<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/NCT03041272</url>
  </required_header>
  <id_info>
    <org_study_id>1609018379</org_study_id>
    <nct_id>NCT03041272</nct_id>
  </id_info>
  <brief_title>Aggressive Incidents in Medical Settings Study</brief_title>
  <acronym>AIMS</acronym>
  <official_title>Aggressive Incidents in Medical Settings Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to identify the incidence rate and characteristics of aggressive&#xD;
      behavior perpetrated by patients and visitors in inpatient medical units and to understand&#xD;
      the role of missed care events, professional quality of life and self-efficacy in&#xD;
      relationship to aggressive events.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective cohort study will examine the incidence of and outcomes associated with&#xD;
      patient and visitor aggressive behavior towards nursing staff practicing on medical inpatient&#xD;
      units. Staff on each unit will be informed about the AIMS study and all eligible nursing&#xD;
      staff will be invited to participate in the study. After completing the informed consent&#xD;
      nursing staff will be asked to complete the baseline demographic form and survey on&#xD;
      professional quality of life. For the data collection phase of the study consented&#xD;
      participants will be educated on use of the AIM log and provided with scenarios to practice&#xD;
      AIM log use. Consented staff will carry event counters and use the AIM log for all shifts&#xD;
      worked over the next 2 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">November 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>unit-level incidence rate of patient and visitor physical aggression</measure>
    <time_frame>2 weeks</time_frame>
    <description>Event counters and logs will be used to record aggressive event data and will be recorded on the AIM log over the 2 week data collection period. The midnight census on each unit will be recorded over the 2 week data collection period and the average number of occupied beds will be used in the calculation of this rate. The formula used will be:&#xD;
(Number of physical aggression events recorded in 2 week period) divided by (Average number of occupied beds in 2 week period)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>unit-level incidence rate of patient and visitor verbal aggression</measure>
    <time_frame>2 weeks</time_frame>
    <description>Event counters and logs will be used to record aggressive event data and will be recorded on the AIM log over the 2 week data collection period. The midnight census on each unit will be recorded over the 2 week data collection period and the average number of occupied beds will be used in the calculation of this rate. The formula used will be:&#xD;
(Number of verbal aggression events recorded in 2 week period) divided by (Average number of occupied beds in 2 week period)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To describe the characteristics of patient and visitor events involving aggressive behavior toward nursing staff in inpatient medical settings.</measure>
    <time_frame>2 weeks</time_frame>
    <description>Data on aggressive events and patient characteristics will be aggregated from the AIM Logs, Descriptive statistics will be used to summarize events including: frequency of each type of event (verbal, physical or both); severity of event; perpetrator of event; precipitant of event; target of event, objects or body parts used, interventions and consequences of events. In addition written descriptions of events will be qualitatively summarized.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>risk of missed care events</measure>
    <time_frame>2 weeks</time_frame>
    <description>Missed care event data will be retrieved from aggressive incident and management logs (AIM log). Analysis will include the standard descriptive statistics. An evaluation of the risk of missed care events will be carried out using initially a dichotomous identification of a missed care event (defined as any reason for missed care) using chi-square tests to identify significant differences by characteristics of aggressive events. Categories of missed care involving direct physical intervention (ambulation, turning, mouth care, feeding, bathing/skin care); psychosocial intervention (patient teaching, emotional support); medication related interventions (assessing effectiveness, within 5 minutes of prn medication); or assessment or monitoring (vital signs, Intake &amp; Output documentation, blood glucose monitoring) will be used in analyses to describe missed care types.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Professional Quality of Life Scale</measure>
    <time_frame>2 weeks</time_frame>
    <description>The relationship of aggressive event exposure rates to scores on the Professional Quality of Life Scale (ProQOL) will be analyzed using chi-square tests to identify significant differences between stratified groups and logistic regression will be used to evaluate differences between high vs low exposure groups (high defined as greater than the median level of exposure in subjects) and professional quality of life scores with adjustment for potential confounders (age, gender, role, length of experience, length of work on unit).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">137</enrollment>
  <condition>Aggression</condition>
  <arm_group>
    <arm_group_label>Nurses and nursing personnel</arm_group_label>
    <description>All registered nurses and assistive nursing personnel, including patient care associates (PCAs) , patient care technicians (PCTs), clinical technicians (CTs), primary employment on the study unit, minimum of 24 hours per week of employment on study unit.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        This prospective cohort study of nursing staff on inpatient medical units will seek to&#xD;
        enroll all RN's and nursing assistive personnel meeting eligibility criteria from three&#xD;
        units at Yale New Haven hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All registered nurses and assistive nursing personnel, including patient care&#xD;
             associates (PCAs) , patient care technicians (PCTs), clinical technicians (CTs),&#xD;
&#xD;
          -  primary employment on the study unit,&#xD;
&#xD;
          -  minimum of 24 hours per week of employment on study unit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any registered nurse or assistive nursing personnel working less than 24 hours per&#xD;
             week,&#xD;
&#xD;
          -  whose primary employment is on a unit not involved in the study or float-pool /&#xD;
             centralized resource staff who do not have a primary employment unit,&#xD;
&#xD;
          -  any nursing staff member still on orientation or working with an orientee.&#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>Joanne Iennaco</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale School of Nursing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Middlesex Hospital</name>
      <address>
        <city>Middletown</city>
        <state>Connecticut</state>
        <zip>06457</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale New Haven Hospital- St. Raphael</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale New Haven Hospital Primary Care Center</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>March 5, 2020</last_update_submitted>
  <last_update_submitted_qc>March 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aggression</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/NCT03041272
org study id: 1609018379
nct id: NCT03041272
lead sponsor: 
has dmc: No
The purpose of this study is to identify the incidence rate and characteristics of aggressive
      behavior perpetrated by patients and visitors in inpatient medical units and to understand
      the role of missed care events, professional quality of life and self-efficacy in
      relationship to aggressive events.
