Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Determining the Impact of a New Physiotherapist Led Primary Care Model for Back Pain

21 de marzo de 2019 actualizado por: Jordan Miller, PT, PhD, Queen's University

Determining the Impact of a New Physiotherapist Led Primary Care Model for Back Pain: A Pilot Cluster Randomized Controlled Trial

This is a pilot cluster randomized controlled trial to determine the feasibility of a cluster randomized trial to evaluate the individual and health system impact of implementing a new physiotherapist-led primary care model for back pain in Canada.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

This study aims to determine the feasibility of conducting a cluster randomized trial in primary care settings in Ontario to evaluate the individual health outcomes and health system impact of implementing a new physiotherapist-led primary care model for people with back pain. The primary purpose of this pilot study is to determine the feasibility including recruitment and retention of primary care teams (sites) and patient participants, carrying out the assessment procedures, and implementing the physiotherapist-led primary care intervention including training the physiotherapist to adopt this role.

Tipo de estudio

Intervencionista

Inscripción (Actual)

100

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

  • Canadá
    • Ontario
      • Kingston, Ontario, Canadá, K7L 3N6
        • Queen's University

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:

  • Adults (18 years and over) with back pain of any duration
  • Seeking primary care for back pain at a participating site
  • Primary care visit may be a first or repeat visit

Exclusion Criteria:

  • Patients who do not consent to participation
  • Patients who report being unable to understand, read, and write English

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: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Modelo de atención primaria dirigido por fisioterapeutas para el dolor de espalda
El modelo de atención primaria para el dolor de espalda liderado por PT implicará la incorporación de un PT dentro del equipo de atención primaria en el primer punto de contacto para las personas con dolor de espalda sin costo para el paciente. Los pacientes en este modelo tendrán la opción de ver al fisioterapeuta o al médico de familia. Se les alentará a reservar con el fisioterapeuta, excepto cuando el motivo principal de la visita sea la renovación de medicamentos o cuando el paciente tenga problemas de salud adicionales que requieran la atención de su médico en la misma visita. Habrá 4 componentes clave de la intervención de atención primaria dirigida por PT: 1) evaluación inicial y detección; 2) Intervención breve individualizada en la primera visita; 3) Navegación de servicios de salud; 4) Brindar atención adicional de fisioterapia a personas con una necesidad insatisfecha.
Conductual: Physiotherapist-led primary care model for back pain
  1. Assessment and screening: taking a history; screening for red flags, comorbidities, and risk factors of ongoing pain and disability; physical examination
  2. Brief individualized intervention at the first visit: effective communication, cognitive reassurance, a few exercises, and advice/strategies to stay active.
  3. Health services navigation: PT assistance with navigating healthcare services based on the assessment findings. First, red-flags requiring emergency or urgent referrals. Next, comorbid conditions that would benefit from care from other healthcare providers. Finally, referral to PT (if appropriate).
  4. Providing additional physiotherapy care to people with an unmet need: Additional physiotherapy care will be provided to patients who have an identified need for physiotherapy but no physiotherapy coverage through private or government health insurance plans.
Comparador activo: Usual care
The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada. This usually includes a visit to a primary care physician, who would perform a history and physical examination, provide LBP education, and prescribe medications and/or refer based on their assessment findings and patient preferences.
Otro: Usual care
The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Recruitment of primary care teams
Periodo de tiempo: Baseline
Ability to recruit four primary care teams (Family Health Teams or Community Health Centres) to paricipate
Baseline
Recruitment of patient participants
Periodo de tiempo: Baseline to 14 weeks
Recruitment rate (participants/week) or total number of participants recruited in 14 weeks
Baseline to 14 weeks
Assessment completion
Periodo de tiempo: Baseline, 6-week 12-week, 6,9,12 month follow-up. The primary time point for this assessment is 12-week follow-up.
Percentage of all assessment items completed by participants completing each assessment
Baseline, 6-week 12-week, 6,9,12 month follow-up. The primary time point for this assessment is 12-week follow-up.
Retention of patient participants
Periodo de tiempo: Retention of participants at 6-week, 12-week, 6, 9, and 12-month follow-up assessments. The primary timeline for this outcome is 12-month follow-up.
Attrition rate
Retention of participants at 6-week, 12-week, 6, 9, and 12-month follow-up assessments. The primary timeline for this outcome is 12-month follow-up.
Physiotherapist confidence in carrying out the interventions
Periodo de tiempo: Baseline
The PT will rate his/her confidence in each component of the intervention after the training on a scale from 0-10 with higher scores indicating greater confidence in carrying out that component of the intervention.
Baseline
Treatment fidelity
Periodo de tiempo: 6-week follow-up
Treatment fidelity will be measured by consistency with the intervention described in the protocol measured through an intervention checklist completed by the physiotherapist and an audit of the EMR notes.
6-week follow-up

