NCT02417181

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,161

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 7, 2016

Status Verified

April 1, 2016

Enrollment Period

1.8 years

First QC Date

March 31, 2015

Last Update Submit

April 6, 2016

Conditions

Keywords

Physician assistantsOut-of-hours medical carePrimary healthcareEmergency Medical Services

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (6)

  • The number of prescriptions; number of test & investigations ordered and referral to the emergency department

    18 months

  • Direct healthcare costs related to care provide by PAs and GPs will be calculated.

    18 months

  • Adherence to the practice guidelines for General Practitioners

    6 months

  • Amount of adverse events and complications

    18 months

  • Patient satisfaction questionaire

    6 months

  • +1 more secondary outcomes

Study Arms (2)

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

Other: Care provided by Physician Assistants

Interventions

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).

Physician Assistants Care

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centrale Huisartsendienst Drenthe

Emmen, 7824 AA, Netherlands

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2015

First Posted

April 15, 2015

Study Start

April 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 7, 2016

Record last verified: 2016-04

Locations