The Effect of Substitution of Out-of-hours Care From General Practitioners to Nurse Practitioners

April 6, 2016 updated by: Radboud University Medical Center

The (Cost-)Effectiveness of Substitution in Out-of-hours Primary Care; Towards an Optimal Balance Between General Practitioners and Nurse Practitioners.

The aim of this study is to explore the effects of substitution in out-of-hours primary care. In consecutive stages an extra General Practitioner (GP) is substituted by a Nurse Practitioner (NP) aiming at replacing 3 out of 4 GPs by NPs. Effects are measured in terms of feasibility and cost-efficiency.

Study Overview

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

Interventional

Enrollment (Actual)

9647

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
        • Centrale Huisartsen Post (CHP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

March 31, 2015

First Submitted That Met QC Criteria

April 2, 2015

First Posted (Estimate)

April 3, 2015

Study Record Updates

Last Update Posted (Estimate)

April 7, 2016

Last Update Submitted That Met QC Criteria

April 6, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

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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