An observational study in Aggression, sponsored by Yale University. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-06.
Sponsored by Yale University · Observational
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.
361 studies on the registry are indexed under Aggression; 51 are open to participants now.
This study's enrollment of 137 is above the median of 100 across 59 observational studies indexed under Aggression.
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Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
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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.
Exclusion 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.
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)
Time frame: 2 weeks
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)
Time frame: 2 weeks
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.
Time frame: 2 weeks
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.
Time frame: 2 weeks
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).
Time frame: 2 weeks
Plan to share: No
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Yale University