Out of Hours Medical CareNCT01388374
The (Cost-)Effectiveness of Nurse Practitioners Working at the Primary Out of Hours Emergency Service
A study testing Other, care provided by Nurse Practitioners in people with Out of Hours Medical Care and Primary Health Care, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
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: 1. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Out of Hours Medical Care, Primary Health Care
- What is being tested?
- Other, care provided by Nurse Practitioners
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,092 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2010to Oct 2012
- Phase
- Interventional
- 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 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Centrale Huisartsen Post (CHP)
Eindhoven, North Brabant, 5623 EJ
About this study
Official title: 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?
Read the 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.
- Conditions
- Out of Hours Medical Care, Primary Health Care
- Being tested
- Other, care provided by Nurse Practitioners
- Keywords
- Delivery of Health Care, Nurse Practitioners, Out of Hours Medical Care, Primary Health Care, Emergency Medical Services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other, care provided by Nurse PractitionersOther
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).
| Study group | Role | What they receive |
|---|---|---|
| General Practitioners Care | No intervention | Usual medical care provided by a general practitioner at the Primary Out of Hours Emergency Service. |
| Nurse Practitioners Care | Experimental | Medical care provided by the Nurse Practitioner at the Primary Out of Hours Emergency Service. Receives: Other: Other, care provided by Nurse Practitioners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accessibility of care
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.
Measured: 15 months
Secondary outcomes (7)
Quality and safety of care
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.
Measured: 15 months
Patient satisfaction
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.
Measured: 15 months
Feasibility
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.
Measured: 15 months
Efficiency of care
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.
Measured: 15 months
Workload
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
Measured: 15 months
Knowledge/competence of the NPs
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.
Measured: 15 months
Cost-analysis
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.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startDec 2010
- Primary completionJul 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (65)Papers the sponsor has linked to this study.
- Other trials for Out of Hours Medical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12,092 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, Dr., Principal investigator, IQ healthcare, UMC St Radboud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388374
- Sponsor's protocol ID
- 80-82800-98-227
- Status last verified
- Apr 2015
- First submitted
- 4 Jul 2011
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bos N et al (2009). Het gebruik van spoedzorg Regio Utrecht 2009. Utrecht: Julius Centrum.
Giesen P, et al (2007). Medische zorg buiten kantooruren: de huisartsenpost of de spoedeisende eerste hulp? Huisarts Wet;50(5):202-6.
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.
PubMed 10633796Jaarsma-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.
PubMed 10719547van 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.
PubMed 12642541van Uden CJ, Crebolder HF. Does setting up out of hours primary care cooperatives outside a hospital reduce demand for emergency care? Emerg Med J. 2004 Nov;21(6):722-3. doi: 10.1136/emj.2004.016071.
PubMed 15496709RVZ (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.
PubMed 16921097Jabaaij et al (2006). Diensten de deur uit. Huisartsen verkopen meer ANW-diensten aan een waarnemer. Med Contact; 61 (46): 1840-2.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01388374
- Acronym / sponsor ID
- 80-82800-98-227
- Conditions
- Out of Hours Medical Care, Primary Health Care
- Keywords
- Delivery of Health Care, Nurse Practitioners, Out of Hours Medical Care, Primary Health Care, Emergency Medical Services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,092 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Dec 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 6 Jul 2011 (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.
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?
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Practitioners Care | No intervention | –Usual medical care provided by a general practitioner at the Primary Out of Hours Emergency Service. |
| Nurse Practitioners Care | Experimental | Other: Other, care provided by Nurse PractitionersMedical care provided by the Nurse Practitioner at the Primary Out of Hours Emergency Service. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Other, care provided by Nurse PractitionersPatients 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). | Other | Nurse Practitioners Care |
Primary outcome
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.
7 secondary outcomes
Quality and safety of care
Time frame: 15 months
Patient satisfaction
Time frame: 15 months
Feasibility
Time frame: 15 months
Efficiency of care
Time frame: 15 months
Workload
Time frame: 15 months
Knowledge/competence of the NPs
Time frame: 15 months
Cost-analysis
Time frame: 15 months
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 22 Apr 2015.
- BackgroundBos N et al (2009). Het gebruik van spoedzorg Regio Utrecht 2009. Utrecht: Julius Centrum.
- BackgroundGiesen P, et al (2007). Medische zorg buiten kantooruren: de huisartsenpost of de spoedeisende eerste hulp? Huisarts Wet;50(5):202-6.
- BackgroundMinisterie van VWS. Beleidsvisie acute zorg. Oktober 2003.
- BackgroundVHN (2009). Benchmarkbulletin 2008. Utrecht: VHN.
- BackgroundGiesen P, et al (2005). How urgent is the presented morbidity on the GP cooperative? Huisarts Wet; 48: 207-10.
- BackgroundDe Jongh M & Welling G (2009). Analyse zorgvraag Huisartsenpost Eindhoven. Eindhoven: De Centrale Huisartsenposten Zuidoost Brabant
- BackgroundGiesen P, et al (2009). Te snel naar de huisartsenpost. Medisch Cont; 64(6)239-42.
- BackgroundIGZ (2004). Spoedeisende hulpverlening; haastige spoed niet overal goed. Den Haag: IGZ
- Background: PubMed 10633796Meyboom-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.
- Background: PubMed 10719547Jaarsma-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.
- Background: PubMed 12642541van 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.
- Background: PubMed 15496709van Uden CJ, Crebolder HF. Does setting up out of hours primary care cooperatives outside a hospital reduce demand for emergency care? Emerg Med J. 2004 Nov;21(6):722-3. doi: 10.1136/emj.2004.016071.
- Projectdescription and dutch documentation related to the projectLink provided by the sponsor.
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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, Dr. principal investigator
IQ healthcare, UMC St Radboud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Other, care provided by Nurse Practitioners in people with Out of Hours Medical Care and Primary Health Care, run by Radboud University Medical Center at 1 site 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 3 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 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Accessibility of care (time frame: 15 months). 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 NCT01388374, which also lists 65 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 22 Apr 2015.