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A Multicenter Research on the Effects of Substitution of Hospital Ward Care From Medical Doctors to Physician Assistants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01835444
Recruitment Status : Completed
First Posted : April 19, 2013
Last Update Posted : May 14, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:

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?

Condition or disease Intervention/treatment
Substitution of Care Other: PA/MD model

Study Design

Study Type : Observational
Actual Enrollment : 2382 participants
Time Perspective: Prospective
Official Title: Worthy Assistants: Does Substituting Hospital Ward Care From Medical Residents to Physician Assistants Result in Cost Savings?
Study Start Date : April 2013
Primary Completion Date : May 2015
Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
MD model
Hospital wards at which ward care is provided only by Medical Doctors (MDs)
PA/MD model
Hospital wards at which ward care is provided by both Physician Assistants (PAs) and Medical Doctors (MDs)
Other: PA/MD model
Intervention wards are hospital wards at which ward care is provided by both Physician Assistants (PAs) and Medical Doctors (MDs)

Outcome Measures

Primary Outcome Measures :
  1. Length of hospital stay [ Time Frame: Patients will be followed for the duration of hospital stay; an expected average of 6 days ]
    The difference between date of discharge and date of admission

Secondary Outcome Measures :
  1. Efficiency of care [ Time Frame: Patients will be followed from hospital admission till 1 month after discharge; an expected average of 1 month and 6 days ]
    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

  2. Quality of hospital ward care [ Time Frame: Patients will be followed from hospital admission till 1 month after discharge; an expected average of 1 month and 6 days ]
    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

  3. Patient quality of life [ Time Frame: 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 ]
    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

  4. Feasibility, barriers and facilitators [ Time Frame: 12 months ]
    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

  5. Care provider experiences [ Time Frame: 12 months ]

    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.

  6. Continuity of care [ Time Frame: 4 months ]
    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

  7. Patient experiences with hospital ward care [ Time Frame: 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 ]
    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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital Ward Care: all patients (age 18 years or older) admitted to a hospital ward will be included in the study.

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01835444

Scheper Ziekenhuis
Emmen, Drenthe, Netherlands
Tjongerschans ziekenhuis
Heerenveen, Friesland, Netherlands, 8441 PW
Gelre Ziekenhuizen
Apeldoorn, Gelderland, Netherlands
Arnhem, Gelderland, Netherlands, 6800 TA
Slingeland Ziekenhuis
Doetinchem, Gelderland, Netherlands
Ziekenhuis de Gelderse Vallei
Ede, Gelderland, Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500HB
Canisius Wilhelmina ziekenhuis
Nijmegen, Gelderland, Netherlands, 6532 SZ
Streekziekenhuis Koningin Beatrix
Winterswijk, Gelderland, Netherlands
Laurentius Ziekenhuis
Roermond, Limburg, Netherlands, 6043 CV
Laurentius Ziekenhuis
Roermond, Limburg, Netherlands
Orbis Medisch Centrum
Sittard, Limburg, Netherlands
VieCuri Medical Center
Venlo, Limburg, Netherlands, 5912 BL
Lievensberg Ziekenhuis
Bergen op Zoom, Noord-Brabant, Netherlands, 4624 VT
Jeroen Bosch Ziekenhuis
Den Bosch, Noord-Brabant, Netherlands
Elkerliek ziekenhuis
Helmond, Noord-Brabant, Netherlands
Fransiscus Ziekenhuis
Roosendaal, Noord-Brabant, Netherlands, 4708 AE
St. Elisabeth Ziekenhuis
Tilburg, Noord-Brabant, Netherlands
TweeSteden Ziekenhuis
Tilburg, Noord-Brabant, Netherlands
Van Weel Bethesda Ziekenhuis
Dirksland, Zeeland, Netherlands
Reinier de Graaf Gasthuis
Delft, Zuid-Holland, Netherlands
Den Haag, Zuid-Holland, Netherlands
Medisch Centrum Haaglanden
Den Haag, Zuid-Holland, Netherlands
UMC Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Principal Investigator: M.G.H. Laurant, PhD IQ healthcare, UMC St Radboud