Viewing Study NCT06651164



Ignite Creation Date: 2024-10-25 @ 7:53 PM
Last Modification Date: 2024-10-26 @ 3:43 PM
Study NCT ID: NCT06651164
Status: RECRUITING
Last Update Posted: None
First Post: 2024-07-22

Brief Title: Psychosomatic Risk Screening
Sponsor: None
Organization: None

Study Overview

Official Title: Psychosomatic Risk Screening in the Inpatient Care of Physically Ill Patients a Feasibility Study
Status: RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 28500 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None