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Learn more: PMC Disclaimer | PMC Copyright Notice BMJ Open . 2026 Mar 18;16(3):e102470. doi: 10.1136/bmjopen-2025-102470 Search in PMC Search in PubMed View in NLM Catalog Add to search Psychosocial risk screening in the inpatient care of physically ill patients: study protocol for a feasibility study Stephan Christoph Feder Stephan Christoph Feder 1 Department of General Internal Medicine, Psychosomatics and Psychotherapy, Heidelberg University Hospital, Heidelberg, Germany 2 Institute of Medical Informatics, Heidelberg University, Heidelberg, Germany Find articles by Stephan Christoph Feder 1, 2, ✉, 0 , Zuhal Simsek Zuhal Simsek 1 Department of General Internal Medicine, Psychosomatics and Psychotherapy, Heidelberg University Hospital, Heidelberg, Germany Find articles by Zuhal Simsek 1, 0 , Joe J Simon Joe J Simon 1 Department of General Internal Medicine, Psychosomatics and Psychotherapy, Heidelberg University Hospital, Heidelberg, Germany Find articles by Joe J Simon 1 , Mechthild Hartmann Mechthild Hartmann 1 Department of General Internal Medicine, Psychosomatics and Psychotherapy, Heidelberg University Hospital, Heidelberg, Germany Find articles by Mechthild Hartmann 1 , Bastian Bruns Bastian Bruns 1 Department of General Internal Medicine, Psychosomatics and Psychotherapy, Heidelberg University Hospital, Heidelberg, Germany 3 Department of Cardiology, Angiology and Pneumology, Heidelberg University Hospital, Heidelberg, Germany Find articles by Bastian Bruns 1, 3 , Till Johannes Bugaj Till Johannes Bugaj 1 Department of General Internal Medicine, Psychosomatics and Psychotherapy, Heidelberg University Hospital, Heidelberg, Germany Find articles by Till Johannes Bugaj 1 , Jonas Hoch Jonas Hoch 4 Department of Internal Medicine, Heidelberg University Hospital, Heidelberg, Germany Find articles by Jonas Hoch 4 , Martin Dugas Martin Dugas 2 Institute of Medical Informatics, Heidelberg University, Heidelberg, Germany Find articles by Martin Dugas 2 , Hans-Christoph Friederich Hans-Christoph Friederich 1 Department of General Internal Medicine, Psychosomatics and Psychotherapy, Heidelberg University Hospital, Heidelberg, Germany 5 German Centre for Mental Health, DZPG, Mannheim/Heidelberg/Ulm, Germany Find articles by Hans-Christoph Friederich 1, 5 Author information Article notes Copyright and License information 1 Department of General Internal Medicine, Psychosomatics and Psychotherapy, Heidelberg University Hospital, Heidelberg, Germany 2 Institute of Medical Informatics, Heidelberg University, Heidelberg, Germany 3 Department of Cardiology, Angiology and Pneumology, Heidelberg University Hospital, Heidelberg, Germany 4 Department of Internal Medicine, Heidelberg University Hospital, Heidelberg, Germany 5 German Centre for Mental Health, DZPG, Mannheim/Heidelberg/Ulm, Germany Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise. None declared. ✉ Dr Stephan Christoph Feder; [email protected] 0 SCF and ZS contributed equally. Received 2025 Mar 19; Accepted 2026 Feb 19; Collection date 2026. Copyright © Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: https://creativecommons.org/licenses/by-nc/4.0/ . PMC Copyright notice PMCID: PMC13007114 PMID: 41857846 Abstract Background The length of hospital stay for patients with physical illnesses is longer for those with mental health comorbidity, particularly in the presence of severe physical multimorbidity. Integrating psychosocial risk screening at hospital admission, with a subsequent care pathway, could address psychosomatic and social care needs early and reduce length of stay. However, implementation may be hindered by organisational factors such as increased staff workload and timely integration into existing processes. In addition, patient factors such as low acceptance of screening and follow-up may affect uptake. This pilot study aims to assess the feasibility of implementing this integrated approach to screening and follow-up in preparation for a confirmatory trial. Methods The present study is a single centre, randomised feasibility study conducted on a pilot ward. Patients will be enrolled and assigned to the intervention or the control group. Only the intervention group will receive tablet-based psychosocial risk screening conducted by ward physicians or medical students in their practical year. If the psychosomatic screening is positive and the patient agrees, he or she is referred to the psychosomatic consultation service. If the social service screening is positive, the patient will be seen by a social worker. The main objective of this study is to assess the feasibility of conducting a full-sized confirmatory trial. An informed consent rate of 30% of eligible patients is set as the feasibility criterion. A study period of 4 months is planned for the feasibility study. The feasibility study will be analysed using descriptive statistics. Ethics and dissemination The study protocol was approved by the Ethics Committee of the Medical Faculty of Heidelberg University (S-301/2024) on 24 May 2024. The