Opioid Use, Opioid-use Disorder, Suicide
Conditions
Keywords
OUD, Opioid Use Disorder Treatment, Suicide prevention, Suicide risk
Brief summary
This study integrates the Mental Health Research Network (MHRN) suicide risk models into Opioid Wizard, an electronic health record (EHR) clinical decision support (CDS) to identify and treat patients at high risk of opioid use disorder (OUD)/overdose or diagnosed with OUD, to alert primary care clinicians (PCCs) to patients at elevated risk for suicide and guide them through structured suicide risk assessment. In both intervention and control clinics, suicide risk scores will be calculated for all Opioid Wizard-eligible patients and relevant EHR data to inform analyses will be archived. In intervention clinics, Opioid Wizard will alert PCCs to Opioid Wizard-eligible patients who are at increased risk of suicide and coach them through use of the Columbia Suicide Severity Risk Scale (CSSRS), a structured tool in the EHR that will help PCCs assess immediate suicide risk. Based on the resulting CSSRS score, Opioid Wizard will provide EHR links for risk-based referrals and follow-up recommendations, including care as usual, routine or emergent referral to behavioral health, or transportation to the emergency department (ED) for further assessment. Primary outcome measures include completion of CSSRS assessments for at-risk patients and patient engagement in outpatient mental health care.
Detailed description
When a patient is at elevated risk of suicide, the PCC will be prompted by Opioid Wizard to complete the CSSRS, easily available to all PCCs in the EHR and saved as discrete data elements. Risk-based (depending on CSSRS score) referral and follow-up recommendations for suicide prevention will be given, with specific care recommendations ranging from care as usual (very low risk) to referral to behavioral health for evaluation and safety planning (moderate to high risk) to immediate evaluation in the emergency department and potential inpatient admission (very high risk), building on workflows developed for use by care managers in in our recently completed suicide prevention trial of over 19,000 people at elevated risk of suicide. (28) The MHRN suicide risk models will be programmed into the EHR, a rigorous process that will take approximately 6 months. This process includes building the model in a testing environment in the EHR, testing the model with fictitious patients in a EHR testing environment and conducting chart audits, revising as needed, testing the model in a different EHR testing environment with real patient data, revising as needed, testing the model by running it silently in the EHR production environment and conducting chart audits, and revising as needed. This is followed by testing in the EHR production environment with 5-15 physicians in 1-2 pilot clinics. Prior to the go-live date for the suicide risk calculator, training on use and interpretation of the suicide risk model and the CSSRS will be provided to all PCCs and their rooming staff in intervention clinics. Training for control clinics will be separate and will provide training on the use of the CSSRS.
Interventions
OTHEROUD-CDS + Suicide Risk Model associated CDS
Access to OUD-CDS + Suicide Risk CDS
Sponsors
National Institute on Drug Abuse (NIDA)
Hennepin Healthcare Research Institute
HealthPartners Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Be aged 18-75 years, inclusive, at the time of index visit 2. Have an OUD diagnosis, be prescribed an active MOUD, or be identified by the opioid risk models as being at high risk of OUD or overdose 3. Be identified at high risk of suicide by the suicide risk models
Exclusion criteria
1. Active parenteral chemotherapy within the last year 2. Stage 4 or equivalent cancer diagnoses 3. Enrolled in hospice or palliative care programs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With CSSRS Completion on the Same Day or in the 14 Days Following Any Outpatient Visit | Observation period (up to 12 months) | EHR documentation of a completed Columbia Suicide Severity Rating Scale (CSSRS) on the same day or in the 14 days following any outpatient visit during the observation period. |
| Number of Outpatient Visits With Adequate Mental Health Engagement | Observation period (up to 12 months) | Adequacy of engagement with mental health care following outpatient visits that occurred between the index visit and the end of the study period. Engagement was adequate if acute suicide risk was 1) documented as moderate or high and the patient had a follow-up mental health visit within 30 days, or 2) undocumented but the patient had a follow-up mental health visit within 30 days, or 3) documented as low. |
| Number of Participants With One or More Suicide Attempts | Two time periods: 1) 12 months prior to enrollment (index visit), and 2) between enrollment and end of observation period (up to 12 months) | Identification of fatal or non-fatal suicide attempts, using ICD-10 diagnostic codes assigned at inpatient or outpatient visits during the outcome measure time frame |
| Number of Participants With One or More Opioid Overdoses | Two time periods: 1) 12 months prior to enrollment (index date), and 2) between enrollment and end of observation period (up to 12 months) | Identification of opioid overdoses, using ICD-10 diagnostic codes assigned at inpatient or outpatient visits during the outcome measure time frame |
Countries
United States
Participant flow
Recruitment details
Study patients had index visits at randomized clinics between August 3, 2021 and April 30, 2022. The index visit was the first visit during the accrual period at which the patient met all study eligibility criteria. First participant enrolled on August 3rd, 2021.
