Trial Outcomes & Findings for The Acceptability and Feasibility of an ED-based, Peer-delivered, Suicide Safety Planning Intervention (NCT NCT04068142)

Results Overview

Evaluate the number of suicidal ideology (SI) patients approached in the ED who agree to receive a safety plan.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

37 participants

Primary outcome timeframe

approach in the ED (typically <1 hour)

Results posted on

2022-01-27

Participant Flow

Participant milestones

Participant milestones
Measure	Clinical Personnel Safety Planning Patients will complete a traditional written suicide safety plan with clinical personnel.	Peer Supporter Safety Planning Patients will complete a traditional written suicide safety plan with peer supporters. Peer Supporter Safety Planning: The rationale for testing a peer-delivered intervention in the emergency department (ED) relies on the following evidence: a) a peer is an individual with lived experience who is now supporting other mental health patients in crisis; b) the experience of a mental health patient in the ED often shapes the perception of the health system, and may influence willingness to seek future care; c) peers may provide more empathetic care than providers without lived experience, which may positively impact patients; d) peer-based programs for patients with serious mental illness that do not involve safety planning are at least as good as non-peer based programs at preventing hospitalizations and promoting engagement in care, with the most promising interventions involving self-management or peer-navigator roles; and e) existing evidence from high-quality studies is scarce, but in moderate-low quality studies has indicated that peers are no less effective than mental health workers
Overall Study STARTED	17	20
Overall Study COMPLETED	15	16
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clinical Personnel Safety Planning n=15 Participants Patients will complete a traditional written suicide safety plan with clinical personnel.	Peer Supporter Safety Planning n=16 Participants Patients will complete a traditional written suicide safety plan with peer supporters. Peer Supporter Safety Planning: The rationale for testing a peer-delivered intervention in the ED relies on the following evidence: a) a peer is an individual with lived experience who is now supporting other mental health patients in crisis; b) the experience of a mental health patient in the ED often shapes the perception of the health system, and may influence willingness to seek future care; c) peers may provide more empathetic care than providers without lived experience, which may positively impact patients; d) peer-based programs for patients with serious mental illness that do not involve safety planning are at least as good as non-peer based programs at preventing hospitalizations and promoting engagement in care, with the most promising interventions involving self-management or peer-navigator roles; and e) existing evidence from high-quality studies is scarce, but in moderate-low quality studies has indicated that peers are no less effective than mental health workers	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=15 Participants	0 Participants n=16 Participants	0 Participants n=31 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=15 Participants	16 Participants n=16 Participants	31 Participants n=31 Participants
Age, Categorical >=65 years	0 Participants n=15 Participants	0 Participants n=16 Participants	0 Participants n=31 Participants
Age, Continuous	45 years n=15 Participants	38.5 years n=16 Participants	39 years n=31 Participants
Sex: Female, Male Female	5 Participants n=15 Participants	10 Participants n=16 Participants	15 Participants n=31 Participants
Sex: Female, Male Male	10 Participants n=15 Participants	6 Participants n=16 Participants	16 Participants n=31 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: approach in the ED (typically <1 hour)

Population: participants

Evaluate the number of suicidal ideology (SI) patients approached in the ED who agree to receive a safety plan.

Outcome measures

Outcome measures
Measure	Clinical Personnel Safety Planning n=15 Participants Patients will complete a traditional written suicide safety plan with clinical personnel.	Peer Supporter Safety Planning n=16 Participants Patients will complete a traditional written suicide safety plan with peer supporters. Peer Supporter Safety Planning: The rationale for testing a peer-delivered intervention in the ED relies on the following evidence: a) a peer is an individual with lived experience who is now supporting other mental health patients in crisis; b) the experience of a mental health patient in the ED often shapes the perception of the health system, and may influence willingness to seek future care; c) peers may provide more empathetic care than providers without lived experience, which may positively impact patients; d) peer-based programs for patients with serious mental illness that do not involve safety planning are at least as good as non-peer based programs at preventing hospitalizations and promoting engagement in care, with the most promising interventions involving self-management or peer-navigator roles; and e) existing evidence from high-quality studies is scarce, but in moderate-low quality studies has indicated that peers are no less effective than mental health workers
Number of Suicidal Ideology (SI) Participants Who Agree to Receive a Safety Plan	15 Participants	16 Participants

PRIMARY outcome

Timeframe: Up to 12 hours

Population: participants

Evaluate the proportion of patients approached who meet all inclusion/exclusion criteria.

