Laboratory&#xD;
      (BWH PSLL) will establish a vibrant learning ecosystem of health services, informatics, and&#xD;
      systems engineering researchers, collaborating with patients and family for evolving and&#xD;
      applying these approaches to adverse event prevention in hospitalized patients. In addition,&#xD;
      a Systems Engineering, Usability, and Integration (SEUI) Core will leverage health systems&#xD;
      engineering approaches to develop and provide a system-wide methodology to aid in the&#xD;
      successful implementation and improvement of Health Information Technology (HIT) tools and a&#xD;
      model known as the Patient SatisfActive® will be developed, tested, and refined to create a&#xD;
      culture of patient- and family-centered care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2015</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2018</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>Clinical Outcomes: Proportion of hospitalizations with any adverse event</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Hospitalizations with the presence of any of the following: Patient Falls with Injury, Severe Hypoglycemia, Inpatient or post hospitalization venous thromboembolism, catheter associated urinary tract infection (CAUTI), Central Line Associated Blood Stream Infection (CLABSI), Opioid related severe adverse drug event, hospital acquired pressure ulcer, severe hospital acquired delirium, rapid response related to arrhythmia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Inertia: When Red flag, % changed to yellow or green during hospitalization</measure>
    <time_frame>up to 21 months</time_frame>
    <description>monitoring time for flags to change within patient safety information technology tools</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Inertia:When Red flag, % changed to green during hospitalization</measure>
    <time_frame>up to 21 months</time_frame>
    <description>monitoring time for flags to change within patient safety information technology tools</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Inertia: Mean time to resolution of red flags (to green or yellow), days</measure>
    <time_frame>up to 21 months</time_frame>
    <description>monitoring time for flags to change within patient safety information technology tools</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Inertia:Mean time to resolution of red flags (to green), days</measure>
    <time_frame>up to 21 months</time_frame>
    <description>monitoring time for flags to change within patient safety information technology tools</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Falls/ Mobility: % patient days of patients at fall risk due to a gait disturbance on sedatives</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care: % patient days of patients at fall risk due to a gait disturbance on sedatives</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Falls/ Mobility:% pt-days of patients at fall risk due to a gait disturbance without Physical Therapy consult order</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care: % patient-days of patients at fall risk due to a gait disturbance without Physical Therapy consult order</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Code Status: % patient-days on study unit with unconfirmed code status</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care: % patient-days on study unit with unconfirmed code status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose Control: % patients with diabetes or hyperglycemia with order for basal insulin</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care: % patients with diabetes or hyperglycemia with order for basal insulin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose Control: % patients with diabetes or hyperglycemia with orders for basal and nutritional insulin</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care: % patients with diabetes or hyperglycemia with orders for basal and nutritional insulin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutrition: % patient-days without any diet order</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care: % patient-days without any diet order</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutrition: % pt-days NPO with insulin aspart ordered at same time</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care:% pt-days NPO with insulin aspart ordered at same time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Venous thromboembolism (VTE): % pt-days with appropriate prophylaxis ordered based on risk and contraindications</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care: % patient-days with appropriate prophylaxis ordered based on risk and contraindications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Venous thromboembolism (VTE):% pt-days with appropriate prophylaxis administered based on risk and contraindications</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care: % pt-days with appropriate prophylaxis administered based on risk and contraindications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Venous thromboembolism (VTE): % ordered pharmacologic prophylaxis doses administered</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care: % ordered pharmacologic prophylaxis doses administered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Control: % pt-days with