Participants by arm
| Arm | Count |
|---|---|
| OUD-CDS + Suicide Risk Model Associated CDS (Intervention Arm) Providers that practice in the clinics in this intervention arm will receive access to the OUD-CDS + Suicide Risk Model associated CDS, for all eligible encounters.
OUD-CDS + Suicide Risk Model associated CDS: Access to OUD-CDS + Suicide Risk CDS | 69 |
| Control Providers that practice in the clinics in this control arm will not receive any access to the OUD-CDS + Suicide Risk Model associated CDS, however these clinical decision-support tools will run silently in the background, collecting data on eligible encounters. | 46 |
| Total | 115 |
Baseline characteristics
| Characteristic | OUD-CDS + Suicide Risk Model Associated CDS (Intervention Arm) | Control | Total |
|---|---|---|---|
| Age, Continuous | 40.4 years STANDARD_DEVIATION 12.2 | 37.6 years STANDARD_DEVIATION 12 | 39.3 years STANDARD_DEVIATION 12.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 65 Participants | 45 Participants | 110 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Medicaid | 57 Participants | 38 Participants | 95 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 54 Participants | 39 Participants | 93 Participants |
| Region of Enrollment United States | 69 participants | 46 participants | 115 participants |
| Sex: Female, Male Female | 38 Participants | 27 Participants | 65 Participants |
| Sex: Female, Male Male | 31 Participants | 19 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 69 | 0 / 46 |
| other Total, other adverse events | 6 / 69 | 3 / 46 |
| serious Total, serious adverse events | 46 / 69 | 23 / 46 |
Outcome results
Primary
Number of Outpatient Visits With Adequate Mental Health Engagement
Adequacy of engagement with mental health care following outpatient visits that occurred between the index visit and the end of the study period. Engagement was adequate if acute suicide risk was 1) documented as moderate or high and the patient had a follow-up mental health visit within 30 days, or 2) undocumented but the patient had a follow-up mental health visit within 30 days, or 3) documented as low.
Time frame: Observation period (up to 12 months)
Population: All outpatient visits between enrollment and the end of the observation period were assessed for appropriate outpatient mental health care engagement. Multiple visits per patient were possible during this time period.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| OUD-CDS + Suicide Risk Model Associated CDS (Intervention Arm) | Number of Outpatient Visits With Adequate Mental Health Engagement | 789 Outpatient visits |
| Control | Number of Outpatient Visits With Adequate Mental Health Engagement | 489 Outpatient visits |
Primary
Number of Participants With CSSRS Completion on the Same Day or in the 14 Days Following Any Outpatient Visit
EHR documentation of a completed Columbia Suicide Severity Rating Scale (CSSRS) on the same day or in the 14 days following any outpatient visit during the observation period.
Time frame: Observation period (up to 12 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OUD-CDS + Suicide Risk Model Associated CDS (Intervention Arm) | Number of Participants With CSSRS Completion on the Same Day or in the 14 Days Following Any Outpatient Visit | 14 Participants |
| Control | Number of Participants With CSSRS Completion on the Same Day or in the 14 Days Following Any Outpatient Visit | 8 Participants |
Primary
Number of Participants With One or More Opioid Overdoses
Identification of opioid overdoses, using ICD-10 diagnostic codes assigned at inpatient or outpatient visits during the outcome measure time frame
Time frame: Two time periods: 1) 12 months prior to enrollment (index date), and 2) between enrollment and end of observation period (up to 12 months)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OUD-CDS + Suicide Risk Model Associated CDS (Intervention Arm) | Number of Participants With One or More Opioid Overdoses | 12 months prior to enrollment | 8 Participants |
| OUD-CDS + Suicide Risk Model Associated CDS (Intervention Arm) | Number of Participants With One or More Opioid Overdoses | Between enrollment and end of observation period | 2 Participants |
| Control | Number of Participants With One or More Opioid Overdoses | 12 months prior to enrollment | 7 Participants |
| Control | Number of Participants With One or More Opioid Overdoses | Between enrollment and end of observation period | 5 Participants |
Primary
Number of Participants With One or More Suicide Attempts
Identification of fatal or non-fatal suicide attempts, using ICD-10 diagnostic codes assigned at inpatient or outpatient visits during the outcome measure time frame
Time frame: Two time periods: 1) 12 months prior to enrollment (index visit), and 2) between enrollment and end of observation period (up to 12 months)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OUD-CDS + Suicide Risk Model Associated CDS (Intervention Arm) | Number of Participants With One or More Suicide Attempts | Between enrollment and observation period | 3 Participants |
| OUD-CDS + Suicide Risk Model Associated CDS (Intervention Arm) | Number of Participants With One or More Suicide Attempts | 12 months prior to enrollment | 19 Participants |
| Control | Number of Participants With One or More Suicide Attempts | Between enrollment and observation period | 0 Participants |
| Control | Number of Participants With One or More Suicide Attempts | 12 months prior to enrollment | 15 Participants |