A Multicenter Research on the Effects of Substitution of Hospital Ward Care From Medical Doctors to Physician Assistants
13 de mayo de 2015 actualizado por: Radboud University Medical Center
Worthy Assistants: Does Substituting Hospital Ward Care From Medical Residents to Physician Assistants Result in Cost Savings?
Reallocation of healthcare is one solution to the problems healthcare is facing. In the Netherlands reallocation of care to Physician Assistants (PAs) hasn't adequately been studied. Given the growing number of PAs, it is essential to evaluate the effectiveness and efficacy of (Dutch) PA services.
This multicenter matched-controlled study aims to evaluate the (cost) effectiveness of substitution of hospital ward care from medical doctors (MDs) to PAs. The traditional model in which the role of house officer is taken by medical doctors MD model) will be compared with a mixed model in which a PA functions as house officer together with a medical doctor (PA/MD model). Hospital wards will be matched on medical specialism and hospital type (i.e. academic;non-academic). On the basis of USA studies, it is hypothesized that the mixed PA/MD model compared to the MD model reduces the costs of healthcare, while improving or maintaining the clinical outcomes, patients and provider satisfaction, and continuity and quality of care.
Primary research question:
• What is the effect of 'mixed PA/MD model' compared with 'MD model' on efficiency of care?
Secondary research questions:
- What is the effect of 'mixed PA/MD model' compared with 'MD model' on clinical and patients outcomes?
- What is the effect of 'mixed PA/MD model' compared with 'MD model' on continuity of care?
- What is the effect of 'mixed PA/MD model' compared with 'MD model' on nurses and (specialist) medicals doctor experiences?
- What are the barriers and facilitating factors considering the implementation of PAs as house officer?
Descripción general del estudio
Tipo de estudio
De observación
Inscripción (Actual)
2382
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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Utrecht, Países Bajos
- UMC Utrecht
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Drenthe
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Emmen, Drenthe, Países Bajos
- Scheper Ziekenhuis
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Friesland
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Heerenveen, Friesland, Países Bajos, 8441 PW
- Tjongerschans Ziekenhuis
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Gelderland
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Apeldoorn, Gelderland, Países Bajos
- Gelre Ziekenhuizen
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Arnhem, Gelderland, Países Bajos, 6800 TA
- Rijnstate
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Doetinchem, Gelderland, Países Bajos
- Slingeland Ziekenhuis
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Ede, Gelderland, Países Bajos
- Ziekenhuis de Gelderse Vallei
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Nijmegen, Gelderland, Países Bajos, 6500HB
- Radboud University Nijmegen Medical Centre
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Nijmegen, Gelderland, Países Bajos, 6532 SZ
- Canisius Wilhelmina Ziekenhuis
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Winterswijk, Gelderland, Países Bajos
- Streekziekenhuis Koningin Beatrix
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Limburg
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Roermond, Limburg, Países Bajos, 6043 CV
- Laurentius ziekenhuis
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Roermond, Limburg, Países Bajos
- Laurentius ziekenhuis
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Sittard, Limburg, Países Bajos
- Orbis Medisch Centrum
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Venlo, Limburg, Países Bajos, 5912 BL
- VieCuri Medical Center
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Noord-Brabant
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Bergen op Zoom, Noord-Brabant, Países Bajos, 4624 VT
- Lievensberg ziekenhuis
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Den Bosch, Noord-Brabant, Países Bajos
- Jeroen Bosch Ziekenhuis
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Helmond, Noord-Brabant, Países Bajos
- Elkerliek Ziekenhuis
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Roosendaal, Noord-Brabant, Países Bajos, 4708 AE
- Fransiscus Ziekenhuis
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Tilburg, Noord-Brabant, Países Bajos
- St. Elisabeth Ziekenhuis
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Tilburg, Noord-Brabant, Países Bajos
- TweeSteden Ziekenhuis
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Zeeland
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Dirksland, Zeeland, Países Bajos
- Van Weel Bethesda Ziekenhuis
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Zuid-Holland
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Delft, Zuid-Holland, Países Bajos
- Reinier de Graaf Gasthuis
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Den Haag, Zuid-Holland, Países Bajos
- HagaZiekenhuis
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Den Haag, Zuid-Holland, Países Bajos
- Medisch Centrum Haaglanden
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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 y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Hospital Ward Care: all patients (age 18 years or older) admitted to a hospital ward will be included in the study.
