- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02188667
Integrating Patient Reported Outcomes (I-PRO) Study for Multidisciplinary Pain Care (I-PRO)
An Integrative and Sustainable Approach to Pain Management in Primary Care
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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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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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: 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.
|
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.
|
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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Provider Satisfaction Survey
Prazo: Up to 15 months
|
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.
|
Up to 15 months
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Patient Satisfaction Survey
Prazo: Up to 15 months
|
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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Hospital Readmission Rates
Prazo: 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
|
Lab Orders and Results
Prazo: Up to 5 years
|
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
|
Prescribed and Dispensed Medications
Prazo: Up to 5 years
|
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.
|
Up to 5 years
|
Pain Intensity
Prazo: 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
|
Medical Costs
Prazo: Up to 5 years
|
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.
|
Up to 5 years
|
Health Care Utilization
Prazo: 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
|
Pain Specialist Referral Rates
Prazo: Up to 5 years
|
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.
|
Up to 5 years
|
Colaboradores e Investigadores
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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- IRB201300433
- 8578749 (Número de outro subsídio/financiamento: Pfizer, Inc.)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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