Motivational Interview Intervention to Help Patients Formulate Their Goals for Medical Care in the Emergency Department
11 de enero de 2022 actualizado por: Kei Ouchi, Brigham and Women's Hospital
A Pilot Study to Test the Acceptability and Feasibility of Brief Motivational Interview Intervention to Help Patients Formulate Their Goals for Medical Care in the Emergency Department
Test the acceptability and feasibility of a brief motivational interview intervention to facilitate advance care planning (ACP) conversations for older adults with serious co-morbid illness being discharged from the emergency department (ED).
The investigators will interview the participants to understand their perception of the intervention and collect patient-reported outcomes data after leaving the ED.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study is designed to engage seriously ill older adults in conversations about their goals of care.
Our intervention is intended to help these patients understand the significance of ED visits in the course of their illnesses.
Tipo de estudio
Intervencionista
Inscripción (Actual)
75
Fase
- No aplica
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
-
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Brigham and Women's Hospital
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-
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
65 años y mayores (Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- ≥65 years of age
- English-speaking
- Capacity to consent
- AND ≥1 Serious illness (New York Heart Association stage 3 or 4 heart failure, oxygen-dependent chronic obstructive lung disease, chronic kidney disease on dialysis, and metastatic cancer.) OR determined by the emergency department provider that the patient has a high likelihood of death in the next 12 months ("I would not be surprised if this patient died in the next 12 months.").
Exclusion Criteria:
- Acute physical or emotional distress
- Determined by emergency department provider not to be appropriate
- Clearly documented goals for medical care already exists (e.g. medical order for life sustaining treatment - MOLST).
- Already enrolled in this study
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: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Intervention Arm
This is a single arm study with all enrolled patients receiving the same brief motivational interview intervention.
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A brief (<7minutes) interview by an emergency department clinician to empower patients to formulate and communicate their goals for medical care with patients' outpatient clinicians.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Patients Who Found the Intervention Acceptable and Provided Suggestions for Improvement
Periodo de tiempo: Immediately following the intervention in the emergency department.
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The investigator will measure quantitatively and qualitatively whether patients found this intervention acceptable and provided suggestions for its improvement.
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Immediately following the intervention in the emergency department.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Acceptability of the Intervention by Administering Clinicians.
Periodo de tiempo: Immediately following the intervention in the emergency department.
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The investigators will ask the emergency department clinicians who administered the intervention to report the intervention acceptability using a Likert scale survey.
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Immediately following the intervention in the emergency department.
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Patient's Quality of Life
Periodo de tiempo: At baseline (in-person) and 1 month after (over the phone) the intervention.
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The investigators will measure patient's quality of life using a validated survey measure (Quality of life at the end of life, QUAL-E, Steinhauser et al. 2004) at baseline and after the intervention.
QUAL-E consists of 25-items and measures 4 domains (symptom impact, relationship with the healthcare provider, preparation for the end of life, and life completion).
Each item is in a 5-point Likert scale ranging from (1 Not at all to 5 Completely), and lower scores indicate better outcomes for all domains except for the preparation for the end of life domain and life completion domain where higher scores indicate better outcomes.
The mean composite score is compared between baseline and 1 month after the intervention.
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At baseline (in-person) and 1 month after (over the phone) the intervention.
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Advance Care Planning Engagement Behavior
Periodo de tiempo: At baseline (in-person) and 1 month after (over the phone) the intervention.
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The investigators will measure patient's behaviors and actions for completing advance care planning using a validated survey measure (advance care planning engagement survey, Sudore et al 2017) at baseline and after the intervention.
The measure is a 4-item survey measuring actions and behaviors of advance care planning.
The additive composite score is calculated and ranges from 1 (least engagement) to 5 (most engagement).
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At baseline (in-person) and 1 month after (over the phone) the intervention.
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Patient Empowerment
Periodo de tiempo: At baseline (in-person) and 1 month after (over the phone) the intervention.
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The investigators will measure patient empowerment by using a validated survey measure (Patient Activation Measure, PAM™) at baseline and after the intervention.
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At baseline (in-person) and 1 month after (over the phone) the intervention.
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Patient Distress
Periodo de tiempo: Within 7 days after the intervention.
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The investigators will measure patient anxiety/distress regarding a particular event (in this case, our intervention) by using a validated survey measure (Impact of Event Scale - Revised, IES-R, Weiss 1996) within a week after the intervention. IES-R is a 22-item, 5-point Likert scale measure (ranging from 0 Not at all to 4 Extremely). Results consist of the mean rating for the total score and raw scores for three subscales: The Avoidance Scale, Intrusion Scale, and the Hyperarousal Scale. The scores give an indication of the level of impairment from post traumatic stress, where: 0 = No symptoms 1 = Few symptoms 2 = Moderate symptoms 3 = A High level of symptoms 4 = An Extremely high level of symptoms |
Within 7 days after the intervention.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Kei Ouchi, MD, MPH, Brigham and Women's Hospital
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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 agosto de 2017
Finalización primaria (Actual)
31 de mayo de 2019
Finalización del estudio (Actual)
31 de mayo de 2019
Fechas de registro del estudio
Enviado por primera vez
3 de julio de 2017
Primero enviado que cumplió con los criterios de control de calidad
3 de julio de 2017
Publicado por primera vez (Actual)
5 de julio de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de enero de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
11 de enero de 2022
Última verificación
1 de enero de 2022
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2016P002637
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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