- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02407847
The Effect of Substitution of Out-of-hours Care From General Practitioners to Nurse Practitioners
The (Cost-)Effectiveness of Substitution in Out-of-hours Primary Care; Towards an Optimal Balance Between General Practitioners and Nurse Practitioners.
Study Overview
Status
Conditions
Intervention / Treatment
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 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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: General Practitioners Care
Usual medical care provided by General Practitioners at the Primary Out-of-Hours Service.
|
|
|
Experimental: Nurse Practitioners Care
Medical care provided by both Nurse Practitioners and General Practitioners at the Primary Out-of-Hours 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 |
|---|---|---|
|
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.
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number and characteristics of patients and experienced workload.
Time Frame: 18 months
|
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.
|
18 months
|
|
Direct healthcare costs related to care provide by NPs and GPs will be calculated.
Time Frame: 18 months
|
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.
|
18 months
|
|
Patient characteristics (composite)
Time Frame: 18 months
|
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.
|
18 months
|
|
The number of prescriptions; number of test & investigations ordered and referral to the emergency department.
Time Frame: 18 months
|
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.
|
18 months
|
Collaborators and Investigators
Publications and helpful links
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
Other Study ID Numbers
- VS_in_spoedzorg
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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