Rheumatic DiseaseNCT03454438
Strategies to Improve Appropriate Referral to Rheumatologists
A study testing Referral strategies in people with Rheumatic Disease and Arthralgia, run by Maasstad Hospital at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatic Disease, Arthralgia
- What is being tested?
- Referral strategies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 544 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Feb 2017to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Limited understanding of the Dutch language.
- Legally incapable or vulnerable subject as described in the Medical Research with Human Subjects Act (WMO).
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Rheumatic Disease, Arthralgia
- Being tested
- Referral strategies
- Keywords
- Referral, Primary care, Rheumatologist
- Medical subject headings
- Rheumatic Diseases, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Referral strategiesProcedure or surgery
Two referral strategies will be compared to usual care, i.e. the control group. Patients will be followed for one year.
| Study group | Role | What they receive |
|---|---|---|
| Algorithm | Experimental | Use of electronic structured referral sheets using the algorithms for rheumatoid arthritis, axial spondyloarthritis and psoriatic arthritis. Receives: Procedure: Referral strategies |
| Triage | Experimental | Triage by rheumatologist in a primary care setting. Receives: Procedure: Referral strategies |
| Usual care | No intervention | Control group consisting of usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (4)
EuroQoL Health questionnaire
The standard analysis for health-related quality of life in cost-effectiveness research, tool in determining Quality adjusted life years (QALYs).
Measured: 12 months
iMTA Medical Consumption Questionnaire
Collects information on non-disease specific health-care consumption.
Measured: 12 months
iMTA Productivity Cost Questionnaire
Measurement of productivity loss and work participation.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start28 Feb 2017
- Primary completion31 Dec 2020
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 544 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maasstad Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angelique Weel-Koenders, Principal investigator, Maasstad Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454438
- Sponsor's protocol ID
- The JOINT referral study
- Status last verified
- May 2022
- First submitted
- 27 Feb 2018
- Last updated
- 3 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34553506
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies to Improve Appropriate Referral to Rheumatologists
- ClinicalTrials.gov ID
- NCT03454438
- Acronym / sponsor ID
- The JOINT referral study
- Conditions
- Rheumatic Disease, Arthralgia
- Keywords
- Referral, Primary care, Rheumatologist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 544 participants (actual)
- Lead sponsor
- Maasstad HospitalUniversity, hospital or other
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 5 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Algorithm | Experimental | Procedure: Referral strategiesUse of electronic structured referral sheets using the algorithms for rheumatoid arthritis, axial spondyloarthritis and psoriatic arthritis. |
| Triage | Experimental | Procedure: Referral strategiesTriage by rheumatologist in a primary care setting. |
| Usual care | No intervention | –Control group consisting of usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Limited understanding of the Dutch language.
- Legally incapable or vulnerable subject as described in the Medical Research with Human Subjects Act (WMO).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Referral strategiesTwo referral strategies will be compared to usual care, i.e. the control group. Patients will be followed for one year. | Procedure or surgery | Algorithm, Triage |
Primary outcome
Percentage of appropriate referred patients
Time frame: 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.
4 secondary outcomes
EuroQoL Health questionnaire
Time frame: 12 months
iMTA Medical Consumption Questionnaire
Time frame: 12 months
iMTA Productivity Cost Questionnaire
Time frame: 12 months
Health-care costs
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Derived from this study: PubMed 34553506van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelique Weel-Koenders principal investigator
Maasstad Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Referral strategies in people with Rheumatic Disease and Arthralgia, run by Maasstad Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of appropriate referred patients (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03454438, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.