Strategies to Improve Appropriate Referral to Rheumatologists

Arthralgia Clinical Trial

Official title:

Strategies to Improve Appropriate Referral to Rheumatologists

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03454438
• Other study ID #: The JOINT referral study
• Status: Completed
• Phase: N/A
• Start date: February 28, 2017
• Est. completion date: August 31, 2021

Study information

• Verified date: May 2022
• Source: Maasstad Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 544
• Est. completion date: August 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arthralgia
• Collagen Diseases
• Rheumatic Disease
• Rheumatic Diseases

Intervention

Procedure:
• Referral strategies
Two referral strategies will be compared to usual care, i.e. the control group. Patients will be followed for one year.

Locations

Country	Name	City	State
Netherlands	Maasstad Hospital	Rotterdam	Zuid Holland

Sponsors (1)

Lead Sponsor	Collaborator
Maasstad Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	EuroQoL Health questionnaire	The standard analysis for health-related quality of life in cost-effectiveness research, tool in determining Quality adjusted life years (QALYs).	12 months
Secondary	iMTA Medical Consumption Questionnaire	Collects information on non-disease specific health-care consumption.	12 months
Secondary	iMTA Productivity Cost Questionnaire	Measurement of productivity loss and work participation.	12 months
Secondary	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.	12 months