- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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?
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Utrecht, 네덜란드
- UMC Utrecht
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Drenthe
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Emmen, Drenthe, 네덜란드
- Scheper Ziekenhuis
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Friesland
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Heerenveen, Friesland, 네덜란드, 8441 PW
- Tjongerschans Ziekenhuis
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Gelderland
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Apeldoorn, Gelderland, 네덜란드
- Gelre Ziekenhuizen
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Arnhem, Gelderland, 네덜란드, 6800 TA
- Rijnstate
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Doetinchem, Gelderland, 네덜란드
- Slingeland Ziekenhuis
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Ede, Gelderland, 네덜란드
- Ziekenhuis de Gelderse Vallei
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Nijmegen, Gelderland, 네덜란드, 6500HB
- Radboud University Nijmegen Medical Centre
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Nijmegen, Gelderland, 네덜란드, 6532 SZ
- Canisius Wilhelmina Ziekenhuis
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Winterswijk, Gelderland, 네덜란드
- Streekziekenhuis Koningin Beatrix
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Limburg
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Roermond, Limburg, 네덜란드, 6043 CV
- Laurentius ziekenhuis
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Roermond, Limburg, 네덜란드
- Laurentius ziekenhuis
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Sittard, Limburg, 네덜란드
- Orbis Medisch Centrum
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Venlo, Limburg, 네덜란드, 5912 BL
- VieCuri Medical Center
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Noord-Brabant
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Bergen op Zoom, Noord-Brabant, 네덜란드, 4624 VT
- Lievensberg ziekenhuis
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Den Bosch, Noord-Brabant, 네덜란드
- Jeroen Bosch Ziekenhuis
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Helmond, Noord-Brabant, 네덜란드
- Elkerliek Ziekenhuis
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Roosendaal, Noord-Brabant, 네덜란드, 4708 AE
- Fransiscus Ziekenhuis
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Tilburg, Noord-Brabant, 네덜란드
- St. Elisabeth Ziekenhuis
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Tilburg, Noord-Brabant, 네덜란드
- TweeSteden Ziekenhuis
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Zeeland
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Dirksland, Zeeland, 네덜란드
- Van Weel Bethesda Ziekenhuis
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Zuid-Holland
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Delft, Zuid-Holland, 네덜란드
- Reinier de Graaf Gasthuis
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Den Haag, Zuid-Holland, 네덜란드
- Hagaziekenhuis
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Den Haag, Zuid-Holland, 네덜란드
- Medisch Centrum Haaglanden
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Length of hospital stay
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Efficiency of care
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: M.G.H. Laurant, PhD, IQ healthcare, UMC St Radboud
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 80-82310-97-12094
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