ClinicalTrials.gg
CompletedNCT03454438Updated May 3, 2022

Strategies to Improve Appropriate Referral to Rheumatologists

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

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Feb 2017, registered Feb 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
544
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Rheumatic Diseases with a site in Netherlands — 2 open to participants now, 3 under way, none of them phase 3. Rheumatic Diseases · Netherlands.

Started
2017
the only one that year
No phase
6 of 11
2 open now
Registered
6th of 11
by date
Lead sponsor
1 of 11
Maasstad Hospital

Among the 11 studies in Rheumatic Diseases with a site in Netherlands, this one is the only one that started in 2017, is one of 6 with no phase, and was the 6th registered.

Rheumatic Diseases

264 studies on the registry are indexed under Rheumatic Diseases; 60 are open to participants now.

Browse Rheumatic Diseases studies →

Open to participants now

2 of the 11 studies in Rheumatic Diseases with a site in Netherlands are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Netherlands have not opened yet or have stopped. Only those recruiting at a site in Netherlands →

Who these studies take

Of the 41 Rheumatic Diseases studies recruiting now, 18 (44%) set no upper age limit and 12 (29%) stop at 75 or younger; 7 take children under 18; 11 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 11 studies in Rheumatic Diseases with a site in Netherlands, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Rheumatic Disease
  • Arthralgia

Keywords

  • Referral
  • Primary care
  • Rheumatologist
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 before enrolment.

Exclusion criteria

Exclusion Criteria:

  • Limited understanding of the Dutch language.
  • Legally incapable or vulnerable subject as described in the Medical Research with Human Subjects Act (WMO).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
544 participants (actual)

Study arms

  • Experimental
    Algorithm

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

    Procedure: Referral strategies

  • Experimental
    Triage

    Triage by rheumatologist in a primary care setting.

    Procedure: Referral strategies

  • No intervention
    Usual care

    Control group consisting of usual care.

Interventions

  • ProcedureReferral strategies

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

06

What researchers measure

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.

    Time frame: 12 months

Secondary outcomes

  1. 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

  2. iMTA Medical Consumption Questionnaire

    Collects information on non-disease specific health-care consumption.

    Time frame: 12 months

  3. iMTA Productivity Cost Questionnaire

    Measurement of productivity loss and work participation.

    Time frame: 12 months

  4. 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

07

Study locations

1 site
  • Maasstad Hospital
    Rotterdam, Zuid Holland 3079, Netherlands
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2017 to primary completion in Dec 2020, 46 months.

Of 72 non-industry interventional studies with no phase under Rheumatic Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 46 months is above that.

Counting every sponsor, half of 74 studies reached it within 26 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2018
First posted
Mar 5, 2018
StartActual
Feb 28, 2017
Primary completionActual
Dec 31, 2020
CompletionActual
Aug 31, 2021
Last update
May 3, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03454438
Lead sponsor
Maasstad Hospital
Responsible party
Sponsor
First posted
Mar 5, 2018
Start date
Feb 28, 2017
Primary completion
Dec 31, 2020
Completion
Aug 31, 2021
Last update
May 3, 2022

Study contacts

Angelique Weel-Koenders
principal investigator · Maasstad Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion