Clinical trial NCT03041272: Aggressive Incidents in Medical Settings Study
Official title: Aggressive Incidents in Medical Settings Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aggression
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2017-02-02
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: unit-level incidence rate of patient and visitor physical aggression
timeFrame: 2 weeks
measure: unit-level incidence rate of patient and visitor verbal aggression
timeFrame: 2 weeks
Secondary outcomes:
measure: To describe the characteristics of patient and visitor events involving aggressive behavior toward nursing staff in inpatient medical settings.
timeFrame: 2 weeks
measure: risk of missed care events
timeFrame: 2 weeks
measure: Professional Quality of Life Scale
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Middletown
country: United States
facility: Middlesex Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital- St. Raphael
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital Primary Care Center
state: Connecticut
Study officials:
affiliation: Yale School of Nursing
name: Joanne Iennaco
role: PRINCIPAL_INVESTIGATOR
References: