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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01388374
Other study ID # 80-82800-98-227
Secondary ID
Status Completed
Phase N/A
First received July 4, 2011
Last updated April 21, 2015
Start date December 2010
Est. completion date October 2012

Study information

Verified date April 2015
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority Netherlands: ZonMw, Netherlands Organisation for Health Research and Development
Study type Interventional

Clinical Trial 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?


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.


Recruitment information / eligibility

Status Completed
Enrollment 12092
Est. completion date October 2012
Est. primary completion date July 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 1 Year and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Intervention

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).

Locations

Country Name City State
Netherlands Centrale Huisartsen Post (CHP) Eindhoven Noord-Brabant

Sponsors (2)

Lead Sponsor Collaborator
Radboud University ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (63)

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* Note: There are 63 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 15 months No
Secondary 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.
15 months Yes
Secondary 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. 15 months No
Secondary 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. 15 months No
Secondary 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.
15 months No
Secondary 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
15 months No
Secondary 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. 15 months No
Secondary 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.
15 months No
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