Value Based Healthcare in Psoriasis

NCT05480917 | Recruiting

• 1 other identifier: ONZ-2022-0184
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 2

Brief Summary

Rationale: Currently, the healthcare sector is under tremendous financial pressure, and many acknowledge that a dramatic shift is required as the current system is not sustainable. Furthermore, the quality of care that is delivered varies strongly. Several solutions have been proposed of which the conceptual framework known as value-based healthcare (VBHC) is further explored in this study for psoriasis. Psoriasis is a chronic inflammatory skin disease which is associated with high treatment costs. Objective: The objective of this study is to investigate the impact of using the VBHC framework for the management of psoriasis. Study design: The IRIS (value In psoRiasIS) study will be a prospective clinical trial in which new patients attending the psoriasis clinic (PsoPlus) of the Ghent University Hospital will be followed up during a period of 1 year. Study population: The study population consists of psoriasis patients attending the PsoPlus for the first time. Main study parameters/endpoints: The main outcome is to determine the value created for new psoriasis patients in PsoPlus over a period of 1 year. Thus, the main study parameters pertain to clinically and patient reported outcomes as well as the full cost for treating patients under the year of review, including referrals to other departments. Secondary outcomes are related to comorbidity control, individual outcomes and determining cost drivers. In addition, a bundled payment scheme should be determined as well as potential improvements in the treatment process.

Conditions

Psoriasis

Keywords

Value-based healthcare; Psoriasis; Value

Outcome Measures

Primary Outcomes (1)

• To determine the value created over a 1 year period while managing psoriasis patients within PsoPlus

  The created value will be considered as a reflection of the evolution of the value score (i.e. the weighted outputs (outcomes in VOS) divided by weighted inputs (costs)) obtained using DEA

  1 year

Secondary Outcomes (11)

• Outcomes

  At 6 and 12 months

• Outcomes

  At 6 and 12 months

• Outcomes

  At 6 and 12 months

• Costs

  At 6 and 12 months

• Costs

  At 6 and 12 months

Study Arms (1)

IRIS

OTHER

Other: Patients receiving PsoPlus care

Interventions

Patients receiving PsoPlus care OTHER

As stated before, both outcomes (via VOS) and costs will be collected. Data on clinical outcomes, such as skin clearance, in the VOS will be collected during follow-up visits at our clinic. Outcomes which are assessed via a questionnaire will be collected using a specialized patient platform (PsoQuest). In addition, for this study the EuroQol 5 Dimensions 5 Level (EQ-5D-5L) questionnaire will need to be filled in. When consultations do not coincide with the time points, data will be collected by a study nurse on a study visit (at our department or the patient's home) and via PsoQuest. A 1 month period will be in place around the time point, meaning that the data can be collected 2 weeks beforehand or afterwards. Cost data will be collected using the TD-ABC approach over the full cycle of care.

IRIS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dermatologist reported diagnosis of psoriasis vulgaris
• New patients that have never visited our specialized psoriasis consultation PsoPlus

You may not qualify if:

• Patients unable to provide consent
• Patients who previously visited our specialized psoriasis consultation PsoPlus within the last 5 years
• Patients who previously visited our psoriasis expert within the last 5 years
• Patients with an uncertain diagnosis of psoriasis
• Patients with all other subtypes of psoriasis
• Patients who are unable to understand the tasks and questionnaires

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Novartis: collaborator
• Janssen, LP: collaborator
• Vlerick Business School: collaborator
• Scientific Research Foundation-Flanders: collaborator

Study Sites (2)

University Hospital Ghent

Ghent, East-Flanders, 9000, Belgium

NOT YET RECRUITING

University Hospital Ghent

Ghent, 9000, Belgium

RECRUITING

Related Publications (2)

• Borzee J, Cardoen B, Roodhooft F, Vyvey E, Lambert J. Understanding psoriasis care costs and the impact of comorbidities: a time-driven activity-based costing analysis in an integrated practice unit. BMJ Open. 2026 Jan 9;16(1):e102879. doi: 10.1136/bmjopen-2025-102879.

  PMID: 41513412 DERIVED

• Hilhorst N, Roman E, Borzee J, Deprez E, Hoorens I, Cardoen B, Roodhooft F, Lambert J. Value in psoriasis (IRIS) trial: implementing value-based healthcare in psoriasis management - a 1-year prospective clinical study to evaluate feasibility and value creation. BMJ Open. 2023 May 23;13(5):e067504. doi: 10.1136/bmjopen-2022-067504.

  PMID: 37221023 DERIVED

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jo Lambert, Prof.

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jo Lambert, Prof.

CONTACT

09 332 22 87; jo.lambert@uzgent.be

Emma Vyvey

CONTACT

09 332 22 87; emma.vyvey@uzgent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The IRIS trial will be a prospective clinical trial in which patients attending the PsoPlus for the first time will be followed during a period of 1 year. The focus will lie on patients with no prior experience with PsoPlus. The study will run for 24 months, of which 12 months will serve as an inclusion period. Both outcomes (VOS) and costs will be collected. The VOS is normally measured on a biannual basis. For this trial these time points are called T0, T1, and T2. Additionally, screening for comorbidities is performed to account for the integrated way of working. Patient as well as disease characteristics are also captured in a standardized way. This is all considered to be standard of care within PsoPlus. Cost data is collected using TD-ABC over the full cycle of care.

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 29, 2022
• Study Start: March 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)