results of this feasibility study will be published in a peer-reviewed journal. Trial registration number NCT06651164 . Keywords: Psychosocial Intervention, Psychometrics, Feasibility Studies, INTERNAL MEDICINE STRENGTHS AND LIMITATIONS OF THIS STUDY. This is an individually randomised controlled pilot study designed to assess the feasibility of a standardised electronic psychosocial screening procedure based on a quality-assured clinical tool that is easily applicable in routine care. Patient pathways are clearly defined and can be readily transferred to other populations with physical illnesses. Blinding of participants and staff is not possible; however, the primary outcome of the definitive trial is objective (length of hospital stay). The generalisability of the feasibility study results may be limited, as all participants were recruited from a single ward at a single centre. Introduction Mental health problems are common with respect to lifetime prevalence and often occur in combination with chronic physical illness. Mental comorbidity in physically ill patients leads to higher morbidity and mortality, greater demands on the healthcare system and higher treatment costs. 1 In a large retrospective analysis of around 28 500 patient records from a tertiary care university hospital, we found that the length of hospital stay for patients with mental comorbidity was 2 days longer than for patients without documented mental comorbidity. This effect was particularly pronounced in the case of severe physical multimorbidity. 2 Furthermore, there is a tremendous lack of recognition and diagnosis of relevant mental comorbidities. 3 It has also been shown that other non-acute medical factors, such as functional limitations, impairments in activities of daily living, frailty, cognitive limitations and the lack of a receiving care facility, prolong the length of stay. 4 , 6 To address these issues in healthcare, some guidelines recommend systematic screening for mental and functional risk factors, but this has not yet been implemented in routine inpatient care. Research has further shown that screening alone does not automatically lead to better outcomes when it is not combined with defined care pathways for those in need of further treatment. 7 8 Hence, screening combined with psychotherapeutic, psychopharmacological and social interventions should be implemented in order to improve health outcomes. This may also have the potential to reduce the length of stay in hospital. However, organisational factors such as an increased workload for staff and the need to integrate screening into existing ward processes in a timely manner may impede the successful implementation of these measures. In addition, patient factors such as low acceptance of screening and subsequent care may also hinder uptake and effectiveness. The objective of the present pilot study is therefore to investigate the feasibility of conducting a confirmatory trial to evaluate the aforementioned screening and integrated care concept. Objectives In this study, the feasibility of the research methods and interventions for conducting a large-scale trial on a psychosocial risk screening with subsequent psychosomatic and/or social services care will be assessed. In reporting this trial protocol, we follow the standard protocol items: recommendations for interventional trials (SPIRIT) guideline to ensure a comprehensive and transparent description of our feasibility study. 9 Methods and analysis Trial design This is a monocentric prospective individually randomised (1:1 ratio), unblinded feasibility study with two parallel arms. Patients are included at admission to inpatient treatment and followed up at discharge and at 3 months after inclusion. Recruitment Recruitment of patients is conducted on a single medical ward. The pilot ward is embedded in a German tertiary care centre at the Medical Hospital of the University of Heidelberg, with a special focus on patients with cardiovascular diseases. Patients are prospectively approached during admission by the attending physician and informed about the study. If the patient agrees to study participation, written informed consent is obtained ( online supplemental material ; Informed consent documents). Whenever inclusion is not possible, the reason is recorded. Participants The target group consists of adult (age ≥18 years) physically ill patients of different disease entities capable of giving informed consent on the pilot ward. Exclusion criteria include acute mental or physical illness requiring immediate further treatment (eg, active suicidal ideation, acute psychotic state, major adverse cardiac event, active bleeding), an expected length of stay too short to carry out a psychosomatic and/or a social service consultation (ie, an expected length of stay of ≤3 days), an insufficient knowledge of the German language or a significant cognitive or hearing impairment. Randomisation and masking Directly following study inclusion, patients are randomly assigned in a 1:1 ratio to one of the two study arms: an intervention group with