Outcome measures

Outcome measures
Measure	Clinical Personnel Safety Planning n=17 Participants Patients will complete a traditional written suicide safety plan with clinical personnel.	Peer Supporter Safety Planning n=20 Participants Patients will complete a traditional written suicide safety plan with peer supporters. Peer Supporter Safety Planning: The rationale for testing a peer-delivered intervention in the ED relies on the following evidence: a) a peer is an individual with lived experience who is now supporting other mental health patients in crisis; b) the experience of a mental health patient in the ED often shapes the perception of the health system, and may influence willingness to seek future care; c) peers may provide more empathetic care than providers without lived experience, which may positively impact patients; d) peer-based programs for patients with serious mental illness that do not involve safety planning are at least as good as non-peer based programs at preventing hospitalizations and promoting engagement in care, with the most promising interventions involving self-management or peer-navigator roles; and e) existing evidence from high-quality studies is scarce, but in moderate-low quality studies has indicated that peers are no less effective than mental health workers
Proportion of Eligible Patients	17 Participants	20 Participants

PRIMARY outcome

Timeframe: Up to 12 hours

Evaluate the quality of the completed safety plans. This will be done by retrospective review after the patient has left the ED. Safety plans will be graded individually, then resolved by consensus, for quality (0=blank, 1=boilerplate, 2=some evidence of personalization, 3=highly personalized; range=0-24) by the investigators using materials developed by Brown and Stanley for this purpose. Using a "safety checklist," responses for each of the 6 safety plan steps will be classified according to the personalization of the information in each step.

Outcome measures

Outcome measures
Measure	Clinical Personnel Safety Planning n=15 Participants Patients will complete a traditional written suicide safety plan with clinical personnel.	Peer Supporter Safety Planning n=16 Participants Patients will complete a traditional written suicide safety plan with peer supporters. Peer Supporter Safety Planning: The rationale for testing a peer-delivered intervention in the ED relies on the following evidence: a) a peer is an individual with lived experience who is now supporting other mental health patients in crisis; b) the experience of a mental health patient in the ED often shapes the perception of the health system, and may influence willingness to seek future care; c) peers may provide more empathetic care than providers without lived experience, which may positively impact patients; d) peer-based programs for patients with serious mental illness that do not involve safety planning are at least as good as non-peer based programs at preventing hospitalizations and promoting engagement in care, with the most promising interventions involving self-management or peer-navigator roles; and e) existing evidence from high-quality studies is scarce, but in moderate-low quality studies has indicated that peers are no less effective than mental health workers
Quality of Safety Plans	8 scores on a scale Interval 7.0 to 9.0	12.5 scores on a scale Interval 10.0 to 16.5

PRIMARY outcome

Timeframe: Up to 12 hours

Population: participants

Evaluate patient satisfaction with safety planning. This will be assessed by having the patient rate their experience with the safety planning process on a 7-point Likert scale (1 - strongly disagree; 2 - disagree; 3 - moderately disagree; 4 - neutral; 5 - moderately agree; 6 - agree; 7 - strongly agree). A Likert scale measures how much someone disagrees or agrees with a particular statement.

Outcome measures

Outcome measures
Measure	Clinical Personnel Safety Planning n=15 Participants Patients will complete a traditional written suicide safety plan with clinical personnel.	Peer Supporter Safety Planning n=16 Participants Patients will complete a traditional written suicide safety plan with peer supporters. Peer Supporter Safety Planning: The rationale for testing a peer-delivered intervention in the ED relies on the following evidence: a) a peer is an individual with lived experience who is now supporting other mental health patients in crisis; b) the experience of a mental health patient in the ED often shapes the perception of the health system, and may influence willingness to seek future care; c) peers may provide more empathetic care than providers without lived experience, which may positively impact patients; d) peer-based programs for patients with serious mental illness that do not involve safety planning are at least as good as non-peer based programs at preventing hospitalizations and promoting engagement in care, with the most promising interventions involving self-management or peer-navigator roles; and e) existing evidence from high-quality studies is scarce, but in moderate-low quality studies has indicated that peers are no less effective than mental health workers
Satisfaction With Safety Planning	4 score on a scale Interval 4.0 to 4.0	4.5 score on a scale Interval 4.0 to 6.0

Adverse Events

Clinical Personnel Safety Planning

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Peer Supporter Safety Planning

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Michael Wilson

UAMS

Phone: 501-686-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place