M05 M06 M45 L40.5 M07 M32 M35.0 M31.5 M31.6 M35.3 M08
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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
Universitätsklinikum Heidelberg - Innere Medizin V