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Trial record 1 of 1 for:    NCT01388374
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The (Cost-)Effectiveness of Nurse Practitioners Working at the Primary Out of Hours Emergency Service

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01388374
Recruitment Status : Completed
First Posted : July 6, 2011
Last Update Posted : April 22, 2015
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Radboud University

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:

  1. 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.
  2. How efficient is the implementation of NPs in the primary out of hours services?
  3. What is the feasibility of the implementation of NPs in the out of hours services? And under which conditions?
  4. What are the barriers and facilitating factors considering the implementation of NPs?

Condition or disease Intervention/treatment Phase
Out of Hours Medical Care Primary Health Care Other: Other, care provided by Nurse Practitioners Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12092 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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 Start Date : December 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

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.
Other: Other, care provided by Nurse Practitioners
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 Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01388374

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Centrale Huisartsen Post (CHP)
Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
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Principal Investigator: M.G.H. Laurant, Dr. IQ healthcare, UMC St Radboud

Additional Information:
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Dierick-van Daele et al (2008). Nurse practitioner in de huisartsenpraktijk: onderzoeksrapport. Maastricht/Eindhoven: UMC Maastricht en Stichting KOH.
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Bussemakers et al (2007). De rolverdeling. Taak-herschikking en taakverdeling in de huisartsenpraktijk. Med Contact; 62 (28): 1216-8.
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Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Radboud University Identifier: NCT01388374     History of Changes
Other Study ID Numbers: 80-82800-98-227
First Posted: July 6, 2011    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015
Keywords provided by Radboud University:
Delivery of Health Care
Nurse Practitioners
Out of Hours Medical Care
Primary Health Care
Emergency Medical Services
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes