Out-of-hours Care ServicesNCT02407847
The Effect of Substitution of Out-of-hours Care From General Practitioners to Nurse Practitioners
A study testing care provided by Nurse Practitioners in people with Out-of-hours Care Services and Primary Healthcare, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The aim of this study is to explore the effects of substitution in out-of-hours primary care. In consecutive stages an extra General Practitioner (GP) is substituted by a Nurse Practitioner (NP) aiming at replacing 3 out of 4 GPs by NPs. Effects are measured in terms of feasibility and cost-efficiency. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Out-of-hours Care Services, Primary Healthcare
- What is being tested?
- care provided by Nurse Practitioners
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,647 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2014to Jan 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients (with urgencylevel U2, U3, U4, or U5) requesting an appointment at the primary out-of-hours service during the weekend between 10am and 6pm.
Who cannot join
- None
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: The (Cost-)Effectiveness of Substitution in Out-of-hours Primary Care; Towards an Optimal Balance Between General Practitioners and Nurse Practitioners.
The aim of this study is to explore the effects of substitution in out-of-hours primary care. In consecutive stages an extra General Practitioner (GP) is substituted by a Nurse Practitioner (NP) aiming at replacing 3 out of 4 GPs by NPs. Effects are measured in terms of feasibility and cost-efficiency.
Read the detailed description
Out-of-hours care in the Netherlands is under pressure. Workload for GPs during out-of-hours care is high and there are concerns about maintaining the quality of care. Since 80% of the complaints shown in out-of-hours care is neither complex nor urgent not all patients necessarily have to be seen by a GP.
A previous study (ID: 80-82800-98-227) indicated that shifting care from GPs to NPs is possible in terms of safety and quality of care and resulted in cost savings due to less treatment. In that study 4 GPs and 1 NP provided care in the experimental condition and 5 GPs provided care in the control condition. Based on the results it is hypothesized that NPs are competent to diagnose and treat at least 75% of the complaints shown in out-of-hours primary care. Substituting more GPs by NPs in out-of-hours care will probably lead to more cost savings.
In the current study care delivered and direct healthcare costs are compared between different team compositions. In the experimental condition care is provided by a team of NPs and GPs. The intervention starts with a team of 4 professionals in both the experimental (3 GPs and 1 NP) and the control (4 GPs) condition; in consecutive stages an extra GP is substituted by an NP aiming at replacing 3 out of 4 GPs with by NPs.
Control: 4 GPs
Stage 1: experimental: 3 GPs \& 1 NP
Stage 2: experimental: 2 GPs \& 2 NPs
Stage 3: experimental: 1 GP \& 3 NPs
Both feasibility and cost-efficiency will lead to recommendations on the optimal balance in a team between GPs and NPs.
- Conditions
- Out-of-hours Care Services, Primary Healthcare
- Being tested
- care provided by Nurse Practitioners
- Keywords
- Nurse practitioners, Primary healthcare, Emergency Medical Services, Substitution of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 General Practitioners at the Primary Out-of-Hours Service. |
| Nurse Practitioners Care | Experimental | Medical care provided by both Nurse Practitioners and General Practitioners at the Primary Out-of-Hours Service. Receives: Other: care provided by Nurse Practitioners |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of consultations per healthcare provider.
To measure substitution of healthcare, the number of consultations per in the experimental and control group, and per healthcare provider will be measured. These data will be derived from electronic medical records.
Measured: 18 months
Secondary outcomes (4)
Number and characteristics of patients and experienced workload.
Objective workload will be measured by the numbers of consults, taking into account the urgency levels of the complaints and type of complaint. These data will be derived from electronic medical records. Subjective workload will be measured by interviews and focusgroups.
Measured: 18 months
Direct healthcare costs related to care provide by NPs and GPs will be calculated.
Costs related to care provided in the experimental and control group, and per discipline will be calculated, including number of consultations, resource use, referrals, and prescriptions.
Measured: 18 months
Patient characteristics (composite)
Patient characteristics of patients seen in the experimental and control group and per healthcare provider include age, gender, urgency and type of complaint. These data will be derived from electronic medical records.
Measured: 18 months
The number of prescriptions; number of test & investigations ordered and referral to the emergency department.
