Clinical trial NCT06651164: Psychosomatic Risk Screening
Official title: Psychosomatic Risk Screening in the Inpatient Care of Physically Ill Patients: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: psychosocial risk factors
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Detailed description: Mental health problems are common in terms of lifetime prevalence and often occur in combination with chronic physical illnesses. Mental comorbidities in physically ill patients lead to higher morbidity and mortality, greater demands on the healthcare system and higher treatment costs.

Among medical inpatients it can therefore be assumed that there is considerable mental comorbidity. In a large retrospective analysis of around 28,500 patient data sets from the Department of Internal Medicine at Heidelberg University Hospital, we could show that the length of stay in hospital for patients with mental comorbidity was extended by a total of 2 days when compared with patients who had no documented mental comorbidity. This effect was particularly pronounced in the case of major physical multimorbidity. In addition to previously documented psychiatric and psychosomatic diseases, there is a tremendous lack of recognition and diagnosis of relevant mental comorbidities. It has also been shown that other non-acute medical factors, such as functional limitations, impairment of activities of daily living, frailty, cognitive limitations or the lack of a receiving care facility, prolong the length of stay.

To address these problems in health care, some guidelines recommend systematic screening for mental and functional risk-factors, but still this has not been implemented in routine inpatient medical wards. The implementation of psychosomatic risk screening as part of the inpatient admission process could be suitable for detecting the need for psychosomatic and social service at an early stage and addressing it accordingly with psychotherapy, psychopharmacy and qualified social support. It may also be possible to reduce the length of stay in hospital. In this pilot project, a psychosocial risk screening with subsequent psychosomatic assessment by a consultant and introduction to social services is to be evaluated with regard to the feasibility of integration into ward procedures and acceptance by patients. The study is designed as a randomized feasibility study. Patients are included in the study on admission to a medical ward and randomly assigned to the intervention or the control group. The intervention group receives the screening and if necessary subsequent further care, the control group does not receive screening.

Screening focuses on previously defined psychosocial risk categories:

As part of the psychosomatic screening, the risk categories of sleep disorder and psychotropic drug use, depression, anxiety disorder, subjective disease burden, risky alcohol consumption, frailty and cognitive impairment are examined based on previous results.

For the social services screening, relevant consultation and intervention needs such as a general need for advice on social law issues, a lack of health insurance, a lack of financial security, the presence of a legal guardian, a need for care at home, an existing or possibly increased level of care and interest in follow-up treatment or rehabilitation measures are queried.

In the event of a conspicuous psychosomatic screening, a consecutive assessment is carried out by a psychosomatic consultant if consent is given. In the event of a conspicuous social services screening, a social worker is called. If the screening is negative, there will be no further assessment or consultation by the respective services at this time.

The current study serves to prepare a larger randomized trial to test the effect of a psychosocial risk screening together with a defined care path on the reduction of length of stay in patients with medical diseases.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Acceptance of study participation
timeFrame: On admission day (day 1) or first possible day of patient consultation
Secondary outcomes:
measure: Compliance with screening procedure/ result
timeFrame: At day 1 /day of risk screening
measure: Compliance with screening recommendations
timeFrame: At day 1 /day of risk screening
measure: Loss to follow up
timeFrame: 3 month after discharge from the ward
measure: Compliance with all study procedures
timeFrame: 3 month after discharge from the ward
measure: Patient's physical health at the time of follow up
timeFrame: 3 month after discharge from the ward
measure: Patient's general wellbeing at the time of follow up
timeFrame: 3 month after discharge from the ward
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Heidelberg University Clinic - Medical Clinic
state: Baden-Württemberg
Study officials:
affiliation: Heidelberg University Clinic - Department for general internal medicine and psychosomatics
name: Hans-Christoph Friederich, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.