NCT03207217

Brief Summary

SIMmersion, in collaboration with the Institute for Family Health (IFH) and the Educational Development Center (EDC) propose to develop a web-based training product, Suicide Prevention Role-plays for Interactive Training (SPiRIT), a series of 4 modules to train providers to more effectively manage patients who screen positive for risk of suicide in this Phase I/Phase II fast-track application. If funded, the team will develop the Risk Assessment module in Phase I and utilize a within group pre-post design to evaluate its feasibility. Twenty practicing clinicians will be recruited to utilize the module and complete a pre-post knowledge test. In Phase II, the team will develop Safety Planning, Access to Lethal Means, and Willingness to Accept a Referral modules. The efficacy of the product to positively influence patient outcomes will be tested with a Historically Controlled Trial (HCT) enlisting 65 practicing clinicians across five IFH sites. All providers will be trained and patient outcomes will be tracked for 6 months post training. This data set will be compared to 6 months of historical data for the same provider group. Primary outcomes of this study will measure the participants' ability in obtain improved patient outcomes related to: 1) rate of same-day C-SSRS Screening; 2) rate of suicide being added to the problem list; 3) rate of same-day safety planning; 4) rate of same day C-SSRS Lifeline/Recent Completion; 5) rate of same-day Risk Assessment; 6) rate of acceptance and attendance to within-Institute referrals for post intervention patients who are offered the referral at the first visit; 7) and lower rates of documented suicide attempts. Ultimately, the development and successful testing of this product would provide the US health care system a novel technology to scale up a clinician's confidence and skill to better manage patients who identify as at-risk for suicide. Additionally, if effective, this product will have a direct impact on patient outcomes, a vital component to any training product that attempts to train health care professionals. The utility and scalability of the proposed product will move health care systems toward the goal of zero deaths from suicide consistent with the Zero suicide approach.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

2.4 years

First QC Date

June 29, 2017

Last Update Submit

June 29, 2017

Conditions

Keywords

Safety PlanningAccess to Lethal MeansZero Suicide

Outcome Measures

Primary Outcomes (7)

  • C-SSRS Screening

    Higher rates of same-day C-SSRS Screening

    Assessment will occur after a 6 month period of tracking patient records for each provider

  • Suicide addition to Problem List

    Higher rates of suicide being added to the problem list

    Assessment will occur after a 6 month period of tracking patient records for each provider

  • Same-day Safety Planning, if a positive screen

    Higher rates of same-day Safety Planning, if a positive screen

    Assessment will occur after a 6 month period of tracking patient records for each provider

  • C-SSRS Lifeline/Recent Completion

    Higher rates of same-day C-SSRS Lifeline/Recent Completion, if a positive screen;

    Assessment will occur after a 6 month period of tracking patient records for each provider

  • Risk Assessment

    Higher rates of same-day Risk Assessment, if a positive screen

    Assessment will occur after a 6 month period of tracking patient records for each provider

  • Within-Institute referrals

    Higher rates of acceptance and attendance to within-Institute referrals for post intervention patients who are offered the referral at the first visit

    Assessment will occur after a 6 month period of tracking patient records for each provider

  • Documented suicide attempts

    Have lower rates of documented suicide attempts

    Assessment will occur after a 6 month period of tracking patient records for each provider

Study Arms (3)

Phase I Knowledge Assessment

EXPERIMENTAL
Other: Web-based training Product

Phase II Efficacy

EXPERIMENTAL
Other: Web-based training Product

Phase II Acceptability

EXPERIMENTAL
Other: Web-based training Product

Interventions

A series of 4 modules to train providers to more effectively manage patients who screen positive for risk of suicide. The modules are: Risk Assessment, Safety Planning, Access to Lethal Means, and Willingness to accept referral.

Phase I Knowledge AssessmentPhase II AcceptabilityPhase II Efficacy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (1) Hold an active license issued by the State of New York for their profession and be in good standing; (2) actively see patients at an IFH site; and (3) have completed IFH's mandated suicide prevention training.

You may not qualify if:

  • (1) have not completed their IFH Suicide Prevention Training as outlined in the IFH's Suicide Prevention Training Policy; or (2) have uncorrected vision or hearing problems that prevent the person from using the software. Specific to Phase II an additional criteria is (3)participated in the Phase 1 feasibility testing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2017

First Posted

July 2, 2017

Study Start

July 1, 2017

Primary Completion

December 1, 2019

Study Completion

March 1, 2020

Last Updated

July 2, 2017

Record last verified: 2017-06