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| ID | Type | Description | Link |
|---|---|---|---|
| PEC 19-303 | Other Grant/Funding Number | VA Quality Enhancement Research Initiative (QUERI) |
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The overall objective of this national quality improvement project is to develop an adaptive implementation strategy to improve the implementation of suicide risk screening and evaluation in Veterans Health Administration ambulatory care settings (i.e., VA Risk ID).
VA Risk ID is the largest implementation of population-based suicide risk screening and evaluation in any United States healthcare system to date. Given the considerable scope of this initiative, several strategies have been employed to support national implementation. To facilitate continuous quality improvement, ongoing evaluation of VA Risk ID and interventions to improve implementation of the three-stage screening and evaluation process are needed. This project is intended to help VHA facilities address challenges to implementing VA Risk ID to fidelity using a sequence of evidence-based implementation strategies (audit and feedback followed by audit and feedback plus external facilitation). By doing so, it will ensure that more Veterans are screened and evaluated for suicide risk, which is the basis of effective, patient-centered suicide risk management. By adapting the implementation intervention "dose" based on facility performance and monitoring implementation over time, this project will allow the program office to focus resources where and when needed the most.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implementation as Usual | No Intervention | Implementation support consisting of clinical decision support tools, trainings, technical assistance and quality assurance to support implementation of VA Suicide Risk Identification Strategy. Available to all facilities. | |
| Audit and Feedback | Experimental | Audit and Feedback will serve as the first stage implementation intervention for sites that do not meet the benchmark for adequate implementation following 9 months of implementation as usual. |
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| External Facilitation | Experimental | Audit and Feedback plus External Facilitation will serve as the second stage implementation intervention for sites that still do not meet the benchmark for adequate implementation following 9 months of implementation as usual plus audit and feedback. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Audit and Feedback | Behavioral | The following components will be incorporated into the audit and feedback intervention: i) individualized facility performance data (site level), ii) frequent delivery intervals (monthly), iii) comparisons with other sites, iv) graphical and text form displays of information, v) constructive, non-punitive tone, vi) target performance or benchmark provided, and vii) specific actions or recommendations for meeting the target. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 1 | C-SSRS uptake is a site level adherence measure of the percentage of patients in ambulatory care who received a timely annual suicide risk screen (i.e., during the first encounter/visit after the annual suicide risk screen reminder was due). Adherence ranges from 0 to 100, higher scores reflect higher adherence. The outcome measure is reported as the change in facility adherence from baseline to month 8 of intervention Phase 1. Higher numbers reflect greater change in adherence from baseline to month 8 of intervention Phase 1. | Change from baseline and intervention Phase 1 month 8 |
| Change in Comprehensive Suicide Risk Evaluation (CSRE) Uptake- Phase 1 | CSRE uptake is a site level adherence measure of the percentage of patients in ambulatory care who had a positive C-SSRS screener and received the CSRE as intended (same day and by the appropriate provider). The score is a facility adherence score. Adherence ranges from 0 to 100, higher scores reflect higher adherence. The outcome measure is reported as the change in facility adherence from baseline to month 8 of intervention Phase 1. Higher numbers reflect greater change in adherence from baseline to month 8 of intervention Phase 1. | Change from baseline and intervention Phase 1 month 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 2a | C-SSRS uptake is a site level adherence measure of the percentage of patients in ambulatory care who received a timely annual suicide risk screen (i.e., during the first encounter/visit after the annual suicide risk screen reminder was due). The score is a facility adherence score. Adherence ranges from 0 to 100, higher scores reflect higher adherence. The outcome measure is reported as the change in facility adherence from month 9 of intervention phase 1 to month 9 of intervention phase 2. Higher numbers reflect greater change in adherence from month 9 of intervention phase 1 to month 9 of intervention phase 2. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nazanin H. Bahraini, PhD | Rocky Mountain Regional VA Medical Center, Aurora, CO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Regional VA Medical Center, Aurora, CO | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32698812 | Derived | Bahraini NH, Matarazzo BB, Barry CN, Post EP, Forster JE, Dollar KM, Dobscha SK, Brenner LA. Protocol: examining the effectiveness of an adaptive implementation intervention to improve uptake of the VA suicide risk identification strategy: a sequential multiple assignment randomized trial. Implement Sci. 2020 Jul 22;15(1):58. doi: 10.1186/s13012-020-01019-6. |
| Label | URL |
|---|---|
| Project Description | View source |
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All sites started with implementation as usual during run-in phase.
