- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01388374
The (Cost-)Effectiveness of Nurse Practitioners Working at the Primary Out of Hours Emergency Service
A Study on the (Cost-)Effectiveness of Nurse Practitioners Working at the Primary Out of Hours Emergency Service and the Feasibility of Implementing These Nurses
The aim of this study is to explore whether the implementation of Nurse Practitioners can lead to a more accessible and efficient patient care at the primary out of hours service.
The primary objectives of the proposed study are:
- What are the effects of the implementation of NPs on the primary out of hours service in comparison with the current out of hours service? Effects in terms of accessibility, objective and subjective workload of general practitioners, quality of care and patient satisfaction.
- How efficient is the implementation of NPs in the primary out of hours services?
- What is the feasibility of the implementation of NPs in the out of hours services? And under which conditions?
- What are the barriers and facilitating factors considering the implementation of NPs?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The emergency care and primary out of hours care in the Netherlands is under pressure. There is a rising demand from patients for acute care at the primary out of hours service (run by General Practitioners) as well as for the emergency departments (EDs) at the hospitals. The workload for healthcare professionals in these acute care setting is high. Without changes in the organization of primary out of hours care and emergency care, the quality, accessibility and efficiency of the acute care can't be guaranteed in the future.
The substitution of care from General Practitioners (GPs) to Nurse Practitioners (NPs) is seen as one possible solution to decrease the GPs' workload and improve accessibility and efficiency of care without reducing the quality of care.
It turned out that about 80% of the acute complaints is U3 and U4 (low complex and not urgent) and does not necessarily to be seen by a physician.
Based on previous research we expect that the NPs are competent to diagnose and treat almost all low complex and not urgent complaints. During surgery hours (day time) the NPs act in about 90% of the consultations independently.
Hypothetical substitution of care should contribute to enhancing quality, improving accessibility and reducing the workload of doctors. It can also benefit the efficiency of the acute (primary out of hours) care.
However, specific scientific evidence for this is lacking.
In this study we examine whether substitution of care from GPs to NPs in a primary out of hours care setting can contribute to a more accessible and efficient patient care. Also the feasibility of implementing NPs in a primary our of hours setting is examined.
Comparison: Care provided by the Nurse Practitioner will be compared to care provided by a General Practitioner.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Noord-Brabant
-
Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
- Centrale Huisartsen Post (CHP)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients (with urgency U2, U3, or U4) requesting an appointment at the primary out of hours emergency service during the weekend between 10.00 and 17.00 hours.
Exclusion Criteria (patients seen by a NP):
- Patients under the age of 1 year
- Patients with psychiatric complaints
- Patients with abdominal pain, abdominal infections, chest pain or neck complaints (angina pectoris), headache and dizziness.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: General Practitioners Care
Usual medical care provided by a general practitioner at the Primary Out of Hours Emergency Service.
|
|
|
EXPERIMENTAL: Nurse Practitioners Care
Medical care provided by the Nurse Practitioner at the Primary Out of Hours Emergency Service.
|
Patients will receive care at the Primary Out of Hours Emergency Service by a Nurse Practitioner instead of a General Practitioner (substitution of care from physicians to nurses).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accessibility of care
Time Frame: 15 months
|
Number of patients that have a consult at the Primary Out of Hours Emergency Service; Waiting time; Productivity by NPs in comparison with productivity by GPs.
|
15 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality and safety of care
Time Frame: 15 months
|
Quality and safety of care will be measured by video/audio recording. In total, 60 consultations/visits will be recorded. 30 of the General Practitioner and 30 of the Nurse Practitioner. The care between these two disciplines will be compared according to the practice guidelines for General Practitioners (list of indicators). Furthermore, we report the amount of adverse events and complications. Also complaints by the patients will be recorded. |
15 months
|
|
Patient satisfaction
Time Frame: 15 months
|
Patient satisfaction will be measured by a questionnaire (CQ-index).
At baseline and three times during the intervention period questionnaires will be sent to patients who had a consult at the Primary Out of Hours Emergency Service.
|
15 months
|
|
Feasibility
Time Frame: 15 months
|
Barriers and facilitators will be explored.
