The (Cost-)Effectiveness of Nurse Practitioners Working at the Primary Out of Hours Emergency Service
Primary Purpose
Out of Hours Medical Care, Primary Health Care
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Other, care provided by Nurse Practitioners
Sponsored by

About this trial
This is an interventional health services research trial for Out of Hours Medical Care focused on measuring Delivery of Health Care, Nurse Practitioners, Out of Hours Medical Care, Primary Health Care, Emergency Medical Services
Eligibility Criteria
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.
Sites / Locations
- Centrale Huisartsen Post (CHP)
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
General Practitioners Care
Nurse Practitioners Care
Arm Description
Usual medical care provided by a general practitioner at the Primary Out of Hours Emergency Service.
Medical care provided by the Nurse Practitioner at the Primary Out of Hours Emergency Service.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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
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.
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.
Full Information
NCT ID
NCT01388374
First Posted
July 4, 2011
Last Updated
April 21, 2015
Sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT01388374
Brief Title
The (Cost-)Effectiveness of Nurse Practitioners Working at the Primary Out of Hours Emergency Service
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12092 (Actual)
8. Arms, Groups, and Interventions
Arm Title
General Practitioners Care
Arm Type
No Intervention
Arm Description
Usual medical care provided by a general practitioner at the Primary Out of Hours Emergency Service.
Arm Title
Nurse Practitioners Care
Arm Type
Experimental
Arm Description
Medical care provided by the Nurse Practitioner at the Primary Out of Hours Emergency Service.
Intervention Type
Other
Intervention Name(s)
Other, care provided by Nurse Practitioners
Intervention Description
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).
Primary Outcome Measure Information:
Title
Accessibility of care
Description
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.
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Quality and safety of care
Description
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.
Time Frame
15 months
Title
Patient satisfaction
Description
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.
Time Frame
15 months
Title
Feasibility
Description
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.
Time Frame
15 months
Title
Efficiency of care
Description
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.
Time Frame
15 months
Title
Workload
Description
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
Time Frame
15 months
Title
Knowledge/competence of the NPs
Description
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.
Time Frame
15 months
Title
Cost-analysis
Description
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.
Time Frame
15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M.G.H. Laurant, Dr.
Organizational Affiliation
IQ healthcare, UMC St Radboud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centrale Huisartsen Post (CHP)
City
Eindhoven
State/Province
Noord-Brabant
ZIP/Postal Code
5623 EJ
Country
Netherlands
12. IPD Sharing Statement
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The (Cost-)Effectiveness of Nurse Practitioners Working at the Primary Out of Hours Emergency Service
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