Substitution of CareNCT01835444
A Multicenter Research on the Effects of Substitution of Hospital Ward Care From Medical Doctors to Physician Assistants
An observational study of Substitution of Care, run by Radboud University Medical Center at 24 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substitution of Care
- What is being tested?
- PA/MD model
- How many people
- 2,382 participants
- Where
- 24 sitesNetherlands
- Study dates
- Apr 2013to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital Ward Care: all patients (age 18 years or older) admitted to a hospital ward will be included in the study.
Who may be able to join
- 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)
Who cannot join
- 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
- Terminal patients
- Not fluent in Dutch language
- Age < 18 years
- Patients in daycare
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Netherlands24 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant
Gelre Ziekenhuizen
Apeldoorn, Gelderland
Rijnstate
Arnhem, Gelderland, 6800 TA
Lievensberg Ziekenhuis
Bergen op Zoom, North Brabant, 4624 VT
Reinier de Graaf Gasthuis
Delft, South Holland
Van Weel Bethesda Ziekenhuis
Dirksland, Zeeland
Slingeland Ziekenhuis
Doetinchem, Gelderland
Ziekenhuis de Gelderse Vallei
Ede, Gelderland
Scheper Ziekenhuis
Emmen, Drenthe
Tjongerschans ziekenhuis
Heerenveen, Provincie Friesland, 8441 PW
Elkerliek ziekenhuis
Helmond, North Brabant
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500HB
Canisius Wilhelmina ziekenhuis
Nijmegen, Gelderland, 6532 SZ
Laurentius Ziekenhuis
Roermond, Limburg, 6043 CV
Laurentius Ziekenhuis
Roermond, Limburg
Fransiscus Ziekenhuis
Roosendaal, North Brabant, 4708 AE
Orbis Medisch Centrum
Sittard, Limburg
HagaZiekenhuis
The Hague, South Holland
Medisch Centrum Haaglanden
The Hague, South Holland
St. Elisabeth Ziekenhuis
Tilburg, North Brabant
TweeSteden Ziekenhuis
Tilburg, North Brabant
UMC Utrecht
Utrecht, Utrecht
VieCuri Medical Center
Venlo, Limburg, 5912 BL
Streekziekenhuis Koningin Beatrix
Winterswijk, Gelderland
About this study
Official title: 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.
Read more
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?
- Conditions
- Substitution of Care
- Being tested
- PA/MD model
- Keywords
- Physician Assistant, Substitution, Hospital ward care, Secondary health care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA/MD modelOther
Intervention wards are hospital wards at which ward care is provided by both Physician Assistants (PAs) and Medical Doctors (MDs)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: PA/MD model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
The difference between date of discharge and date of admission
Measured: Patients will be followed for the duration of hospital stay; an expected average of 6 days
Secondary outcomes (7)
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
Measured: Patients will be followed from hospital admission till 1 month after discharge; an expected average of 1 month and 6 days
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
Measured: Patients will be followed from hospital admission till 1 month after discharge; an expected average of 1 month and 6 days
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
Measured: 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
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
Measured: 12 months
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.
Measured: 12 months
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
Measured: 4 months
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Substitution of CareStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 2,382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- M.G.H. Laurant, PhD, Principal investigator, IQ healthcare, UMC St Radboud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01835444
- Sponsor's protocol ID
- 80-82310-97-12094
- Status last verified
- May 2015
- First submitted
- 5 Apr 2013
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28793317Timmermans 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.
PubMed 28698344Timmermans 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.
PubMed 26695837Timmermans 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.
PubMed 24472112
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Worthy Assistants: Does Substituting Hospital Ward Care From Medical Residents to Physician Assistants Result in Cost Savings?
- ClinicalTrials.gov ID
- NCT01835444
- Acronym / sponsor ID
- 80-82310-97-12094
- Conditions
- Substitution of Care
- Keywords
- Physician Assistant, Substitution, Hospital ward care, Secondary health care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,382 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Apr 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 19 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MD model | – | –Hospital wards at which ward care is provided only by Medical Doctors (MDs) |
| PA/MD model | – | Other: PA/MD modelHospital wards at which ward care is provided by both Physician Assistants (PAs) and Medical Doctors (MDs) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital Ward Care: all patients (age 18 years or older) admitted to a hospital ward will be included in the study.
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
- Terminal patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PA/MD modelIntervention wards are hospital wards at which ward care is provided by both Physician Assistants (PAs) and Medical Doctors (MDs) | Other | PA/MD model |
Primary outcome
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
7 secondary outcomes
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
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
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
Feasibility, barriers and facilitators
Time frame: 12 months
Care provider experiences
Time frame: 12 months
Continuity of care
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2015.
- Derived from this study: PubMed 28793317Timmermans 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.
- Derived from this study: PubMed 28698344Timmermans 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.
- Derived from this study: PubMed 26695837Timmermans 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.
- Derived from this study: PubMed 24472112Timmermans 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M.G.H. Laurant, PhD principal investigator
IQ healthcare, UMC St Radboud
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substitution of Care, run by Radboud University Medical Center at 24 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: Patients will be followed for the duration of hospital stay; an expected average of 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01835444, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2015.