- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06582173
Mapping the Healthcare Pathway to Multidisciplinary Assessment of 12-25 Year Olds With Somatic Symptom Disorder (PSOMA)
Mapping the Healthcare Pathway to Specialised Multidisciplinary Assessment of 12-25 Year Olds With Somatic Symptom Disorder: a Monocentric Descriptive Study Based on Interviews Assisted by a Biographical Grid
Study Overview
Status
Intervention / Treatment
Detailed Description
Somatic symptom disorders (SSD), previously labelled Somatoform disorders, are known to challenge healthcare professionals and systems, as those common conditions reducing quality of life often lead to excessive referrals and investigations before adequate diagnosis and management. Although studies have proved multiple interventions to be effective and cost-effective in various clinical settings, little is known about the accurate healthcare utilization associated with SSD. Such analysis faces the complexity of SSD detection and labelling due to heterogeneous clinical presentations and disputed cross-disciplinary classifications. Even though healthcare is known to be a core theme of patient experience of SSD, the investigators lack data describing the trajectory of care and the expectations, perceived help and triggering events associated with healthcare services use. A better understanding of the healthcare pathway those patients follow will help implement evidence-based treatment effectively.
The aim of this study is to trace back the pathway of care that individuals follow before they eventually undergo a specialised multidisciplinary assessment.
This descriptive study relies on data retrospectively collected from patients and their parents during face-to-face interviews assisted by a biographical grid. Inclusion criteria for patients are to be aged 12 to 25 years old and to be diagnosed with SSD by a specialised multidisciplinary team. Variables measured to describe the healthcare pathway are chosen according to professional experience and literature review. They are collected alongside concomitant life events both to reduce memory bias and to explore determinants and effects of healthcare consumption as a secondary outcome. The subjective experience of this healthcare pathway described by patients and their parents is analysed qualitatively in the verbatim of the audio recorded interview.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Marie Benhammani-Godard
- Phone Number: 0033158411190
- Email: marie.godard@aphp.fr
Study Contact Backup
- Name: Maude LUDOT-GREGOIRE, MD, PhD
- Phone Number: +33 1 58 41 24 26
- Email: maude.ludot@aphp.fr
Study Locations
-
-
IDF
-
Paris, IDF, France, 75014
- Maison de Solenn Maison des Adolescents, Cochin Hospital
-
Principal Investigator:
- Maude LUDOT-GREGOIRE, MD
-
Contact:
- Maude LUDOT-GREGOIRE, MD, PhD
- Phone Number: +33 1 58 41 24 26
- Email: maude.ludot@aphp.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Participants are selected among patients assessed in the recruiting centre, whatever their course after assessment.
The recruiting centre is an adolescent clinic which is part of a public teaching hospital in Paris, France. The centre provides inpatient and outpatient care delivered by a multidisciplinary team. Patients aged 11 to 18 can be referred to this centre by a healthcare professional or can directly access to care, regardless of their living area.
For each patient included, parents are asked to participate to research interviews to help map the healthcare pathway their child followed.
Description
Inclusion Criteria:
Criteria relating to the population studied:
- Age between 12 and 25 years old
- Diagnosis of somatic symptom disorder and derivatives (DSM 5) after specialized multidisciplinary evaluation by the team of the Maison des Adolescents of Cochin hospital (Maison de Solenn).
Criteria relating to the additional population participating in the research:
- Being a parent of a subject who has received the diagnosis of somatic symptom disorder and derivatives (DSM 5) after specialized multidisciplinary evaluation at the Maison des Adolescents of Cochin Hospital (Maison de Solenn).
Exclusion Criteria:
Criteria relating to the population studied:
- Age less than 12 years or greater than 25 years at the time of assessment,
- Subject presenting ongoing psychiatric decompensation, that is to say a state of mental health breaking with their baseline state and requiring rapid care which does not allow a research interview to be carried out.
