ED-observasjon for opioidbruksforstyrrelse
Måling av bedring i kvaliteten på legevakt-initiert behandling for opioidbruksforstyrrelser ved bruk av observasjon
This is a multicenter, randomized clinical comparative effectiveness trial (RCT) in which patients with untreated OUD presenting to a Northwell Health Emergency Department (ED), NYULH-Brooklyn, NYULH-Tisch, and Bellevue Hospital will be randomized (1:1) to be managed clinically through either a standard ED visit or an extended visit through ED observation (EDOU).
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
In this hybrid implementation-effectiveness study, there is no direct research intervention. Rather, clinical care with well-documented effectiveness will be delivered at the discretion of clinical staff guided by clinical protocols for the management of OUD with MOUD (Medications for Opioid Use Disorder) introduced at each site prior to study enrollment. Enrolled patients will be randomized to ED vs. EDOU and to participate in assessments conducted at the index visit and at 30 days and 90 days. Patient level data will also be matched with Medicaid claims data for more robust analyses and to support the development of clinical quality measures.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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New Jersey
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Newark, New Jersey, Forente stater, 07103
- Rutgers University-University Hospital
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New York
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Brooklyn, New York, Forente stater, 11220
- NYULH-Brooklyn
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New Hyde Park, New York, Forente stater, 11040
- Northwell Health - Long Island Jewish Medical Center
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New York, New York, Forente stater, 10016
- Bellevue
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New York, New York, Forente stater, 10016
- NYULH-Tisch
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Staten Island, New York, Forente stater, 10305
- Northwell Health - Staten Island University Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Is 18 years of age or older
- Is able to speak English sufficiently to understand study procedures
- Has a history of non-medical opioid use
- Is a potential candidate for ED-based MOUD treatment initiation and referral at the site as confirmed by clinical staff
- s not receiving MOUD through ongoing formal addiction treatment or pain management at the time of index ED visit
- Is willing to receive either standard ED care or enhanced ED care in EDOU depending on random assignment
- Presents to the ED during study screening hours
Exclusion Criteria:
- Unwilling or unable to provide written/electronic informed consent/HIPAA Authorization for research procedures, including research visits at baseline and Day 30 and Day 90, and/or consent for the release of health records and data matching for a period of 2 years following enrollment and 1 year prior to enrollment.
- Currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or that could prevent participation in the study
- Presents from a medical-based extended care facility (e.g., skilled nursing facility)
- Previous participation in the current study
- Inadequate locator information (unable or unwilling to provide one unique mean of contact).
- Has acute, severe medical, psychiatric, or concurrent substance use problem or meets other criteria that would exclude the patient (clinically) from placement in EDOU according to EDOU placement clinical protocols.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Standard visit
Participants will have standard Emergency Department visit as per standard operating procedures which should last approximately 3 -5 hours. |
Standard visit |
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Eksperimentell: Extended visit with Observation
Participants will have extended Emergency Department visit by having an observation (which could be up to 23 hours) time in addition to the standard ED visit. In addition, information will be gathered about about the participants, use of opioids, healthcare visits, the quality of health, life, and treatment, and other topics. Urine or saliva or both may also be collected. |
Emergency Department Observation Units (EDOU) would allow the highest risk patients - those presenting for nonfatal overdose - to receive their first dose of BUP before leaving the ED. Operationally defined to include placement in an observation unit and/or placement under observation status with care provided by Emergency Medicine and/or other services (e.g., Internal medicine, Psychiatry) |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of participants who receive Emergency Department (ED)-initiated Buprenorphine (BUP)
Tidsramme: Week 1 (~7-10 days)
|
Receipt of ED-initiated BUP will be operationally defined to include administration of BUP and/or prescription for BUP as part of the ED/Emergency Department Observation (Units) (EDOU) visit. This measure will be abstracted from the health record primarily. |
Week 1 (~7-10 days)
|
|
Proportion of participants who receive ED-initiated or ED-expedited BUP
Tidsramme: Week 1 (~7-10 days)
|
Receipt of ED-initiated/expedited BUP will be operationally defined to include the provision of a specific "warm" referral or transfer of care to a provider, clinic, or treatment setting with the capacity to administer and/or prescribe BUP within 24 hours of completion of the ED/EDOU visit. Eligible transition of care will be will described further in the Manual of Operations (MOP) and will include direct transport or handoff to an outpatient provider immediately from the ED, provision of an appointment within 24 hours (with a specific time and location), transfer to general inpatient or inpatient OUD/addiction treatment. Neither confirmation of a completed appointment (i.e., patient shows up and is seen) nor receipt of BUP at the dedicated follow-up appointment will be required as the patient and treating provider may elect to treat with alternative regimes (e.g., methadone, naltrexone). This measure will be abstracted from the health record primarily. |
Week 1 (~7-10 days)
|
|
Proportion of participants who receive ED-initiated or ED-expedited Medications for Opioid Use Disorder (MOUD)
Tidsramme: Week 1 (~7-10 days)
|
Receipt of ED-initiated MOUD, inclusive of BUP, methadone, or naltrexone. |
Week 1 (~7-10 days)
|
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The proportion of participants who are successfully linked to formal addiction treatment within one week following the completion of their index ED/EDOU visit
Tidsramme: Week 1 (~7-10 days)
|
Successful linkage to formal addiction treatment will be defined as confirmed attendance at formal addiction treatment for OUD following completion of the ED/EDOU visit. Formal addiction treatment will be those treatments consistent with the American Society of Addiction Medicine's (ASAM) level of care (1-4) and will include a range of clinical settings, including office-based providers of BUP or naltrexone, Opioid Treatment Programs (OTPs), intensive outpatient, inpatient, or residential treatments. Means of confirmation will include direct contact with the facility and/or treating clinician or other objective means (e.g., medical record review). |
Week 1 (~7-10 days)
|
|
The proportion of participants who are confirmed to be engaged in formal addiction treatment for OUD on the 30th day following the completion of their index ED/EDOU visit
Tidsramme: Day 30
|
Engagement in treatment for OUD will be defined as confirmed enrollment in formal addiction treatment for OUD on the 30th day following completion of the ED/EDOU visit. Attendance at two or more visits for formal addiction treatment within the 30-day period also constitutes engagement. |
Day 30
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Endring i andelen deltakere som testet positivt for ulovlige opioider/stoffer
Tidsramme: Baseline, dag 30
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Baseline, dag 30
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Endring i andelen deltakere som testet positivt for ulovlige opioider/stoffer
Tidsramme: Dag 30, Dag 90
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Dag 30, Dag 90
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Endring i antall overdosehendelser og risikoatferd
Tidsramme: Utgangspunkt, dag 30
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Utgangspunkt, dag 30
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Endring i antall overdosehendelser og risikoatferd
Tidsramme: Dag 30, Dag 90
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Dag 30, Dag 90
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Endring i andel deltakere som rapporterte behandlingstilfredshet
Tidsramme: Utgangspunkt, dag 30
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Utgangspunkt, dag 30
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Endring i andel av deltakere som rapporterte behandlingstilfredshet
Tidsramme: Dag 30, Dag 90
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Dag 30, Dag 90
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Change in number of days of opioid and other drug use
Tidsramme: Baseline, Day 30
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Measured by the Timeline Follow-Back (TLFB) procedure will be used to elicit the participant's self-reported use of illicit substances at baseline and throughout study participation. |
Baseline, Day 30
|
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Change in number of days of opioid and other drug use
Tidsramme: Day 30, Day 90
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Measured by the Timeline Follow-Back (TLFB) procedure will be used to elicit the participant's self-reported use of illicit substances at baseline and throughout study participation. |
Day 30, Day 90
|
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Change in score on EuroQol-5 Dimensions (EQ-5D) Scale
Tidsramme: Baseline, Day 30
|
EuroQol-5 Dimensions (EQ-5D): The EuroQol is a structured interview that collects general health information applicable to a wide range of health conditions and treatment, providing a simple descriptive profile and a single index value for health status between 0 (dead) and 1 (full health). |
Baseline, Day 30
|
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Change in score on EuroQol-5 Dimensions (EQ-5D) Scale
Tidsramme: Day 30, Day 90
|
EuroQol-5 Dimensions (EQ-5D): The EuroQol is a structured interview that collects general health information applicable to a wide range of health conditions and treatment, providing a simple descriptive profile and a single index value for health status between 0 (dead) and 1 (full health). |
Day 30, Day 90
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Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS-29) Scale
Tidsramme: Baseline, Day 30
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Assessment of quality of life in seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) all assessed using the PROMIS-29 questionnaire. PROMIS-29 is scored on a T-score metric with a mean of 50 and a standard deviation of 10 in the U.S. general population, with a higher score representing more symptoms. |
Baseline, Day 30
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Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS-29) Scale
Tidsramme: Day 30, Day 90
|
Assessment of quality of life in seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) all assessed using the PROMIS-29 questionnaire. PROMIS-29 is scored on a T-score metric with a mean of 50 and a standard deviation of 10 in the U.S. general population, with a higher score representing more symptoms. |
Day 30, Day 90
|
|
Change in score on Patient Health Questionnaire (PHQ)-9 Scale
Tidsramme: Baseline, Day 30
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The PHQ-9 is a 9-item instrument used for screening, diagnosing, monitoring and measuring the severity of depression. Each item is rated from 0 (not at all) to 3 (nearly every day). Total scores range from 0-27. Scores are interpreted as follows: Minimal Depression: 0-4, Mild depression: 5-9, Moderate depression: 10-14, Moderately severe depression: 15-19, Severe depression: 20-27. |
Baseline, Day 30
|
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Change in score on Patient Health Questionnaire (PHQ)-9 Scale
Tidsramme: Day 30, Day 90
|
The PHQ-9 is a 9-item instrument used for screening, diagnosing, monitoring and measuring the severity of depression. Each item is rated from 0 (not at all) to 3 (nearly every day). Total scores range from 0-27. Scores are interpreted as follows: Minimal Depression: 0-4, Mild depression: 5-9, Moderate depression: 10-14, Moderately severe depression: 15-19, Severe depression: 20-27. |
Day 30, Day 90
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Change in score on Treatment Effectiveness Assessment (TEA) Scale
Tidsramme: Baseline, Day 30
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Treatment Effectiveness Assessment (TEA) scale is comprised of 4 questions about substance use, health, lifestyle, and community. Participants respond the questions on how they have improved in that area on a scale from 1 (not better at all) to 10 (very much better). Higher scores indicate overall improvement and effectiveness of treatment. |
Baseline, Day 30
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Change in score on Treatment Effectiveness Assessment (TEA) Scale
Tidsramme: Day 30, Day 90
|
Treatment Effectiveness Assessment (TEA) scale is comprised of 4 questions about substance use, health, lifestyle, and community. Participants respond the questions on how they have improved in that area on a scale from 1 (not better at all) to 10 (very much better). Higher scores indicate overall improvement and effectiveness of treatment. |
Day 30, Day 90
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Change in proportion of participants who reported changes in social determinants of health (e.g., homelessness, employment)
Tidsramme: Baseline, Day 30
|
Self reported by participants. |
Baseline, Day 30
|
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Change in proportion of participants who reported changes in social determinants of health (e.g., homelessness, employment)
Tidsramme: Day 30, Day 90
|
Self reported by participants. |
Day 30, Day 90
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Ryan McCormack, MD, NYU Langone Health
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20-01951
- 5R33DA049265-03 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD-delingstidsramme
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Tilgangskriterier for IPD-deling
The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to ryan.mccormack@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
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