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

Primary Healthcare Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02407847
• Other study ID #: VS_in_spoedzorg
• Status: Completed
• Phase: N/A
• First received: March 31, 2015
• Last updated: April 6, 2016
• Start date: May 2014
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Ministry of Health, Welfare and Sport
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9647
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

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

Related Conditions & MeSH terms

• Out-of-hours Care Services
• Primary Healthcare

Intervention

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 (3)

Lead Sponsor	Collaborator
Radboud University	Centrale Huisartsenpost Eindhoven (CHP), Stichting Kwaliteit en Ontwikkeling Huisartsenzorg

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number and characteristics of patients and experienced workload.	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	No
Secondary	Direct healthcare costs related to care provide by NPs and GPs will be calculated.	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	No
Secondary	Patient characteristics (composite)	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	No
Secondary	The number of prescriptions; number of test & investigations ordered and referral to the emergency department.	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	No