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Completed

NCT Number: NCT03454438

Strategies to Improve Appropriate Referral to Rheumatologists

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maasstad Hospital

Rotterdam, South Holland, 3079, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Referral strategies

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. EuroQoL Health questionnaire

    Time frame: 12 months

    The standard analysis for health-related quality of life in cost-effectiveness research, tool in determining Quality adjusted life years (QALYs).

  2. iMTA Medical Consumption Questionnaire

    Time frame: 12 months

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

  3. iMTA Productivity Cost Questionnaire

    Time frame: 12 months

    Measurement of productivity loss and work participation.

  4. Health-care costs

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Maasstad Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Mar 5, 2018
Registry last updated
May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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