Trial Outcomes & Findings for UH3 Pragmatic Suicide Prevention Trial (NCT NCT02326883)

Last Updated: 2021-10-19

Results Overview

Electronic health records and insurance claims data will be searched for any nonfatal suicide attempts or self-harm during the 18 months after randomization. Fatal suicide attempts will be identified from state mortality data.

Recruitment status

COMPLETED

Study phase

Target enrollment

18882 participants

Primary outcome timeframe

18 Months after randomization

Results posted on

2021-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	Care Management The Care Management intervention will last up to a year and includes routine outreach to assess ongoing risk of suicide attempt, and care management to monitor and facilitate ongoing engagement in outpatient follow-up. The Care Manager will coordinate care with treating mental health and primary care providers (ongoing usual care) using Epic Staff Messaging (or telephone contacts if necessary). Care Management: The Care Management intervention includes routine outreach to assess ongoing risk of suicide attempt and care management to monitor and facilitate ongoing engagement in outpatient follow-up. The Care Manager will coordinate care with treating mental health and primary care providers (ongoing usual care) using Epic Staff Messaging (or telephone contacts if necessary).	Skills Training The Skills Training intervention will last up to a year and uses an online skills training program to support patients in developing and using self-management skills for emotion regulation and crisis management. A Coach will monitor each participant's use of the program and send periodic messages (using Epic secure messaging) to encourage and support use of the program and practice of program skills. Skills Training: The Skills Training intervention uses an online skills training program to support patients in developing and using self-management skills for emotion regulation and crisis management. A Coach will monitor each participant's use of the program and send periodic messages (using Epic secure messaging) to encourage and support use of the program and practice of program skills.	Usual Care Those assigned to the Usual Care group will not be approached or contacted. Usual Care: Those assigned to usual care will not be contacted at all by study staff and will continue to receive usual care from treating primary care and mental health providers.
Overall Study STARTED	6314	6312	6256
Overall Study COMPLETED	6230	6227	6187
Overall Study NOT COMPLETED	84	85	69

Reasons for withdrawal

Reasons for withdrawal
Measure	Care Management The Care Management intervention will last up to a year and includes routine outreach to assess ongoing risk of suicide attempt, and care management to monitor and facilitate ongoing engagement in outpatient follow-up. The Care Manager will coordinate care with treating mental health and primary care providers (ongoing usual care) using Epic Staff Messaging (or telephone contacts if necessary). Care Management: The Care Management intervention includes routine outreach to assess ongoing risk of suicide attempt and care management to monitor and facilitate ongoing engagement in outpatient follow-up. The Care Manager will coordinate care with treating mental health and primary care providers (ongoing usual care) using Epic Staff Messaging (or telephone contacts if necessary).	Skills Training The Skills Training intervention will last up to a year and uses an online skills training program to support patients in developing and using self-management skills for emotion regulation and crisis management. A Coach will monitor each participant's use of the program and send periodic messages (using Epic secure messaging) to encourage and support use of the program and practice of program skills. Skills Training: The Skills Training intervention uses an online skills training program to support patients in developing and using self-management skills for emotion regulation and crisis management. A Coach will monitor each participant's use of the program and send periodic messages (using Epic secure messaging) to encourage and support use of the program and practice of program skills.	Usual Care Those assigned to the Usual Care group will not be approached or contacted. Usual Care: Those assigned to usual care will not be contacted at all by study staff and will continue to receive usual care from treating primary care and mental health providers.
Overall Study Disenrolled or died prior to first follow-up day - not included in outcome or adverse event counts	84	85	69

Baseline Characteristics

UH3 Pragmatic Suicide Prevention Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Care Management n=6230 Participants The Care Management intervention will last up to a year and includes routine outreach to assess ongoing risk of suicide attempt, and care management to monitor and facilitate ongoing engagement in outpatient follow-up. The Care Manager will coordinate care with treating mental health and primary care providers (ongoing usual care) using Epic Staff Messaging (or telephone contacts if necessary). Care Management: The Care Management intervention includes routine outreach to assess ongoing risk of suicide attempt and care management to monitor and facilitate ongoing engagement in outpatient follow-up. The Care Manager will coordinate care with treating mental health and primary care providers (ongoing usual care) using Epic Staff Messaging (or telephone contacts if necessary).	Skills Training n=6227 Participants The Skills Training intervention will last up to a year and uses an online skills training program to support patients in developing and using self-management skills for emotion regulation and crisis management. A Coach will monitor each participant's use of the program and send periodic messages (using Epic secure messaging) to encourage and support use of the program and practice of program skills. Skills Training: The Skills Training intervention uses an online skills training program to support patients in developing and using self-management skills for emotion regulation and crisis management. A Coach will monitor each participant's use of the program and send periodic messages (using Epic secure messaging) to encourage and support use of the program and practice of program skills.	Usual Care n=6187 Participants Those assigned to the Usual Care group will not be approached or contacted. Usual Care: Those assigned to usual care will not be contacted at all by study staff and will continue to receive usual care from treating primary care and mental health providers.	Total n=18644 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	5254 Participants n=5 Participants	5293 Participants n=7 Participants	5280 Participants n=5 Participants	15827 Participants n=4 Participants
Age, Categorical >=65 years	976 Participants n=5 Participants	934 Participants n=7 Participants	907 Participants n=5 Participants	2817 Participants n=4 Participants
Sex: Female, Male Female	4195 Participants n=5 Participants	4160 Participants n=7 Participants	4188 Participants n=5 Participants	12543 Participants n=4 Participants
Sex: Female, Male Male	2035 Participants n=5 Participants	2067 Participants n=7 Participants	1999 Participants n=5 Participants	6101 Participants n=4 Participants
Race/Ethnicity, Customized Non-Hispanic White	4723 Participants n=5 Participants	4651 Participants n=7 Participants	4561 Participants n=5 Participants	13935 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic	495 Participants n=5 Participants	495 Participants n=7 Participants	595 Participants n=5 Participants	1585 Participants n=4 Participants
Race/Ethnicity, Customized Asian, Non-Hispanic	179 Participants n=5 Participants	183 Participants n=7 Participants	194 Participants n=5 Participants	556 Participants n=4 Participants
Race/Ethnicity, Customized Black, Non-Hispanic	241 Participants n=5 Participants	272 Participants n=7 Participants	237 Participants n=5 Participants	750 Participants n=4 Participants
Race/Ethnicity, Customized American Indian, Non-Hispanic	56 Participants n=5 Participants	42 Participants n=7 Participants	35 Participants n=5 Participants	133 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	24 Participants n=5 Participants	29 Participants n=7 Participants	23 Participants n=5 Participants	76 Participants n=4 Participants
Race/Ethnicity, Customized More than one race	170 Participants n=5 Participants	188 Participants n=7 Participants	203 Participants n=5 Participants	561 Participants n=4 Participants
Race/Ethnicity, Customized Other or not recorded	342 Participants n=5 Participants	376 Participants n=7 Participants	399 Participants n=5 Participants	1117 Participants n=4 Participants
Region of Enrollment United States	6230 participants n=5 Participants	6227 participants n=7 Participants	6187 participants n=5 Participants	18644 participants n=4 Participants
Site of recruitment Mental Health Specialty Clinic	3071 Participants n=5 Participants	3111 Participants n=7 Participants	3040 Participants n=5 Participants	9222 Participants n=4 Participants
Site of recruitment General Medical Clinic	3159 Participants n=5 Participants	3116 Participants n=7 Participants	3147 Participants n=5 Participants	9422 Participants n=4 Participants
PHQ9 item 9 score More than half the days	4180 Participants n=5 Participants	4177 Participants n=7 Participants	4141 Participants n=5 Participants	12498 Participants n=4 Participants
PHQ9 item 9 score Nearly every day	2050 Participants n=5 Participants	2050 Participants n=7 Participants	2046 Participants n=5 Participants	6146 Participants n=4 Participants

PRIMARY outcome

Timeframe: 18 Months after randomization

Population: Participants were analyzed according to initial assignment, regardless of intervention participation. Follow-up time was censored at time of disenrollment from the participating health system or death due to cause other than self-harm.