The performance of the two conditions as well as the healthcare providers will be measures by number of prescriptions; number of test \& investigations ordered and referral to the emergency department. These data will be derived from electronic medical records.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startMay 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Out-of-hours Care ServicesStudies 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
- 9,647 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting Kwaliteit en Ontwikkeling Huisartsenzorg, Centrale Huisartsenpost Eindhoven (CHP)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407847
- Sponsor's protocol ID
- VS_in_spoedzorg
- Status last verified
- Apr 2016
- First submitted
- 31 Mar 2015
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
van der Biezen M, Wensing M, van der Burgt R, Laurant M. Towards an optimal composition of general practitioners and nurse practitioners in out-of-hours primary care teams: a quasi-experimental study. BMJ Open. 2017 May 30;7(5):e015509. doi: 10.1136/bmjopen-2016-015509.
PubMed 28559458
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The (Cost-)Effectiveness of Substitution in Out-of-hours Primary Care; Towards an Optimal Balance Between General Practitioners and Nurse Practitioners.
- ClinicalTrials.gov ID
- NCT02407847
- Acronym / sponsor ID
- VS_in_spoedzorg
- Conditions
- Out-of-hours Care Services, Primary Healthcare
- Keywords
- Nurse practitioners, Primary healthcare, Emergency Medical Services, Substitution of care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9,647 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Stichting Kwaliteit en Ontwikkeling Huisartsenzorg, Centrale Huisartsenpost Eindhoven (CHP)
- Study start
- May 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 3 Apr 2015 (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 the effects of substitution in out-of-hours primary care. In consecutive stages an extra General Practitioner (GP) is substituted by a Nurse Practitioner (NP) aiming at replacing 3 out of 4 GPs by NPs. Effects are measured in terms of feasibility and cost-efficiency.
Detailed description
Out-of-hours care in the Netherlands is under pressure. Workload for GPs during out-of-hours care is high and there are concerns about maintaining the quality of care. Since 80% of the complaints shown in out-of-hours care is neither complex nor urgent not all patients necessarily have to be seen by a GP.
A previous study (ID: 80-82800-98-227) indicated that shifting care from GPs to NPs is possible in terms of safety and quality of care and resulted in cost savings due to less treatment. In that study 4 GPs and 1 NP provided care in the experimental condition and 5 GPs provided care in the control condition. Based on the results it is hypothesized that NPs are competent to diagnose and treat at least 75% of the complaints shown in out-of-hours primary care. Substituting more GPs by NPs in out-of-hours care will probably lead to more cost savings.
In the current study care delivered and direct healthcare costs are compared between different team compositions. In the experimental condition care is provided by a team of NPs and GPs. The intervention starts with a team of 4 professionals in both the experimental (3 GPs and 1 NP) and the control (4 GPs) condition; in consecutive stages an extra GP is substituted by an NP aiming at replacing 3 out of 4 GPs with by NPs.
Control: 4 GPs
Stage 1: experimental: 3 GPs \& 1 NP
Stage 2: experimental: 2 GPs \& 2 NPs
Stage 3: experimental: 1 GP \& 3 NPs
Both feasibility and cost-efficiency will lead to recommendations on the optimal balance in a team between GPs and NPs.
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 General Practitioners at the Primary Out-of-Hours Service. |
| Nurse Practitioners Care | Experimental | Other: care provided by Nurse PractitionersMedical care provided by both Nurse Practitioners and General Practitioners at the Primary Out-of-Hours Service. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients (with urgencylevel U2, U3, U4, or U5) requesting an appointment at the primary out-of-hours service during the weekend between 10am and 6pm.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| 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
The number of consultations per healthcare provider.
Time frame: 18 months
To measure substitution of healthcare, the number of consultations per in the experimental and control group, and per healthcare provider will be measured. These data will be derived from electronic medical records.
4 secondary outcomes
Number and characteristics of patients and experienced workload.
Time frame: 18 months
Direct healthcare costs related to care provide by NPs and GPs will be calculated.
Time frame: 18 months
Patient characteristics (composite)
Time frame: 18 months
The number of prescriptions; number of test & investigations ordered and referral to the emergency department.
Time frame: 18 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 7 Apr 2016.
- Derived from this study: PubMed 28559458van der Biezen M, Wensing M, van der Burgt R, Laurant M. Towards an optimal composition of general practitioners and nurse practitioners in out-of-hours primary care teams: a quasi-experimental study. BMJ Open. 2017 May 30;7(5):e015509. doi: 10.1136/bmjopen-2016-015509.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing care provided by Nurse Practitioners in people with Out-of-hours Care Services and Primary Healthcare, 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 1 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 7 Apr 2016. 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?
The number of consultations per healthcare provider. (time frame: 18 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 NCT02407847, which also lists 1 linked publication.
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 7 Apr 2016.