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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Radboud University
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01835444
First received: April 5, 2013
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

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 Intervention
Substitution of Care
Other: PA/MD model

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Worthy Assistants: Does Substituting Hospital Ward Care From Medical Residents to Physician Assistants Result in Cost Savings?

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Length of hospital stay [ Time Frame: Patients will be followed for the duration of hospital stay; an expected average of 6 days ] [ Designated as safety issue: No ]
    The difference between date of discharge and date of admission


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • Feasibility, barriers and facilitators [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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

  • Care provider experiences [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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.


  • Continuity of care [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 2550
Study Start Date: April 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01835444

Contacts
Contact: M.G.H. Laurant, PhD +31243614937 m.laurant@iq.umcn.nl

Locations
Netherlands
Scheper Ziekenhuis Recruiting
Emmen, Drenthe, Netherlands
Contact: Van den Berg, PhD    0031 591 691 911      
Sub-Investigator: Van den Berg, PhD         
Tjongerschans ziekenhuis Completed
Heerenveen, Friesland, Netherlands, 8441 PW
Gelre Ziekenhuizen Recruiting
Apeldoorn, Gelderland, Netherlands
Contact: A. Puntman, PhD    0031 55 581 8181      
Sub-Investigator: A. Puntman, MPA         
Rijnstate Completed
Arnhem, Gelderland, Netherlands, 6800 TA
Slingeland Ziekenhuis Completed
Doetinchem, Gelderland, Netherlands
Ziekenhuis de Gelderse Vallei Recruiting
Ede, Gelderland, Netherlands
Contact: E. Ponfoort, PhD    0031 318 434 343      
Sub-Investigator: E. Ponfoort, PhD         
Radboud University Nijmegen Medical Centre Not yet recruiting
Nijmegen, Gelderland, Netherlands, 6500HB
Contact: M. Laurant, PhD    0031 24 3615305    m.laurant@iq.umcn.nl   
Principal Investigator: M. Laurant, PhD         
Sub-Investigator: R. Takes, PhD         
Canisius Wilhelmina ziekenhuis Completed
Nijmegen, Gelderland, Netherlands, 6532 SZ
Streekziekenhuis Koningin Beatrix Completed
Winterswijk, Gelderland, Netherlands
Laurentius Ziekenhuis Completed
Roermond, Limburg, Netherlands
Laurentius Ziekenhuis Completed
Roermond, Limburg, Netherlands, 6043 CV
Orbis Medisch Centrum Recruiting
Sittard, Limburg, Netherlands
Contact: T. Hoofwijk, PhD    0031 88 459 7777      
Sub-Investigator: T. Hoofwijk, PhD         
VieCuri Medical Center Completed
Venlo, Limburg, Netherlands, 5912 BL
Lievensberg Ziekenhuis Recruiting
Bergen op Zoom, Noord-Brabant, Netherlands, 4624 VT
Contact: G. Meermans    0031 164 278 000      
Sub-Investigator: G. Meermans, PhD         
Jeroen Bosch Ziekenhuis Completed
Den Bosch, Noord-Brabant, Netherlands
Elkerliek ziekenhuis Completed
Helmond, Noord-Brabant, Netherlands
Fransiscus Ziekenhuis Completed
Roosendaal, Noord-Brabant, Netherlands, 4708 AE
St. Elisabeth Ziekenhuis Recruiting
Tilburg, Noord-Brabant, Netherlands
Contact: J. Heisterkamp, PhD    0031 13 539 1313      
Sub-Investigator: J. Heisterkamp, PhD         
TweeSteden Ziekenhuis Recruiting
Tilburg, Noord-Brabant, Netherlands
Contact: J. Retera, PhD    0031 13 465 5655      
Sub-Investigator: J. Retera, PhD         
Van Weel Bethesda Ziekenhuis Recruiting
Dirksland, Zeeland, Netherlands
Contact: F. Riemens, MPA    0031 187 607 300      
Sub-Investigator: F. Riemens, MPA         
Reinier de Graaf Gasthuis Recruiting
Delft, Zuid-Holland, Netherlands
Contact: C. Smit, PhD    0031 15 260 3060      
Sub-Investigator: C. Smit, PhD         
HagaZiekenhuis Recruiting
Den Haag, Zuid-Holland, Netherlands
Contact: B. Knippenberg, PhD    0013 70 210 0000      
Sub-Investigator: B. Knippenberg, PhD         
Medisch Centrum Haaglanden Recruiting
Den Haag, Zuid-Holland, Netherlands
Contact: A. de Vries, PhD    0031 070 330 20 00      
Sub-Investigator: A. De Vries, PhD         
UMC Utrecht Recruiting
Utrecht, Netherlands
Contact: W. Braunius, PhD    0031 88 755 5555      
Sub-Investigator: W. Braunius, PhD         
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: M.G.H. Laurant, PhD IQ healthcare, UMC St Radboud
  More Information

Additional Information:
No publications provided by Radboud University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01835444     History of Changes
Other Study ID Numbers: 80-82310-97-12094
Study First Received: April 5, 2013
Last Updated: July 1, 2014
Health Authority: Netherlands: ZonMw, Netherlands Organisation for Health Research and Development

Keywords provided by Radboud University:
Physician Assistant
Substitution
Hospital ward care
Secondary health care

ClinicalTrials.gov processed this record on July 29, 2014