Outcome measures

Outcome measures
Measure	Care Management n=6230 Participants The Care Management intervention will last up to a year and includes routine outreach to assess ongoing risk of suicide attempt, and care management to monitor and facilitate ongoing engagement in outpatient follow-up. The Care Manager will coordinate care with treating mental health and primary care providers (ongoing usual care) using Epic Staff Messaging (or telephone contacts if necessary). Care Management: The Care Management intervention includes routine outreach to assess ongoing risk of suicide attempt and care management to monitor and facilitate ongoing engagement in outpatient follow-up. The Care Manager will coordinate care with treating mental health and primary care providers (ongoing usual care) using Epic Staff Messaging (or telephone contacts if necessary).	Skills Training n=6227 Participants The Skills Training intervention will last up to a year and uses an online skills training program to support patients in developing and using self-management skills for emotion regulation and crisis management. A Coach will monitor each participant's use of the program and send periodic messages (using Epic secure messaging) to encourage and support use of the program and practice of program skills. Skills Training: The Skills Training intervention uses an online skills training program to support patients in developing and using self-management skills for emotion regulation and crisis management. A Coach will monitor each participant's use of the program and send periodic messages (using Epic secure messaging) to encourage and support use of the program and practice of program skills.	Usual Care n=6187 Participants Those assigned to the Usual Care group will not be approached or contacted. Usual Care: Those assigned to usual care will not be contacted at all by study staff and will continue to receive usual care from treating primary care and mental health providers.
Time to Fatal or Non-fatal Suicide Attempt or Self-Harm	548 Days of follow-up time Interval 404.0 to 548.0	548 Days of follow-up time Interval 398.0 to 548.0	548 Days of follow-up time Interval 409.0 to 548.0

Adverse Events

Care Management

Serious events: 71 serious events

Other events: 0 other events

Deaths: 133 deaths

Skills Training

Serious events: 92 serious events

Other events: 0 other events

Deaths: 132 deaths

Usual Care

Serious events: 69 serious events

Other events: 0 other events

Deaths: 118 deaths

Serious adverse events

Serious adverse events
Measure	Care Management n=6230 participants at risk The Care Management intervention will last up to a year and includes routine outreach to assess ongoing risk of suicide attempt, and care management to monitor and facilitate ongoing engagement in outpatient follow-up. The Care Manager will coordinate care with treating mental health and primary care providers (ongoing usual care) using Epic Staff Messaging (or telephone contacts if necessary). Care Management: The Care Management intervention includes routine outreach to assess ongoing risk of suicide attempt and care management to monitor and facilitate ongoing engagement in outpatient follow-up. The Care Manager will coordinate care with treating mental health and primary care providers (ongoing usual care) using Epic Staff Messaging (or telephone contacts if necessary).	Skills Training n=6227 participants at risk The Skills Training intervention will last up to a year and uses an online skills training program to support patients in developing and using self-management skills for emotion regulation and crisis management. A Coach will monitor each participant's use of the program and send periodic messages (using Epic secure messaging) to encourage and support use of the program and practice of program skills. Skills Training: The Skills Training intervention uses an online skills training program to support patients in developing and using self-management skills for emotion regulation and crisis management. A Coach will monitor each participant's use of the program and send periodic messages (using Epic secure messaging) to encourage and support use of the program and practice of program skills.	Usual Care n=6187 participants at risk Those assigned to the Usual Care group will not be approached or contacted. Usual Care: Those assigned to usual care will not be contacted at all by study staff and will continue to receive usual care from treating primary care and mental health providers.
Psychiatric disorders Self-harm leading to death or hospitalization	1.1% 71/6230 • Number of events 71 • Adverse events were ascertained for up to 18 months after randomization, censored at time of death or disenrollment from the participating health systems. Mortality was ascertained by linkage to state mortality data. Serious adverse events: Suicide attempts leading to hospitalization were ascertained from electronic health records and insurance claims data. No other adverse events were ascertained, collected, or recorded.	1.5% 92/6227 • Number of events 92 • Adverse events were ascertained for up to 18 months after randomization, censored at time of death or disenrollment from the participating health systems. Mortality was ascertained by linkage to state mortality data. Serious adverse events: Suicide attempts leading to hospitalization were ascertained from electronic health records and insurance claims data. No other adverse events were ascertained, collected, or recorded.	1.1% 69/6187 • Number of events 69 • Adverse events were ascertained for up to 18 months after randomization, censored at time of death or disenrollment from the participating health systems. Mortality was ascertained by linkage to state mortality data. Serious adverse events: Suicide attempts leading to hospitalization were ascertained from electronic health records and insurance claims data. No other adverse events were ascertained, collected, or recorded.

Other adverse events

Adverse event data not reported

Additional Information

Gregory Simon, Investigator

Kaiser Permanente Washington Health Research Institute

Phone: 206-287-2979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place