SPOT: UH3 Pragmatic Suicide Prevention Trial

• Sponsor: Kaiser Permanente (Other)
• Overall Status: Completed
• CT.gov ID: NCT02326883
• Collaborator: National Institute of Mental Health (NIMH) (NIH), HealthPartners Institute (Other), National Institutes of Health (NIH) (NIH), National Center for Complementary and Integrative Health (NCCIH) (NIH)
• Enrollment: 18,882
• Arms: 3
• Actual Duration (Months): 61

Study Details

Study Description

Brief Summary

This pragmatic clinical trial will evaluate the effectiveness of two population-based outreach programs for preventing suicide attempts among patients identified as at-risk. The study will be conducted at Kaiser Permanente (KP) Washington (the lead site) and at HealthPartners, KP Colorado and KP Northwest. Electronic health records will be used to identify outpatients aged 18 or older who respond to a routinely administered PHQ depression questionnaire by reporting thoughts of death or self-harm "most of the days" or "nearly every day". This trial will be limited to patients receiving care from one of the four participating health systems. Eligible patients will be automatically assigned to continue in usual care (1/3) or to either of the two intervention programs (1/3 each). 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. Both intervention programs involve outreach by Epic secure messaging (with optional telephone outreach for those not reading messages). 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 treatment by primary and behavioral health care providers using Epic Staff Messaging (or telephone contacts if necessary). 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. Each intervention continues for up to one year. In all three groups (Usual Care, Care Management, and Skills Training) virtual data warehouse data will be used to identify likely suicide attempts over 18 months following randomization. Analyses will compare risk of suicide attempt among all those randomized, regardless of response to the initial invitation or level of participation in the intervention programs. Comparison of all those randomized is the only scientifically valid method for assessing the overall impact of either program on population-level risk of suicide attempt.

Condition or Disease	Intervention/Treatment	Phase
Depression; Suicidal Ideation	Behavioral: Care Management; Behavioral: Skills Training; Behavioral: Usual Care	N/A

Detailed Description

Each week, a programmer will use Epic/Clarity data to identify adult outpatients who completed a PHQ depression questionnaire in the previous week and reported thoughts of death or self-harm "most of the days" or "nearly every day". This trial will be limited to patients receiving care from one of the three participating health systems.

Those identified will be automatically assigned to continued Usual Care or to one of two intervention programs (Care Management or Skills Training).

The Care Management intervention includes periodic outreach to assess ongoing risk of suicide attempt and as-needed care management to facilitate engagement in ongoing outpatient follow-up. Contacts will occur by secure messaging (with the option of telephone outreach for those who do not read messages). Each contact will include a request to complete a new risk assessment questionnaire (the abbreviated Columbia Suicide Severity Rating Scale used at each site) unless a risk assessment was recently documented in the medical record. Using an algorithm tested in pilot studies, the Care Manager will determine appropriate timing of follow-up and (if not already scheduled) communicate with the participant to facilitate appropriate follow-up care. Time between outreach contacts will vary from 2 weeks to 2 months, depending on the most recent risk assessment. Outreach contacts will continue up to 12 months. All outreach contacts will be documented in the Epic electronic health record in the same manner as any other mental health clinical contacts. The Care Manager(s) will be licensed mental health clinician(s) with experience in suicide risk assessment, supervised by site specific clinician investigators. A detailed protocol for the Care Management program (including sample messages) is included with this application.

The Skills Training intervention is an online program intended to teach specific skills for emotion regulation and crisis management. The content of the program is derived from Dialectical Behavior Therapy, an evidence-based psychotherapy designed for people at risk for suicide attempts. The program includes four modules or chapters, each focused on a specific skill. Each chapter includes written and video didactic instruction, video examples, in-vivo practice, and written homework exercises. The program will be supported by a Coach who will send periodic messages (via Epic secure messaging) encouraging use of the program and practice of specific skills. Coaching messages will be scheduled every 1-3 weeks during the first 3 months of the program and every 1-3 months over the following 9 months (varying according to each participant's level of participation and progress in the program). All coaching messages will be documented in the Epic electronic health record in the same manner as any other mental health clinical contacts. The Coach(es) will be licensed mental health clinician(s) supervised by site specific clinician investigators. The online program will be delivered by a secure website (KP Washington Health Research Institute's DatStat server), and participants will reach the program using encrypted personalized links sent to them via Epic secure messaging. This trial does not have open enrollment, please see the public facing website at www.NowMattersNow.org

Those assigned to Usual Care will not be contacted.

For all patients in all three intervention groups, a site programmer will extract data from the Virtual Data Warehouse to identify probable suicide attempts over 18 months following randomization.

Study Design

• Study Type: Interventional
• Actual Enrollment: 18882 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: UH3 Pragmatic Trial of Population-based Programs to Prevent Suicide Attempt
• Actual Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Apr 1, 2020
• Actual Study Completion Date: Apr 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Behavioral: 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).
Experimental: 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.	Behavioral: 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.
Active Comparator: Usual Care Those assigned to the Usual Care group will not be approached or contacted.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. Time to Fatal or Non-fatal Suicide Attempt or Self-Harm [18 Months after randomization]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

We propose to include all patients at the participating sites who:

• Complete PHQ questionnaire and respond to item 9 (regarding thoughts of death or self-harm) "more than half the days" or "nearly every day"

• Are currently enrolled in one of the four participating health systems

• Are age 18 or older

• Recent use of Epic Secure Messaging

Exclusion Criteria:

• Recorded diagnosis of dementia or developmental delay

• Previously invited to participate in the UH2 pilot trial

• Non-English speaker

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Kaiser Permanente
• National Institute of Mental Health (NIMH)
• HealthPartners Institute
• National Institutes of Health (NIH)
• National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Greg Simon, MD, MPH, KP Washington

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 23, 2016

More Information

Publications

• Simon GE, Beck A, Rossom R, Richards J, Kirlin B, King D, Shulman L, Ludman EJ, Penfold R, Shortreed SM, Whiteside U. Population-based outreach versus care as usual to prevent suicide attempt: study protocol for a randomized controlled trial. Trials. 2016 Sep 15;17(1):452. doi: 10.1186/s13063-016-1566-z.

