Primary HealthcareNCT02417181
The (Cost-)Effectiveness of Physician Assistants Working at the Primary Out of Hours Emergency Service
A study testing Care provided by Physician Assistants in people with Primary Healthcare and Out-of-hours Medical Care, run by Radboud University Medical Center at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Primary Healthcare, Out-of-hours Medical Care
- What is being tested?
- Care provided by Physician Assistants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,161 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Primary Healthcare, Out-of-hours Medical Care
- Being tested
- Care provided by Physician Assistants
- Keywords
- Physician assistants, Out-of-hours medical care, Primary healthcare, Emergency Medical Services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care provided by Physician AssistantsOther
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).
| Study group | Role | What they receive |
|---|---|---|
| General Practitioners Care | No intervention | Usual medical care provided by a general practitioner at the out-of-hours primary care service |
| Physician Assistants Care | Experimental | Medical care provided by the Physician Assistant at the out-of-hours primary care service Receives: Other: Care provided by Physician Assistants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
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.
Measured: 18 months
Secondary outcomes (6)
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.
Measured: 18 months
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.
Measured: 18 months
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).
Measured: 6 months
Amount of adverse events and complications
The amount of adverse events and complications will be recorded, as well as complaints by the patients.
Measured: 18 months
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)
Measured: 6 months
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).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startApr 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HealthcareStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting Kwaliteit en Ontwikkeling Huisartsenzorg, GP Cooperative Emmen (CHD Emmen)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417181
- Sponsor's protocol ID
- PA_in_spoedzorg
- Status last verified
- Apr 2016
- First submitted
- 31 Mar 2015
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The (Cost-)Effectiveness of Physician Assistants Working at the Primary Out of Hours Emergency Service
- ClinicalTrials.gov ID
- NCT02417181
- Acronym / sponsor ID
- PA_in_spoedzorg
- Conditions
- Primary Healthcare, Out-of-hours Medical Care
- Keywords
- Physician assistants, Out-of-hours medical care, Primary healthcare, Emergency Medical Services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,161 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Stichting Kwaliteit en Ontwikkeling Huisartsenzorg, GP Cooperative Emmen (CHD Emmen)
- Study start
- Apr 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Practitioners Care | No intervention | –Usual medical care provided by a general practitioner at the out-of-hours primary care service |
| Physician Assistants Care | Experimental | Other: Care provided by Physician AssistantsMedical care provided by the Physician Assistant at the out-of-hours primary care service |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care provided by Physician AssistantsPatients 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). | Other | Physician Assistants Care |
Primary outcome
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.
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.
6 secondary outcomes
The number of prescriptions; number of test & investigations ordered and referral to the emergency department
Time frame: 18 months
Direct healthcare costs related to care provide by PAs and GPs will be calculated.
Time frame: 18 months
Adherence to the practice guidelines for General Practitioners
Time frame: 6 months
Amount of adverse events and complications
Time frame: 18 months
Patient satisfaction questionaire
Time frame: 6 months
Knowledge test concerning frequently presented complaints
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care provided by Physician Assistants in people with Primary Healthcare and Out-of-hours Medical Care, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2016.