Strategies to Improve Appropriate Referral to Rheumatologists
Primary Purpose
Rheumatic Disease, Arthralgia
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Referral strategies
Sponsored by
About this trial
This is an interventional screening trial for Rheumatic Disease focused on measuring Referral, Primary care, Rheumatologist
Eligibility Criteria
Inclusion Criteria:
- A primary care patient who is referred by the GP to the rheumatology outpatient clinic
- Subject must be able to understand and communicate with the rheumatologist
- Participant must give a written signed and dated informed consent before enrolment.
Exclusion Criteria:
- Limited understanding of the Dutch language.
- Legally incapable or vulnerable subject as described in the Medical Research with Human Subjects Act (WMO).
Sites / Locations
- Maasstad Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Algorithm
Triage
Usual care
Arm Description
Use of electronic structured referral sheets using the algorithms for rheumatoid arthritis, axial spondyloarthritis and psoriatic arthritis.
Triage by rheumatologist in a primary care setting.
Control group consisting of usual care.
Outcomes
Primary Outcome Measures
Percentage of appropriate referred patients
Percentage of appropriate referred patients as proportion of all patients referred to the rheumatologist by the general practitioner (GP). Appropriate referred defined as patient diagnosed with an inflammatory rheumatic disease (IRD) as assessed by a rheumatologist, with an IRD as final diagnosis.
Secondary Outcome Measures
EuroQoL Health questionnaire
The standard analysis for health-related quality of life in cost-effectiveness research, tool in determining Quality adjusted life years (QALYs).
iMTA Medical Consumption Questionnaire
Collects information on non-disease specific health-care consumption.
iMTA Productivity Cost Questionnaire
Measurement of productivity loss and work participation.
Health-care costs
Amount of outpatient clinic visits (visits to medical specialist, supporting staff, other staff), diagnostics (laboratory analyses, imaging), therapy (medication, medical procedures, over the counter medication), general practitioner consultation, medication use prescribed by general practitioner.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03454438
Brief Title
Strategies to Improve Appropriate Referral to Rheumatologists
Official Title
Strategies to Improve Appropriate Referral to Rheumatologists
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 28, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
August 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maasstad Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this cluster randomized controlled trial is to improve the number of effectively referred patients with IRD to the rheumatology outpatient clinic with either use of validated referral pro formas or triage of IRD by specialists in a primary care setting compared to usual care. In addition, the investigators want to provide tools for the general practitioner to recognise IRD and improve early referral of patients with IRD, and a cost-effectiveness analysis will be performed to evaluate the decreasing effect on health-care cost.
Detailed Description
Rationale: Currently, only 22% of all patients referred to the rheumatologist by primary care are diagnosed with an inflammatory rheumatic disease (IRD). Previous research has shown that structured referral sheets and community-based specialist service improve appropriateness of referrals.
Objective: The aim of this study is to improve the number of effectively referred patients with IRD to the rheumatology outpatient clinic with either use of validated referral pro formas or triage of IRD by specialists in a primary care setting compared to usual care. In addition, the investigators want to provide tools for the general practitioner to recognise IRD and improve early referral of patients with IRD, and a cost-effectiveness analysis will be performed to evaluate the decreasing effect on health-care cost.
Study design: Cluster randomized trial with randomization of general practitioner clinics.
Study population: Primary care patients of 18 years or older who are suspected of an IRD and considered by a GP for referral to a rheumatologist.
Intervention: One group of GPs will use a standardized referral strategy for IRD, another group will consist of triage by a rheumatologist in the local primary care clinic, the third group is usual care.
Main study parameters/endpoints: Percentage of patients diagnosed with an IRD by a rheumatologists after 12 months. In addition, cost effectiveness, quality of life, work participation and health care costs at baseline and after 12 months.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is no additional risk to participating patients. Patients might benefit from early referral since the referral pro formas point out important aspects of IRD that are frequently overlooked. Patients will be requested to fill in three online questionnaires related to quality of life, work participation and socio-economic costs. There are no additional visits, physical examinations or other tests.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatic Disease, Arthralgia
Keywords
Referral, Primary care, Rheumatologist
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
544 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Algorithm
Arm Type
Experimental
Arm Description
Use of electronic structured referral sheets using the algorithms for rheumatoid arthritis, axial spondyloarthritis and psoriatic arthritis.
Arm Title
Triage
Arm Type
Experimental
Arm Description
Triage by rheumatologist in a primary care setting.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Control group consisting of usual care.
Intervention Type
Procedure
Intervention Name(s)
Referral strategies
Intervention Description
Two referral strategies will be compared to usual care, i.e. the control group. Patients will be followed for one year.
Primary Outcome Measure Information:
Title
Percentage of appropriate referred patients
Description
Percentage of appropriate referred patients as proportion of all patients referred to the rheumatologist by the general practitioner (GP). Appropriate referred defined as patient diagnosed with an inflammatory rheumatic disease (IRD) as assessed by a rheumatologist, with an IRD as final diagnosis.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
EuroQoL Health questionnaire
Description
The standard analysis for health-related quality of life in cost-effectiveness research, tool in determining Quality adjusted life years (QALYs).
Time Frame
12 months
Title
iMTA Medical Consumption Questionnaire
Description
Collects information on non-disease specific health-care consumption.
Time Frame
12 months
Title
iMTA Productivity Cost Questionnaire
Description
Measurement of productivity loss and work participation.
Time Frame
12 months
Title
Health-care costs
Description
Amount of outpatient clinic visits (visits to medical specialist, supporting staff, other staff), diagnostics (laboratory analyses, imaging), therapy (medication, medical procedures, over the counter medication), general practitioner consultation, medication use prescribed by general practitioner.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A primary care patient who is referred by the GP to the rheumatology outpatient clinic
Subject must be able to understand and communicate with the rheumatologist
Participant must give a written signed and dated informed consent before enrolment.
Exclusion Criteria:
Limited understanding of the Dutch language.
Legally incapable or vulnerable subject as described in the Medical Research with Human Subjects Act (WMO).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelique Weel-Koenders
Organizational Affiliation
Maasstad Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maasstad Hospital
City
Rotterdam
State/Province
Zuid Holland
ZIP/Postal Code
3079
Country
Netherlands
12. IPD Sharing Statement
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Strategies to Improve Appropriate Referral to Rheumatologists
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