Suicide, AttemptedPROTECTNCT05609487
Evaluation of the Safety Plan to Prevent Suicidal Reiteration
A study testing As usual and Protection plan in people with Suicide, Attempted, run by Hôpital le Vinatier at 1 site in France.
Trial summary
Each year, suicide is the cause of 8,580 deaths in France, it is the second leading cause of death among 15-24 year olds. People who have made a first suicide attempt are identified as being at greater risk of repeating a suicidal gesture, particularly in the first month following the gesture . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Suicide, Attempted
- What is being tested?
- As usual and Protection plan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,387 participants
- Where
- 1 siteFrance
- Study dates
- 25 Sep 2023to 31 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Seen in an emergency department
- Admitted in emergency department following a suicide attempt <48h
- whose duration of care does not exceed 24 hours
- For whom the care project results in a return home,
- Who agree to be included in the Vigilans system
- Who have social security coverage
- Fluent in French
Who cannot join
- Refusal to participate in the study
- Refusal to be accompanied by the Vigilans system
- Hospitalisation for more than 24 hours in the immediate aftermath of the suicide attempt
- Under protective measures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Le Vinatier
Bron, AURA, 69678 CEDEX
POULET EMMANUEL, PUPH, 0033437915120 ext. +33, emmanuel.poulet@chu-lyon.fr
SARTELET Lydie, 0033437915531, lydie.sartelet@ch-le-vinatier.fr
About this study
Official title: Evaluation of the Effectiveness of the Implementation of a Safety Plan by the Emergency Nurse to Prevent Suicidal Reiteration - National Multicenter Randomized Controlled Trial in Stepped-wedge
Each year, suicide is the cause of 8,580 deaths in France, it is the second leading cause of death among 15-24 year olds. People who have made a first suicide attempt are identified as being at greater risk of repeating a suicidal gesture, particularly in the first month following the gesture . At the same time, Brief Intervention Contact (BIC) is recognized as effective in reducing suicide deaths.
A new brief intervention to prevent suicidal attempts has been developed in the United States by Santley \& Brown (2012) the results of its effectiveness are very encouraging.
Read more
Investigators hypothesise that the implementation of a safety plan by the emergency department for suicidal patients included in the Vigilans system leads to a greater reduction in the reiteration of suicidality at 6 months compared to the usual management.
Our main objective is to evaluate the effectiveness of the implementation of a safety plan by the emergency department nurse before discharge from the emergency department in reducing suicidal reiteration at six months after the suicide attempt, for suicidal patients included in the Vigilans programe, compared with the Vigilans programe alone.
Our secondary objectives are
- Reduce the reiteration of the suicidal act at 1 month
- Encourage engagement in care at 1 month and 6 months
- Reduce the use of emergency departments at 1 month and 6 months due to a suicidal crisis
- Decrease suicide mortality at 6 months
To study the implementation of the intervention:
- To measure the quality of completion, and the duration of completion of the safety plan at 1 month, and 6 months.
- Assess the acceptability of the safety plan by emergency department nurses, and then by the vigilantes.
- Assess the acceptability of the safety plan by patient
Read the detailed description
Each year, suicide is the cause of 8,580 deaths in France , and although the suicide rate in France has decreased by 10% over the last ten years, it is the second leading cause of death among 15-24 year olds.
People who have made a first suicide attempt are identified as being at greater risk of repeating a suicidal gesture, particularly in the first month following the gesture . At the same time, Brief Intervention Contact (BIC) is recognised as effective in reducing suicide deaths.
In 2012, two American psychiatrists developed and evaluated the effectiveness of a tool for preventing the recurrence of suicide: the safety plan. It consists of a list of strategies co-constructed by a trained health professional with the person concerned, which make it possible to deal with thoughts of suicide. It is deployed in 6 steps.
Once completed, it is kept by the user and can be used in complete autonomy at the first signs of a potential suicidal crisis.
This prevention tool, whose initial results across the Atlantic are very encouraging, is not used in daily practice in France.
The main objective of the study is therefore to evaluate its effectiveness at 6 months when it is implemented by the emergency room nurse, before discharge, for people already included in the VigilanS programme.
The VigilanS programme is the national system for preventing suicidal recurrence and consists of three complementary strategies:
- Firstly, a resource card indicates a toll-free number, open during the day, for people who have made a gesture. Respondents are health professionals (vigilance workers) who can assess and guide people in the event of a recurrence of suicidal thoughts.
- Then investigators contact the person's existing care network, investigators inform the attending doctor, but also other care providers (psychologist, physiotherapist, liberal nurse...) of their patient's inclusion in the system.
- Finally, telephone calls are made by the health professionals in the first month following discharge, and six months after the suicidal act. In parallel, a postcard is sent monthly during the first 4 months to continue the link.
This national study will work with 11 hospitals with a Vigilans service and will be implemented in 19 emergency departments. Doctors, nurses and health managers will be identified in each center.
The first step of the study is to translate the tool (the safety plan), with the help of a committee of experts and specialized translators.
Then investigators will evaluate its effectiveness with 2,387 study participants included in the 19 emergency departments over a two-year period.
Each participating center (the emergency department) will initially be in an observation (or control) phase, i.e. the safety plan will not be used by the care workers. Then in a second phase, the research team will implement the practice of the tool through training, and in a third phase the center will be in the intervention phase, i.e. it will use the tool in daily practice.
The order of training, where the practice is implemented in the units, is chosen by randomization.
The main objective of the study is to evaluate six months after the suicide attempt, by a telephone call that will ask the patient if he or she has made a suicidal attempt again.
Investigators will thus be able to compare a population that has not received the tool (the control group) with a population that has received the tool (the intervention group) and thus measure its effectiveness.
Finally, the last stage of the study consists of evaluating the use of the tool by emergency service professionals, the Vigilans device, and the participants in the study. To do this, investigators will use questionnaires (evaluation scales) and conduct semi-structured interviews with several participants
- Conditions
- Suicide, Attempted
- Being tested
- As usual, Protection plan
- Medical subject headings
- Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
As usualOther
Patients included in the control phase, i.e. without intervention, will be asked not to oppose participation in the research, after having received the presentation of the study and the information notice. The data collection will be similar to the data collection during the intervention period.
Protection planDevice
The intervention consists of making the protection plan in a co-constructed process with the care user. This tool is built in 6 steps, is written and takes 20 to 40 minutes to complete.
These 6 steps allow to identify the first signs of a suicidal crisis and to identify different strategies to face it. They are constructed in an ascending order, with the aim of being used by the care user in an autonomous situation.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Step in "control group" This stepped wedge study does not use two parallel treatment arms. The stepped wedge design allows each center to be its own "control group" and then, after implementation of the practice by the research team, to become a "intervention group".
The characteristics of these two phases are detailed below. Patients included in the control phase, i.e. without intervention, will be asked not to oppose participation in the research, after having received the presentation of the study and the information notice. The data collection will be similar to the data collection during the intervention period. Receives: Other: As usual |
| Protection plan group | Other | The intervention consists of making the protection plan in a co-constructed process with the care user. This tool is built in 6 steps, is written and takes 20 to 40 minutes to complete.
These 6 steps allow to identify the first signs of a suicidal crisis and to identify different strategies to face it. They are constructed in an ascending order, with the aim of being used by the care user in an autonomous situation. Receives: Device: Protection plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidal recurrence at 6 months
Suicidal reiteration is characterized by non-fatal suicidal behavior, self-inflicted injury with a desire to end one's life that does not result in death (WHO).
Measured: 6 months
Secondary outcomes (3)
Suicidal recurrence
Suicidal reiteration is characterized by non-fatal suicidal behavior, self-inflicted injury with a desire to end one's life that does not result in death (WHO).
Measured: one month
Commitment to healthcare
Currently in mental health care? Y/N number of appointments in mental health care since the suicide attempt
Measured: One month and 6 months
Death by suicide attempt
Collected by cross-referencing information from the Vigilans system, by contacting the doctor or family members and other contacts. In the event of a lost person with no vital status data, civil status registers may be used.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start25 Sep 2023
- Primary completion15 Jan 2026 (estimated)
- Study completion31 Dec 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 Suicide, AttemptedStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study is structured in three phases: 1) translation and adaptation of the safety plan into French; 2) effectiveness study; and 3) evaluation of the implementation of the safety plan in practice
- Masking
- None (open label)
- Enrolment
- 2,387 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BENOIT CHALANCON, IDE, Principal investigator, CH LE VINATIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609487
- Sponsor's protocol ID
- 2022-A00163-40
- Acronym
- PROTECT
- Status last verified
- Sep 2024
- First submitted
- 1 Nov 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chalancon B, Haesebaert J, Vacher A, Vieux M, Simon L, Subtil F, Colin C, Poulet E, Leaune E; Investigator Associates; Expanded Scientific Nursing Committee. Implementing a nurse-led safety planning intervention in emergency departments to prevent suicide reattempts: a stepped-wedge randomized controlled trial protocol (French multicentre randomized controlled trial with a stepped-wedge design). BMC Nurs. 2025 May 19;24(1):558. doi: 10.1186/s12912-025-03121-w.
