NCT03454438

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
544

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

May 3, 2022

Status Verified

May 1, 2022

Enrollment Period

3.8 years

First QC Date

February 27, 2018

Last Update Submit

May 2, 2022

Conditions

Rheumatic DiseaseArthralgia

Keywords

ReferralPrimary careRheumatologist

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • EuroQoL Health questionnaire

    12 months

  • iMTA Medical Consumption Questionnaire

    12 months

  • iMTA Productivity Cost Questionnaire

    12 months

  • Health-care costs

    12 months

Study Arms (3)

Algorithm

EXPERIMENTAL

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

Procedure: Referral strategies

Triage

EXPERIMENTAL

Triage by rheumatologist in a primary care setting.

Procedure: Referral strategies

Usual care

NO INTERVENTION

Control group consisting of usual care.

Interventions

Referral strategiesPROCEDURE

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

AlgorithmTriage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Limited understanding of the Dutch language.
  • Legally incapable or vulnerable subject as described in the Medical Research with Human Subjects Act (WMO).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maasstad Hospital

Rotterdam, South Holland, 3079, Netherlands

Location

Related Publications (1)

  • van Delft ETAM, Barreto DL, van der Helm-van Mil AHM, Alves C, Hazes JMW, Kuijper TM, Weel-Koenders AEAM. Diagnostic Performance and Clinical Utility of Referral Rules to Identify Primary Care Patients at Risk of an Inflammatory Rheumatic Disease. Arthritis Care Res (Hoboken). 2022 Dec;74(12):2100-2107. doi: 10.1002/acr.24789. Epub 2022 Jul 31.

    PMID: 34553506DERIVED

MeSH Terms

Conditions

Rheumatic DiseasesArthralgia

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesJoint DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Angelique Weel-Koenders

    Maasstad Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 5, 2018

Study Start

February 28, 2017

Primary Completion

December 31, 2020

Study Completion

August 31, 2021

Last Updated

May 3, 2022

Record last verified: 2022-05

Locations

NL(1)