ViolenceeDASA+APP FINCT06342531
More Effective Violence Risk Management - eDASA+APP FI
A study testing eDASA+APP FI in people with Violence, run by University of Turku at 1 site in Finland.
Trial summary
The main goal of this study is to evaluate if the Finnish version of eDASA+APP (electronic Dynamic Appraisal of Situational Aggression + Aggression Prevention Protocol), a clinical decision support system (CDSS), has an impact on reducing workplace violence, use of coercive measures and increasing nurses' job… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Violence
- What is being tested?
- eDASA+APP FI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jun 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- adult psychiatric wards
Who cannot join
- psychiatric wards specialized only for the care of people with intellectual disabilities, wards providing care for both adults and underaged patients (eating disorder units)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: More Effective Violence Risk Management for Psychiatric Wards - eDASA+APP FI
The main goal of this study is to evaluate if the Finnish version of eDASA+APP (electronic Dynamic Appraisal of Situational Aggression + Aggression Prevention Protocol), a clinical decision support system (CDSS), has an impact on reducing workplace violence, use of coercive measures and increasing nurses' job satisfaction in adult psychiatric inpatient care.
Read the detailed description
The study includes three phases: 1) exploring attitudes of nurses and nurse managers towards validated tools, violence risk assessment and management, 2) a pre-implementation including a co-design process of the eDASA+APP to ensure optimal integration and adaptation to local context and integration into the local EPIC based EHR system together with relevant stakeholders (health care staff and expert-by-experience), and 3) a quasi-experimental implementation study to evaluate the impact of the intervention (eDASA+APP FI).
- Conditions
- Violence
- Being tested
- eDASA+APP FI
- Keywords
- violence risk assessment, DASA, Dynamic Appraisal of Situational Aggression, mental health nursing, EPIC, electronic health records, violence risk management, inpatient psychiatric care, coercive measures, clinical decision support system, CDSS, co-design, nurse-patient collaboration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eDASA+APP FIBehavioural
A CDSS for nurses to assist in their daily short-term violence risk assessment and management, is integrated into an EPIC-based EHR system.
| Study group | Role | What they receive |
|---|---|---|
| eDASA+APP FI | Experimental | Nurses in the study wards are using a CDSS 'eDASA+APP FI' in their daily clinical work to aid their short-term violence risk assessment and management, together with a patient if possible, to identify patients at elevated risk for violence in the coming 24 hours and to decrease (or maintain low) the risk with evidence-based, non-invasive nursing interventions. Receives: Behavioral: eDASA+APP FI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Workplace violence
Violence experienced by healthcare staff in the wards, routinely collected data
Measured: Pre-post (3 months)
Secondary outcomes (2)
Coercive measures
Routinely monitored and collected by the wards according to the Finnish Mental Health Act
Measured: Pre-post (3 months)
Job satisfaction
Nurses yearly job satisfaction survey will be used (Nurse Engagement Survey (NESplus))
Measured: Pre-post (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start1 Jun 2024
- Primary completion1 Dec 2024
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ViolenceStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A pre-post design (quasi-experimental), a cluster design
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Responsible party
- Principal investigator, Tella Lantta, University of Turku
- Investigators
- Tella Lantta, PhD, Principal investigator, Department of Nursing Science, University of Turku, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342531
- Sponsor's protocol ID
- 210324
- Acronym
- eDASA+APP FI
- Status last verified
- Apr 2025
- First submitted
- 26 Mar 2024
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Griffith JJ, Meyer D, Maguire T, Ogloff JRP, Daffern M. A Clinical Decision Support System to Prevent Aggression and Reduce Restrictive Practices in a Forensic Mental Health Service. Psychiatr Serv. 2021 Aug 1;72(8):885-890. doi: 10.1176/appi.ps.202000315. Epub 2021 May 17.
PubMed 33993715
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- More Effective Violence Risk Management for Psychiatric Wards - eDASA+APP FI
- ClinicalTrials.gov ID
- NCT06342531
- Acronym / sponsor ID
- eDASA+APP FI / 210324
- Conditions
- Violence
- Keywords
- violence risk assessment, DASA, Dynamic Appraisal of Situational Aggression, mental health nursing, EPIC, electronic health records, violence risk management, inpatient psychiatric care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Apr 2024 (actual)
- 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 main goal of this study is to evaluate if the Finnish version of eDASA+APP (electronic Dynamic Appraisal of Situational Aggression + Aggression Prevention Protocol), a clinical decision support system (CDSS), has an impact on reducing workplace violence, use of coercive measures and increasing nurses' job satisfaction in adult psychiatric inpatient care.
Detailed description
The study includes three phases: 1) exploring attitudes of nurses and nurse managers towards validated tools, violence risk assessment and management, 2) a pre-implementation including a co-design process of the eDASA+APP to ensure optimal integration and adaptation to local context and integration into the local EPIC based EHR system together with relevant stakeholders (health care staff and expert-by-experience), and 3) a quasi-experimental implementation study to evaluate the impact of the intervention (eDASA+APP FI).
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A pre-post design (quasi-experimental), a cluster design
| Arm | Type | Receives |
|---|---|---|
| eDASA+APP FI | Experimental | Behavioral: eDASA+APP FINurses in the study wards are using a CDSS 'eDASA+APP FI' in their daily clinical work to aid their short-term violence risk assessment and management, together with a patient if possible, to identify patients at elevated risk for violence in the coming 24 hours and to decrease (or maintain low) the risk with evidence-based, non-invasive nursing interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult psychiatric wards
Key exclusion criteria (1 listed)
- psychiatric wards specialized only for the care of people with intellectual disabilities, wards providing care for both adults and underaged patients (eating disorder units)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eDASA+APP FIA CDSS for nurses to assist in their daily short-term violence risk assessment and management, is integrated into an EPIC-based EHR system. | Behavioural | eDASA+APP FI |
Primary outcome
Workplace violence
Time frame: Pre-post (3 months)
Violence experienced by healthcare staff in the wards, routinely collected data
2 secondary outcomes
Coercive measures
Time frame: Pre-post (3 months)
Job satisfaction
Time frame: Pre-post (3 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Background: PubMed 33993715Griffith JJ, Meyer D, Maguire T, Ogloff JRP, Daffern M. A Clinical Decision Support System to Prevent Aggression and Reduce Restrictive Practices in a Forensic Mental Health Service. Psychiatr Serv. 2021 Aug 1;72(8):885-890. doi: 10.1176/appi.ps.202000315. Epub 2021 May 17.
- 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.
Tella Lantta, PhD principal investigator
Department of Nursing Science, University of Turku, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eDASA+APP FI in people with Violence, run by University of Turku at 1 site in Finland.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Workplace violence (time frame: Pre-post (3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06342531, which also lists 1 linked publication.
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 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.