• Responsible Party: Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT02326883
• Other Study ID Numbers: 4UH3MH007755; UH2AT007755; UH3MH007755
• First Posted: Dec 30, 2014
• Last Update Posted: Oct 19, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Suicide; Suicidal Ideation

Study Results

Participant Flow

Arm/Group Title	Care Management	Skills Training	Usual Care
Arm/Group Description	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).	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.	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.
Period Title: Overall Study
STARTED	6314	6312	6256
COMPLETED	6230	6227	6187
NOT COMPLETED	84	85	69

Baseline Characteristics

Arm/Group Title	Care Management	Skills Training	Usual Care	Total
Arm/Group Description	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).	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.	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 of all reporting groups
Overall Participants	6230	6227	6187	18644
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	5254 84.3%	5293 85%	5280 85.3%	15827 84.9%
>=65 years	976 15.7%	934 15%	907 14.7%	2817 15.1%
Sex: Female, Male (Count of Participants)
Female	4195 67.3%	4160 66.8%	4188 67.7%	12543 67.3%
Male	2035 32.7%	2067 33.2%	1999 32.3%	6101 32.7%
Race/Ethnicity, Customized (Count of Participants)
Non-Hispanic White	4723 75.8%	4651 74.7%	4561 73.7%	13935 74.7%
Hispanic	495 7.9%	495 7.9%	595 9.6%	1585 8.5%
Asian, Non-Hispanic	179 2.9%	183 2.9%	194 3.1%	556 3%
Black, Non-Hispanic	241 3.9%	272 4.4%	237 3.8%	750 4%
American Indian, Non-Hispanic	56 0.9%	42 0.7%	35 0.6%	133 0.7%
Native Hawaiian or Pacific Islander	24 0.4%	29 0.5%	23 0.4%	76 0.4%
More than one race	170 2.7%	188 3%	203 3.3%	561 3%
Other or not recorded	342 5.5%	376 6%	399 6.4%	1117 6%
Region of Enrollment (participants) [Number]
United States	6230 100%	6227 100%	6187 100%	18644 100%
Site of recruitment (Count of Participants)
Mental Health Specialty Clinic	3071 49.3%	3111 50%	3040 49.1%	9222 49.5%
General Medical Clinic	3159 50.7%	3116 50%	3147 50.9%	9422 50.5%
PHQ9 item 9 score (Count of Participants)
More than half the days	4180 67.1%	4177 67.1%	4141 66.9%	12498 67%
Nearly every day	2050 32.9%	2050 32.9%	2046 33.1%	6146 33%

Outcome Measures

1. Primary Outcome

Title	Time to Fatal or Non-fatal Suicide Attempt or Self-Harm
Description	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.
Time Frame	18 Months after randomization

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Care Management	Skills Training	Usual Care
Arm/Group Description	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).	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.	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.
Measure Participants	6230	6227	6187
Median (Inter-Quartile Range) [Days of follow-up time]	548	548	548

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Care Management, Usual Care
	Comments	Comparison of participants assigned to Care Management intervention to those assigned to continued Usual Care
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.61
	Comments	A priori two-sided comparison of Care Management condition to Usual Care
	Method	Log Rank
	Comments	A priori Bonferonni-corrected threshold for statistical significance was 0.025.
Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95%; 0.86 to 1.33
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.12
	Estimation Comments	To clarify direction of comparison: relative hazard of suicide attempt among participants assigned to Care Management was 1.07 (95% CI 0.86 - 1.33) higher compared to participants assigned to Usual Care

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Skills Training, Usual Care
	Comments	Comparison of Skills Training to Usual Care
	Type of Statistical Test	Superiority
	Comments	A priori two-sided comparison of Skills Training to usual care.
Statistical Test of Hypothesis	p-Value	0.02
	Comments	A priori Bonferonni-corrected threshold for statistical significance was 0.025.
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	1.29
	Confidence Interval	(2-Sided) 95%; 1.05 to 1.59
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.14
	Estimation Comments	To clarify direction of comparison: relative hazard of suicide attempt in participants assigned to Skills Training was 1.29 (95% CI 1.05-1.59) times higher than in those assigned to Usual Care

Adverse Events

Time Frame	Adverse events were ascertained for up to 18 months after randomization, censored at time of death or disenrollment from the participating health systems.
Adverse Event Reporting Description	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.
Arm/Group Title	Care Management		Skills Training		Usual Care
Arm/Group Description	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).		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.		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.
All Cause Mortality
	Care Management		Skills Training		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	133/6230 (2.1%)		132/6227 (2.1%)		118/6187 (1.9%)
Serious Adverse Events
	Care Management		Skills Training		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	71/6230 (1.1%)		92/6227 (1.5%)		69/6187 (1.1%)
Psychiatric disorders
Self-harm leading to death or hospitalization	71/6230 (1.1%)	71	92/6227 (1.5%)	92	69/6187 (1.1%)	69
Other (Not Including Serious) Adverse Events
	Care Management		Skills Training		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

Participation in interventions was relatively low (but this reflects "real world" conditions. Interventions could have influenced likelihood that self-harm would lead to care-seeking or be recognized and recorded by treating clinicians. Usual care in other settings might differ from usual care in these four health systems.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.