We collect this information through semi-structured interviews with GPs, practice assistants, NPs and physicians working at the Primary Out of Hours Emergency Service.
|
15 months
|
|
Efficiency of care
Time Frame: 15 months
|
To measure the efficiency of healthcare, we will measure type of consultation; duration of the consult; type of care provider; number of patients; number of prescriptions; number of test & investigations ordered, referral to other healthcare providers and the emergency department. These data will be derived from the electronic medical records and patient questionnaires. |
15 months
|
|
Workload
Time Frame: 15 months
|
Objective workload will be measured by the numbers of consults, taking into account the urgency levels of the complaints. This data will be derived from the electronic medical records Subjective workload will be measured by a questionnaire. General practitioners as well as the practice assistants at the Primary Out of Hours Emergency Service receive a questionnaire before and after the intervention period to measure satisfaction with care and workload issues |
15 months
|
|
Knowledge/competence of the NPs
Time Frame: 15 months
|
After 9 months, we will measure the knowledge of NPs with regard to a number of frequently presented complaints.
We will use a 'knowledge test' used to examine the knowledge of GP trainees.
Besides NPs also a random selection of GPs (with similar experience of practice) will be invited to fill in the knowledge test.
|
15 months
|
|
Cost-analysis
Time Frame: 15 months
|
All costs related to care provided by NPs and GPs will be calculated, including number of consultations, resource use, referrals, etc. We will also include the costs for training of GPs and NPs. The EQ-D5 will be used as standardized measure for health status of the patient. |
15 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: M.G.H. Laurant, Dr., IQ healthcare, UMC St Radboud
Publications and helpful links
General Publications
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- Ministerie van VWS. Beleidsvisie acute zorg. Oktober 2003.
- VHN (2009). Benchmarkbulletin 2008. Utrecht: VHN.
- Giesen P, et al (2005). How urgent is the presented morbidity on the GP cooperative? Huisarts Wet; 48: 207-10.
- De Jongh M & Welling G (2009). Analyse zorgvraag Huisartsenpost Eindhoven. Eindhoven: De Centrale Huisartsenposten Zuidoost Brabant
- Giesen P, et al (2009). Te snel naar de huisartsenpost. Medisch Cont; 64(6)239-42.
- IGZ (2004). Spoedeisende hulpverlening; haastige spoed niet overal goed. Den Haag: IGZ
- Meyboom-de Jong B, van der Kam WJ, Pierik EG, Bosveld HP. [No Friday afternoon peak in the number of patients referred to the emergency room at De Weezenlanden Hospital of Zwolle, May/June 1997]. Ned Tijdschr Geneeskd. 1999 Dec 18;143(51):2562-6. Dutch.
- Jaarsma-van Leeuwen I, Hammacher ER, Hirsch R, Janssens M. [Patients without referral treated in the emergency room: patient characteristics and motives]. Ned Tijdschr Geneeskd. 2000 Feb 26;144(9):428-31. Dutch.
- van Uden CJ, Winkens RA, Wesseling GJ, Crebolder HF, van Schayck CP. Use of out of hours services: a comparison between two organisations. Emerg Med J. 2003 Mar;20(2):184-7. doi: 10.1136/emj.20.2.184.
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- RVZ (2003). Acute zorg [Achtergrondstudie].( www.rvz.net )
- Giesen P, Franssen E, Mokkink H, van den Bosch W, van Vugt A, Grol R. Patients either contacting a general practice cooperative or accident and emergency department out of hours: a comparison. Emerg Med J. 2006 Sep;23(9):731-4. doi: 10.1136/emj.2005.032359.
- Jabaaij et al (2006). Diensten de deur uit. Huisartsen verkopen meer ANW-diensten aan een waarnemer. Med Contact; 61 (46): 1840-2.
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- Helsloot et al (2006). De eerste schakel. De huisartsgeneeskundige inbreng in de acute zorgketen. Medisch Cont; 61(6): 653-5.
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- Dierick-van Daele et al (2008). Nurse practitioner in de huisartsenpraktijk: onderzoeksrapport. Maastricht/Eindhoven: UMC Maastricht en Stichting KOH.
- de Leeuw et al (2009). Taakherschikking in de huisartsenpraktijk: introductie van de Physician Assistant. Utrecht: UMC Utrecht, Julius Centrum voor Gezondheidswetenschappen en Eerstelijns Geneeskunde.
