Strategies to Improve Appropriate Referral to Rheumatologists

Sponsor

Maasstad Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03454438

Collaborator

(none)

544

Enrollment

Location

Arms

Actual Duration (Months)

10.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatic Disease Arthralgia	Procedure: Referral strategies	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

544 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Strategies to Improve Appropriate Referral to Rheumatologists

Actual Study Start Date :

Feb 28, 2017

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Aug 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Algorithm Use of electronic structured referral sheets using the algorithms for rheumatoid arthritis, axial spondyloarthritis and psoriatic arthritis.	Procedure: Referral strategies Two referral strategies will be compared to usual care, i.e. the control group. Patients will be followed for one year.
Experimental: Triage Triage by rheumatologist in a primary care setting.	Procedure: Referral strategies Two referral strategies will be compared to usual care, i.e. the control group. Patients will be followed for one year.
No Intervention: Usual care Control group consisting of usual care.

Arm

Intervention/Treatment

Experimental: Algorithm

Use of electronic structured referral sheets using the algorithms for rheumatoid arthritis, axial spondyloarthritis and psoriatic arthritis.

Procedure: Referral strategies

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

Experimental: Triage

Triage by rheumatologist in a primary care setting.

Procedure: Referral strategies

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

No Intervention: Usual care

Control group consisting of usual care.

Outcome Measures

Primary Outcome Measures

Percentage of appropriate referred patients [12 months]
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 [12 months]
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 [12 months]
Collects information on non-disease specific health-care consumption.
iMTA Productivity Cost Questionnaire [12 months]
Measurement of productivity loss and work participation.
Health-care costs [12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).