Criteria relating to the additional population participating in the research:
None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adolescents
Patients aged 12 to 25 years old and diagnosed with SSD by a specialised multidisciplinary team
|
Face-to-face interviews assisted by a biographical grid. Healthcare event of the adolescent :
Biographical of the adolescent :
|
|
Parents
Parents of an adolescent included
|
Face-to-face interviews assisted by a biographical grid. Healthcare event of the adolescent :
Biographical of the adolescent :
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Occurrence of healthcare events
Time Frame: Day of inclusion
|
Successive healthcare events of individuals with somatic symptom disorder, from first symptoms to specialised multidisciplinary assessment
|
Day of inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Raise of healthcare events occurrence
Time Frame: Day of inclusion
|
Raise of healthcare events occurrence following the occurrence of somatic symptoms. From first symptoms to specialised multidisciplinary assessment |
Day of inclusion
|
|
Raise of life events occurrence
Time Frame: Day of inclusion
|
From first symptoms to specialised multidisciplinary assessment
|
Day of inclusion
|
|
Decrease of healthcare events occurrence
Time Frame: Day of inclusion
|
Decrease of healthcare events occurrence following the occurrence of somatic symptoms. From first symptoms to specialised multidisciplinary assessment |
Day of inclusion
|
|
Decrease of life events occurrence
Time Frame: Day of inclusion
|
From first symptoms to specialised multidisciplinary assessment
|
Day of inclusion
|
|
Modification of somatic symptoms occurrence
Time Frame: Day of inclusion
|
From first symptoms to specialised multidisciplinary assessment
|
Day of inclusion
|
|
Modification of life events occurrence
Time Frame: Day of inclusion
|
Modification of life events occurrence following healthcare.
From first symptoms to specialised multidisciplinary assessment
|
Day of inclusion
|
|
Qualitative analysis of the transcribed interviews
Time Frame: Up to 24 months
|
Identification of themes emerging from the qualitative analysis of the transcribed interviews
|
Up to 24 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Maude LUDOT-GREGOIRE, MD, PhD, Maison des Adolescents - Cochin Hospital - AP-HP
Publications and helpful links
General Publications
- Sawyer SM, Azzopardi PS, Wickremarathne D, Patton GC. The age of adolescence. Lancet Child Adolesc Health. 2018 Mar;2(3):223-228. doi: 10.1016/S2352-4642(18)30022-1. Epub 2018 Jan 30.
- Joustra ML, Janssens KA, Bultmann U, Rosmalen JG. Functional limitations in functional somatic syndromes and well-defined medical diseases. Results from the general population cohort LifeLines. J Psychosom Res. 2015 Aug;79(2):94-9. doi: 10.1016/j.jpsychores.2015.05.004. Epub 2015 May 16.
- van Dessel N, den Boeft M, van der Wouden JC, Kleinstauber M, Leone SS, Terluin B, Numans ME, van der Horst HE, van Marwijk H. Non-pharmacological interventions for somatoform disorders and medically unexplained physical symptoms (MUPS) in adults. Cochrane Database Syst Rev. 2014 Nov 1;2014(11):CD011142. doi: 10.1002/14651858.CD011142.pub2.
- Wortman MSH, Lokkerbol J, van der Wouden JC, Visser B, van der Horst HE, Olde Hartman TC. Cost-effectiveness of interventions for medically unexplained symptoms: A systematic review. PLoS One. 2018 Oct 15;13(10):e0205278. doi: 10.1371/journal.pone.0205278. eCollection 2018.
- Gosselin A, Desgrees du Lou A, Lelievre E; PARCOURS Study Group. How to use sequence analysis for life course epidemiology? An example on HIV-positive Sub-Saharan migrants in France. J Epidemiol Community Health. 2018 Jun;72(6):507-512. doi: 10.1136/jech-2017-209739. Epub 2018 Feb 2.
- Kachaner A, Harim M, Combier A, Trouvin AP, Avouac J, Ranque B, Piot MA. Management perspectives from patients with fibromyalgia experiences with the healthcare pathway: a qualitative study. Front Med (Lausanne). 2023 Dec 1;10:1231951. doi: 10.3389/fmed.2023.1231951. eCollection 2023.
- Hinton D, Kirk S. Families' and healthcare professionals' perceptions of healthcare services for children and young people with medically unexplained symptoms: a narrative review of the literature. Health Soc Care Community. 2016 Jan;24(1):12-26. doi: 10.1111/hsc.12184. Epub 2015 Feb 16.
- Ludot M, Merlo M, Ibrahim N, Piot MA, Lefevre H, Carles ME, Harf A, Moro MR. ["Somatic symptom disorders" in adolescence. A systematic review of the recent literature]. Encephale. 2021 Dec;47(6):596-604. doi: 10.1016/j.encep.2021.04.007. Epub 2021 Sep 16. French.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP240890
- 2024-A01371-46 (Other Identifier: France : Ministry of Health)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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