Native-RISE (Risk Identification for Suicide and Enhanced Care)

NCT06782516 | Enrolling By Invitation DMC

• 1 other identifier: IRB00026145
• Study Type: interventional
• Target: 1,687
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this research is to test a systems-level suicide prevention strategy, Native-RISE (Risk Identification for Suicide and Enhanced care), that combines predictive analytics and brief contact interventions (BCIs) to reduce suicide in health systems serving Native Americans (NAs). This project aims to prove the effectiveness and scalability of Native-RISE within three Indian Health Service (IHS) health care clinics (Whiteriver, Chinle and Shiprock) already implementing suicide prevention programs and serving the White Mountain Apache Tribe (WMAT) and Navajo Nation (NN).

Conditions

Suicide Prevention

Outcome Measures

Primary Outcomes (1)

• Rate of suicide attempts among individuals flagged at elevated risk

  Rate of suicide attempts among individuals flagged at elevated risk is tracked through International Classification of Diseases (ICD) codes and chief complaints as recorded in the participating health system.

  12 months

Secondary Outcomes (1)

• Number of contacts with Case Managers (Reach of Brief Contact Interventions (BCI))

  12 months

Study Arms (4)

Case Managers WITH algorithm AND with provider risk notification (SI/SA/Binge/NSSI)

EXPERIMENTAL

Case Managers who see the algorithm classification + IHS provider risk notification \& resource card distribution. These participants present with suicide ideation (SI), suicide attempt (SA), binge substance use (Binge), or non-suicidal self injury (NSSI).

Device: System of Care - combination of algorithm and Brief Contact Intervention

Case Managers withOUT algorithm AND with provider risk notification (SI/SA/Binge/NSSI)

ACTIVE COMPARATOR

Case Managers who do NOT see the algorithm classification + IHS provider risk notification \& resource card distribution. These participants present with suicide ideation (SI), suicide attempt (SA), binge substance use (Binge), or non-suicidal self injury (NSSI).

Behavioral: Active Comparator - Provider notification of risk status

Case Managers WITH algorithm AND provider risk notification (high risk history, no SI/SA/Binge/NSSI

EXPERIMENTAL

Case Managers who see the algorithm classification + provider risk notification; participants get resource card distribution. High risk participants based on algorithm classification.

Device: System of Care - combination of algorithm and Brief Contact Intervention

Provider risk notification alone (high risk history, without SI/SA/Binge/NSSI)

ACTIVE COMPARATOR

Provider risk notification alone; participants get resource card distribution. High risk participants based on algorithm classification.

Behavioral: Active Comparator - Provider notification of risk status

Interventions

Active Comparator - Provider notification of risk status BEHAVIORAL

Clinical Providers receive a risk notification and a resource card is provided to the participant.

Case Managers withOUT algorithm AND with provider risk notification (SI/SA/Binge/NSSI); Provider risk notification alone (high risk history, without SI/SA/Binge/NSSI)

System of Care - combination of algorithm and Brief Contact Intervention DEVICE

Case managers see the Native-RISE algorithm classification and Clinical Providers receive a risk notification. A resource card is provided to the participant.

Case Managers WITH algorithm AND provider risk notification (high risk history, no SI/SA/Binge/NSSI; Case Managers WITH algorithm AND with provider risk notification (SI/SA/Binge/NSSI)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-75
• Visit at least one of the three participating IHS clinics
• Identified as at risk of suicide by either an existing method or the new Native-RISE risk model algorithm

You may not qualify if:

• None

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead

Study Sites (3)

Chinle Navajo Nation Center for Indigenous Health

Chinle, Arizona, 86503, United States

Location

Whiteriver Center for Indigenous Health

Whiteriver, Arizona, 85941, United States

Location

Shiprock Center for Indigenous Health

Shiprock, New Mexico, 87420, United States

Location

Related Publications (2)

• Haroz EE, Rebman P, Goklish N, Garcia M, Suttle R, Maggio D, Clattenburg E, Mega J, Adams R. Performance of Machine Learning Suicide Risk Models in an American Indian Population. JAMA Netw Open. 2024 Oct 1;7(10):e2439269. doi: 10.1001/jamanetworkopen.2024.39269.

  PMID: 39401036 BACKGROUND

• Adams R, Haroz EE, Rebman P, Suttle R, Grosvenor L, Bajaj M, Dayal RR, Maggio D, Kettering CL, Goklish N. Developing a suicide risk model for use in the Indian Health Service. Npj Ment Health Res. 2024 Oct 16;3(1):47. doi: 10.1038/s44184-024-00088-5.

  PMID: 39414996 BACKGROUND

MeSH Terms

Conditions

Suicide Prevention

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Emily Haroz, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Native-RISE Model is a predictive algorithm for suicide risk in Native American populations. The algorithm was developed based on analysis of over 330,000 visits and designed to identify people at risk of a suicide attempt or death within 90 days of the last visit. The evaluation of the model initial results have been published with the model having an area under the ROC (AUROC) 0.83 \[0.80-0.86\]) and performing better than existing care (AUROC 0.64 \[0.61-0.67\]).

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 20, 2025
• Study Start: December 1, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)