- Laurant M, Harmsen M, Wollersheim H, Grol R, Faber M, Sibbald B. The impact of nonphysician clinicians: do they improve the quality and cost-effectiveness of health care services? Med Care Res Rev. 2009 Dec;66(6 Suppl):36S-89S. doi: 10.1177/1077558709346277.
- Laurant MGH (2007). Changes in skill mix. The impact of adding nurses to the primary care team. [Thesis] Nijmegen: Radboud University Nijmegen.
- Laurant M, Reeves D, Hermens R, Braspenning J, Grol R, Sibbald B. Substitution of doctors by nurses in primary care. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD001271. doi: 10.1002/14651858.CD001271.pub2.
- Meulepas MA (2007). Evaluation of a chronic care model for primary care. [Thesis] Nijmegen: Radboud University Nijmegen.
- Horrocks S, Anderson E, Salisbury C. Systematic review of whether nurse practitioners working in primary care can provide equivalent care to doctors. BMJ. 2002 Apr 6;324(7341):819-23. doi: 10.1136/bmj.324.7341.819.
- Hooker (2000). The economic basis of physician assistant practice. Physician Assist; 24: 51-66.
- Laurant MG, Hermens RP, Braspenning JC, Akkermans RP, Sibbald B, Grol RP. An overview of patients' preference for, and satisfaction with, care provided by general practitioners and nurse practitioners. J Clin Nurs. 2008 Oct;17(20):2690-8. doi: 10.1111/j.1365-2702.2008.02288.x. Epub 2008 Jul 17.
- Hollinghurst S, Horrocks S, Anderson E, Salisbury C. Comparing the cost of nurse practitioners and GPs in primary care: modelling economic data from randomised trials. Br J Gen Pract. 2006 Jul;56(528):530-5.
- Dierick-van Daele AT, Spreeuwenberg C, Derckx EW, Metsemakers JF, Vrijhoef BJ. Critical appraisal of the literature on economic evaluations of substitution of skills between professionals: a systematic literature review. J Eval Clin Pract. 2008 Aug;14(4):481-92. doi: 10.1111/j.1365-2753.2008.00924.x. Epub 2008 Jul 9.
- Vrijhoef B (2002). Effect evaluation of substituting physicians for nurses in the care for chronically ill. Maastricht: University of Maastricht.
- Miller W, Riehl E, Napier M, Barber K, Dabideen H. Use of physician assistants as surgery/trauma house staff at an American College of Surgeons-verified Level II trauma center. J Trauma. 1998 Feb;44(2):372-6. doi: 10.1097/00005373-199802000-00025.
- Schermerhorn et al. (2010). De huisartsenpost te druk? Er gloort licht aan de horizon.... De NP!. Gorinchem: CHP Gorinchem.
- Burgt R van der, Derckx E, Toemen T (2009). Taakherschikking in de huisartsenzorg: ANW -eindrapport preparatory grant ZonMW-. Eindhoven, Stichting KOH
- Spenkelink-Schut et al (2009). Training the Physician Assistant in the Netherlands. JEPA; 19 (40): 46-53.
- Bussemakers et al (2007). De rolverdeling. Taak-herschikking en taakverdeling in de huisartsenpraktijk. Med Contact; 62 (28): 1216-8.
- Hooker et al (2007). The globalization of the physician assistant profession. Journal of Physician Assistant Education; 18: 76-85.
- Spenkelink-Schut et al (2006). De Phyisician Assistant. Een niuewe masteropleiding binnen het medisch domein van de gezondheidszorg in Nederland. Vakblad voor opleiding in het gezondheidszorgonderwijs; 5: 18-22.
- Toemen Th. (2006). Master of ANP-Huisartsenzorg 2004-2006: overzicht inhoud en ICPC-codes modules patiëntenzorg huisarts-geneeskunde. Stichting KOH, Eindhoven.
- Toemen Th., Ram P. (2006). De NPH-opleiders begeleid -begeleiding van opleiders van nurse practitioners werkzaam in de huisarstenpraktijk. Stichting KOH, Eindhoven.
- Derckx, EWCC et al (2006). De Nurse Practitioner in de huisartsenpraktijk biedt perspectief! Modern Medicine; 30(3): 103-7.
- Bruurs et al. Het ijs is gebroken. Eerste ervaringen met physician assistant stemmen hoopvol. Med Contact; 60:443-6.
- Grol R & Schrijvers AJP (2005). Onderzoeksprogramma Spoedzorg. Nijmegen/Utrecht: Centre for Quality of Care Research/ Julius Centrum
- Engelen L & Schoonhoven L (2009). Arbeidsmarktproblematiek binnen de spoedzorgketen. Nijmegen: Acute Zorgregio Oost.
- Derckx & Toemen (2005). Tussen Cure en Care. Nurse Practitioner in de huisartsenpraktijk verdient ichtzelf terug. Med Contact; 60(49):1992-5.
- Sixma et al (2008). Handboek CQI Ontwikkeling: ricthlijnene en voorschriften voor de ontwikkeling van een CQI meetinstrument (versie 2.0). Utrecht: Centrum Klantervaringen Zorg.
- Moll van Charante E, Giesen P, Mokkink H, Oort F, Grol R, Klazinga N, Bindels P. Patient satisfaction with large-scale out-of-hours primary health care in The Netherlands: development of a postal questionnaire. Fam Pract. 2006 Aug;23(4):437-43. doi: 10.1093/fampra/cml017. Epub 2006 Apr 26.
- Carret ML, Fassa AG, Kawachi I. Demand for emergency health service: factors associated with inappropriate use. BMC Health Serv Res. 2007 Aug 18;7:131. doi: 10.1186/1472-6963-7-131.
- Tummers, G. (2002) Workorganisation, work characteristics and their physiological effects on nurses in the Netherlands. International Journal of stressmanagement, 9(3), 183-206.
- Dale J, Green J, Reid F, Glucksman E. Primary care in the accident and emergency department: I. Prospective identification of patients. BMJ. 1995 Aug 12;311(7002):423-6. doi: 10.1136/bmj.311.7002.423.
- Kinnersley P, Anderson E, Parry K, Clement J, Archard L, Turton P, Stainthorpe A, Fraser A, Butler CC, Rogers C. Randomised controlled trial of nurse practitioner versus general practitioner care for patients requesting "same day" consultations in primary care. BMJ. 2000 Apr 15;320(7241):1043-8. doi: 10.1136/bmj.320.7241.1043.
- Wensing M, Grol R, Asberg J, van Montfort P, van Weel C, Felling A. Does the health status of chronically ill patients predict their judgements of the quality of general practice care? Qual Life Res. 1997 May;6(4):293-9. doi: 10.1023/a:1018405207552.
- Oostenbrink et al (2004). Handleiding voor kostenonderzoek, methoden en richtlijnprijzen voor economische evalauties in de gezondheidszorg. Den Haag
- Drummond, M. F., O'Brien, B., Stoddart, G. L. & Torrance, G. W. (2003) Methods for the economic evaluation of health care programmes, second edition., Oxford, Oxford University Press.
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- Meulepas M, Laurant M, Derckx E. (2009). Taakherschikking in de huissartsenzorg: POH GGZ als versterking van de eerstelijns GGZ. Modellenwwegwijzer POH GGZ. Eindhoven:Meetpunt Kwaliteit.
- Derckx, EWCC, vander Burgt M.R, de Bakker D. Vrijhoef HJM (2009): Naar een landelijke implementatie van de NP en de PA in de eerste lijn.Eindhoven: Stichting KOH
- Van Der Biezen M, Adang E, Van Der Burgt R, Wensing M, Laurant M. The impact of substituting general practitioners with nurse practitioners on resource use, production and health-care costs during out-of-hours: a quasi-experimental study. BMC Fam Pract. 2016 Sep 13;17(1):132. doi: 10.1186/s12875-016-0528-6.
- Wijers N, Schoonhoven L, Giesen P, Vrijhoef H, van der Burgt R, Mintjes J, Wensing M, Laurant M. The effectiveness of nurse practitioners working at a GP cooperative: a study protocol. BMC Fam Pract. 2012 Aug 7;13:75. doi: 10.1186/1471-2296-13-75.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 80-82800-98-227
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