psychosocial risk screening and subsequent integrated psychosocial care path or a control group without systematic screening. Randomisation is stratified by age (under 70 years vs 70 years or older) and gender (female vs male), resulting in four strata. Within each stratum, allocation is generated electronically using a computer-based random sequence provided by a data manager unaffiliated with study conduct, with a restriction to avoid more than two consecutive allocations to the same study arm within a stratum. No weighting is applied in the analysis. Due to the study design, patients and study staff cannot be blinded; however, outcome assessment is conducted by personnel blinded to group allocation. Study procedures Patients are included in the study by the medical staff on admission to the pilot ward. If the patient consents to study participation, he or she is randomly assigned to the intervention or the control group. The intervention group receives tablet-based psychosocial risk screening conducted by the ward physicians or medical students in their final year of training and, if necessary, subsequent further care by psychosomatic consultation and/or social service consultation. For the predominantly older and often multimorbid patient population, the screening questions are read aloud and completed by the physician or the advanced medical student. If required, staff support the response process by rephrasing questions while preserving their original content. If the screening is negative, there are no further consultations by the respective service. The control group does not receive psychosocial risk screening. The psychosocial risk screening takes 5 to 10 min. On discharge from the ward, all included patients are requested to provide a rating of healthcare services quality. This short discharge interview takes 3 to 5 min. Three months following discharge, all patients participating in the study are contacted via telephone and interviewed using the screening questionnaire and open-ended questions regarding subsequent treatments after discharge and their health status. The telephone interview takes between 15 and 30 min (see figure 1 ). Figure 1. Study flow chart. Open in a new tab Intervention All patients in the intervention group are interviewed during admission regarding psychosocial risk factors using a tablet-based screening tool. To create the screening tool, we used IMI-EDC, as the electronic data capture (EDC) system. 10 11 It implements the operational data model (ODM) from clinical data interchange standards consortium (CDISC), which is an internationally established standard for structured data storage with semantic annotation and an audit trail. 10 11 IMI-EDC supports findability, accessibility, interoperability and reusability (FAIR) principles for data description, storage and publication. 12 Data from the IMI-EDC database are automatically transferred to the hospital information system and integrated into the electronic patient record. Domains of the psychosomatic risk screening include sleep, mental health, subjective distress, frailty and cognitive impairment. Although patients on the ward frequently experience cardiological symptoms, such as reduced physical capacity, dyspnoea, chest tightness or chest pain, these symptoms are not included in the screening, as they are already routinely assessed as part of standard clinical care. Risk factors are assessed using established and validated measures which are described below together with their respective cut-offs: Sleep disorders are assessed by patient self-report. A significant sleep disorder will be documented if the patient reports regular sleep disturbances and is taking psychotropic drugs or sleeping pills on a daily basis. Screening for depression or an anxiety disorder is carried out using the widely established patient health questionnaire (PHQ-D) in the short version comprising 4 items (PHQ-4). The PHQ-2 and generalised anxiety disorder-2 (GAD-2) each consist of two questions asking about symptoms such as ‘little interest or pleasure in activities’ and ‘nervousness or worry’ over the past 2 weeks. Answers are rated on a scale from 0 to 3 (‘not at all’ to ‘almost every day’). A score of ≥3 on the PHQ-2 indicates depression, while a score of ≥3 on the GAD-2 indicates GAD. 13 The subjective burden of illness is assessed using a numerical rating scale. Patients indicate on a scale from 0 to 10 (0=not distressed at all, 10=extremely distressed) how distressed they have felt in the past week, including the day of the screening. The screening is based on the Distress Thermometer of the National Comprehensive Cancer Network (NCCN) in the USA. For threshold values of 5 and 6, moderate and high levels of stress were identified. 