The (Cost-)Effectiveness of Physician Assistants Working at the Primary Out of Hours Emergency Service

April 6, 2016 updated by: Radboud University Medical Center
The aim of this study is to explore the effect of substituting General Practitioners (GPs) by Physician Assistants (PAs) in out-of-hours primary care. Effects are measured in terms of the implication for the care model, quality of care delivered by PAs in comparison to GPs; the complaints treated by PAs in comparison to GPs; safety, efficiency and patient satisfaction. Lastly, this study will provide insight in the changes in costs of healthcare.

Study Overview

Detailed Description

Out-of-hours care in the Netherlands is under pressure. Workload for general practitioners (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 are low complex and not urgent, not all patients necessarily have to be seen by a physician. Shifting care from GPs to physician assistants (PAs) is considered to be a possible method to reduce workload while maintaining high quality and safety of care.

Previous research, on PAs in primary care during office hours, has shown PAs were found to be acceptable, effective and efficient in complementing the work of GPs.

We hypothesize that in a team of PAs and GPs working out-of-hours primary care, the PAs will deliver care to less urgent and complex complaints, deliver quality of care comparable to GPs and their implementation will lead to a reduction in cost of healthcare.

We compare care provided by a team of PAs and GPs with a team of only GPs. Within the team of PAs and GPs we make a comparison between the two healthcare professionals.

Study Type

Interventional

Enrollment (Actual)

10161

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

      • Emmen, Netherlands, 7824 AA
        • Centrale Huisartsendienst Drenthe

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients (with urgency U2, U3, U4, or U5) requesting an appointment at the primary out of hours emergency service during the weekend between 9.00 and 17.00 hours.

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 a general practitioner at the out-of-hours primary care service
Experimental: Physician Assistants Care
Medical care provided by the Physician Assistant at the out-of-hours primary care service
Patients will receive care at the out-of-hours primary care service by a Physician Assistant 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
Number of patients
Time Frame: 18 months
To measure substitution of healthcare, the number of consultations in the experimental and control group and per discipline will be measured. These data will be derived from the electronic medical records.
18 months
Patient characteristics (composite)
Time Frame: 18 months
Patient characteristics of patients seen in the experimental and control group and per discipline include age, gender, urgency and type of complaint. These data will be derived from the electronic medical records.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 disciplines will be measures by number of prescriptions; number of test & investigations ordered and referral to the emergency department. These data will be derived from the electronic medical records.
18 months
Direct healthcare costs related to care provide by PAs 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
Adherence to the practice guidelines for General Practitioners
Time Frame: 6 months
Adherence of the PA to the practice guidelines for General Practitioners will be measured by video recordings of in total 30 consultations/visits of the PA. Two independent General Practitioners will score the adherence by a list of indicators. Outcomes will be compared by scores of GPs and Nurse Practitioners (measured in previous research).
6 months
Amount of adverse events and complications
Time Frame: 18 months
The amount of adverse events and complications will be recorded, as well as complaints by the patients.
18 months
Patient satisfaction questionaire
Time Frame: 6 months
Patient satisfaction will be measured using an abridgment of the CQ-index questionnaire. During the intervention period 200 questionnaires will be sent to patients who had either a consult with the PA or with the GP at the out-of-hours primary care service. Results will be compared with results on the CQ-index of the GP and NP (measured in previous research)
6 months
Knowledge test concerning frequently presented complaints
Time Frame: 1 month
Knowledge of PAs will be measured with regard to a number of frequently presented complaints by using a knowledge test. Results are compared with the results on the knowledge test of GPs and NPs (measured in previous research).
1 month

Collaborators and Investigators

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

April 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 10, 2015

First Posted (Estimate)

April 15, 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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