PubMed 40389942
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the Implementation of a Safety Plan by the Emergency Nurse to Prevent Suicidal Reiteration - National Multicenter Randomized Controlled Trial in Stepped-wedge
- ClinicalTrials.gov ID
- NCT05609487
- Acronym / sponsor ID
- PROTECT / 2022-A00163-40
- Conditions
- Suicide, Attempted
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,387 participants (estimated)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Nov 2022 (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.
Each year, suicide is the cause of 8,580 deaths in France, it is the second leading cause of death among 15-24 year olds. People who have made a first suicide attempt are identified as being at greater risk of repeating a suicidal gesture, particularly in the first month following the gesture . At the same time, Brief Intervention Contact (BIC) is recognized as effective in reducing suicide deaths.
A new brief intervention to prevent suicidal attempts has been developed in the United States by Santley \& Brown (2012) the results of its effectiveness are very encouraging.
Investigators hypothesise that the implementation of a safety plan by the emergency department for suicidal patients included in the Vigilans system leads to a greater reduction in the reiteration of suicidality at 6 months compared to the usual management.
Our main objective is to evaluate the effectiveness of the implementation of a safety plan by the emergency department nurse before discharge from the emergency department in reducing suicidal reiteration at six months after the suicide attempt, for suicidal patients included in the Vigilans programe, compared with the Vigilans programe alone.
Our secondary objectives are
- Reduce the reiteration of the suicidal act at 1 month
- Encourage engagement in care at 1 month and 6 months
- Reduce the use of emergency departments at 1 month and 6 months due to a suicidal crisis
- Decrease suicide mortality at 6 months
To study the implementation of the intervention:
- To measure the quality of completion, and the duration of completion of the safety plan at 1 month, and 6 months.
- Assess the acceptability of the safety plan by emergency department nurses, and then by the vigilantes.
- Assess the acceptability of the safety plan by patient
Detailed description
Each year, suicide is the cause of 8,580 deaths in France , and although the suicide rate in France has decreased by 10% over the last ten years, it is the second leading cause of death among 15-24 year olds.
People who have made a first suicide attempt are identified as being at greater risk of repeating a suicidal gesture, particularly in the first month following the gesture . At the same time, Brief Intervention Contact (BIC) is recognised as effective in reducing suicide deaths.
In 2012, two American psychiatrists developed and evaluated the effectiveness of a tool for preventing the recurrence of suicide: the safety plan. It consists of a list of strategies co-constructed by a trained health professional with the person concerned, which make it possible to deal with thoughts of suicide. It is deployed in 6 steps.
Once completed, it is kept by the user and can be used in complete autonomy at the first signs of a potential suicidal crisis.
This prevention tool, whose initial results across the Atlantic are very encouraging, is not used in daily practice in France.
The main objective of the study is therefore to evaluate its effectiveness at 6 months when it is implemented by the emergency room nurse, before discharge, for people already included in the VigilanS programme.
The VigilanS programme is the national system for preventing suicidal recurrence and consists of three complementary strategies:
- Firstly, a resource card indicates a toll-free number, open during the day, for people who have made a gesture. Respondents are health professionals (vigilance workers) who can assess and guide people in the event of a recurrence of suicidal thoughts.
- Then investigators contact the person's existing care network, investigators inform the attending doctor, but also other care providers (psychologist, physiotherapist, liberal nurse...) of their patient's inclusion in the system.
- Finally, telephone calls are made by the health professionals in the first month following discharge, and six months after the suicidal act. In parallel, a postcard is sent monthly during the first 4 months to continue the link.
This national study will work with 11 hospitals with a Vigilans service and will be implemented in 19 emergency departments. Doctors, nurses and health managers will be identified in each center.
The first step of the study is to translate the tool (the safety plan), with the help of a committee of experts and specialized translators.