14 An even more conservative cut-off value of 7 was selected for the present screening. Screening for the risk of an alcohol-related disorder is carried out using the most frequently used questionnaire alcohol use disorders identification test-consumption (AUDIT-C). The questionnaire comprises three items and is useful for settings with limited time resources to detect risky alcohol consumption, harmful alcohol use or alcohol dependence. First, the frequency of alcohol consumption is asked. Then the amount of alcohol consumed is documented. Finally, the frequency of excessive alcohol consumption is determined. For all three items, the answers are graded on a scale from 0 to 4. The scores for the three items are then summed up. For men, values ≥5 and for women values ≥4 trigger further diagnostics. 15 The psychosomatic screening is supplemented by screening for frailty as a further risk factor for prognosis. Screening for frailty is carried out in patients aged ≥70 using the widely established clinical frailty scale (CFS), which is validated for patients aged ≥65. This encompasses a clinical and anamnestic overall assessment of the patient’s level of physical function. Nine clinical conditions are described, each of which is assigned a number between one for a markedly good state of fitness and nine for a terminally ill person. From a value of 5 onwards, patients are classified as being at increased risk of frailty. A value of 5 corresponds to a low degree of frailty, meaning that affected persons are slowed down in their activities and need help with more complex everyday tasks. 16 The six-item screener (SIS) is used to screen for cognitive deficits in patients over the age of 70. This was compiled from those items of the widely used mini mental state examination (MMSE), which are conspicuous for the earliest stage of cognitive impairment. Patients are first asked to memorise and reproduce a sequence of three words. This is followed by three questions for temporal orientation, graded by year, month and day of the week. Then the three memorised words must be reproduced. A maximum of 6 points can be achieved. For the threshold value of ≥5 also used in the present study, cognitive disorders relevant to everyday life are excluded with a high degree of probability. 17 18 For the social services part of the screening, common and relevant reasons for seeking advice were assessed. The social services screening checks for the presence of classic risk constellations or reasons for seeking advice (eg, social law issues, discharge planning) by means of a yes/no query. A particular focus was placed on constellations that either represent a psychosocial stress factor or cover a need for post-inpatient care. 19 For both the psychosomatic and the social service components of the screening, the screening is considered positive if there is an abnormal finding in at least a single subcategory. Once the screening has been completed, the results are immediately evaluated electronically and can be viewed by the staff person carrying out the screening. Additionally, a report is sent to the hospital information system, 10 which can be viewed by both the medical staff of the ward and the psychosomatic consultants and social service workers. The physician or medical student who performed the screening informs the patient of the result of the psychosocial risk screening (positive or negative). If the psychosomatic screening is positive, the patient is asked if he or she is ready to have a psychosomatic consultation, which lasts approximately 15 to 45 min. If the social services screening is positive, the social service contacts the patient, with the consultation lasting approximately 10 to 45 min. During the social services consultation, advice is provided based on the information needs identified by patients during the screening. Alternatively, clearly identifiable needs are addressed, for example, by submitting applications or assisting patients in submitting applications. These interventions take place on the day of psychosocial risk screening or at the earliest possible time point ( table 1 ). Table 1. Schedule of enrolment, interventions and assessments. Timepoint Study period Enrolment/allocation Post-allocation Close-out t 0 on admission t → t 1 at discharge t 2 3 months post t 1 Enrolment Eligibility screen X Informed consent X Baseline assessment X Allocation X Interventions Screening and subsequent care path: Psychosomatic and social risks and needs ( Insomnia, PHQ-4, AUDIT-C, NCCN-Distress, CFS, SIS, Social-Risks ) Psychosomatic and/or social worker consultation Treatment as usual (control): Psychosomatic and/or social worker consultation only by patient request or medical necessity Assessments Sociodemographics ( sex, age, family status, education ) X Medical data ( diagnoses, current treatment ) X X Psychosocial interventions during inpatient treatment ( recommendation of psychosocial counselling, use of psychosomatic and social worker consultation ) X Overall treatment satisfaction ( HCAHPS ) X Psychosomatic and social risks and needs ( Insomnia, PHQ-4, AUDIT-C, NCCN-Distress, CFS, SIS, Social-Risks ) X * Subjective physical health and well-being (VAS ) X Open in a new tab * Also used for screening in the intervention group at t 1 . AUDIT-C, Alcohol Use Disorders Identification Test-Consumption; CFS, Clinical Frailty Scale; HCAHPS, Hospital Consumer Assessment