138 VHA facilities were recruited and enrolled. Sites were allocated to different implementation strategies based on performance.
| ID | Title | Description |
|---|---|---|
| FG000 | Implementation As Usual | This arm included sites that responded to implementation as usual during run-in and continued with implementation as usual throughout the trial period. There were no sites in Arm 1 as none of the facilities implemented adequately after the run-in phase. |
| FG001 | Audit & Feedback Responders Continue | This arm included sites that did not implement adequately after the run-in phase, received audit & feedback (A&F) in Phase 1, responded to A&F, and continued A&F in Phase 2. |
| FG002 | Audit & Feedback Responders Switch | This arm included sites that did not implement adequately after the run-in phase, received A&F in Phase 1, responded to A&F and switched to A&F Light in Phase 2. (Note. IAU became A&F Light during Phase 2). |
| FG003 | Audit & Feedback Non-Responders Continue | This arm included sites that did not implement adequately after the run-in phase, received A&F in Phase 1, did not respond to A&F, and continued A&F in Phase 2. |
| FG004 | Audit & Feedback Non-Responders Add Facilitation | This arm included sites that did not implement adequately after the run-in phase, received A&F in Phase 1, did not respond to A&F, and accepted and received A&F + External Facilitation in Phase 2. (Note. Only included sites that accepted EF). |
| FG005 | Implementation As Usual to Audit & Feedback Light | This arm included sites that did not implement adequately after the run-in phase, continued with IAU in Phase 1, and received A&F Light in Phase 2. (Note. IAU became A&F Light during Phase 2) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 Intervention |
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| Phase 2 Intervention |
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Participants are not the unit of analysis; sites/medical centers are the unit of analysis.
| ID | Title | Description |
|---|---|---|
| BG000 | Implementation As Usual | This group included sites that responded to implementation as usual during run-in and continued with implementation as usual throughout the trial period. There were no sites in Arm 1 as none of the facilities implemented adequately after the run-in phase. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 1 | C-SSRS uptake is a site level adherence measure of the percentage of patients in ambulatory care who received a timely annual suicide risk screen (i.e., during the first encounter/visit after the annual suicide risk screen reminder was due). Adherence ranges from 0 to 100, higher scores reflect higher adherence. The outcome measure is reported as the change in facility adherence from baseline to month 8 of intervention Phase 1. Higher numbers reflect greater change in adherence from baseline to month 8 of intervention Phase 1. | All sites that completed Phase 1 are included in the analysis. Sites that received Audit & Feedback in addition to Implementation as Usual during Phase 1 are compared to sites that only received Implementation as Usual during Phase 1. | Posted | Mean | 95% Confidence Interval | change in percent adherence | Change from baseline and intervention Phase 1 month 8 | Sites/Facilities | Sites/Facilities |
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No adverse event data were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Implementation As Usual | This arm included sites that responded to implementation as usual during run-in and continued with implementation as usual throughout the trial period. There were no sites in Arm 1 as none of the facilities implemented adequately after the run-in phase. |
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Shortened study timeline due to COVID; study phases needed to be shortened potentially limiting ability to detect an impact of phase 1 intervention- audit & feedback
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nazanin Bahraini, PhD | VA Rocky Mountain MIRECC | 720-723-6490 | Nazanin.Bahraini@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 15, 2019 | Mar 7, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 17, 2024 | Jan 17, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Sequential Multiple Assignment Randomized Trial
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| External Facilitation | Behavioral | Facilitation will be conducted by a team of facilitators who will employ the facilitation process to improve uptake of VA Risk ID. Trained external facilitators will flexibly deliver the facilitation process utilizing an integrated set of implementation strategies (e.g., stakeholder engagement, identification of barriers and facilitators, education, problem solving, the use of formative data, communication, and ongoing support). |
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| Change from month 9 of intervention phase 1 and month 9 of intervention phase 2 |
| Change in Comprehensive Suicide Risk Evaluation (CSRE) Uptake-Phase 2a | CSRE uptake is a site level adherence measure of the percentage of patients in ambulatory care who had a positive C-SSRS screener and received the CSRE as intended (same day and by the appropriate provider). The score is a facility adherence score. Adherence ranges from 0 to 100, higher scores reflect higher adherence. The outcome measure is reported as the change in facility adherence from month 9 of intervention phase 1 to month 9 of intervention phase 2. Higher numbers reflect greater change in adherence from month 9 of intervention phase 1 to month 9 of intervention phase 2. | Change from month 9 of intervention phase 1 and month 9 of intervention phase 2 |
