NCT02407847

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,647

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 7, 2016

Status Verified

April 1, 2016

Enrollment Period

1.7 years

First QC Date

March 31, 2015

Last Update Submit

April 6, 2016

Conditions

Keywords

Nurse practitionersPrimary healthcareEmergency Medical ServicesSubstitution of care

Outcome Measures

Primary Outcomes (1)

  • The number of consultations per healthcare provider.

    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 Outcomes (4)

  • Number and characteristics of patients and experienced workload.

    18 months

  • Direct healthcare costs related to care provide by NPs and GPs will be calculated.

    18 months

  • Patient characteristics (composite)

    18 months

  • The number of prescriptions; number of test & investigations ordered and referral to the emergency department.

    18 months

Study Arms (2)

General Practitioners Care

NO INTERVENTION

Usual medical care provided by General Practitioners at the Primary Out-of-Hours Service.

Nurse Practitioners Care

EXPERIMENTAL

Medical care provided by both Nurse Practitioners and General Practitioners at the Primary Out-of-Hours Service.

Other: care provided by Nurse Practitioners

Interventions

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).

Nurse Practitioners Care

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centrale Huisartsen Post (CHP)

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Related Publications (1)

  • van der Biezen M, Wensing M, van der Burgt R, Laurant M. Towards an optimal composition of general practitioners and nurse practitioners in out-of-hours primary care teams: a quasi-experimental study. BMJ Open. 2017 May 30;7(5):e015509. doi: 10.1136/bmjopen-2016-015509.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2015

First Posted

April 3, 2015

Study Start

May 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 7, 2016

Record last verified: 2016-04

Locations