Descripción
Inclusion criteria:
• Wards using a mixed PA/physician model (with PA ward coverage of at least 50% of the available ward hours per week, during dayshifts on weekdays) or a physician model (daily coverage by a (specialized medical doctor)
Exclusion criteria on ward level:
- Wards from specialty hospitals
- Wards with only PAs in training
- Wards with a nurse practitioner (NP) in the role of house officer (NP, NP/MD or PA/NP/MD model)
- Pediatric and psychiatric wards, intensive care units
Exclusion criteria on patient level:
- Terminal patients
- Not fluent in Dutch language
- Age < 18 years
- Patients in daycare
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
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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MD model
Hospital wards at which ward care is provided only by Medical Doctors (MDs)
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PA/MD model
Hospital wards at which ward care is provided by both Physician Assistants (PAs) and Medical Doctors (MDs)
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Intervention wards are hospital wards at which ward care is provided by both Physician Assistants (PAs) and Medical Doctors (MDs)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Length of hospital stay
Periodo de tiempo: Patients will be followed for the duration of hospital stay; an expected average of 6 days
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The difference between date of discharge and date of admission
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Patients will be followed for the duration of hospital stay; an expected average of 6 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Efficiency of care
Periodo de tiempo: Patients will be followed from hospital admission till 1 month after discharge; an expected average of 1 month and 6 days
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Relevant costs associated with the principal admission (length of hospital stay, resource use, consultation of health care suppliers, salaries) and costs that occurred after discharge (unplanned readmission, presentation at emergency departments, visits of general practitioner, required home care) will be calculated, considering a follow-up period from admission until 1 month after discharge.
All volumes will be collected in detail at an individual patient level, primarily from medical patient records and patient and care provider questionnaires.
Medical costs will be calculated by multiplying the volumes of healthcare use with corresponding unit prices, derived from the Dutch Manual for Costing Research
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Patients will be followed from hospital admission till 1 month after discharge; an expected average of 1 month and 6 days
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Quality of hospital ward care
Periodo de tiempo: Patients will be followed from hospital admission till 1 month after discharge; an expected average of 1 month and 6 days
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To estimate the quality of ward care, a set of objective indicators has been developed through literature review and clinical input from a physician panel.
We have selected both clinical indicators and process indicators, with a follow-up period of maximum 1 month after discharge.
Clinical indicators were based on the national set of indicators for quality of hospital care from the Dutch Health Care Inspectorate (IGZ) and consider the incidences of inhospital mortality, cardiopulmonary resuscitation, unplanned readmission, presentation at emergency department after discharge,unplanned transfer to Intensive Care Unit, development of hospital infections, pressure sore and fever, and pain scores .
Process indicators are the number of days between a patients discharge and the date of written turnover to general practitioner or other hospital, and acquaintance with the patient within 24 hours after admission
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Patients will be followed from hospital admission till 1 month after discharge; an expected average of 1 month and 6 days
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Patient quality of life
Periodo de tiempo: Patients will be followed from hospital admission till 1 month after discharge; an expected average of 1 month and 6 days. Measurements of quality of life will be performed at hospital admission, hospital discharge and 1 month after discharge
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Patient experienced quality of life will be measured by the EQ-5D questionnaire.
This questionnaire will be distributed at hospital admission, hospital discharge, and 1 month after discharge
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Patients will be followed from hospital admission till 1 month after discharge; an expected average of 1 month and 6 days. Measurements of quality of life will be performed at hospital admission, hospital discharge and 1 month after discharge
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Feasibility, barriers and facilitators
Periodo de tiempo: 12 months
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Semi-structured (group)interviews will be held with PAs, (specialized) medical doctors, ward nurses and heads of the departments.
