- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01488630
Substance Treatment and HIV Testing and Referral System (STaRS)
Substance Treatment Referral System
The lack of substance screening and referral in healthcare settings is a significant problem with far-reaching consequences, including excess morbidity, premature mortality, and inflated healthcare costs. An easy to use, time-efficient referral system is needed to address this problem. The Substance Treatment Referral Systems (STaRS), a computer assisted screening and referral system, was developed to meet this need.
STaRS Phase I demonstrated the feasibility of STaRS to meet this need. All aims and evaluation goals of the Phase I study were met or exceeded. The purpose of the Phase II research is to demonstrate the clinical utility and commercial viability of STaRS.
Specific Aims of Phase II are:
- Integrate STaRS with the Epic electronic health record used in the Cooper Health System in Camden, N.J.
- Document STaRS' effectiveness in (a) increasing the number of referrals provided for substance abuse treatment and HIV screening, and (b) increasing the proportion of patients that initiate specialty treatment.
- Evaluate clinician acceptance and impact upon revenue generation.
The research will be conducted at Cooper Family Medicine (CFM) department of Cooper University Hospital in New Jersey. We will determine the rate of referrals and treatment initiation for 3,500 adult patients treated during treatment as usual (the time before STaRS is implemented at CFM) as well as 3,500 adult patients treated after the introduction of STaRS. Patients will be asked about the referral initiation process, and CFM healthcare providers will be asked to evaluate the system from a clinical and administrative prospective. Finally, billing records will be reviewed during the STaRS implementation to determine whether STaRS impacted revenue for the practices.
Descripción general del estudio
Descripción detallada
STaRS is a computer assisted screening and referral system for problem substance use, designed for use in medical settings. The primary function of STaRS is to facilitate physician referrals for tobacco, alcohol, other drugs, and HIV screening, tailored to the patient's condition and circumstances (e.g., zip code and insurance).
A prototype of STaRS was developed and found to be feasible in medical settings in Phase I. Phase II research will demonstrate clinical utility and commercial viability of the system in a medical setting (e.g., Cooper University Hospital Family Medicine practices). Prior to beginning the Phase II research, focus groups were conducted to refine changes to the STaRS software. These focus groups consisted of healthcare providers from Cooper Family Medicine (CFM) practices.
The Phase II research will be conducted in several parts, described in the following sub-studies, conducted simultaneously:
- Referral Sub-Study. To determine the impact of STaRS on the rate of referral for substance abuse treatment and HIV screening, 7,000 adult patients' charts will be reviewed (3,500 patients seen prior to STaRs implementation and 3,500 patients seen after STaRS implementation).
- Treatment Initiation Sub-Study. To test the effectiveness of STaRS on treatment initiation, 140 patients who receive referrals during the STaRS implementation will be telephoned by research staff and invited to participate in this sub-study to document treatment initiation. Treatment initiation refers to whether the patient has made contact or scheduled an appointment with the referral provider.
- Billing and Revenue Generation Sub-Study. Seven thousand medical records will be reviewed for the referral study (described above). Patients who were given referrals for substance use and HIV screening will have their billing records reviewed by the Cooper Research Assistant (RA). The goal is to determine the amount billed for the session in which the referral was made and the amount paid by the insurer (or Medicaid, Medicare). This data will be used to determine the effectiveness of STaRS to increase revenues for the practices.
- Provider Evaluation of STaRS Sub-Study. At the conclusion of the study, focus groups will be conducted with the CFM healthcare providers. The focus groups will have 3 goals: Rating the STaRS system on ease of use and clinical utility; soliciting suggestions regarding enhancements to STaRS and procedures to implementation and training; and identifying any factors that may have influenced the providers to screen or refer patients.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
New Jersey
-
Camden, New Jersey, Estados Unidos, 08102
- Cooper Family Medicine
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- All English-speaking adult patients (>= 18 years old) who received a referral for substance abuse treatment or HIV/AIDS screening from Cooper Family Medicine practices during the study period, and who can be reached at a home telephone or have a monthly cell phone plan.
Exclusion Criteria:
- Patients < 18 years old and patients with poor English comprehension, or who do not have reliable telephone access (i.e., no phone access or buys minutes for a "disposable" cell phone)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Poner en pantalla
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Sin intervención: Treatment as Usual
Chart review only.
|
|
Experimental: STaRS
Patients asked to participate in follow-up study to get information on whether they went to referral recommended by their provider through the STaRS system.
|
The intervention entails testing an automated substance abuse treatment referral system (STaRS) to be implemented in primary care practices through electronic health record systems to improve 1) referral rates to specialty care providers, 2) patient treatment initiation with the specialty care providers, and 3) revenues to the practices.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Referral Rates for Substance Abuse Treatment and HIV Testing
Periodo de tiempo: Completed after 3500 pre-STaRS charts and 3500 STaRS intervention charts are reviewed, over a period of one year
|
A total of 7000 electronic health records ( referred to as "charts") will be reviewed for referral rates.
Those charts include 3500 pre-STaRS charts (treatment as usual arm) and 3500 STaRS charts (intervention arm)
|
Completed after 3500 pre-STaRS charts and 3500 STaRS intervention charts are reviewed, over a period of one year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Treatment Initiation
Periodo de tiempo: 70 pre-STarS patients and 70 STaRS patients are enrolled, over a period of six months
|
7000 charts will be reviewed, 140 patients who received referrals for substance abuse and/or HIV testing will be enrolled in the treatment initiation study (70 with referrals from pre-STaRS charts and 70 with referrals from STaRS intervention charts.
|
70 pre-STarS patients and 70 STaRS patients are enrolled, over a period of six months
|
Billing Revenue
Periodo de tiempo: 7000 charts reviewed, over a period of one year
|
A total of 7000 electronic health records will be reviewed for referral rates (3500 pre-STaRS, 3500 STaRS intervention).
Charts of patients who received referrals will be further examined to obtain billing information.
This will help determine the impact that STaRS has on increasing revenues to the CFM practices.
|
7000 charts reviewed, over a period of one year
|
Provider Satisfaction
Periodo de tiempo: Last month of the study, November 2012
|
Focus groups will be conducted with healthcare providers who used the STaRS to make referrals.
Data collected at focus groups will be used to improve future versions of STaRS.
|
Last month of the study, November 2012
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Grant Grissom, PhD, Polaris Health Directions
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 (Actual)
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
- N44DA-10-5543
- STaRS (Identificador de registro: STaRS)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre STaRS
-
University of OklahomaReclutamientoRelacionado con el embarazo | Trastornos por uso de sustancias | Negligencia infantilEstados Unidos
-
Brown UniversityNational Institute of Mental Health (NIMH); The University of AkronReclutamientoVIH | Violencia Doméstica | Comportamiento de reducción de riesgos | Violencia de GéneroEstados Unidos
-
University of OxfordBeijing Normal University; Beijing Stars and Rain Education Institute for AutismTerminadoAbuso infantil | Relaciones entre padres e hijos | Desorden del espectro autista | Crianza de los hijos | Problema de comportamiento infantil | Relaciones familiares | Problema de salud mentalPorcelana
-
Bahçeşehir UniversityNevsehir Haci Bektas Veli UniversityAún no reclutandoEsguinces de tobillo | Presentación funcional | Kinesiofobia | Déficit sensorial | Inestabilidad del tobilloPavo