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| ID | Type | Description | Link |
|---|---|---|---|
| 3UG1DA013727-20S5 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Drug Abuse Treatment Clinical Trials Network | NETWORK |
| The Emmes Company, LLC | INDUSTRY |
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of the Peer Intervention to Link Overdose Survivors to Treatment (PILOT) study is to improve outcomes for individuals after surviving an overdose involving opioids. This study will be comparing the enhanced peer intervention known as PILOT for overdose survivors with treatment as usual (TAU) provided in the Emergency Department.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer | Experimental |
| |
| Treatment As Usual Peer | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer | Behavioral | Participants will meet with the PILOT Peer consistently throughout the 6 months of study participation. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Self-reported Overdose Risk Behaviors at 180 Days (6 Months) After Index ED Admission | Past month total score on the modified Overdose Risk Behavior Checklist (OBRC) at 180 days (6 months post-randomization) compared between experimental groups. The ORBC was a 13-item scale with 11 of the items used to generate a total score (ranging from 0-44); higher scores indicate greater frequency and number of overdose risk behaviors. | 180 days (6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Steps Achieved Along a Modified SUD Cascade of Care | Number of steps achieved along a modified substance use disorder (SUD) Cascade of Care (0-11 steps possible) at 180 days post-randomization (6 months). Higher scores are associated with better outcomes. | 180 days (6 months) |
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To be included in this study participants must:
Be 18 years of age or older at time of first contact by research staff (no upper age limit for inclusion).
Meet one of the following non-fatal overdose involving opioids (NFOO) criteria:
Be able to provide sufficient locator information, defined as identifying at least two individual contacts other than the participant.
Be able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study as determined by research staff.
Be willing and able to confirm future SUD treatment receipt as evidenced by 2 out of 3 of the following: (a) signing appropriate releases to for study staff to confirm treatment with follow-up provider; (b) having technology necessary to visualize medication bottles and transmit to study team utilizing HIPAA-compliant platform; and/or (c) able and willing to undergo toxicology tests (in person or via HIPAA-compliant videoconferencing).
Exclusion criteria include those who are:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly Barth, DO | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy Health Youngstown | Youngstown | Ohio | 44501 | United States | ||
| Prisma Health Upstate |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39288373 | Derived | Papa C, McClure EA, McCauley J, Haynes L, Matheson T, Jones R, Jennings L, Lawdahl T, Ward R, Brady K, Barth KS. Peer Intervention to Link Overdose Survivors to Treatment (PILOT): Protocol for a Multisite, Randomized Controlled Trial Conducted Within the National Institute on Drug Abuse Clinical Trials Network. JMIR Res Protoc. 2024 Sep 17;13:e60277. doi: 10.2196/60277. |
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This study will comply with the NIH Data Sharing Policy and Implementation Guidance (https://grants.nih.gov/grants/policy/data\_sharing/data\_sharing\_guidance.htm) and the HEAL Public Access and Data Sharing Policy (https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/research/heal-public-access-data-sharing-policy).
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Participants were identified and recruited from the ED at the time of ED admission (primary method of recruitment). Recruitment, approaching patients, screening, consent, and study procedures were completed in-person or remotely, utilizing HIPAA-compliant videoconferencing. Participants could be approached, screened and randomized after ED admission and could be randomized after screening had occurred in the ED.
A randomized, controlled, parallel group design was implemented across three sites within the National Drug Abuse Treatment Clinical Trials Network (CTN): Prisma Health Systems (Southern Consortium Node); Mercy Health (Ohio Valley Node), and Providence Regional Medical Center (Pacific Northwest Node). From December 2021 through February 2024, 150 participants identified in the ED as opioid overdose survivors were approached to participate in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer | Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer: Participants will meet with the PILOT Peer consistently throughout the 6 months of study participation. Treatment As Usual Peer: Participants will receive recovery resources and standard of care procedures specific to the Emergency Department. |
| FG001 | Treatment As Usual Peer | Treatment As Usual Peer: Participants will receive recovery resources and standard of care procedures specific to the Emergency Department. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer | Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer: Participants will meet with the PILOT Peer consistently throughout the 6 months of study participation. Treatment As Usual Peer: Participants will receive recovery resources and standard of care procedures specific to the Emergency Department. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Self-reported Overdose Risk Behaviors at 180 Days (6 Months) After Index ED Admission | Past month total score on the modified Overdose Risk Behavior Checklist (OBRC) at 180 days (6 months post-randomization) compared between experimental groups. The ORBC was a 13-item scale with 11 of the items used to generate a total score (ranging from 0-44); higher scores indicate greater frequency and number of overdose risk behaviors. | Intent to treat analysis. All randomized subjects were included in the analysis. A participant contributed to the Day 180 estimate if they had all fixed effect covariates including baseline ORBC score and an ORBC score at Day 180 | Posted | Mean | Standard Deviation | units on a scale | 180 days (6 months) |
|
28 weeks
Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.
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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 | Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer | Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer: Participants will meet with the PILOT Peer consistently throughout the 6 months of study participation. Treatment As Usual Peer: Participants will receive recovery resources and standard of care procedures specific to the Emergency Department. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment | Unknown cause of death |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ralph Ward | Medical University of South Carolina | 843-876-6110 | wardrc@musc.edu |
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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 26, 2022 | Jan 13, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 11, 2024 | Jan 13, 2025 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 3, 2021 | Feb 27, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000083682 | Opiate Overdose |
| D062787 | Drug Overdose |
| ID | Term |
|---|---|
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment As Usual Peer | Behavioral | Participants will receive recovery resources and standard of care procedures specific to the Emergency Department. |
|
| Greenville |
| South Carolina |
| 29605 |
| United States |
| Providence Regional Medical Center | Everett | Washington | 98201 | United States |
| Death |
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| Other |
|
| BG001 | Treatment As Usual Peer | Treatment As Usual Peer: Participants will receive recovery resources and standard of care procedures specific to the Emergency Department. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Baseline ORBC score | Mean | Standard Deviation | units on a scale |
|
| OG001 | Treatment as Usual (TAU) Arm | Receives routine clinical treatment in the ED including TAU peer support specialists able to provide Screening, Brief Intervention, Referral to Treatment (SBIRT) interventions for patients presenting with substance use disorders or substance-related issues. |
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|
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| Secondary | Number of Steps Achieved Along a Modified SUD Cascade of Care | Number of steps achieved along a modified substance use disorder (SUD) Cascade of Care (0-11 steps possible) at 180 days post-randomization (6 months). Higher scores are associated with better outcomes. | Posted | Mean | Standard Deviation | units on a scale | 180 days (6 months) |
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|
|
| 2 |
| 72 |
| 21 |
| 72 |
| 0 |
| 72 |
| EG001 | Treatment As Usual Peer | Treatment As Usual Peer: Participants will receive recovery resources and standard of care procedures specific to the Emergency Department. | 2 | 78 | 18 | 78 | 0 | 78 |
| Death | Cardiac disorders | Systematic Assessment | Cardiac arrest |
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| Death | Injury, poisoning and procedural complications | Systematic Assessment | Overdose |
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| Death | General disorders | Systematic Assessment | Unknown cause of death |
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| Hospitalization | Psychiatric disorders | Systematic Assessment | Altered Mental Status |
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| Hospitalization | Injury, poisoning and procedural complications | Systematic Assessment | Overdose |
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| Hospitalization | Psychiatric disorders | Systematic Assessment | Psychiatric Evaluation |
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| Hospitalization | Injury, poisoning and procedural complications | Systematic Assessment | Cocaine abuse, Suicidal Ideation |
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| Hospitalization | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Chest pain |
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| Hospitalization | Infections and infestations | Systematic Assessment | Pain from wound infection |
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| Hospitalization | General disorders | Systematic Assessment | Cancer |
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| Hospitalization | Social circumstances | Systematic Assessment | Neck pain; Motor vehicle collision |
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| Hospitalization | Infections and infestations | Systematic Assessment | Osteomyelitis/Discitis |
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| Hospitalization | Infections and infestations | Systematic Assessment | Subacute bacterial endocarditis; drug overdose |
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| Hospitalization | Psychiatric disorders | Systematic Assessment | Hallucination |
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| Hospitalization | Psychiatric disorders | Systematic Assessment | Psychosocial stressors |
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| Hospitalization | Psychiatric disorders | Systematic Assessment | Anxiety |
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| Hospitalization | General disorders | Systematic Assessment | Self care deficit |
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| Hospitalization | General disorders | Systematic Assessment | Mid-sternal chest pain; opioid withdrawal |
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| Hospitalization | Cardiac disorders | Systematic Assessment | Acute on chronic congestive hearth failure |
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| Hospitalization | Surgical and medical procedures | Systematic Assessment | Scheduled hip surgery |
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| Hospitalization | Infections and infestations | Systematic Assessment | Wound infection post-surgery |
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| Hospitalization | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Pregnancy complication in 3rd trimester |
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| Hospitalization | Injury, poisoning and procedural complications | Systematic Assessment | Drug overdose |
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| Hospitalization | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Double pneumonia/respiratory issues |
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| Hospitalization | Psychiatric disorders | Systematic Assessment | Suicidal ideation |
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| Hospitalization | Injury, poisoning and procedural complications | Systematic Assessment | Excessive use of ecstasy |
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| Hospitalization | Psychiatric disorders | Systematic Assessment | Mental health problem |
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| Hospitalization | Injury, poisoning and procedural complications | Systematic Assessment | Polysubstance abuse |
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| Hospitalization | Psychiatric disorders | Systematic Assessment | Acute psychosis |
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| Hospitalization | General disorders | Systematic Assessment | COVID positive |
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| Hospitalization | Surgical and medical procedures | Systematic Assessment | Scheduled surgery |
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| Hospitalization | Injury, poisoning and procedural complications | Systematic Assessment | Acute CVA; Accidental fentanyl overdose |
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| Hospitalization | Infections and infestations | Systematic Assessment | Cellulitis of hand, right |
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| Hospitalization | Renal and urinary disorders | Systematic Assessment | Rhabdomyolysis; Renal failure |
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| Hospitalization | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Acute respiratory failure; Asthma |
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| Hospitalization | Renal and urinary disorders | Systematic Assessment | Rhabdomyolysis; Acute kidney injury |
|
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| D009293 | Opioid-Related Disorders |
| D000079524 | Narcotic-Related Disorders |
| D001523 | Mental Disorders |