The interviews will cover experiences with the utilized ward model, communication between professionals, satisfaction, and barriers and facilitators related to the utilization of the 'mixed PA/MD model'.
Specific attention will be paid to the role and functioning of PAs
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12 months
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Care provider experiences
Periodo de tiempo: 12 months
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Job satisfaction, subjective workload and stress reaction of PAs, (specialized) medical doctors and ward nurses will be measured by a self-administered questionnaire. Job satisfaction will be measured by an adapted version of the job satisfaction questionnaire of McCranie, stress reaction will be measured by a short version of the General Health Questionnaire (GHQ-12) Objective workload will be measured by calculating the ratio between number of working hours at the hospital ward, and the number of patients the PA or medical doctor is responsible for. |
12 months
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Continuity of care
Periodo de tiempo: 4 months
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Continuity of care will be measured by deriving the number of rotations of PAs and medical doctors at the hospital ward from work schedules, which will be assessed during 4 weeks, spread over 4 months
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4 months
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Patient experiences with hospital ward care
Periodo de tiempo: Patients will be followed for the duration of hospital stay; an expected average of 6 days. Measurement of patient experiences will be performed at discharge
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Patient experiences with medical ward care will be assessed by a self-administered questionnaire at discharge.
This questionnaire focuses on satisfaction with communication, experienced continuity of care and cooperation, and the patients view on the medical competencies of the ward care provider
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Patients will be followed for the duration of hospital stay; an expected average of 6 days. Measurement of patient experiences will be performed at discharge
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: M.G.H. Laurant, PhD, IQ healthcare, UMC St Radboud
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
- Timmermans MJC, van Vught AJAH, Peters YAS, Meermans G, Peute JGM, Postma CT, Smit PC, Verdaasdonk E, de Vries Reilingh TS, Wensing M, Laurant MGH. The impact of the implementation of physician assistants in inpatient care: A multicenter matched-controlled study. PLoS One. 2017 Aug 9;12(8):e0178212. doi: 10.1371/journal.pone.0178212. eCollection 2017.
- Timmermans MJC, van den Brink GT, van Vught AJAH, Adang E, van Berlo CLH, Boxtel KV, Braunius WW, Janssen L, Venema A, van den Wildenberg FJ, Wensing M, Laurant MGH. The involvement of physician assistants in inpatient care in hospitals in the Netherlands: a cost-effectiveness analysis. BMJ Open. 2017 Jul 10;7(7):e016405. doi: 10.1136/bmjopen-2017-016405.
- Timmermans MJ, van Vught AJ, Van den Berg M, Ponfoort ED, Riemens F, van Unen J, Wobbes T, Wensing M, Laurant MG. Physician assistants in medical ward care: a descriptive study of the situation in the Netherlands. J Eval Clin Pract. 2016 Jun;22(3):395-402. doi: 10.1111/jep.12499. Epub 2015 Dec 23.
- Timmermans MJ, van Vught AJ, Wensing M, Laurant MG. The effectiveness of substitution of hospital ward care from medical doctors to physician assistants: a study protocol. BMC Health Serv Res. 2014 Jan 28;14:43. doi: 10.1186/1472-6963-14-43. Erratum In: BMC Health Serv Res. 2016;16(1):115.
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 abril de 2013
Finalización primaria (Actual)
1 de mayo de 2015
Finalización del estudio (Actual)
1 de mayo de 2015
Fechas de registro del estudio
Enviado por primera vez
5 de abril de 2013
Primero enviado que cumplió con los criterios de control de calidad
18 de abril de 2013
Publicado por primera vez (Estimar)
19 de abril de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
14 de mayo de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
13 de mayo de 2015
Última verificación
1 de mayo de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 80-82310-97-12094
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. .