MED &gt; 100 mg</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care: % pt-days with MED &gt; 100 mg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Control: % patient-days with opioids ordered and no adjunctive medications ordered</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care: % patient-days with opioids ordered and no adjunctive medications ordered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Control:% pt-days with opioids administered and no Richmond Agitation-Sedation Scale (RASS) score recorded</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care: % pt-days with opioids administered and no Richmond Agitation-Sedation Scale (RASS) score recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibiotic Management: % patient-days with patients on broad-spectrum gram-positive and broad-spectrum gram-negative antibiotics for &gt; 72 hours</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care: % pt-days with patients on broad-spectrum gram-positive and broad-spectrum gram-negative antibiotics for &gt; 72 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibiotic Management: % pt-days with pts on broad-spectrum antibiotics for &gt; 72 hours</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care: % patient-days with patients on broad-spectrum antibiotics for &gt; 72 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delirium Management: % patient-days Confusion Assessment Method (CAM) positive</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care: % patient-days Confusion Assessment Method (CAM) positive</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delirium Management: % patient-days of patients at high risk for delirium on sedatives</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care: % patient-days of patients at high risk for delirium on sedatives</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delirium Management: % patient-days of patients at high risk for delirium on ramelteon</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care: % patient-days of patients at high risk for delirium on ramelteon</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delirium Management: % patient-days of patients with hyperactive delirium on neuroleptics</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care: % patient-days of patients with hyperactive delirium on neuroleptics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular Access: % patient-days with central line in place</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care: % patient-days with central line in place</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Foley Care: % patient-days with Foley catheter in place</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care: % patient-days with Foley catheter in place</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Foley Care: % patient-days with Foley documented but not ordered</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care: % patient-days with Foley documented but not ordered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Foley Care: % patient-days with Foley documented but Nurse Driven Protocol (NDP) not ordered</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care: % patient-days with Foley documented but NDP not ordered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Telemetry: % patient-days of high risk patients without any telemetry</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care: % patient-days of high risk patients without any telemetry bottom page 5 mock tables</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Telemetry: % patient-days of low risk patients on telemetry &gt; 72h</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care: % patient-days of low risk patients on telemetry &gt; 72h</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bowel Regimen: % pt-days of patients on opioids and no bowel regimen ordered</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care: % pt-days of patients on opioids and no bowel regimen ordered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bowel Regimen:% patient-days where on opioids, no bowel movement 2 or more days, and no bowel regimen administered</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Processes of care: % patient-days where on opioids, no bowel movement 2 or more days, and no bowel regimen administered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fall / Mobility: Patient Falls based on safety reports per 1000 patient-days</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Safety Outcomes: Patient Falls based on safety reports per 1000 patient-days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fall / Mobility: Falls with injury based on safety reports per 1000 patient-days</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Safety Outcomes: Falls with injury based on safety reports per 1000 patient-days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose Control: Patient-day-weighted mean glucose</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Safety Outcomes: Patient-day-weighted mean glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose Control: Proportion of glucose readings 70-180 mg/dL, mean per patient</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Safety Outcomes: Proportion of glucose readings 70-180 mg/dL, mean per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose Control: Proportion of patient-days with hypoglycemia</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Safety Outcomes: Proportion of patient-days with hypoglycemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose Control: Proportion of patient-days with severe hypoglycemia</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Safety Outcomes: Proportion of patient-days with severe hypoglycemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Venous Thromboembolism: proportion of hospitalizations with hospital-acquired VTE</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Safety Outcomes: proportion of hospitalizations with hospital-acquired VTE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Venous Thromboembolism: proportion of hospitalizations with VTE within 30 days of discharge</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Safety Outcomes: proportion of hospitalizations with VTE within 30 days of discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Control: proportion of hospitalizations with opioid induced depression of consciousness or respiration</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Safety Outcomes: proportion of hospitalizations with opioid induced depression of consciousness or respiration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Control: proportion of hospitalizations of patients on opioids who required narcan</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Safety Outcomes: proportion of hospitalizations of patients on opioids who required narcan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Control: proportion of hospitalizations with severe opioid-related adverse drug event</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Safety Outcomes: proportion of patients on opioids who had rapid response, code blue, ICU transfer, Bipap, mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Control: proportion of hospitalizations of patients on opioids with any opioid-related Adverse Drug Event</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Safety Outcomes: proportion of hospitalizations of patients on opioids with any opioid-related Adverse Drug Event</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pressure Ulcers: proportion of hospitalizations with hospital-acquired pressure ulcer</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Safety outcomes: proportion of hospitalizations with hospital-acquired pressure ulcer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pressure Ulcers: proportion of hospitalizations with pressure ulcer worsening in stage from admission to discharge</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Safety outcomes: proportion of hospitalizations with hospital-acquired pressure ulcer worsening in stage from admission to discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delirium Management: proportion of hospitalizations requiring mechanical restraints</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Safety outcomes: proportion of hospitalizations requiring mechanical restraints</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delirium Management: proportion of hospitalizations requiring code gray and requiring security</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Safety outcomes: proportion of hospitalizations requiring code gray and requiring security</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular Access: Central Line Associated Blood Stream Infection (CLABSI) per 1000 patient-days</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Safety outcomes: Central Line Associated Blood Stream Infection (CLABSI) per 1000 patient-days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Foley Care: Central Line Associate Urinary Tract Infection per 1000 patient-days</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Safety outcomes: Central Line Associate Urinary Tract Infection per 1000 patient-days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Telemetry: proportion of hospitalizations for rapid response for arrhythmia</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Safety outcomes: proportion of hospitalizations for rapid response for arrhythmia</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Provider perceptions of safety, communication based on Agency for Healthcare Research and Quality (AHRQ) patient safety climate survey</measure>
    <time_frame>up to 21 months</time_frame>
    <description>perceived teamwork climate on hospital care units based on Agency for Healthcare Research and Quality (AHRQ) patient safety climate survey</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient activation, engagement, satisfaction based on Patient Activation Measure (PAM 13)</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Patient and caregiver perceptions of how well clinical team kept them safe based on Patient Activation Measure (PAM 13)</description>
  </other_outcome>
  <other_outcome>
    <measure>Usability of tools/ technology based on Health iTues survey</measure>
    <time_frame>up to 21 months</time_frame>
    <description>usability of technology- ease of use based on Health iTues survey</description>
  </other_outcome>
  <other_outcome>
    <measure>Effects on workflow</measure>
    <time_frame>up to 21 months</time_frame>
    <description>cognitive burden based on direct observations</description>
  </other_outcome>
  <other_outcome>