of Healthcare Providers and Systems; NCCN, National Comprehensive Cancer Network; PHQ, Patient Health Questionnaire; SIS, Six Item Screener; VAS, Visual Analogue Scale. Control group Patients assigned to the control group are not screened for possible psychosocial risk factors. They receive treatment as usual. Besides medical treatment, this may also include consultations by a psychosomatic specialist and/or a social worker if (a) The patient asks for it or (b) The staff deems it necessary at any time during the inpatient stay ( table 1 ). Assessments At baseline (study inclusion) sociodemographic (age, gender, education and family status) and medical data (date of and diagnosis at hospital admission) are directly collected from all participating patients. Furthermore, patients in the intervention group receive additional assessments within the psychosocial risk screening (see intervention). At discharge from the ward, final diagnoses, treatments (including contacts with psychosomatic and social workers), psychotropic medication (including possible changes), subsequent treatment (recommendations) based on psychosomatic or social service consultation are extracted from the medical records. Length of hospital stay is calculated as a potential primary outcome for the main trial. Moreover, all patients included in the study receive a brief discharge interview using the two global items of the hospital consumer assessment of healthcare providers and systems (HCAHPS): the overall rating of the hospital and the willingness to recommend it to friends and family (Giordano, Elliott et al 2010). Three months after discharge, all patients included in the study receive a follow-up interview via telephone (see data collection) ( table 1 ). Outcomes The primary objective of this feasibility study is to determine the acceptance of study participation as a marker of consent to screening and as a key variable for study success. We therefore determine the rate of eligible patients accepting study participation on admission as the primary outcome parameter. Based on previous results on patient participation in clinical trials, 20 , 22 we set a minimum informed consent rate of 30% among eligible patients as a threshold for the feasibility of a confirmatory study on screening within an integrated psychosomatic and social service care concept. Secondary objectives are focused on the practicality of conducting the entire screening process, the team’s management of screening results, the willingness of included patients to participate in study interventions such as psychosomatic and social service consultations and follow-up interviews (loss to follow-up) and finally on exploring possible effects of the intervention. Therefore, the following secondary outcome parameters are recorded: Staff compliance with screening results : we will determine the rate of screenings that result in adequate clinical procedures, for example, organising psychosomatic consultation and/or social service consultation in case of positive screening on the day of the risk screening. Patient compliance with screening recommendations : we will determine the rate of study patients willing to meet with a psychosomatic consultant and/or social worker, if indicated by risk screening. Loss to follow-up : we will determine the rate of study participants who complete follow-up assessment 3 months after discharge from the ward. Compliance with all study procedures : we will determine the rate of study patients with fully completed study procedures (electronic risk screening, consultation with a psychosomatic expert and/or social worker, follow-up assessment) 3 months after discharge from the ward. Physical health at the time of follow-up : we will determine differences in physical health between patients randomised to the screening group compared with patients randomised to the control group using a visual analogue scale (VAS) 3 months after discharge from the ward. Patient’s general well-being at the time of follow-up : we will determine differences in general well-being between patients randomised to the screening group compared with patients randomised to the control group using a VAS 3 months after discharge from the ward. Patient’s need for psychosocial services : we will determine differences in the psychosocial needs between patients randomised to the screening group compared with patients randomised to the control group using the established screening thresholds 3 months after discharge from the ward. Sample size No formal sample size calculation was conducted for this pilot phase. For resource-related reasons, a period of 4 months is set for patient recruitment for the feasibility study. We anticipate that approximately 500 patients will be screened for eligibility over 4 months (based on an average ward population of n=125 per month). This sample size is considered sufficient to inform the assessment of acceptance, recruitment and feasibility of the design for a future randomised controlled trial. Data analysis All analyses will be carried out using SPSS statistical