DepressionSPOTNCT02326883

UH3 Pragmatic Suicide Prevention Trial

A study testing Care Management and Skills Training in people with Depression and Suicidal Ideation, run by Kaiser Permanente.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Depression, Suicidal Ideation
What is being tested?: Care Management and Skills Training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18,882 participants
Where: No sites listed yet
Study dates: Mar 2015to Apr 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Recorded diagnosis of dementia or developmental delay
Previously invited to participate in the UH2 pilot trial
Non-English speaker

About this study

Official title: UH3 Pragmatic Trial of Population-based Programs to Prevent Suicide Attempt

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.

Read the 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.

Conditions: Depression, Suicidal Ideation
Being tested: Care Management, Skills Training, Usual Care
Medical subject headings: Depression, Suicidal Ideation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Care ManagementBehavioural
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 TrainingBehavioural
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 CareBehavioural
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.

Study groups in NCT02326883
Study group	Role	What they receive
Care Management	Experimental	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). Receives: Behavioral: Care Management
Skills Training	Experimental	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. Receives: Behavioral: Skills Training
Usual Care	Active comparator	Those assigned to the Usual Care group will not be approached or contacted. Receives: Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Fatal or Non-fatal Suicide Attempt or Self-Harm
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.
Measured: 18 Months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2015Apr 2020

First posted30 Dec 2014 (estimated)
Study startMar 2015
Primary completionApr 2020
Study completionApr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
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: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 18,882 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02326883
Sponsor's protocol ID: 4UH3MH007755
Other IDs: UH2AT007755, UH3MH007755
Acronym: SPOT
Status last verified: Sep 2021
First submitted: 23 Dec 2014
Last updated: 19 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: This person-level dataset will include the following variables: * Time to suicide attempt or death * Time to censoring for disenrollment or death from other cause * Age group * Sex * Race/ethnicity * Site of care (mental health specialty, primary care, other) * PHQ9 item 9 score at baseline * Year of enrollment * Intervention assignment (Skills Training, Risk Assessment/Care Management, Usual Care) We do not propose to include study site (health system) in this publicly available dataset given concerns by participating health systems that such data could be used for inappropriate comparisons of suicide attempt rates across health systems.

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.
PubMed 27634417
Simon GE, Shortreed SM, Rossom RC, Beck A, Clarke GN, Whiteside U, Richards JE, Penfold RB, Boggs JM, Smith J. Effect of Offering Care Management or Online Dialectical Behavior Therapy Skills Training vs Usual Care on Self-harm Among Adult Outpatients With Suicidal Ideation: A Randomized Clinical Trial. JAMA. 2022 Feb 15;327(7):630-638. doi: 10.1001/jama.2022.0423.
PubMed 35166800
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
PubMed 33884617
Whiteside U, Richards J, Simon GE. Brief Interventions via Electronic Health Record Messaging for Population-Based Suicide Prevention: Mixed Methods Pilot Study. JMIR Form Res. 2021 Apr 12;5(4):e21127. doi: 10.2196/21127.
PubMed 33843599

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: UH3 Pragmatic Trial of Population-based Programs to Prevent Suicide Attempt
ClinicalTrials.gov ID: NCT02326883
Acronym / sponsor ID: SPOT / 4UH3MH007755
Conditions: Depression, Suicidal Ideation
Study type: Interventional
Recruitment status: Completed
Enrolment: 18,882 participants (actual)
Lead sponsor: Kaiser PermanenteUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH), HealthPartners Institute, National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
Study start: Mar 2015 (actual)
Primary completion: Apr 2020 (actual)
Study completion: Apr 2020 (actual)
First posted: 30 Dec 2014 (estimated)
Results: Posted 19 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

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

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Care Management	Experimental	Behavioral: Care ManagementThe 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).
Skills Training	Experimental	Behavioral: Skills TrainingThe 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.
Usual Care	Active comparator	Behavioral: Usual CareThose assigned to the Usual Care group will not be approached or contacted.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

Recorded diagnosis of dementia or developmental delay
Previously invited to participate in the UH2 pilot trial
Non-English speaker

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
Care ManagementThe 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).	Behavioural	Care Management
Skills TrainingThe 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.	Behavioural	Skills Training
Usual CareThose 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.	Behavioural	Usual Care

Primary outcome

Time to Fatal or Non-fatal Suicide Attempt or Self-Harm
Time frame: 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.

Results and safety

Results posted to the registry on 19 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Care Management	6,314	6,230
Skills Training	6,312	6,227
Usual Care	6,256	6,187

Primary outcome: Time to Fatal or Non-fatal Suicide Attempt or Self-Harm

Time frame: 18 Months after randomization. Median (Inter-Quartile Range). Unit: Days of follow-up time

Measure	Care Management n = 6230	Skills Training n = 6227	Usual Care n = 6187
Value	548 (404 to 548)	548 (398 to 548)	548 (409 to 548)

Care Management vs Usual Care: Cox Proportional Hazard: 1.07 (95% CI 0.86 to 1.33), p = 0.61, Log Rank
Skills Training vs Usual Care: Cox Proportional Hazard: 1.29 (95% CI 1.05 to 1.59), p = 0.02, Log Rank

Population analysed: 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.

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Care Management	71 of 6,230 (1.1%)	0 of 0	133 of 6,230
Skills Training	92 of 6,227 (1.5%)	0 of 0	132 of 6,227
Usual Care	69 of 6,187 (1.1%)	0 of 0	118 of 6,187

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27634417Simon 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.
Derived from this study: PubMed 35166800Simon GE, Shortreed SM, Rossom RC, Beck A, Clarke GN, Whiteside U, Richards JE, Penfold RB, Boggs JM, Smith J. Effect of Offering Care Management or Online Dialectical Behavior Therapy Skills Training vs Usual Care on Self-harm Among Adult Outpatients With Suicidal Ideation: A Randomized Clinical Trial. JAMA. 2022 Feb 15;327(7):630-638. doi: 10.1001/jama.2022.0423.
Derived from this study: PubMed 33884617Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
Derived from this study: PubMed 33843599Whiteside U, Richards J, Simon GE. Brief Interventions via Electronic Health Record Messaging for Population-Based Suicide Prevention: Mixed Methods Pilot Study. JMIR Form Res. 2021 Apr 12;5(4):e21127. doi: 10.2196/21127.
Individual participant dataSharing planned: Yes. This person-level dataset will include the following variables: * Time to suicide attempt or death * Time to censoring for disenrollment or death from other cause * Age group * Sex * Race/ethnicity * Site of care (mental health specialty, primary care, other) * PHQ9 item 9 score at baseline * Year of enrollment * Intervention assignment (Skills Training, Risk Assessment/Care Management, Usual Care) We do not propose to include study site (health system) in this publicly available dataset given concerns by participating health systems that such data could be used for inappropriate comparisons of suicide attempt rates across health systems.

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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. This study is not recruiting at the moment.

Greg Simon, MD, MPH principal investigator

KP Washington

Questions about this trial

What is this clinical trial studying?

A study testing Care Management and Skills Training in people with Depression and Suicidal Ideation, run by Kaiser Permanente.

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 5 inclusion and 3 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: finished, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 19 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Fatal or Non-fatal Suicide Attempt or Self-Harm (time frame: 18 Months after randomization). 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 NCT02326883, which also lists 4 linked publications.

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 Oct 2021.