Then investigators will evaluate its effectiveness with 2,387 study participants included in the 19 emergency departments over a two-year period.
Each participating center (the emergency department) will initially be in an observation (or control) phase, i.e. the safety plan will not be used by the care workers. Then in a second phase, the research team will implement the practice of the tool through training, and in a third phase the center will be in the intervention phase, i.e. it will use the tool in daily practice.
The order of training, where the practice is implemented in the units, is chosen by randomization.
The main objective of the study is to evaluate six months after the suicide attempt, by a telephone call that will ask the patient if he or she has made a suicidal attempt again.
Investigators will thus be able to compare a population that has not received the tool (the control group) with a population that has received the tool (the intervention group) and thus measure its effectiveness.
Finally, the last stage of the study consists of evaluating the use of the tool by emergency service professionals, the Vigilans device, and the participants in the study. To do this, investigators will use questionnaires (evaluation scales) and conduct semi-structured interviews with several participants
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is structured in three phases: 1) translation and adaptation of the safety plan into French; 2) effectiveness study; and 3) evaluation of the implementation of the safety plan in practice
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: As usualStep in "control group" This stepped wedge study does not use two parallel treatment arms. The stepped wedge design allows each center to be its own "control group" and then, after implementation of the practice by the research team, to become a "intervention group". The characteristics of these two phases are detailed below. Patients included in the control phase, i.e. without intervention, will be asked not to oppose participation in the research, after having received the presentation of the study and the information notice. The data collection will be similar to the data collection during the intervention period. |
| Protection plan group | Other | Device: Protection planThe intervention consists of making the protection plan in a co-constructed process with the care user. This tool is built in 6 steps, is written and takes 20 to 40 minutes to complete. These 6 steps allow to identify the first signs of a suicidal crisis and to identify different strategies to face it. They are constructed in an ascending order, with the aim of being used by the care user in an autonomous situation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age or older
- Seen in an emergency department
- Admitted in emergency department following a suicide attempt <48h
- whose duration of care does not exceed 24 hours
- For whom the care project results in a return home,
Key exclusion criteria (4 listed)
- Refusal to participate in the study
- Refusal to be accompanied by the Vigilans system
- Hospitalisation for more than 24 hours in the immediate aftermath of the suicide attempt
- Under protective measures.
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 |
|---|---|---|
| As usualPatients included in the control phase, i.e. without intervention, will be asked not to oppose participation in the research, after having received the presentation of the study and the information notice. The data collection will be similar to the data collection during the intervention period. | Other | Control group |
| Protection planThe intervention consists of making the protection plan in a co-constructed process with the care user. This tool is built in 6 steps, is written and takes 20 to 40 minutes to complete. These 6 steps allow to identify the first signs of a suicidal crisis and to identify different strategies to face it. They are constructed in an ascending order, with the aim of being used by the care user in an autonomous situation. | Device | Protection plan group |
Primary outcome
Suicidal recurrence at 6 months
Time frame: 6 months
Suicidal reiteration is characterized by non-fatal suicidal behavior, self-inflicted injury with a desire to end one's life that does not result in death (WHO).
3 secondary outcomes
Suicidal recurrence
Time frame: one month
Commitment to healthcare
Time frame: One month and 6 months
Death by suicide attempt
Time frame: 6 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 19 Sep 2024.
- Derived from this study: PubMed 40389942Chalancon B, Haesebaert J, Vacher A, Vieux M, Simon L, Subtil F, Colin C, Poulet E, Leaune E; Investigator Associates; Expanded Scientific Nursing Committee. Implementing a nurse-led safety planning intervention in emergency departments to prevent suicide reattempts: a stepped-wedge randomized controlled trial protocol (French multicentre randomized controlled trial with a stepped-wedge design). BMC Nurs. 2025 May 19;24(1):558. doi: 10.1186/s12912-025-03121-w.
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Suicide
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.
BENOIT CHALANCON, IDE principal investigator
CH LE VINATIER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing As usual and Protection plan in people with Suicide, Attempted, run by Hôpital le Vinatier at 1 site in France.
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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 19 Sep 2024. 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 France. 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?
Contact BENOIT CHALANCON, IDE (0033437915210, benoit.chalancon@ch-le-vinatier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicidal recurrence at 6 months (time frame: 6 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 NCT05609487, 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 19 Sep 2024.