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

Primary Purpose

Primary Healthcare, Out-of-hours Medical Care

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Care provided by Physician Assistants
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Primary Healthcare focused on measuring Physician assistants, Out-of-hours medical care, Primary healthcare, Emergency Medical Services

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centrale Huisartsendienst Drenthe

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

General Practitioners Care

Physician Assistants Care

Arm Description

Usual medical care provided by a general practitioner at the out-of-hours primary care service

Medical care provided by the Physician Assistant at the out-of-hours primary care service

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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).
Amount of adverse events and complications
The amount of adverse events and complications will be recorded, as well as complaints by the patients.
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)
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).

Full Information

First Posted
March 31, 2015
Last Updated
April 6, 2016
Sponsor
Radboud University Medical Center
Collaborators
Stichting Kwaliteit en Ontwikkeling Huisartsenzorg, GP Cooperative Emmen (CHD Emmen)
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1. Study Identification

Unique Protocol Identification Number
NCT02417181
Brief Title
The (Cost-)Effectiveness of Physician Assistants Working at the Primary Out of Hours Emergency Service
Official Title
The (Cost-)Effectiveness of Physician Assistants Working at the Primary Out of Hours Emergency Service
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Stichting Kwaliteit en Ontwikkeling Huisartsenzorg, GP Cooperative Emmen (CHD Emmen)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Healthcare, Out-of-hours Medical Care
Keywords
Physician assistants, Out-of-hours medical care, Primary healthcare, Emergency Medical Services

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
General Practitioners Care
Arm Type
No Intervention
Arm Description
Usual medical care provided by a general practitioner at the out-of-hours primary care service
Arm Title
Physician Assistants Care
Arm Type
Experimental
Arm Description
Medical care provided by the Physician Assistant at the out-of-hours primary care service
Intervention Type
Other
Intervention Name(s)
Care provided by Physician Assistants
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of patients
Description
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.
Time Frame
18 months
Title
Patient characteristics (composite)
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
The number of prescriptions; number of test & investigations ordered and referral to the emergency department
Description
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.
Time Frame
18 months
Title
Direct healthcare costs related to care provide by PAs and GPs will be calculated.
Description
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.
Time Frame
18 months
Title
Adherence to the practice guidelines for General Practitioners
Description
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).
Time Frame
6 months
Title
Amount of adverse events and complications
Description
The amount of adverse events and complications will be recorded, as well as complaints by the patients.
Time Frame
18 months
Title
Patient satisfaction questionaire
Description
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)
Time Frame
6 months
Title
Knowledge test concerning frequently presented complaints
Description
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).
Time Frame
1 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Centrale Huisartsendienst Drenthe
City
Emmen
ZIP/Postal Code
7824 AA
Country
Netherlands

12. IPD Sharing Statement

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

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