    <measure>Adherence to PSLL patient safety information technology tools</measure>
    <time_frame>up to 21 months</time_frame>
    <description>use of tool by providers and patients</description>
  </other_outcome>
  <other_outcome>
    <measure>Health care utilization</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Length of stay of patients</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Reported Safety Concerns- MySafeCare reporting tool</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Rate of submissions into the MySafeCare reporting tool per 1000 patient days (confidence interval)</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of hospitalizations with code blue or rapid response</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Other Clinical Outcomes: Proportion of hospitalizations with cardio-respiratory code or rapid response</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of hospitalizations with ICU transfer</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Other Clinical Outcomes: Proportion of hospitalizations with ICU transfer</description>
  </other_outcome>
  <other_outcome>
    <measure>Average time of discharge</measure>
    <time_frame>up to 21 months</time_frame>
    <description>time of discharge averaged</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Activation Measure (PAM-13)</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Patient Activation as measured by the PAM 13 survey</description>
  </other_outcome>
  <other_outcome>
    <measure>30-day non-elective readmission</measure>
    <time_frame>up to 21 months</time_frame>
    <description>30-day non-elective readmission</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Satisfaction (HCAHPS)</measure>
    <time_frame>up to 21 months</time_frame>
    <description>Patient Satisfaction as measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21000</enrollment>
  <condition>Central Line-Associated Bloodstream Infection (CLABSI)</condition>
  <condition>Venous Thromboembolism</condition>
  <condition>Patient Fall</condition>
  <condition>Catheter-Associated Infection</condition>
  <condition>Severe Hypoglycemia</condition>
  <condition>Opioid-Related Severe Adverse Drug Event</condition>
  <condition>Hospital Acquired Pressure Ulcer</condition>
  <condition>Adverse Drug Event</condition>
  <condition>Severe Hospital Acquired Delerium</condition>
  <condition>Rapid Response Related to Arrhythmia</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients and providers on hospital care units where the PSLL patient safety health information technology tools are implemented, during the interventional phase of a stepped wedge randomized trial design.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients on hospital care units where the PSLL patient safety health information technology tools have been implemented or are to be implemented, but are not during the usual care phase of a stepped wedge randomized trial design.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Patient Safety health information technology</intervention_name>
    <description>Patient safety technology toolkits on hospital care units</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients 18-99 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients under age 18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</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>
  <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>July 2019</verification_date>
  <study_first_submitted>October 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>July 8, 2019</last_update_submitted>
  <last_update_submitted_qc>July 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2019</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>Senior Vice President and Chief Innovation Officer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Catheter-Related Infections</mesh_term>
    <mesh_term>Thromboembolism</mesh_term>
    <mesh_term>Venous Thromboembolism</mesh_term>
    <mesh_term>Pressure Ulcer</mesh_term>
    <mesh_term>Hypoglycemia</mesh_term>
    <mesh_term>Drug-Related Side Effects and Adverse Reactions</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/NCT02969343
org study id: 5P30HS023535
nct id: NCT02969343
lead sponsor: 
collaborator: 
has dmc: No
The Brigham and Women's Hospital (BWH) Patient Safety Learning Laboratory (PSLL) focuses on
      developing health information technology (HIT) tools to engage patients, family, and
      professional care team members in reliable identification, assessment, and reduction of
      patient safety threats in real-time, before they manifest in actual harm.
The Brigham and Women's Hospital (BWH) Patient Safety Learning Laboratory (PSLL) will develop
      systems approaches to integrating health information technology (HIT), stakeholder engagement
      mechanisms, and process design/engineering methods focused on patient safety, development and
      enhancement of tools, health care system interventions, and translation into practice. The
      three technological toolkits to be developed as part of the Patient Safety Learning
      Laboratory (PSLL) are:1) Patient-centered Fall Prevention Toolkit which aims to engage
      patients and their family caregivers in the design of HIT tools to prevent patient falls and
      related injuries during an acute hospitalization; 2) Patient Safety Checklist Tool to improve
      patient safety and quality outcomes, provider efficiency, and team communication; and 3)
      MySafeCare Patient Safety Reporting System which aims to iteratively develop and evaluate the
      impact of a patient safety reporting system on patient safety and fosters a health system
      focused on collaborative learning. The Brigham and Women's Patient Safety Learning Laboratory
      (BWH PSLL) will establish a vibrant learning ecosystem of health services, informatics, and
      systems engineering researchers, collaborating with patients and family for evolving and
      applying these approaches to adverse event prevention in hospitalized patients. In addition,
      a Systems Engineering, Usability, and Integration (SEUI) Core will leverage health systems
      engineering approaches to develop and provide a system-wide methodology to aid in the
      successful implementation and improvement of Health Information Technology (HIT) tools and a
      model known as the Patient SatisfActive® will be developed, tested, and refined to create a
      culture of patient- and family-centered care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Clinical Outcomes: Proportion of hospitalizations with any adverse event
time frame: up to 21 months
description: Hospitalizations with the presence of any of the following: Patient Falls with Injury, Severe Hypoglycemia, Inpatient or post hospitalization venous thromboembolism, catheter associated urinary tract infection (CAUTI), Central Line Associated Blood Stream Infection (CLABSI), Opioid related severe adverse drug event, hospital acquired pressure ulcer, severe hospital acquired delirium, rapid response related to arrhythmia
measure: Clinical Inertia: When Red flag, % changed to yellow or green during hospitalization
time frame: up to 21 months
description: monitoring time for flags to change within patient safety information technology tools
measure: Clinical Inertia:When Red flag, % changed to green during hospitalization
time frame: up to 21 months
description: monitoring time for flags to change within patient safety information technology tools
measure: Clinical Inertia: Mean time to resolution of red flags (to green or yellow), days
time frame: up to 21 months
description: monitoring time for flags to change within patient safety information technology tools
measure: Clinical Inertia:Mean time to resolution of red flags (to green), days
time frame: up to 21 months
description: monitoring time for flags to change within patient safety information technology tools
measure: Patient Falls/ Mobility: % patient days of patients at fall risk due to a gait disturbance on sedatives
time frame: up to 21 months
description: Processes of care: % patient days of patients at fall risk due to a gait disturbance on sedatives
measure: Patient Falls/ Mobility:% pt-days of patients at fall risk due to a gait disturbance without Physical Therapy consult order
time frame: up to 21 months
description: Processes of care: % patient-days of patients at fall risk due to a gait disturbance without Physical Therapy consult order
measure: Code Status: % patient-days on study unit with unconfirmed code status
time frame: up to 21 months
description: Processes of care: % patient-days on study unit with unconfirmed code status
measure: Glucose Control: % patients with diabetes or hyperglycemia with order for basal insulin
time frame: up to 21 months
description: Processes of care: % patients with diabetes or hyperglycemia with order for basal insulin
measure: Glucose Control: % patients with diabetes or hyperglycemia with orders for basal and nutritional insulin
time frame: up to 21 months
description: Processes of care: % patients with diabetes or hyperglycemia with orders for basal and nutritional insulin
measure: Nutrition: % patient-days without any diet order
time frame: up to 21 months
description: Processes of care: % patient-days without any diet order
measure: Nutrition: % pt-days NPO with insulin aspart ordered at same time
time frame: up to 21 months
description: Processes of care:% pt-days NPO with insulin aspart ordered at same time
measure: Venous thromboembolism (VTE): % pt-days with appropriate prophylaxis ordered based on risk and contraindications
time frame: up to 21 months
description: Processes of care: % patient-days with appropriate prophylaxis ordered based on risk and contraindications
measure: Venous thromboembolism (VTE):% pt-days with appropriate prophylaxis administered based on risk and contraindications
time frame: up to 21 months
description: Processes of care: % pt-days with appropriate prophylaxis administered based on risk and contraindications
measure: Venous thromboembolism (VTE): % ordered pharmacologic prophylaxis doses administered
time frame: up to 21 months
description: Processes of care: % ordered pharmacologic prophylaxis doses administered
measure: Pain Control: % pt-days with MED > 100 mg
time frame: up to 21 months
description: Processes of care: % pt-days with MED > 100 mg
measure: Pain Control: % patient-days with opioids ordered and no adjunctive medications ordered
time frame: up to 21 months
description: Processes of care: % patient-days with opioids ordered and no adjunctive medications ordered
measure: Pain Control:% pt-days with opioids administered and no Richmond Agitation-Sedation Scale (RASS) score recorded
time frame: up to 21 months