This prospective cohort study will examine the incidence of and outcomes associated with
      patient and visitor aggressive behavior towards nursing staff practicing on medical inpatient
      units. Staff on each unit will be informed about the AIMS study and all eligible nursing
      staff will be invited to participate in the study. After completing the informed consent
      nursing staff will be asked to complete the baseline demographic form and survey on
      professional quality of life. For the data collection phase of the study consented
      participants will be educated on use of the AIM log and provided with scenarios to practice
      AIM log use. Consented staff will carry event counters and use the AIM log for all shifts
      worked over the next 2 weeks.
observational model: Cohort
time perspective: Prospective
measure: unit-level incidence rate of patient and visitor physical aggression
time frame: 2 weeks
description: Event counters and logs will be used to record aggressive event data and will be recorded on the AIM log over the 2 week data collection period. The midnight census on each unit will be recorded over the 2 week data collection period and the average number of occupied beds will be used in the calculation of this rate. The formula used will be:
(Number of physical aggression events recorded in 2 week period) divided by (Average number of occupied beds in 2 week period)
measure: unit-level incidence rate of patient and visitor verbal aggression
time frame: 2 weeks
description: Event counters and logs will be used to record aggressive event data and will be recorded on the AIM log over the 2 week data collection period. The midnight census on each unit will be recorded over the 2 week data collection period and the average number of occupied beds will be used in the calculation of this rate. The formula used will be:
(Number of verbal aggression events recorded in 2 week period) divided by (Average number of occupied beds in 2 week period)
measure: To describe the characteristics of patient and visitor events involving aggressive behavior toward nursing staff in inpatient medical settings.
time frame: 2 weeks
description: Data on aggressive events and patient characteristics will be aggregated from the AIM Logs, Descriptive statistics will be used to summarize events including: frequency of each type of event (verbal, physical or both); severity of event; perpetrator of event; precipitant of event; target of event, objects or body parts used, interventions and consequences of events. In addition written descriptions of events will be qualitatively summarized.
measure: risk of missed care events
time frame: 2 weeks
description: Missed care event data will be retrieved from aggressive incident and management logs (AIM log). Analysis will include the standard descriptive statistics. An evaluation of the risk of missed care events will be carried out using initially a dichotomous identification of a missed care event (defined as any reason for missed care) using chi-square tests to identify significant differences by characteristics of aggressive events. Categories of missed care involving direct physical intervention (ambulation, turning, mouth care, feeding, bathing/skin care); psychosocial intervention (patient teaching, emotional support); medication related interventions (assessing effectiveness, within 5 minutes of prn medication); or assessment or monitoring (vital signs, Intake & Output documentation, blood glucose monitoring) will be used in analyses to describe missed care types.
measure: Professional Quality of Life Scale
time frame: 2 weeks
description: The relationship of aggressive event exposure rates to scores on the Professional Quality of Life Scale (ProQOL) will be analyzed using chi-square tests to identify significant differences between stratified groups and logistic regression will be used to evaluate differences between high vs low exposure groups (high defined as greater than the median level of exposure in subjects) and professional quality of life scores with adjustment for potential confounders (age, gender, role, length of experience, length of work on unit).
arm group label: Nurses and nursing personnel
description: All registered nurses and assistive nursing personnel, including patient care associates (PCAs) , patient care technicians (PCTs), clinical technicians (CTs), primary employment on the study unit, minimum of 24 hours per week of employment on study unit.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joanne Iennaco
role: Principal Investigator
affiliation: Yale School of Nursing
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Aggression
sharing ipd: No