AggressionAIMSNCT03041272
Aggressive Incidents in Medical Settings Study
An observational study of Aggression, run by Yale University at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aggression
- How many people
- 137 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2017to Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Middlesex Hospital
Middletown, Connecticut, 06457
Yale New Haven Hospital- St. Raphael
New Haven, Connecticut, 06511
Yale New Haven Hospital Primary Care Center
New Haven, Connecticut, 06519
About this study
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.
Read the 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.
- Conditions
- Aggression
- Medical subject headings
- Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 2 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study startJan 2017
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AggressionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanne Iennaco, Principal investigator, Yale School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041272
- Sponsor's protocol ID
- 1609018379
- Acronym
- AIMS
- Status last verified
- Mar 2020
- First submitted
- 25 Jan 2017
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aggressive Incidents in Medical Settings Study
- ClinicalTrials.gov ID
- NCT03041272
- Acronym / sponsor ID
- AIMS / 1609018379
- Conditions
- Aggression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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)
3 secondary outcomes
To describe the characteristics of patient and visitor events involving aggressive behavior toward nursing staff in inpatient medical settings.
Time frame: 2 weeks
risk of missed care events
Time frame: 2 weeks
Professional Quality of Life Scale
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne Iennaco principal investigator
Yale School of Nursing
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aggression, run by Yale University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
unit-level incidence rate of patient and visitor physical aggression (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.