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

Primary Healthcare Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02417181
• Other study ID #: PA_in_spoedzorg
• Status: Completed
• Phase: N/A
• First received: March 31, 2015
• Last updated: April 6, 2016
• Start date: April 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10161
• 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 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:

Study Design

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

Related Conditions & MeSH terms

• Emergencies
• Out-of-hours Medical Care
• Primary Healthcare

Intervention

Other:
• Care provided by Physician Assistants
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).

Locations

Country	Name	City	State
Netherlands	Centrale Huisartsendienst Drenthe	Emmen

Sponsors (3)

Lead Sponsor	Collaborator
Radboud University	GP Cooperative Emmen (CHD Emmen), Stichting Kwaliteit en Ontwikkeling Huisartsenzorg

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients	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	No
Primary	Patient characteristics (composite)	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	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 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	No
Secondary	Direct healthcare costs related to care provide by PAs 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	Adherence to the practice guidelines for General Practitioners	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	No
Secondary	Amount of adverse events and complications	The amount of adverse events and complications will be recorded, as well as complaints by the patients.	18 months	No
Secondary	Patient satisfaction questionaire	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	No
Secondary	Knowledge test concerning frequently presented complaints	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	No