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Aggressive Incidents in Medical Settings Study (AIMS)

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ClinicalTrials.gov Identifier: NCT03041272
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : March 6, 2020
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Description
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Brief Summary:
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.

Condition or disease
Aggression

Detailed Description:
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.
Study Design
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Study Type : Observational
Actual Enrollment : 137 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Aggressive Incidents in Medical Settings Study
Actual Study Start Date : January 2017
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017
Groups and Cohorts
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Group/Cohort
Nurses and nursing personnel
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.


Outcome Measures
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Primary Outcome Measures :
  1. unit-level incidence rate of patient and visitor physical aggression [ Time Frame: 2 weeks ]

    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)


  2. unit-level incidence rate of patient and visitor verbal aggression [ Time Frame: 2 weeks ]

    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)



Secondary Outcome Measures :
  1. To describe the characteristics of patient and visitor events involving aggressive behavior toward nursing staff in inpatient medical settings. [ Time Frame: 2 weeks ]
    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.

  2. risk of missed care events [ Time Frame: 2 weeks ]
    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.

  3. Professional Quality of Life Scale [ Time Frame: 2 weeks ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This prospective cohort study of nursing staff on inpatient medical units will seek to enroll all RN's and nursing assistive personnel meeting eligibility criteria from three units at Yale New Haven hospital.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Any registered nurse or assistive nursing personnel working less than 24 hours per week,
  • whose primary employment is on a unit not involved in the study or float-pool / centralized resource staff who do not have a primary employment unit,
  • any nursing staff member still on orientation or working with an orientee.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041272


Locations
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United States, Connecticut
Middlesex Hospital
Middletown, Connecticut, United States, 06457
Yale New Haven Hospital- St. Raphael
New Haven, Connecticut, United States, 06511
Yale New Haven Hospital Primary Care Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Joanne Iennaco Yale School of Nursing
More Information
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03041272    
Other Study ID Numbers: 1609018379
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Aggression
Behavioral Symptoms