software, version 31.0.1.0 (IBM). Summary statistics will be used to describe all variables of interest. Descriptive analyses (numbers, percentages, means, SD, mean differences, effect sizes with corresponding CIs) will be performed to analyse recruitment rate, screening results and follow-up data. A primary analysis will determine the proportion of patients included in the study among all eligible patients as the primary outcome. Secondary analyses related to implementation of screening results and inpatient psychosocial treatment, as well as clinical and psychosocial needs and well-being at time of follow-up, will be based on descriptive statistics as well. All analyses will be performed by an independent statistician. An interim analysis of the data is not planned. Confidentiality Contact details and identifying data of the patients, the results of the randomised allocation and the clinical data of the screening are each stored in separate files. Access to each file is password protected. The clinically collected study data will be used as diagnostic basis for further interventions of psychosomatic consultant and/or social service worker. The information is only accessible to the relevant clinicians. The names of patients and all other confidential information are subject to medical confidentiality and the provisions of the general data protection regulation (GDPR) and the State and Federal Data Protection Act (LDSG and BDSG). The pseudonymisation code is held by the person responsible for data protection in the study. As soon as possible after publication of the results, patient data will be anonymised. Patient data may only be passed on in pseudonymised form. Third parties will not have access to original documents. Collected data will be stored for ten years. Trial status The clinical part of the data collection began on 2 June 2024 and ran until 2 October 2024. Data in the post-inpatient telephone follow-up survey was collected until 7 February 2025. Since then, additional data extraction and data cleansing have been conducted. Data analysis is scheduled to start at the end of April 2025. This pilot feasibility study was first registered on https://clinicaltrials.gov/on 22 July 2024. Discussion Mental health problems often coexist with chronic physical illnesses. It is likely that a significant proportion of these mental health problems go unrecognised even in clinical wards, yet they represent a significant factor in the recovery and length of stay of these patients. Early diagnosis and treatment are at present sporadic unless medical staff are sensitised to these issues and distress is systematically followed up. However, a systematic approach to the early detection and standardised, timely management of psychosocial risk constellations during hospitalisation has, to our knowledge, not yet been established. The aim of our screening approach is to provide a simple tool for assessing the most relevant categories of psychosocial distress that can be administered by ward staff within a short period of time without extensive training. We believe that the simplicity of the questionnaire’s structure and administration, as well as its brevity, renders it suitable for implementation in areas with a high patient volume. Should assessments and subsequent further interventions be found to be feasible, they can be used in multiple areas of inpatient treatment without requiring modification. However, the effects of screening and subsequently tailored interventions need to be studied in a future full-sized clinical trial. The current feasibility study will contribute essential information for the successful implementation of such a trial and help to answer the question of how to reduce the length of stay of physically ill inpatients. Ethics and dissemination The investigation is carried out in accordance with the current version of the Declaration of Helsinki. The study protocol was submitted to the Ethics Committee of the Heidelberg Medical Faculty for review before the start of the study (S-301/2024). Participation is voluntary. Before the start of the study, the study participants are informed verbally and in writing about the nature and scope of the planned study, in particular about the possible benefits for their health and any risks. Their consent is documented by signing the informed consent form. Supplementary material online supplemental file 1 bmjopen-16-3-s001.pdf (516.1KB, pdf) DOI: 10.1136/bmjopen-2025-102470 Acknowledgements The authors acknowledge the medical team of the study ward of the Medical Clinic of Heidelberg University Hospital for carrying out the screening as part of routine clinical operations, as well as the social services and the psychosomatic consultation service for carrying out the respective psychosocial interventions. We also gratefully acknowledge the patients for their participation in this study. Footnotes Funding: This study was sponsored by the University Hospital Heidelberg (Im Neuenheimer Feld 672, 69120 Heidelberg, Germany, 0049 6221/56-0). 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