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Clinical Trials/NCT03041272
NCT03041272CompletedNot Applicable

Aggressive Incidents in Medical Settings Study

Yale University3 sites in 1 country137 target enrollmentStarted: January 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
137
Locations
3
Primary Endpoint
unit-level incidence rate of patient and visitor physical aggression

Study Overview

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.

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

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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)

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 Outcomes

  • risk of missed care events(2 weeks)
  • Professional Quality of Life Scale(2 weeks)
  • To describe the characteristics of patient and visitor events involving aggressive behavior toward nursing staff in inpatient medical settings.(2 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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