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Impact of a Behavioral Tele-health Program on the Quality of Recovery for Patients Undergoing Total Joint Replacement Surgery

4 de mayo de 2022 actualizado por: Lucid Lane, Inc

Impact of Daily, Digital and Behavioral Tele-health Tapering Program for Perioperative Surgical Patients Exposed to Opioids.

The quality of recovery after surgery is multi-factorial and includes both physical and mental factors. Persistent pain after surgery is a common problem after major surgery and can result in persistent opioid use. The investigators will be evaluating if the addition of a pain coach/councilor before and after surgery, through a tele health platform (LucidLane) can improve participant's recovery from major joint surgery.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

103

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

  • Estados Unidos
    • California
      • Palo Alto, California, Estados Unidos, 94304
        • Reclutamiento
        • Palo Alto Division - VA Palo Alto Health Care System
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Kyle T Harrison, MD

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

21 años a 90 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Male or female patients between the ages of 21-90 years old
  • Patient is opioid naive i.e hasn't used opioid medication for 30 days prior to surgery
  • Patient willing to use Lucid Lane program to provide behavioral health support for up to 4 weeks before surgery and 4 weeks after surgery.
  • Patient is willing to discuss Lucid Lane progress with Palo Alto VA's medical team and prescribing clinicians.
  • Patient is willing to sign a Lucid Lane Client Agreement.
  • Patient is willing to sign an informed consent form

Exclusion Criteria:

  • Serious mental illnesses including schizophrenia-spectrum disorders, severe bipolar disorder, and severe major depression.
  • Active suicidal ideations
  • Patient is on methadone or buprenorphine for treatment of opioid use disorder(i.e. for treatment of addiction, and not for treatment of pain)
  • Patient unwilling to use or not possessing access to a device that allows for video visits(e.g. a smart phone, tablet, or computer)
  • Patients who are in palliative care
  • Unable to use English to participate in the consent process, the intervention or study assessments.
  • Unable to provide informed consent to participate

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: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Treatment

Patients participate in the Lucid Lane therapy program including working with a mental health pain coach for up to 4 weeks before surgery and 4 weeks after surgery.

All patients receive therapy provided by Lucid Lane, for 4 weeks after surgery
Conductual: Lucid Lane Therapy Program
This intervention is designed to aid participants with pre-surgery anxiety management and surgery prep and pain management post-surgery. Participants will be assigned a Lucid Lane pain coach who will utilize mindfulness, cognitive behavioral therapy, group therapy, and mind-body therapies, to accomplish those goals.
Comparador activo: Control

Patients will participate in a a surgery preparedness course provided by the VA before surgery (Standard of Care) and Lucid Lane therapy after surgery

All patients receive therapy provided by Lucid Lane, for 4 weeks after surgery
Conductual: Lucid Lane Therapy Program
This intervention is designed to aid participants with pre-surgery anxiety management and surgery prep and pain management post-surgery. Participants will be assigned a Lucid Lane pain coach who will utilize mindfulness, cognitive behavioral therapy, group therapy, and mind-body therapies, to accomplish those goals.
Conductual: Surgical Preparedness Course
This intervention is designed to help the participant prepare for their upcoming surgery. Classes will include discussions around managing chronic pain before surgery, building mental resilience, dealing with the uncertainty of a new diagnosis or treatment plan, questions to ask their anesthesiologist before and on the day of surgery, what to expect during their potential stay at the hospital, and how to optimize their recovery after surgery. Sessions will often include expert doctors who focus on surgery and medical management around it.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) or Hip Injury and Osteoarthritis Outcome Score (HOOS) and
Periodo de tiempo: Up to 4 months
The KOOS and HOOS are questionnaires designed to assess short and long-term patient-relevant outcomes following knee/hip injury. They are self-administered and assess five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee/hip-related quality of life. The scores are normalized on a scale of 0 to 100, where 0 indicates severe problems and 100 indicates no problems.
Up to 4 months
Change in Pain Catastrophizing scale
Periodo de tiempo: Up to 4 months
The Pain catastrophizing scale (PCS) is a self administered, 13-item questionnaire, used to assess a patient's tendency to magnify the threat value of a pain stimulus. It assess rumination, magnification and helplessness. Responses are recorded on a scale of 0-4, where 0 represents absence of the thought and 4 represents the presence of the thought all the time. The scale has a min score of 0 and a max score of 52. A higher score indicates more pain catastrophizing .
Up to 4 months
Change in Depression Scores
Periodo de tiempo: Up to 4 months
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self administered questionnaire used to screen and monitor the severity of depressive symptoms. It inquires about depressive features, that align with the diagnostic and statistical manual of mental disorders, over the course of 2 weeks. Responses are recorded on a scale of 0-3, where 0 represents absence of the symptom and 3 represents its presence nearly every day.
Up to 4 months
Change in Anxiety Scores
Periodo de tiempo: Up to 4 months
The General Anxiety Disorder-7 (GAD-7) is a self administered, 7-item questionnaire used to measure general anxiety disorder and its severity. Responses are recorded on a scale of 0-3, where 0 represents an absence of the symptom and 3 represents presence nearly every day.
Up to 4 months

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Percent tapered off opioid (50% MME)
Periodo de tiempo: 4 weeks after surgery
4 weeks after surgery

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Lucid Lane, Inc

Colaboradores

Stanford University
VA Palo Alto Health Care System

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)

4 de mayo de 2021

Finalización primaria (Anticipado)

1 de abril de 2023

Finalización del estudio (Anticipado)

1 de abril de 2023

Fechas de registro del estudio

Enviado por primera vez

22 de abril de 2022

Primero enviado que cumplió con los criterios de control de calidad

4 de mayo de 2022

Publicado por primera vez (Actual)

10 de mayo de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de mayo de 2022

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

4 de mayo de 2022

Última verificación

1 de mayo de 2022

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 56984

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

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. .

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