description: Processes of care: % pt-days with opioids administered and no Richmond Agitation-Sedation Scale (RASS) score recorded
measure: Antibiotic Management: % patient-days with patients on broad-spectrum gram-positive and broad-spectrum gram-negative antibiotics for > 72 hours
time frame: up to 21 months
description: Processes of care: % pt-days with patients on broad-spectrum gram-positive and broad-spectrum gram-negative antibiotics for > 72 hours
measure: Antibiotic Management: % pt-days with pts on broad-spectrum antibiotics for > 72 hours
time frame: up to 21 months
description: Processes of care: % patient-days with patients on broad-spectrum antibiotics for > 72 hours
measure: Delirium Management: % patient-days Confusion Assessment Method (CAM) positive
time frame: up to 21 months
description: Processes of care: % patient-days Confusion Assessment Method (CAM) positive
measure: Delirium Management: % patient-days of patients at high risk for delirium on sedatives
time frame: up to 21 months
description: Processes of care: % patient-days of patients at high risk for delirium on sedatives
measure: Delirium Management: % patient-days of patients at high risk for delirium on ramelteon
time frame: up to 21 months
description: Processes of care: % patient-days of patients at high risk for delirium on ramelteon
measure: Delirium Management: % patient-days of patients with hyperactive delirium on neuroleptics
time frame: up to 21 months
description: Processes of care: % patient-days of patients with hyperactive delirium on neuroleptics
measure: Vascular Access: % patient-days with central line in place
time frame: up to 21 months
description: Processes of care: % patient-days with central line in place
measure: Foley Care: % patient-days with Foley catheter in place
time frame: up to 21 months
description: Processes of care: % patient-days with Foley catheter in place
measure: Foley Care: % patient-days with Foley documented but not ordered
time frame: up to 21 months
description: Processes of care: % patient-days with Foley documented but not ordered
measure: Foley Care: % patient-days with Foley documented but Nurse Driven Protocol (NDP) not ordered
time frame: up to 21 months
description: Processes of care: % patient-days with Foley documented but NDP not ordered
measure: Telemetry: % patient-days of high risk patients without any telemetry
time frame: up to 21 months
description: Processes of care: % patient-days of high risk patients without any telemetry bottom page 5 mock tables
measure: Telemetry: % patient-days of low risk patients on telemetry > 72h
time frame: up to 21 months
description: Processes of care: % patient-days of low risk patients on telemetry > 72h
measure: Bowel Regimen: % pt-days of patients on opioids and no bowel regimen ordered
time frame: up to 21 months
description: Processes of care: % pt-days of patients on opioids and no bowel regimen ordered
measure: Bowel Regimen:% patient-days where on opioids, no bowel movement 2 or more days, and no bowel regimen administered
time frame: up to 21 months
description: Processes of care: % patient-days where on opioids, no bowel movement 2 or more days, and no bowel regimen administered
measure: Fall / Mobility: Patient Falls based on safety reports per 1000 patient-days
time frame: up to 21 months
description: Safety Outcomes: Patient Falls based on safety reports per 1000 patient-days
measure: Fall / Mobility: Falls with injury based on safety reports per 1000 patient-days
time frame: up to 21 months
description: Safety Outcomes: Falls with injury based on safety reports per 1000 patient-days
measure: Glucose Control: Patient-day-weighted mean glucose
time frame: up to 21 months
description: Safety Outcomes: Patient-day-weighted mean glucose
measure: Glucose Control: Proportion of glucose readings 70-180 mg/dL, mean per patient
time frame: up to 21 months
description: Safety Outcomes: Proportion of glucose readings 70-180 mg/dL, mean per patient
measure: Glucose Control: Proportion of patient-days with hypoglycemia
time frame: up to 21 months
description: Safety Outcomes: Proportion of patient-days with hypoglycemia
measure: Glucose Control: Proportion of patient-days with severe hypoglycemia
time frame: up to 21 months
description: Safety Outcomes: Proportion of patient-days with severe hypoglycemia
measure: Venous Thromboembolism: proportion of hospitalizations with hospital-acquired VTE
time frame: up to 21 months
description: Safety Outcomes: proportion of hospitalizations with hospital-acquired VTE
measure: Venous Thromboembolism: proportion of hospitalizations with VTE within 30 days of discharge
time frame: up to 21 months
description: Safety Outcomes: proportion of hospitalizations with VTE within 30 days of discharge
measure: Pain Control: proportion of hospitalizations with opioid induced depression of consciousness or respiration
time frame: up to 21 months
description: Safety Outcomes: proportion of hospitalizations with opioid induced depression of consciousness or respiration
measure: Pain Control: proportion of hospitalizations of patients on opioids who required narcan
time frame: up to 21 months
description: Safety Outcomes: proportion of hospitalizations of patients on opioids who required narcan
measure: Pain Control: proportion of hospitalizations with severe opioid-related adverse drug event
time frame: up to 21 months
description: Safety Outcomes: proportion of patients on opioids who had rapid response, code blue, ICU transfer, Bipap, mechanical ventilation
