Ignite Creation Date:
2024-05-05 @ 10:40 PM
Last Modification Date:
2024-10-26 @ 10:21 AM
Study NCT ID:
NCT01150994
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
2010-06-24
Brief Title:
Emergency Department Safety Assessment and Follow-up Evaluation ED-SAFE
Sponsor:
University of Massachusetts Worcester
Organization:
University of Massachusetts Worcester
Study Overview
Official Title:
Emergency Department Safety Assessment and Follow-up Evaluation ED-SAFE
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ED-SAFE
Brief Summary:
The NIMH s RFA-Suicide Prevention in Emergency Medicine Departments recognizes the emergency department ED as an important setting to increase suicide detection and prevention efforts but observes that evidence-based practice guidelines do not exist In response we have designed the Emergency Department Safety Assessment and Follow-up Evaluation ED-SAFE trial The ED-SAFE study will be conducted using a quasi-experimental design appropriate for studying systems-based change The study consists of two components Screening Outcome Intervention Evaluation and three phases of data collection Treatment as Usual Screening Alone and Intervention During each phase 480 suicidal patients 1440 total will be enrolled and followed using multiple methods for 12 months
The Screening Outcome Component
The Screening Outcome component will use data collected during the Treatment as Usual and Screening Alone phases Consistent with systems-change principles when universal screening is incorporated during the Screening Alone phase it will be completed by the primary nurse as part of routine care Primarily it will focus on testing a practical approach to screen ED patients for suicidal ideation and behavior and will assess its impact on suicide detection process outcomes and suicide behaviors
Intervention Evaluation Component
The Intervention Evaluation component will use data from the Treatment as Usual Screening Alone and Intervention Phases During the Intervention phase each ED will implement a multi-component systems-based Intervention called the Safety Assessment and Follow-up Telephone Intervention SAFTI The SAFTI will combine elements of a safety planning administered by nursing staff in the ED and b Coping Long Term with Active Suicide Program CLASP-ED a series of up to 7 semi-structured telephone advising calls to the patient and 4 to the significant other over the 12 months after the ED visit Safety planning will be implemented universally to all suicidal patients regardless of whether they are ultimately enrolled into the trial as part of a comprehensive suicide management protocol eg it is a systems-based change However for practical and budgetary considerations the CLASP-ED telephone advising calls will be administered only to participants enrolled into the study
Our overarching hypotheses will be tested using a combination of the Screening Outcome component and the Intervention Evaluation Component We predict that screening will improve detection of suicidal ideation and the intervention will enhance the quality of care and reduce suicide outcomes
The Screening Outcome Component
The Screening Outcome component will use data collected during the Treatment as Usual and Screening Alone phases Consistent with systems-change principles when universal screening is incorporated during the Screening Alone phase it will be completed by the primary nurse as part of routine care Primarily it will focus on testing a practical approach to screen ED patients for suicidal ideation and behavior and will assess its impact on suicide detection process outcomes and suicide behaviors
Intervention Evaluation Component
The Intervention Evaluation component will use data from the Treatment as Usual Screening Alone and Intervention Phases During the Intervention phase each ED will implement a multi-component systems-based Intervention called the Safety Assessment and Follow-up Telephone Intervention SAFTI The SAFTI will combine elements of a safety planning administered by nursing staff in the ED and b Coping Long Term with Active Suicide Program CLASP-ED a series of up to 7 semi-structured telephone advising calls to the patient and 4 to the significant other over the 12 months after the ED visit Safety planning will be implemented universally to all suicidal patients regardless of whether they are ultimately enrolled into the trial as part of a comprehensive suicide management protocol eg it is a systems-based change However for practical and budgetary considerations the CLASP-ED telephone advising calls will be administered only to participants enrolled into the study
Our overarching hypotheses will be tested using a combination of the Screening Outcome component and the Intervention Evaluation Component We predict that screening will improve detection of suicidal ideation and the intervention will enhance the quality of care and reduce suicide outcomes
Detailed Description:
see summary above
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1U01MH088278-01 | NIH | None | httpsreporternihgovquickSearch1U01MH088278-01 |