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Screen for Early Diagnosis II: upgrading university-level rheumatological early care with a focus on the delegability of tasks to clinical nurse specialists

Screen for Early Diagnosis II: upgrading university-level rheumatological early care with a focus on the delegability of tasks to clinical nurse specialists - SCREENED 2.0

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00037130
Enrollment
970
Registered
2025-06-17
Start date
2023-02-23
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M05 M06 M45 L40.5 M07 M32 M35.0 M31.5 M31.6 M35.3 M08

Interventions

Group 1: Screening consultation module 1: Delegation module: Patients with a suspected diagnosis of rheumatoid arthritis (RA), axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA) who are atte

Sponsors

Universitätsklinikum Heidelberg - Innere Medizin V
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: In general: • Written informed consent Screening consultation modules: • First-time rheumatological evaluation as part of the screening consultation, following record-based pre-screening • confirmation of a suspected rheumatoid arthritis (RA), axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA) diagnosis during the on-site assessment. Pre-screening follow-up submodule: • Medical rejection of an appointment request in pre-screening, primarily due to a non-rheumatological suspected diagnosis. RAREarly submodule: • Confirmed diagnosis and at least six months of treatment at the centre: • for RA, axSpA or PsA (frequent inflammatory rheumatic diseases) OR • a rare rheumatic disease (primary Sjögren's syndrome (pSS), systemic lupus erythematosus (SLE), giant cell arteritis (GCA), complicated polymyalgia rheumatica or juvenile idiopathic arthritis (JIA))

Exclusion criteria

Exclusion criteria: In general: • Minors • Patients unable to give consent Screening consultation modules: • Patients with an inflammatory rheumatic disease that has already been confirmed and pre-treated by a rheumatologist prior to the screening consultation. • Other suspected inflammatory rheumatic diagnoses than RA, axSpA or PsA in the on-site assessment. Pre-screening follow-up submodule: • Medical rejection of a appointment request in the pre-screening due primarily to non-fulfilment of another entry criterion (e.g. place of residence outside the catchment area, minors, history of pre-existing rheumatological care). Submodule RAREarly: • Other common inflammatory rheumatic diagnoses (e.g. reactive or Crohn's/ulcerative colitis-associated spondyloarthritis without axial involvement, uncomplicated polymyalgia rheumatica, mixed connective tissue diseases, or vasculitides other than those mentioned). • Unclear or unconfirmed inflammatory rheumatic diagnosis • Course of treatment at the centre of less than 6 months.

Design outcomes

Primary

MeasureTime frame
The added benefit of delegation to a clinical nurse specialist within an established university-level rheumatological early care programme in terms of saving physicians' working time in screening consultations.

Secondary

MeasureTime frame
1) Screening consultation module: The added benefit of delegation to a clinical nurse specialist within an established university-level rheumatological early care programme in terms of a) Non-inferiority in terms of patient satisfaction following the screening consultation b) Non-inferiority in terms of functional status, quality of life, depression and perceived illness in the short-term follow-up. 2) Pre-screening sub-process: a) The learning curve for the clinical nurse specialist in pre-screening b) Saving physicians' working time by delegating pre-screening tasks c) Follow-up of new patients rejected by physicians during pre-screening due to suspected non-rheumatological diagnoses (pre-screening follow-up sub-module) (d) Recording and comparing patient flows and pre-screening decisions with data from preliminary study S-704/2017. 3) Sub-processes: screening consultation and further treatment. a) Recording and comparison of demographic data and disease spectrum with data from preliminary study S-704/2017 b) Recording and comparison of key early care figures with data from preliminary study S-704/2017 c) Functional status and quality of life at further 6-month follow-up points d) Recording and comparison of diagnostic indicators with data from preliminary study S-704/2017 (e) Recording and comparison of key figures for consultation organisation with data from preliminary study S-704/2017. 4) Patient journey (submodule RAREarly): a) Recording and comparison of early care indicators for frequent and rare disease entities b) Recording and comparison of individual patient journeys for frequent and rare disease entities.

Countries

Germany

Contacts

Public ContactKarolina Gente

Universitätsklinikum Heidelberg - Innere Medizin V

karolina.gente@med.uni-heidelberg.de+49 6221 56 8030

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026