Aggressive Incidents in Medical Settings Study

Completed

• Conditions: Aggression

• Registration Number: NCT03041272
• Lead Sponsor: Yale University

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 Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-01-31
• Study First Posted: 2017-02-02
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-05
• Last Update Posted: 2020-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
unit-level incidence rate of patient and visitor physical aggression	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	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

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

Trial Locations

Locations (3)

Yale New Haven Hospital Primary Care Center; 🇺🇸 New Haven, Connecticut, United States

Middlesex Hospital; 🇺🇸 Middletown, Connecticut, United States

Yale New Haven Hospital- St. Raphael; 🇺🇸 New Haven, Connecticut, United States