An interventional study of Referral strategies in Rheumatic Disease and Arthralgia, sponsored by Maasstad Hospital. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-03.
Sponsored by Maasstad Hospital · Not applicable, Interventional, and Screening
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.
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.
Exclusion Criteria:
Use of electronic structured referral sheets using the algorithms for rheumatoid arthritis, axial spondyloarthritis and psoriatic arthritis.
Procedure: Referral strategies
Triage by rheumatologist in a primary care setting.
Procedure: Referral strategies
Control group consisting of usual care.
Two referral strategies will be compared to usual care, i.e. the control group. Patients will be followed for one year.
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.
Time frame: 12 months
EuroQoL Health questionnaire
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
iMTA Medical Consumption Questionnaire
Collects information on non-disease specific health-care consumption.
Time frame: 12 months
iMTA Productivity Cost Questionnaire
Measurement of productivity loss and work participation.
Time frame: 12 months
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.
Time frame: 12 months
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Maasstad Hospital