Aggressive Incidents in Medical Settings Study

Aggression Clinical Trial

— AIMS  

Official title:

Aggressive Incidents in Medical Settings Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03041272
• Other study ID #: 1609018379
• Status: Completed
• Start date: January 2017
• Est. completion date: November 2017

Study information

• Verified date: March 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aggression

Locations

Country	Name	City	State
United States	Middlesex Hospital	Middletown	Connecticut
United States	Yale New Haven Hospital Primary Care Center	New Haven	Connecticut
United States	Yale New Haven Hospital- St. Raphael	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	unit-level incidence rate of patient and visitor physical aggression	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 weeks
Primary	unit-level incidence rate of patient and visitor verbal aggression	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)	2 weeks
Secondary	To describe the characteristics of patient and visitor events involving aggressive behavior toward nursing staff in inpatient medical settings.	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 weeks
Secondary	risk of missed care events	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.	2 weeks
Secondary	Professional Quality of Life Scale	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).	2 weeks