| Change in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 2b | C-SSRS uptake is a site level adherence measure of the percentage of patients in ambulatory care who received a timely annual suicide risk screen (i.e., during the first encounter/visit after the annual suicide risk screen reminder was due). The score is a facility adherence score. Adherence ranges from 0 to 100, higher scores reflect higher adherence. The outcome measure is reported as the change in facility adherence from month 9 of intervention phase 1 to month 9 of intervention phase 2. Higher numbers reflect greater change in adherence from month 9 of intervention phase 1 to month 9 of intervention phase 2. | Change from month 9 of intervention phase 1 and month 9 of intervention phase 2 |
| Change in Comprehensive Suicide Risk Evaluation (CSRE) Uptake-Phase 2b | CSRE uptake is a site level adherence measure of the percentage of patients in ambulatory care who had a positive C-SSRS screener and received the CSRE as intended (same day and by the appropriate provider). The score is a facility adherence score. Adherence ranges from 0 to 100, higher scores reflect higher adherence. The outcome measure is reported as the change in facility adherence from month 9 of intervention phase 1 to month 9 of intervention phase 2. Higher numbers reflect greater change in adherence from month 9 of intervention phase 1 to month 9 of intervention phase 2. | Change from month 9 of intervention phase 1 and month 9 of intervention phase 2 |
| COMPLETED |
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| NOT COMPLETED |
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| Audit & Feedback Responders Continue |
This group included sites that did not implement adequately after the run-in phase, received audit & feedback (A&F) in Phase 1, responded to A&F, and continued A&F in Phase 2. Phase 1: randomized to A&F arm Phase 2: randomized A&F arm again |
| BG002 | Audit & Feedback Responders Switch | This group included sites that did not implement adequately after the run-in phase, received A&F in Phase 1, responded to A&F and switched to A&F Light in Phase 2. (Note. IAU became A&F Light during Phase 2). Phase 1: randomized to A&F arm Phase 2: randomized A&F Light arm |
| BG003 | Audit & Feedback Non-Responders Continue | This group included sites that did not implement adequately after the run-in phase, received A&F in Phase 1, did not respond to A&F, and continued A&F in Phase 2. Phase 1: randomized to A&F arm Phase 2: randomized A&F arm again |
| BG004 | Audit & Feedback Non-Responders Add Facilitation | This group included sites that did not implement adequately after the run-in phase, received A&F in Phase 1, did not respond to A&F, and accepted and received A&F + External Facilitation in Phase 2. (Note. Only included sites that accepted EF). Phase 1: randomized to A&F arm Phase 2: randomized to A&F plus External Facilitation arm |
| BG005 | Implementation As Usual to Audit & Feedback Light | This group included sites that did not implement adequately after the run-in phase, continued with IAU in Phase 1, and received A&F Light in Phase 2. (Note. IAU became A&F Light during Phase 2) Phase 1: randomized to Implementation as Usual arm Phase 2: received implementation as usual which became A&F Light |
| BG006 | Total | Total of all reporting groups |
| Site/Facilities |
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| years |
| Site/Facilities |
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| Sex: Female, Male | Count of Units | Site/Facilities | Site/Facilities |
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| Race (NIH/OMB) | Count of Units | Site/Facilities | Site/Facilities |
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| Region of Enrollment | Number | Site/Facilities | Site/Facilities |
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| Facility Complexity | The Facility Complexity Model classifies VA medical facility complexity level based on patient population, clinical services offered, educational and research missions, and administrative complexity. Level-1a facilities are the most complex and level-3 facilities are the least complex. Levels 1a-1c will be considered high complexity, level 2- medium complexity and level 3- low complexity. | Count of Units | Site/Facilities | Site/Facilities |
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| Phase 1: Audit & Feedback |
This arm included sites that received audit and feedback in additional to implementation as usual during Phase 1. |
| OG001 | Phase 1: Implementation As Usual | This arm included all sites that received implementation as usual during Phase 1. |
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| Primary | Change in Comprehensive Suicide Risk Evaluation (CSRE) Uptake- Phase 1 | CSRE uptake is a site level adherence measure of the percentage of patients in ambulatory care who had a positive C-SSRS screener and received the CSRE as intended (same day and by the appropriate provider). The score is a facility adherence score. Adherence ranges from 0 to 100, higher scores reflect higher adherence. The outcome measure is reported as the change in facility adherence from baseline to month 8 of intervention Phase 1. Higher numbers reflect greater change in adherence from baseline to month 8 of intervention Phase 1. | All sites that completed Phase 1 are included in the analysis. Sites that received Audit & Feedback in addition to Implementation as Usual during Phase 1 are compared to sites that only received Implementation as Usual during Phase 1. | Posted | Mean | 95% Confidence Interval | change in percent adherence | Change from baseline and intervention Phase 1 month 8 | Sites/Facilities | Sites/Facilities |
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| Secondary | Change in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 2a | C-SSRS uptake is a site level adherence measure of the percentage of patients in ambulatory care who received a timely annual suicide risk screen (i.e., during the first encounter/visit after the annual suicide risk screen reminder was due). The score is a facility adherence score. Adherence ranges from 0 to 100, higher scores reflect higher adherence. The outcome measure is reported as the change in facility adherence from month 9 of intervention phase 1 to month 9 of intervention phase 2. Higher numbers reflect greater change in adherence from month 9 of intervention phase 1 to month 9 of intervention phase 2. | Responding sites that continued to received audit & feedback during Phase 2 are compared to responding sites that switched to audit & feedback light during Phase 2. For Phase 2, it was pre-specified to compare only Audit & Feedback Light to Audit and Feedback for the group of sites that responded to Audit & Feedback during Phase 1. | Posted | Mean | 95% Confidence Interval | change in percent adherence | Change from month 9 of intervention phase 1 and month 9 of intervention phase 2 | Sites/Facilities | Sites/Facilities |
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| Secondary | Change in Comprehensive Suicide Risk Evaluation (CSRE) Uptake-Phase 2a | CSRE uptake is a site level adherence measure of the percentage of patients in ambulatory care who had a positive C-SSRS screener and received the CSRE as intended (same day and by the appropriate provider). The score is a facility adherence score. Adherence ranges from 0 to 100, higher scores reflect higher adherence. The outcome measure is reported as the change in facility adherence from month 9 of intervention phase 1 to month 9 of intervention phase 2. Higher numbers reflect greater change in adherence from month 9 of intervention phase 1 to month 9 of intervention phase 2. | Responding sites that continued to received audit & feedback during Phase 2 are compared to responding sites that switched to audit & feedback light during Phase 2. For Phase 2, it was pre-specified to compare only Audit & Feedback Light to Audit and Feedback for the group of sites that responded to Audit & Feedback during Phase 1. | Posted | Mean | 95% Confidence Interval | change in percent adherence | Change from month 9 of intervention phase 1 and month 9 of intervention phase 2 | Sites/Facilities | Sites/Facilities |
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| Secondary | Change in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 2b | C-SSRS uptake is a site level adherence measure of the percentage of patients in ambulatory care who received a timely annual suicide risk screen (i.e., during the first encounter/visit after the annual suicide risk screen reminder was due). The score is a facility adherence score. Adherence ranges from 0 to 100, higher scores reflect higher adherence. The outcome measure is reported as the change in facility adherence from month 9 of intervention phase 1 to month 9 of intervention phase 2. Higher numbers reflect greater change in adherence from month 9 of intervention phase 1 to month 9 of intervention phase 2. | Nonresponding sites that received audit and feedback in Phase 2 are compared to nonresponding sites that received audit & feedback plus external facilitation during Phase 2. | Posted | Mean | 95% Confidence Interval | change in percent adherence | Change from month 9 of intervention phase 1 and month 9 of intervention phase 2 | Sites/Facilities | Sites/Facilities |
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| Secondary | Change in Comprehensive Suicide Risk Evaluation (CSRE) Uptake-Phase 2b | CSRE uptake is a site level adherence measure of the percentage of patients in ambulatory care who had a positive C-SSRS screener and received the CSRE as intended (same day and by the appropriate provider). The score is a facility adherence score. Adherence ranges from 0 to 100, higher scores reflect higher adherence. The outcome measure is reported as the change in facility adherence from month 9 of intervention phase 1 to month 9 of intervention phase 2. Higher numbers reflect greater change in adherence from month 9 of intervention phase 1 to month 9 of intervention phase 2. | Nonresponding sites that received audit and feedback in Phase 2 are compared to nonresponding sites that received audit & feedback plus external facilitation during Phase 2. | Posted | Mean | 95% Confidence Interval | change in percent adherence | Change from month 9 of intervention phase 1 and month 9 of intervention phase 2 | Sites/Facilities | Sites/Facilities |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Audit & Feedback Responders Continue | This arm included sites that did not implement adequately after the run-in phase, received audit & feedback (A&F) in Phase 1, responded to A&F, and continued A&F in Phase 2. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Audit & Feedback Responders Switch | This arm included sites that did not implement adequately after the run-in phase, received A&F in Phase 1, responded to A&F and switched to A&F Light in Phase 2. (Note. IAU became A&F Light during Phase 2). | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Audit & Feedback Non-Responders Continue | This arm included sites that did not implement adequately after the run-in phase, received A&F in Phase 1, did not respond to A&F, and continued A&F in Phase 2. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | Audit & Feedback Non-Responders Add Facilitation | This arm included sites that did not implement adequately after the run-in phase, received A&F in Phase 1, did not respond to A&F, and accepted and received A&F + External Facilitation in Phase 2. (Note. Only included sites that accepted EF). | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | Implementation As Usual to Audit & Feedback Light | This arm included sites that did not implement adequately after the run-in phase, continued with IAU in Phase 1, and received A&F Light in Phase 2. (Note. IAU became A&F Light during Phase 2) | 0 | 0 | 0 | 0 | 0 | 0 |
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