What is the Optimal Follow-up for Patients With Systemic Sclerosis?

Study Overview
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Brief Summary
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Systemic sclerosis (SSc) is a complex multisystem rheumatic autoimmune disease. Currently, evidence based guidelines for frequency and intensity of follow-up of SSc patients are not available. Based on expert consensus annual extensive evaluation is recommended. To provide comprehensive multidisciplinary care integrated with evaluation of organ involvement and as such, reducing health care utilization while improving the quality of care for the patient, the Leiden Combined Care in SSc (CCISS) pathway was started in 2009. Data collected on disease progression in the patients that participate in this care pathway show that 50% of the patients have relatively mild disease, without any disease progression over time. Therefore there is a need for tailor made care in SSc patients in accordance to disease activity. To enable this, a prediction model was developed that can identify patients with low risk for disease progression.

Detailed Description
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Objectives: To evaluate in SSc patients with low risk for disease progression 1) whether assessment in an outpatient clinic setting is an acceptable alternative for evaluation in the Care Pathway. Outcome parameters we will evaluate include 1) health care utilization, 2) patients' perception of the disease and delivery of care, 3) health-related quality of life and 4) disease progression. Health care utilization as primary outcome is defined as number of contacts with heath care providers during 12 months. Study population: Patients with a clinical diagnosis of SSc that participated in the Combined Care in Systemic Sclerosis cohort from Leiden University Medical Center (LUMC), or in the comparable care pathway of the Haga hospital and Haaglanden Medical Center (HMC), and that have had at least two care pathway evaluations are eligible to participate in this study.

Official Title
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Value Based Health Care in Systemic Sclerosis: What is the Optimal Follow-up for Patients With Systemic Sclerosis?

Conditions
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Systemic Sclerosis

Intervention / Treatment
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* Other: Outpatient Clinic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participation in the prospective Haga, HMC or LUMC cohort Clinical diagnosis of SSc Age of ≥18 years >= two evaluations in the Care Pathway Low or intermediate risk for disease progression according to the prediction model Written informed consent Exclusion Criteria: Patients with SSc who are part of ongoing (randomized) trials Patients who have had an autologous stem cell transplantation in the past five years Patients with SSc who were categorized as high risk for disease progression according to the prediction model.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Annual screening at outpatient clinic<br>After signing informed consent, patients with low risk for disease progression (in the low or intermediate risk group) wil be randomized into the intervention group (annual assessment at the outpatient clinic). Due to the nature of the intervention, the randomization will not be blinded, as this is not possible. | Other: Outpatient Clinic<br>* Follow-up in outpatient clinic<br>|
| No Intervention: Annual screening at Care Pathway Systemic Sclerosis<br>After signing informed consent, patients with low risk for disease progression (in the low or intermediate risk group) will be randomized into the control group (annual assessment at the care pathway). Due to the nature of the intervention, the randomization will not be blinded, as this is not possible. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health care utilization Baseline | Includes different health-care services: rheumatologist, other medical specialists, General Practioner (GP), health professionals, hospital admission, hospital based day-care. Number of contacts/visits within previous 6 months will be counted. | Baseline | 
| Health care utilization after 6 months | Includes different health-care services: rheumatologist, other medical specialists, General Practioner (GP), health professionals, hospital admission, hospital based day-care. Number of contacts/visits within previous 6 months will be counted. | 6 months | 
| Health care utilization after 12 months | Includes different health-care services: rheumatologist, other medical specialists, General Practioner (GP), health professionals, hospital admission, hospital based day-care. Number of contacts/visits within previous 6 months will be counted. | 12 months | 
| Health care utilization after 18 months | Includes different health-care services: rheumatologist, other medical specialists, General Practioner (GP), health professionals, hospital admission, hospital based day-care. Number of contacts/visits within previous 6 months will be counted. | 18 months | 
| Health care utilization after 24 months | Includes different health-care services: rheumatologist, other medical specialists, General Practioner (GP), health professionals, hospital admission, hospital based day-care. Number of contacts/visits within previous 6 months will be counted. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease progression | Defined as progression in different organ systems. | Baseline, 6 months, 12 months, 18 months, 24 months | 
| health-related quality of life using 36-item short form survey (SF-36) | SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. Rely upon patient self-reporting. | Baseline, 6 months, 12 months, 18 months, 24 months | 
| health-related quality of life using EuroQol 5D (EQ5D) | comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. each dimension has 5 levels varying from no problems until extreme problems. Each answer results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.The EQ visual analogue scale (VAS) records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's judgement. | Baseline, 6 months, 12 months, 18 months, 24 months | 
| Illness perception using the validated instrument Brief Illness Perception Questionnaire (BIPQ ) | A nine-item scale designed to rapidly assess the cognitive and emotional representations of illness. Each question is be answered with a number on a scale of 0 until 10. | Baseline, 6 months, 12 months, 18 months, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prediction model, Systemic Sclerosis, Value based health care