- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02417181
The (Cost-)Effectiveness of Physician Assistants Working at the Primary Out of Hours Emergency Service
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Emmen, Netherlands, 7824 AA
- Centrale Huisartsendienst Drenthe
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PA_in_spoedzorg
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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