NCT03041272

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

10 months

First QC Date

January 25, 2017

Last Update Submit

March 5, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • To describe the characteristics of patient and visitor events involving aggressive behavior toward nursing staff in inpatient medical settings.

    2 weeks

  • risk of missed care events

    2 weeks

  • Professional Quality of Life Scale

    2 weeks

Study Arms (1)

Nurses and nursing personnel

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Middlesex Hospital

Middletown, Connecticut, 06457, United States

Location

Yale New Haven Hospital- St. Raphael

New Haven, Connecticut, 06511, United States

Location

Yale New Haven Hospital Primary Care Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Aggression

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Study Officials

  • Joanne Iennaco

    Yale School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2017

First Posted

February 2, 2017

Study Start

January 1, 2017

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

March 6, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations