- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01153373
Dynamic Assessment and Referral System - Evaluation (DARSSA)
The Dynamic Assessment and Referral System for Substance Abuse: Evaluation
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Screening process. All patients who verbally consent to being screened by the RA will undergo a computer assisted screening for substance abuse (Rapid Screener) administered by the research assistant. Patients who use tobacco, misuse alcohol, or use illicit drugs will be further screened for eligibility to participate in the randomized trial. Eligible patients will be invited to participate and will sign the consent form. Participants will then be assigned to one of the two conditions by the computer using a random number generator. Results obtained as part of the Rapid Screener will be for research purposes only. They will not be reported to healthcare providers, unless the participant is enrolled into the study and is assigned to the DARSSA Intervention condition (see below).
Minimal Intervention Control. All patients that give consent to participate in the study ("participants") who are randomly assigned to the control condition will complete the computerized DARSSA for assessment purposes only. The reports will not be printed or dynamic referrals generated, and all patients will receive treatment-as-usual by their ED providers. This will preserve the treatment-as-usual nature of the baseline while maintaining consistency in the administration of the DARSSA between phases of the study. Although ED clinicians will know that a study is being conducted in the ED, they will not be informed of the results of the research assessment, nor will they be given any instruction or training beforehand to change their standard screening, counseling, and referral practices. This means that substance use screening is likely to be inconsistent and counseling or referrals by provider rare. To maintain ethical standards, the RAs will provide a substance abuse treatment resource list (passive referral list) to all subjects who screen positive, even though this often does not happen during routine clinical practice. Additionally, suicidal ideation is not directly assessed as part of the study, but it is possible that participants will spontaneously report suicidal ideation. If this happens, the RA will notify the treating physician. Both of these efforts could conceivably introduce interventions the patient may not otherwise have received, but there is no viable alternative if the investigators are to ensure patient safety.
DARSSA Intervention. All participants randomized to the DARSSA Intervention will be given instructions for how to complete the assessment. Since the DARSSA is self-administered and, like all Polaris products, does not require computer literacy, instructions will be simple and do not require a clinician to administer. Once completed, the treating emergency physician will be expected to (1) give substance using patients the Patient Feedback Report, (2) recommend they review it carefully, and (3) encourage them to consider following up with the referrals. Any additional assessment or counseling will be optional and left to individual provider practice. We considered creating a standardized counseling protocol but decided against it. We want to maintain an ecologically valid evaluation. In the "real world," providers would not be given extensive health behavior counseling training or asked to follow a standardized counseling protocol when implementing the DARSSA. Training providers on health behavior counseling would act as an additional intervention in its own right, and it could potentially mask our ability to determine what effect the DARSSA alone is having.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Worcester, Massachusetts, Estados Unidos, 01655
- UMass Memorial Medical Center - University Campus
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age 18 years or older and receiving treatment in the ED
Exclusion Criteria:
- sustained altered mental status (e.g., psychosis, delirium, disorientation, unresponsive)
- hostile or agitated behavior
- sexual assault victims
- trauma patients who are on backboards or who must remain supine
- severe illness that would preclude conversation or interface with a computer (e.g., intubation, persistent vomiting, severe pain)
- or factors precluding follow-up, like transient residence or lack of a telephone.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: Minimal Intervention Control
All patients that give consent to participate in the study ("participants") who are randomly assigned to the control condition will complete the computerized DARSSA for assessment purposes only.
The reports will not be printed or dynamic referrals generated, and all patients will receive treatment-as-usual by their ED providers.
|
Conductual: Self-administered computerized assessment for tobacco, substance abuse, and alcohol use.
All patients that give consent to participate in the study ("participants") who are randomly assigned to the control condition will complete the computerized DARSSA for assessment purposes only.
|
|
Comparador activo: DARSSA Intervention
All participants randomized to the DARSSA Intervention will be given instructions for how to complete the assessment.
Once completed, the treating emergency physician will be expected to (1) give substance using patients the Patient Feedback Report, (2) recommend they review it carefully, and (3) encourage them to consider following up with the referrals.
|
All participants randomized to the DARSSA Intervention will be given instructions for how to complete the assessment.
Once completed, the treating emergency physician will be expected to (1) give substance using patients the Patient Feedback Report, (2) recommend they review it carefully, and (3) encourage them to consider following up with the referrals.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Prevalence of detected tobacco, alcohol, and drug use in emergency room patients.
Periodo de tiempo: November 2009 - June 2013
|
When comparing the intervention (DARSSA) group to the treatment as usual group, is there an increase in the detected prevalence of tobacco use, alcohol use, and drug abuse.
|
November 2009 - June 2013
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Increase in delivery of health care (i.e. - education/counseling/referral) for emergency room patients that report tobacco use, alcohol use, and/or substance abuse.
Periodo de tiempo: November 2009 - June 2013
|
When the intervention (DARSSA) group is compared to the treatment as usual group, is there an increase in the amount of education/counseling/referral for emergency room patients who report tobacco use, alcohol use, and/or substance abuse.
|
November 2009 - June 2013
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Haskins BL, Davis-Martin R, Abar B, Baumann BM, Harralson T, Boudreaux ED. Health Evaluation and Referral Assistant: A Randomized Controlled Trial of a Web-Based Screening, Brief Intervention, and Referral to Treatment System to Reduce Risky Alcohol Use Among Emergency Department Patients. J Med Internet Res. 2017 May 1;19(5):e119. doi: 10.2196/jmir.6812.
- Boudreaux ED, Abar B, Haskins B, Bauman B, Grissom G. Health evaluation and referral assistant: a randomized controlled trial to improve smoking cessation among emergency department patients. Addict Sci Clin Pract. 2015 Nov 5;10:24. doi: 10.1186/s13722-015-0045-2.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- H-13419
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