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Piloting Acute Care to Primary Care Linkage of Safety Net Patients (TSOS III)

18 de febrero de 2021 actualizado por: Douglas Zatzick, University of Washington
This pilot study will evaluate the implementation of a stepped care intervention that combines Cognitive-Behavioral Therapy, Motivational Interviewing, psychotropic medications, and information technology innovations at a level 1 trauma center to community linkage components to reduce the symptoms of posttraumatic stress disorder and related comorbidities in injured trauma survivors treated in the emergency department and surgical inpatient settings.

Descripción general del estudio

Descripción detallada

The investigators plan to implement a pilot linkage program in which trauma center based care facilitators will use a population-based recruitment strategy to facilitate outpatient follow-up for acutely injured trauma center inpatients and emergency department patients. All patients recruited into the trial will be low income patients with one or more of the following characteristics: being uninsured, low income older adults, low income mothers, and other high risk individuals who lack health insurance. Patients will be linked for care to one of the community health centers participating in Washington State.

In phase I, patients will be recruited from the trauma center inpatient trauma surgery service and emergency departments. In phase one, no randomization will occur; patients will be linked to one of the community health centers. Patients who consent to the protocol will be assessed in the surgical inpatient units or emergency department. After the baseline assessment, all patients will be immediately assigned a bachelor's, MSW, or RN level care manager. The care managers will elicit and address posttraumatic concerns, and attempt linkage of patients to community programs. Care managers may also deliver motivational interviewing and cognitive behavioral therapy interventions. Patient may also be linked to psychopharmacologic interventions targeting PTSD. Follow-up assessments will occur in the weeks and months after the injury and will assess patterns of health service utilization and symptomatic outcomes. Phase I will establish the feasibility of recruitment and follow-up, acceptability of care management for patients, as well as the pragmatics of linkage to community programs.

Piloting in phase II will depend on the results of phase I; the phase II pilot will build and extend upon phase I. In phase II, patients will be randomized to either intervention or control conditions. Patients randomized to the intervention condition will be met by a care manager who may address patients' initial needs and concerns. Care managers may also deliver Motivational Interviewing and Cognitive Behavioral Therapy interventions. Patients may also be linked to psychopharmacologic interventions targeting PTSD. The care manager will attempt to link patients to participating community health centers. Linkages may occur by the telephone, or through web-based clinical registry tools that are under development by the intervention team. Some linkages may occur in person. To determine if intervention patients are successfully linked more frequently than controls, all patients will be followed from the time of designation at hospital admission to outpatient primary care appointments. Follow-up outcome assessments will occur in the weeks and months post-injury and will includes assessments of patterns of health service utilization, function, and symptomatic outcomes.

Tipo de estudio

Intervencionista

Inscripción (Actual)

4

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Washington
      • Seattle, Washington, Estados Unidos, 98104
        • Harborview Medical Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • English-speaking
  • Admitted to Harborview Medical Center with injuries sufficiently severe enough to require inpatient admission
  • Experienced a traumatic injury
  • Exhibits symptoms of PTSD while in the hospital ward
  • Low-income

Exclusion Criteria:

  • History of head, spinal, or other injury that may prevent participation in the ward interview
  • Requires immediate intervention due to conditions such as self-inflicted injury, active psychosis, or active mania
  • Currently incarcerated
  • Likely to face criminal charges
  • Lives outside of the state of Washington
  • Not low-income

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Stepped care
Combination of behavioral therapy and drug therapy
Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.
Otros nombres:
  • TCC
Motivational interviewing is designed to address alcohol and drug use.
Otros nombres:
  • MI
Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care.
Comparador activo: Standard care provided to injured trauma survivors
Standard care control includes the usual treatment for injured trauma survivors
Otros nombres:
  • Licenciado en Letras

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline Alcohol Use Disorders Identification at 1 Month
Periodo de tiempo: Baseline, Up to 12 months after injury
The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome.
Baseline, Up to 12 months after injury
Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month
Periodo de tiempo: Baseline, Up to 12 months after injury
The investigators will use the PTSD Checklist - Civilian (PCL-C). The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. The measure can also provide a rating of symptoms consistent with a diagnosis of PTSD.
Baseline, Up to 12 months after injury
Change in Functional Status at 1 Month
Periodo de tiempo: Baseline, Up to 12 months after injury
The investigators will use the Medical Outcomes Study Short Form healthy survey (MOS SF-12/36) physical components summary to assess physical function. The minimum and maximum scores are 0-100 with higher scores representing a better outcome.
Baseline, Up to 12 months after injury

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Increased Satisfaction With Global Care
Periodo de tiempo: Up to 12 months after injury
Assessed using the Posttraumatic Growth Inventory (PTGI) and Satisfaction with Care (NSCOT)
Up to 12 months after injury
Injury Relapse
Periodo de tiempo: Up to 5 years after injury
Assessed using Healthcare Utilization Questions (NSCOT)
Up to 5 years after injury
Work, Disability, and Legal Outcomes
Periodo de tiempo: Up to 12 months after injury
Assessed using Work, Disability and Legal (NSCOT) and Sheehan Disability Scale (SDS)
Up to 12 months after injury

Colaboradores e Investigadores

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Publicaciones y enlaces útiles

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Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de enero de 2011

Finalización primaria (Actual)

1 de noviembre de 2011

Finalización del estudio (Actual)

1 de noviembre de 2011

Fechas de registro del estudio

Enviado por primera vez

29 de abril de 2011

Primero enviado que cumplió con los criterios de control de calidad

2 de mayo de 2011

Publicado por primera vez (Estimar)

4 de mayo de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de marzo de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

18 de febrero de 2021

Última verificación

1 de febrero de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • 40069

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