Value Based Healthcare in Psoriasis

NCT05480917 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2024-05-10

No results posted yet for this study

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

Interventions

OTHER

Patients receiving PsoPlus care

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.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY
  • Janssen, LP

    collaborator INDUSTRY
  • Vlerick Business School

    collaborator UNKNOWN
  • Scientific Research Foundation-Flanders

    collaborator UNKNOWN
  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Jo Lambert, Prof. · University Hospital, Ghent

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2025-03-01
Completion
2025-09-01

Countries

  • Belgium

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05480917 on ClinicalTrials.gov