Integrating Patient Reported Outcomes (I-PRO) Study for Multidisciplinary Pain Care (I-PRO)
29 de marzo de 2016 actualizado por: University of Florida
An Integrative and Sustainable Approach to Pain Management in Primary Care
The purpose of this study is to assess the impact of clinician education, electronic health record integrated patient reported outcomes, and electronic health record integrated decision support on pain-related care quality, outcomes, and service utilization.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The initiative has three components to aid clinicians' care of patients with chronic noncancer pain: (1) education, (2) standardized patient reported outcomes data collection, and (3) evidence-based brief treatment reminders. Practices will be randomized to either receive the three novel components (treatment group) or continue with usual care (control group).
Providers in the treatment group will be asked (a) to complete a series of six online education modules in pain care, (b) will be given access to new patient reported outcomes questionnaire data collected from patients within the electronic health record, (c) asked to review this data and related care recommendations during the patient visit, and (d) asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
Providers in the control group will provide care as usual to patients and will be asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
Primary study outcomes include comparison of treatment and control group provider and patient satisfaction surveys. Secondary outcome measures include provider referral rates, patient outcomes, patient treatments recommended/ordered, and patient service utilization/costs.
Tipo de estudio
Intervencionista
Inscripción (Actual)
21
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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Florida
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Gainesville, Florida, Estados Unidos, 32607
- Family Medicine at Hampton Oaks
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Gainesville, Florida, Estados Unidos, 32608
- Family Medicine at Haile Plantation
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Gainesville, Florida, Estados Unidos, 32641
- Eastside Community Practice
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Gainesville, Florida, Estados Unidos, 32669
- Family Medicine at Jonesville
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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
18 años a 89 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Providers at one of six active Community Health and Family Medicine locations in the University of Florida Health system Gainesville service area (Hampton Oaks, Eastside, Jonesville, and Haile) between May 1, 2014 and September 1, 2015
- Doctor of Medicine (MD), Doctor of Osteopathic Medicine (DO), Advanced Registered Nurse Practitioner (ARNP), Physician Assistant (PA) or other faculty professional providing primary care services
Exclusion Criteria:
- Residents or other trainees at one of four active Community Health and Family Medicine locations in the University of Florida Health system Gainesville service area (Hampton Oaks, Eastside, Jonesville, and Haile) between May 1, 2014 and September 1, 2015
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 paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Providers of Novel Care
Providers in the treatment group will be asked (1) to complete a series of six online education modules in pain care, (2) will be given access to new patient reported outcomes questionnaire data collected from patients within the electronic health record, (3) asked to review this data and related care recommendations during the patient visit, and (4) asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
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Providers in the treatment group will be asked (1) to complete a series of six online education modules in pain care, (2) will be given access to new patient reported outcomes questionnaire data collected from patients within the electronic health record, (3) asked to review this data and related care recommendations during the patient visit, and (4) asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
|
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Comparador falso: Providers of Usual Care
Providers in the control group will provide care as usual to patients and will be asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
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Providers in the control group will provide care as usual to patients and will be asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Provider Satisfaction Survey
Periodo de tiempo: Up to 15 months
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This is a 16 item web based questionnaire about general experiences and satisfaction with providing care to patients with chronic noncancer pain.
Data will be collected at baseline (June 2014) and monthly thereafter through the end of the study period (July 2014 - September 2015).
Provider satisfaction data for both the treatment and control groups will be compared.
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Up to 15 months
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Patient Satisfaction Survey
Periodo de tiempo: Up to 15 months
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This is a four to five question phone survey (depending on whether patient is seeing a provider in a treatment or control group) about general and pain-specific satisfaction with visit.
Data will be collected after each visit for chronic noncancer pain through the study period (July 2014 - September 2015).
Patient satisfaction data for both the treatment and control groups will be compared.
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Up to 15 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Hospital Readmission Rates
Periodo de tiempo: Up to 5 years
|
The data will be collected retrospectively for a history of hospital readmission rates (June 2011 - June 2014).
Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends.
Data for both the treatment and control groups will be compared.
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Up to 5 years
|
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Lab Orders and Results
Periodo de tiempo: Up to 5 years
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The data will be collected retrospectively for a history of lab orders and results (June 2011 - June 2014).
Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends.
Data will be
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Up to 5 years
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Prescribed and Dispensed Medications
Periodo de tiempo: Up to 5 years
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The data will be collected retrospectively for a history of prescribed and dispensed medications (June 2011 - June 2015).
Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends.
Data for both the treatment and control groups will be compared.
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Up to 5 years
|
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Pain Intensity
Periodo de tiempo: Up to 5 years
|
The data will be collected retrospectively for a history of pain intensity (June 2011 - June 2014).
Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends.
Data for both the treatment and control groups will be compared.
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Up to 5 years
|
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Medical Costs
Periodo de tiempo: Up to 5 years
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The data will be collected retrospectively for a history of medical costs (June 2011 - June 2014).
Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends.This will include cost of pain related care for charge amounts and billed amounts for specialist services, hospital services, and utilization of non-physician services (e.g., pharmacy, physical therapy, etc.).
Data for both the treatment and control groups will be compared.
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Up to 5 years
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Health Care Utilization
Periodo de tiempo: Up to 5 years
|
The data will be collected retrospectively for a history of health care utilization (June 2011 - June 2014).
Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends.
This will include utilization of specialist services, hospital services, and utilization of non-physician services (e.g., pharmacy, physical therapy, etc.).
Data for both the treatment and control groups will be compared.
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Up to 5 years
|
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Pain Specialist Referral Rates
Periodo de tiempo: Up to 5 years
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The data will be collected retrospectively for a history of pain specialist referral rates (June 2011 - June 2014).
Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends.
Data for both the treatment and control groups will be compared.
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Up to 5 years
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Christopher A Harle, PhD, University of Florida
- Investigador principal: Robert W Hurley, MD, PhD, University of Florida
- Investigador principal: Nicole Marlow, PhD, University of Florida
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
1 de julio de 2014
Finalización primaria (Actual)
1 de marzo de 2016
Finalización del estudio (Actual)
1 de marzo de 2016
Fechas de registro del estudio
Enviado por primera vez
7 de julio de 2014
Primero enviado que cumplió con los criterios de control de calidad
9 de julio de 2014
Publicado por primera vez (Estimar)
11 de julio de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
30 de marzo de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
29 de marzo de 2016
Última verificación
1 de marzo de 2016
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- IRB201300433
- 8578749 (Otro número de subvención/financiamiento: Pfizer, Inc.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
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. .