measure: Pain Control: proportion of hospitalizations of patients on opioids with any opioid-related Adverse Drug Event
time frame: up to 21 months
description: Safety Outcomes: proportion of hospitalizations of patients on opioids with any opioid-related Adverse Drug Event
measure: Pressure Ulcers: proportion of hospitalizations with hospital-acquired pressure ulcer
time frame: up to 21 months
description: Safety outcomes: proportion of hospitalizations with hospital-acquired pressure ulcer
measure: Pressure Ulcers: proportion of hospitalizations with pressure ulcer worsening in stage from admission to discharge
time frame: up to 21 months
description: Safety outcomes: proportion of hospitalizations with hospital-acquired pressure ulcer worsening in stage from admission to discharge
measure: Delirium Management: proportion of hospitalizations requiring mechanical restraints
time frame: up to 21 months
description: Safety outcomes: proportion of hospitalizations requiring mechanical restraints
measure: Delirium Management: proportion of hospitalizations requiring code gray and requiring security
time frame: up to 21 months
description: Safety outcomes: proportion of hospitalizations requiring code gray and requiring security
measure: Vascular Access: Central Line Associated Blood Stream Infection (CLABSI) per 1000 patient-days
time frame: up to 21 months
description: Safety outcomes: Central Line Associated Blood Stream Infection (CLABSI) per 1000 patient-days
measure: Foley Care: Central Line Associate Urinary Tract Infection per 1000 patient-days
time frame: up to 21 months
description: Safety outcomes: Central Line Associate Urinary Tract Infection per 1000 patient-days
measure: Telemetry: proportion of hospitalizations for rapid response for arrhythmia
time frame: up to 21 months
description: Safety outcomes: proportion of hospitalizations for rapid response for arrhythmia
measure: Provider perceptions of safety, communication based on Agency for Healthcare Research and Quality (AHRQ) patient safety climate survey
time frame: up to 21 months
description: perceived teamwork climate on hospital care units based on Agency for Healthcare Research and Quality (AHRQ) patient safety climate survey
measure: Patient activation, engagement, satisfaction based on Patient Activation Measure (PAM 13)
time frame: up to 21 months
description: Patient and caregiver perceptions of how well clinical team kept them safe based on Patient Activation Measure (PAM 13)
measure: Usability of tools/ technology based on Health iTues survey
time frame: up to 21 months
description: usability of technology- ease of use based on Health iTues survey
measure: Effects on workflow
time frame: up to 21 months
description: cognitive burden based on direct observations
measure: Adherence to PSLL patient safety information technology tools
time frame: up to 21 months
description: use of tool by providers and patients
measure: Health care utilization
time frame: up to 21 months
description: Length of stay of patients
measure: Patient Reported Safety Concerns- MySafeCare reporting tool
time frame: up to 21 months
description: Rate of submissions into the MySafeCare reporting tool per 1000 patient days (confidence interval)
measure: Proportion of hospitalizations with code blue or rapid response
time frame: up to 21 months
description: Other Clinical Outcomes: Proportion of hospitalizations with cardio-respiratory code or rapid response
measure: Proportion of hospitalizations with ICU transfer
time frame: up to 21 months
description: Other Clinical Outcomes: Proportion of hospitalizations with ICU transfer
measure: Average time of discharge
time frame: up to 21 months
description: time of discharge averaged
measure: Patient Activation Measure (PAM-13)
time frame: up to 21 months
description: Patient Activation as measured by the PAM 13 survey
measure: 30-day non-elective readmission
time frame: up to 21 months
description: 30-day non-elective readmission
measure: Patient Satisfaction (HCAHPS)
time frame: up to 21 months
description: Patient Satisfaction as measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS)
arm group label: Intervention
arm group type: Experimental
description: Patients and providers on hospital care units where the PSLL patient safety health information technology tools are implemented, during the interventional phase of a stepped wedge randomized trial design.
arm group label: Usual Care
arm group type: No Intervention
description: Patients on hospital care units where the PSLL patient safety health information technology tools have been implemented or are to be implemented, but are not during the usual care phase of a stepped wedge randomized trial design.
intervention type: Behavioral
intervention name: Patient Safety health information technology
description: Patient safety technology toolkits on hospital care units
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David W Bates, MD MSc
role: Principal Investigator
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: Senior Vice President and Chief Innovation Officer
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Sepsis
mesh term: Catheter-Related Infections
mesh term: Thromboembolism
mesh term: Venous Thromboembolism
mesh term: Pressure Ulcer
mesh term: Hypoglycemia
mesh term: Drug-Related Side Effects and Adverse Reactions
sharing ipd: No