- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02417181
The (Cost-)Effectiveness of Physician Assistants Working at the Primary Out of Hours Emergency Service
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Out-of-hours care in the Netherlands is under pressure. Workload for general practitioners (GPs) during out-of-hours care is high and there are concerns about maintaining the quality of care. Since 80% of the complaints shown in out-of-hours care are low complex and not urgent, not all patients necessarily have to be seen by a physician. Shifting care from GPs to physician assistants (PAs) is considered to be a possible method to reduce workload while maintaining high quality and safety of care.
Previous research, on PAs in primary care during office hours, has shown PAs were found to be acceptable, effective and efficient in complementing the work of GPs.
We hypothesize that in a team of PAs and GPs working out-of-hours primary care, the PAs will deliver care to less urgent and complex complaints, deliver quality of care comparable to GPs and their implementation will lead to a reduction in cost of healthcare.
We compare care provided by a team of PAs and GPs with a team of only GPs. Within the team of PAs and GPs we make a comparison between the two healthcare professionals.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Emmen, Holanda, 7824 AA
- Centrale Huisartsendienst Drenthe
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Patients (with urgency U2, U3, U4, or U5) requesting an appointment at the primary out of hours emergency service during the weekend between 9.00 and 17.00 hours.
Exclusion criteria:
- None
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: General Practitioners Care
Usual medical care provided by a general practitioner at the out-of-hours primary care service
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Experimental: Physician Assistants Care
Medical care provided by the Physician Assistant at the out-of-hours primary care service
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Patients will receive care at the out-of-hours primary care service by a Physician Assistant instead of a General Practitioner (substitution of care from physicians to nurses).
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of patients
Prazo: 18 months
|
To measure substitution of healthcare, the number of consultations in the experimental and control group and per discipline will be measured.
These data will be derived from the electronic medical records.
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18 months
|
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Patient characteristics (composite)
Prazo: 18 months
|
Patient characteristics of patients seen in the experimental and control group and per discipline include age, gender, urgency and type of complaint.
These data will be derived from the electronic medical records.
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18 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The number of prescriptions; number of test & investigations ordered and referral to the emergency department
Prazo: 18 months
|
The performance of the two conditions as well as the disciplines will be measures by number of prescriptions; number of test & investigations ordered and referral to the emergency department.
These data will be derived from the electronic medical records.
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18 months
|
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Direct healthcare costs related to care provide by PAs and GPs will be calculated.
Prazo: 18 months
|
Costs related to care provided in the experimental and control group, and per discipline will be calculated, including number of consultations, resource use, referrals, and prescriptions.
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18 months
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Adherence to the practice guidelines for General Practitioners
Prazo: 6 months
|
Adherence of the PA to the practice guidelines for General Practitioners will be measured by video recordings of in total 30 consultations/visits of the PA.
Two independent General Practitioners will score the adherence by a list of indicators.
Outcomes will be compared by scores of GPs and Nurse Practitioners (measured in previous research).
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6 months
|
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Amount of adverse events and complications
Prazo: 18 months
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The amount of adverse events and complications will be recorded, as well as complaints by the patients.
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18 months
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Patient satisfaction questionaire
Prazo: 6 months
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Patient satisfaction will be measured using an abridgment of the CQ-index questionnaire.
During the intervention period 200 questionnaires will be sent to patients who had either a consult with the PA or with the GP at the out-of-hours primary care service.
Results will be compared with results on the CQ-index of the GP and NP (measured in previous research)
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6 months
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Knowledge test concerning frequently presented complaints
Prazo: 1 month
|
Knowledge of PAs will be measured with regard to a number of frequently presented complaints by using a knowledge test.
Results are compared with the results on the knowledge test of GPs and NPs (measured in previous research).
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1 month
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Colaboradores e Investigadores
Patrocinador
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PA_in_spoedzorg
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