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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01835444
Other study ID # 80-82310-97-12094
Secondary ID
Status Completed
Phase N/A
First received April 5, 2013
Last updated May 13, 2015
Start date April 2013
Est. completion date May 2015

Study information

Verified date May 2015
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority Netherlands: ZonMw, Netherlands Organisation for Health Research and Development
Study type Observational

Clinical Trial 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?


Recruitment information / eligibility

Status Completed
Enrollment 2382
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Netherlands Gelre Ziekenhuizen Apeldoorn Gelderland
Netherlands Rijnstate Arnhem Gelderland
Netherlands Lievensberg Ziekenhuis Bergen op Zoom Noord-Brabant
Netherlands Reinier de Graaf Gasthuis Delft Zuid-Holland
Netherlands Jeroen Bosch Ziekenhuis Den Bosch Noord-Brabant
Netherlands HagaZiekenhuis Den Haag Zuid-Holland
Netherlands Medisch Centrum Haaglanden Den Haag Zuid-Holland
Netherlands Van Weel Bethesda Ziekenhuis Dirksland Zeeland
Netherlands Slingeland Ziekenhuis Doetinchem Gelderland
Netherlands Ziekenhuis de Gelderse Vallei Ede Gelderland
Netherlands Scheper Ziekenhuis Emmen Drenthe
Netherlands Tjongerschans ziekenhuis Heerenveen Friesland
Netherlands Elkerliek ziekenhuis Helmond Noord-Brabant
Netherlands Canisius Wilhelmina ziekenhuis Nijmegen Gelderland
Netherlands Radboud University Nijmegen Medical Centre Nijmegen Gelderland
Netherlands Laurentius Ziekenhuis Roermond Limburg
Netherlands Laurentius Ziekenhuis Roermond Limburg
Netherlands Fransiscus Ziekenhuis Roosendaal Noord-Brabant
Netherlands Orbis Medisch Centrum Sittard Limburg
Netherlands St. Elisabeth Ziekenhuis Tilburg Noord-Brabant
Netherlands TweeSteden Ziekenhuis Tilburg Noord-Brabant
Netherlands UMC Utrecht Utrecht
Netherlands VieCuri Medical Center Venlo Limburg
Netherlands Streekziekenhuis Koningin Beatrix Winterswijk Gelderland

Sponsors (2)

Lead Sponsor Collaborator
Radboud University ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Length of hospital stay The difference between date of discharge and date of admission Patients will be followed for the duration of hospital stay; an expected average of 6 days No
Secondary Efficiency of care 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 Patients will be followed from hospital admission till 1 month after discharge; an expected average of 1 month and 6 days No
Secondary Quality of hospital ward care 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 Patients will be followed from hospital admission till 1 month after discharge; an expected average of 1 month and 6 days No
Secondary Patient quality of life 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 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 No
Secondary Feasibility, barriers and facilitators 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 12 months No
Secondary Care provider experiences 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 No
Secondary Continuity of care 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 4 months No
Secondary Patient experiences with hospital ward care 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 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 No