Clinical trial NCT06025617: DISTRESS Trial Functional Disorders - the DISTRESS Trial
Official title: Comprehensive Evaluation of a New Diagnostic Clinic for Functional Disorders - the DISTRESS Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bodily Distress Syndrome
Functional Somatic Disorder
Keywords: Fibromyalgia
Irritable Bowel Syndrome
Chronic Fatigue Syndrome
Somatoform Disorders
Lead sponsor: Regionshospitalet Silkeborg
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2023-09-06
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A Diagnostic Clinic for Functional Somatic Disorders (FSD) has been set up at the outpatient diagnostic center at Regionshospitalet Silkeborg. The objective of the clinic is to support General Practitioners (GPs) by offering early stage diagnostic evaluation of whether a patient has an FSD or the symptoms were caused by another physical illness or mental disorder.

As a novelty in this project, Internal Medicine consultants examine the patients for FSD, after having received training in diagnosing FSD by FSD experts. By performing diagnostic evaluation for physical diseases and FSD simultaneously, the investigators believe that the new clinic shall be able to accelerate the establishment of a final diagnosis for these patients who would otherwise likely undergo a protracted diagnostic course involving sequential evaluations at various specialty clinics.

The DISTRESS trial is a pragmatic randomized clinical trial which aims to evaluate the Diagnostic Clinic for FSD in terms of clinical cost-effectiveness outcomes.

Detailed description: Functional Somatic Disorders (FSD) are conditions where patients present with characteristic patterns of physical symptoms, accompanied by impairment or disability. FSD is a clinical diagnosis for which no clinical or paraclinical tests at present have been found useable for establishing the diagnosis. The disorders range from mild and transient to severe, chronic and disabling, and are common in all medical settings, both in primary and secondary care. FSD is costly for society due to high health care use, and the reduction of patients' labor market participation. Arguably, insufficient diagnostic availability is part of the reason some patients develop more severe, chronic and disabling FSD. The Diagnostic Clinic for FSD was set up at Regionshospitalet to alleviate this diagnostic need in the secondary care setting.

The DISTRESS trial is a pragmatic randomized clinical trial. After referral by their GP, patients are randomized 1:1 into two study arms: Intervention and Control. The referring GP must specify which diagnostic evaluations he/she requests both in the intervention and in the control group.

Intervention arm: Patients in this arm shall be examined by an internal medicine specialist trained in FSD diagnostic evaluation at The Diagnostic Clinic for FSD. After parallel evaluation for FSD and other physical conditions, patients are given their diagnosis, along with patient education in what FSD is, as well as a letter to their GP regarding recommended management and treatment options.

Control arm: The comparison group in the randomized clinical trial will receive diagnostic as usual at the Diagnostic center or elsewhere in the secondary sector in The Central Denmark Region.

In this clinical trial, the investigators aim to evaluate the effectiveness in terms of health-related utility improvement for the patients as well as the healthcare and societal costs and cost-effectiveness of the clinic, compared to diagnostic as usual.

Eligibility criteria: Study population:

Participants were drawn from the population of the Central Denmark Region. To be considered for inclusion, patients had to be referred by their GP.

Inclusion Criteria:

* Being referred to the clinic by their GP due to symptoms consistent with a possible diagnosis of moderate or severe FSD.
* Symptoms having been present for at least 6 months and no more than 3 years.
* Having undergone at least 2 diagnostic evaluations (e.g. imaging studies or specialist evaluations) at physical specialty clinics or hospitals in the past year.
* Age 18-60.
* Being of ethnic western cultural upbringing.
* Understands and speaks Danish fluently.

Exclusion Criteria:

* Having another severe chronic disease which explains the reduced level of functioning.
* Having been previously referred to or evaluated for FSD at this or another clinic specializing in functional disorders.
* Previous diagnosis of FSD.
* Alcohol or other substance-dependency or -abuse.
* Emergent psychiatric illness or emergent elevated risk of harm to self or others requiring psychiatric evaluation for possible need of acute or sub-acute psychiatric hospitalization.
* Current or prior diagnosis of psychosis (ICD10 F2x diagnosis), bipolar affective disorder (ICD10 F31.x diagnosis) or depression with psychotic symptoms (ICD10 F32.3 or F33.3 diagnosis).
* Currently pregnant.

Primary outcomes:
measure: Healthcare services utilization (i.e. direct costs)
timeFrame: 12 months prior to randomization and 12 months' follow-up
measure: Cost-effectiveness analysis (CEA) (direct and indirect costs)
timeFrame: 12 months prior to randomization and 12 months' follow-up
Secondary outcomes:
measure: Public expenses associated with occupational status and social benefits (i.e. indirect costs)
timeFrame: 12 months prior to randomization and 12 months' follow-up
measure: Effectiveness: Health-related quality of life (via the the Short Form 36 Total Score)
timeFrame: Baseline, 3- and 12-months' follow-up
measure: Effectiveness: Perceived physical health
timeFrame: Baseline, 3- and 12-months' follow-up
measure: Effectiveness (via Patient-reported Clinical Global Improvement)
timeFrame: At 3- and 12-months' follow-up
Other outcomes:
measure: Symptom level comparison
timeFrame: At 3- and 12 months follow-up
measure: Health anxiety
timeFrame: At 3- and 12 months follow-up
measure: Overall physical health
timeFrame: At 3- and 12 months follow-up
Locations:
city: Silkeborg
country: Denmark
facility: Regionshospitalet Silkeborg
Study officials:
affiliation: Regionshospitalet Silkeborg
name: Michael M Madsen, MD MPH MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Funktionelle Lidelser, Aarhus Universitetshospital
name: Lise K Gormsen, MD PhD
role: STUDY_CHAIR
affiliation: Regionshospitalet Silkeborg
name: Christian Trolle, MD PhD
role: STUDY_DIRECTOR
affiliation: Funktionelle Lidelser, Aarhus Universitetshospital
name: Per Fink, MD Dr. Med PhD
role: STUDY_DIRECTOR
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