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Self-reported disability
Periodo de tiempo: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measured using the Roland Morris Disability Questionnaire (0 to 24 with higher scores indicating greater disability)
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Self-reported pain intensity
Periodo de tiempo: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measured using a numeric pain rating scale from 0 to 10 with higher scores indicating greater pain intensity (measured at rest, during walking, and during a lifting task)
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Health Related Quality of Life
Periodo de tiempo: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measured using the EuroQoL-5D-5L (0 to 100 with greater scores indicating greater self-reported health related quality of life)
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Global rating of change
Periodo de tiempo: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measured using an 11-point scale (-5 to +5 with negative scores indicating a worsening of physical functioning related to back pain and positive scores indicating an improvement of physical functioning related to back pain)
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Satisfaction with health care
Periodo de tiempo: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measured using an 11-point scale(-5 to +5 with negative scores indicating a dissatisfaction with health care received and positive scores indicating satisfaction with health care received)
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Catastrophic Thinking
Periodo de tiempo: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measured using the Pain Catastrophizing Scale (0 to 52 with higher scores indicating greater catastrophic thinking)
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Depressive symptoms
Periodo de tiempo: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measured using the 9-item Patient Health Questionnaire (PHQ-9) (0 to 27 with greater scores indicating increased depressive symptoms)
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Adverse events
Periodo de tiempo: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measured using an adverse events questionnaire that asks 1) if the patient has experienced any adverse events as a result of the treatments received (yes/no); 2) how long the event lasted (hours or days); 3) how severe the adverse event was (0-10 scale); 4) what adverse events were experienced.
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Health care accessibility
Periodo de tiempo: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Percentage of patients receiving care within 48 hours.
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Health care accessibility
Periodo de tiempo: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Percentage of patients who score medium or high risk on the STarT Back tool who receive physiotherapy care.
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Health care utilization
Periodo de tiempo: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
All health care visits (aggregated and dis-aggregated) including: primary care visits, emergency department visits, hospitalizations, surgeries, consultations with other health care providers, diagnostic imaging, medications, and other care received by the patient
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Costs (piloted for a cost utility analysis in a future trial)
Periodo de tiempo: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Includes all health care costs plus societal costs using a human capital approach for loss of productivity
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Medications prescribed
Periodo de tiempo: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Measured as a process outcome
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Diagnostic imaging ordered
Periodo de tiempo: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Measured as a process outcome
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
referrals to other health care providers made
Periodo de tiempo: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Measured as a process outcome
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
notes made by primary care provider to employers or insurers
Periodo de tiempo: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Measured as a process outcome
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up

Colaboradores e Investigadores

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

Patrocinador

Queen's University

Colaboradores

Canadian Institutes of Health Research (CIHR)

Investigadores

  • Investigador principal: Jordan Miller, PhD, Queen's University

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.

Publicaciones Generales

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)

20 de septiembre de 2017

Finalización primaria (Actual)

15 de enero de 2019

Finalización del estudio (Actual)

15 de enero de 2019

Fechas de registro del estudio

Enviado por primera vez

16 de octubre de 2017

Primero enviado que cumplió con los criterios de control de calidad

24 de octubre de 2017

Publicado por primera vez (Actual)

25 de octubre de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de marzo de 2019

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

21 de marzo de 2019

Última verificación

1 de marzo de 2019

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 6021536

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

There is no plan to share individual participant data from this pilot study. This data will be used to inform the protocol for a fully powered cluster randomized trial.

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. .

Ensayos clínicos sobre Dolor de espalda

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

CROs by country

CROs in China

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones

Suscribir