Psychosomatic Risk Screening

NCT06651164 | Completed

• 1 other identifier: S-301/2024
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

Mental health problems are common in terms of lifetime prevalence and often occur in combination with chronic physical illnesses. It is therefore reasonable to assume that there is considerable mental health comorbidity among inpatients. A recent retrospective analysis of patient data from a tertiary care internal medicine clinic also showed that the length of stay in hospital was longer for patients with mental comorbidity. This effect was particularly pronounced in the case of severe physical multimorbidity. Our hypothesis is that the implementation of psychosocial risk screening as part of the inpatient admission process is suitable to identify the need for psychosomatic and social service counselling and treatment at an early stage and to address it appropriately from a medical, psychological and social service perspective in order to reduce the length of inhouse treatment. Two consecutive studies are planned to test this hypothesis. The present study is a randomised feasibility study. Patients will be enrolled and assigned to the intervention or control group. Only the intervention group will receive screening. The psychosomatic and social screening will be differentiated according to previously defined risk categories. In some cases, established standardised questionnaires (PHQ-4, Audit-C, Clinical Frailty Scale, Six Item Screener) are used. In other cases, we have developed our own questions. Patients are screened by physicians or students in their practical year when they are admitted to our pilot ward. If the psychosomatic screening is positive and the patient agrees, they are referred to the psychosomatic consultation service. If the social service screening is positive, the patient will be seen by the social service. The main objective of this study is to obtain informed consent from 30% of the eligible patients as a parameter for the feasibility and acceptance of such screening within an integrated psychosomatic and social service care concept. A study period of 3 months is planned for the feasibility study. The feasibility study will be analysed using descriptive statistics. The main study, which has not yet been applied for, is planned as a randomised intervention study. The main objective criterion will be to reduce the length of stay through screening and, if necessary, timely psychosomatic or social counselling.

Conditions

Cardiovascular Diseases

Keywords

psychosocial risk factors

Outcome Measures

Primary Outcomes (1)

• Acceptance of study participation

  The main target criterion of the feasibility study is the rate of patients accepting study We will determine the rate of eligible patients accepting study participation as the main target criterion of the feasibility study.

  On admission day (day 1) or first possible day of patient consultation

Secondary Outcomes (6)

• Compliance with screening procedure/ result

  At day 1 /day of risk screening

• Compliance with screening recommendations

  At day 1 /day of risk screening

• Loss to follow up

  3 month after discharge from the ward

• Compliance with all study procedures

  3 month after discharge from the ward

• Patient's physical health at the time of follow up

  3 month after discharge from the ward

Study Arms (2)

Intervention: psychosocial risk screening conducted

EXPERIMENTAL

Patients in the intervention group are interviewed during admission on possible risk factors using the tablet-based screening questionnaire. The survey takes about 10 minutes. Once the screening has been completed, the results are immediately evaluated electronically and can be viewed by the person carrying out the screening. The patient is informed of the result (conspicuous/not conspicuous). If the psychosomatic screening is positive, the patient is asked if she/he is willing to be visited by a psychosomatic consultant. This contact will last about 15-45 minutes. If the social services screening is positive, the social services will introduce themselves in any case. Depending on the needs for regulation or counseling, this will result in a contact of 10-45 minutes. We use established and validated metrics and questionnaires.

Diagnostic Test: psychosocial risk screening

Control: psychosocial risk screening is not conducted

NO INTERVENTION

Patients assigned to the control group will be treated as usual. Besides medical treatment this may also include consultations from a psychosomatic specialist and/or a social worker if the patient asks for it or the staff deems it necessary.

Interventions

psychosocial risk screening DIAGNOSTIC_TEST

* combined tablet-based screening questionnaire for psychosomatic screening and social service screening * in case of positive psychosomatic or social service screening subsequent psychosomatic and / or social service consultation

Intervention: psychosocial risk screening conducted

Eligibility Criteria

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

You may qualify if:

• The target group are all adult (age \>=18 years) physically ill patients capable of giving consent on the pilot ward.

You may not qualify if:

• Acute mental illnesses that require immediate further treatment (e.g., active suicidal ideation, acute psychotic state)
• The length of stay is too short to carry out a psychosomatic and/or a social services consultation. This can be assumed if the expected length of stay is less than or equal to three days.
• Insufficient knowledge of the German language.
• Cognitive impairment or significant hearing impairment that makes it impossible for the person carrying out the screening and answering the questions adequately.
• in case of re-admission if patient has already been included in the trial

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Heidelberg University Clinic - Medical Clinic

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Related Publications (1)

• Stahl-Toyota S, Nikendei C, Nagy E, Bonsel S, Rollmann I, Unger I, Szendrodi J, Frey N, Michl P, Muller-Tidow C, Jager D, Friederich HC, Hochlehnert A. Interaction of mental comorbidity and physical multimorbidity predicts length-of-stay in medical inpatients. PLoS One. 2023 Jun 22;18(6):e0287234. doi: 10.1371/journal.pone.0287234. eCollection 2023.

  PMID: 37347745 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Hans-Christoph Friederich, Prof. Dr.

  Heidelberg University Clinic - Department for general internal medicine and psychosomatics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Hans-Christoph Friederich

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: October 21, 2024
• Study Start: June 1, 2024
• Primary Completion: October 2, 2024
• Study Completion: February 7, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)