Clinical Trial: Aggressive Incidents in Medical Settings Study

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

Official Title: Aggressive Incidents in Medical Settings Study

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 Summary: 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.
Sponsor: Yale University

Current Primary Outcome:

  • 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)



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.
  • 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).


Original Secondary Outcome: Same as current

Information By: Yale University

Dates:
Date Received: January 25, 2017
Date Started: January 2017
Date Completion: June 2017
Last Updated: April 24, 2017
Last Verified: January 2017