- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01835444
A Multicenter Research on the Effects of Substitution of Hospital Ward Care From Medical Doctors to Physician Assistants
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?
Aperçu de l'étude
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Utrecht, Pays-Bas
- UMC Utrecht
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Drenthe
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Emmen, Drenthe, Pays-Bas
- Scheper Ziekenhuis
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Friesland
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Heerenveen, Friesland, Pays-Bas, 8441 PW
- Tjongerschans Ziekenhuis
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Gelderland
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Apeldoorn, Gelderland, Pays-Bas
- Gelre Ziekenhuizen
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Arnhem, Gelderland, Pays-Bas, 6800 TA
- Rijnstate
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Doetinchem, Gelderland, Pays-Bas
- Slingeland Ziekenhuis
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Ede, Gelderland, Pays-Bas
- Ziekenhuis de Gelderse Vallei
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Nijmegen, Gelderland, Pays-Bas, 6500HB
- Radboud University Nijmegen Medical Centre
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Nijmegen, Gelderland, Pays-Bas, 6532 SZ
- Canisius Wilhelmina Ziekenhuis
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Winterswijk, Gelderland, Pays-Bas
- Streekziekenhuis Koningin Beatrix
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Limburg
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Roermond, Limburg, Pays-Bas, 6043 CV
- Laurentius ziekenhuis
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Roermond, Limburg, Pays-Bas
- Laurentius ziekenhuis
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Sittard, Limburg, Pays-Bas
- Orbis Medisch Centrum
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Venlo, Limburg, Pays-Bas, 5912 BL
- VieCuri Medical Center
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Noord-Brabant
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Bergen op Zoom, Noord-Brabant, Pays-Bas, 4624 VT
- Lievensberg ziekenhuis
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Den Bosch, Noord-Brabant, Pays-Bas
- Jeroen Bosch Ziekenhuis
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Helmond, Noord-Brabant, Pays-Bas
- Elkerliek Ziekenhuis
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Roosendaal, Noord-Brabant, Pays-Bas, 4708 AE
- Fransiscus Ziekenhuis
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Tilburg, Noord-Brabant, Pays-Bas
- St. Elisabeth Ziekenhuis
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Tilburg, Noord-Brabant, Pays-Bas
- TweeSteden Ziekenhuis
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Zeeland
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Dirksland, Zeeland, Pays-Bas
- Van Weel Bethesda Ziekenhuis
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Zuid-Holland
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Delft, Zuid-Holland, Pays-Bas
- Reinier de Graaf Gasthuis
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Den Haag, Zuid-Holland, Pays-Bas
- HagaZiekenhuis
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Den Haag, Zuid-Holland, Pays-Bas
- Medisch Centrum Haaglanden
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Length of hospital stay
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Efficiency of care
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: M.G.H. Laurant, PhD, IQ healthcare, UMC St Radboud
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 80-82310-97-12094
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