The (Cost-)Effectiveness of Nurse Practitioners Working at the Primary Out of Hours Emergency Service

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT01388374
First received: July 4, 2011
Last updated: July 5, 2011
Last verified: March 2010
  Purpose

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 Intervention
Out of Hours Medical Care
Primary Health Care
Other: Other, care provided by Nurse Practitioners

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Accessibility of care [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]

    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 careprovider 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 [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Barriers and facilitators will be explored. We collect this information through semi-structured interviews with GPs, practice assistents, NPs and physicians working at the Primary Out of Hours Emergency Service.

  • Efficiency of care [ Time Frame: 15 months ] [ Designated as safety issue: No ]

    To measure the efficiency of healthcare, we will measure type of consultation; duration of the consult; type of careprovider; 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 [ Time Frame: 15 months ] [ Designated as safety issue: No ]

    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 assistents at the Primary Out of Hours Emergency Service recieve a questionnaire before and after the intervention period to measure satisfaction with care and workload issues


  • Knowledge/competence of the NPs [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    After 9 months, we will measure the knowlegde of NPs with regard to a number of frequently presented complaints. We will use a 'knowlegde 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-effectiveness [ Time Frame: 15 months ] [ Designated as safety issue: No ]

    All costs related to care proveide 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.



Estimated Enrollment: 1400
Study Start Date: December 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: General Practitioners Care
Usual medical care provided by a general 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).
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).

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.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01388374

Contacts
Contact: M.G.H. Laurant, Dr. +31243614305 m.laurant@iq.umcn.nl

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

Additional Information:
Publications:
Jaarsma van Leeuwen I, et al (2000). Patiënten zonder verwijzing op de afdeling Spoedeisende Hulp: patiëntkarakteristieken en motieven. Ned Tijdschr Geneeskd (2000); 144: 428-31.
Spenkelink-Schut et al (2006). De Phyisician Assistant. Een niuewe masteropleiding binnen het medisch domein van de gezondheidszorg in Nederland. Vakblad voor opleiding in het gezondheidszorgonderwijs; 5: 18-22.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Miranda Laurant, UMC St Radboud
ClinicalTrials.gov Identifier: NCT01388374     History of Changes
Other Study ID Numbers: 80-82800-98-227
Study First Received: July 4, 2011
Last Updated: July 5, 2011
Health Authority: Netherlands: ZonMw, Netherlands Organisation for Health Research and Development

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:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 22, 2014