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Development of intersectoral medical care for patients with chronic critical illness

Development of intersectoral medical care for patients with chronic critical illness - E=MC2

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00029326
Enrollment
57
Registered
2022-08-10
Start date
2022-08-21
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post intensive care syndrome Chronic critical illness J44.9 G62.80 G72.80 Z99.0

Interventions

Group 1: Pre-intervention: No change in standard therapy in the intensive care facilities Intervention: Regular telemedicine rounds conducted by experienced intensive care physicians connect out-of-h

Sponsors

Charité - Universitätsmedizin Berlin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Consenting and non-consenting patients who have a guardian or a proxy. The patients are all of legal age and long-term ventilated. All male and female, sick and long-term ventilated residents of the participating ventilator communities can be included. Parallel participation in another study is possible. All health insurance providers are possible.

Exclusion criteria

Exclusion criteria: Refusal by the patient or their authorised representative or carer.

Design outcomes

Primary

MeasureTime frame
Primary Endpoint - Access to measurement of PROMs: The primary endpoint is the proportion of patients with PRO measurements recorded in the patient records. For each patient, it is determined whether (y/n) there has been a PRO measurement performed and documented 3 months prior to the pri-mary endpoint measurement or since admission to the out-of-hospital intensive care facility if admitted within the previous 3 months. Primary Endpoint - Rehospitalisation: For each patient, at each of the five primary endpoint measurement time points, we record the number of hospital readmissions within 3 months before the respective measurement time point or since admission to the out-of-hospital intensive care facility if admitted within the previous 3 months.

Secondary

MeasureTime frame
Post-Intensive Care Syndrome Presence of a post-intensive care syndrome (PICS yes/no) at the measurement time points, defined according to Spies et al. Health-related quality of life Health-Related Quality of Life (HR-QoL, scale 0-10), Health-Related Quality of Life (HR-QoL, scale 0-10) (foreign assessment), and the Severe Respiratory Insufficiency Questionnaire (SRI), at the measurement time points.  Mental health: Patient Health Questionnaire-8 (PHQ-8), Generalized Anxiety Disorder-7 (GAD-7) (depression, anxiety disorders and post-traumatic stress disorder) Cognition: Mini-Cognitive Assessment Instrument (MiniCog), Trail Making Test A and B were administered at the measurement time points.  Mobility: Timed Up-and-Go Test (TUAG) and hand strength at the measurement time points.  Pain: Behavioural Pain Scale (BPS) Baseline characteristics Age, gender, mother tongue, marital status, education level, height and weight, BMI, tracheal cannula, Charlson Comorbidity Index, main/treatment diagnosis, secondary diagnoses, start of ventilation, admission to the ventilator community, palliative therapy, number of weaning attempts, ventilation parameters on admission (FiO2, PEEP, Pinsp), was an advance directive available before ventilation? Interview study: (1) The secondary endpoints of the qualitative analysis in the interview study are as follows: The individual significance of chronic critical illness (CCI) for patients and their relatives (2) Influence of experience on own decisions for medical measures. (3) The individual assessment of CCI and the influences on the assessment of the s quality of life by the team members/caregivers. (4) To explore in interviews how moral distress affects the team. Evaluation of anonymous user survey (nurses/family doctors/healthcare professionals): User-friendliness and acceptance of telemedicine care were assessed using a five-point Likert scale. Health economic costs of care: (1) Quantification of the

Countries

Germany

Contacts

Public ContactClaudia Spies

Klinik für Anästhesiologie und Intensivmedizin (CCM/CVK) Charité Campus Virchow-Klinikum

claudia.spies@charite.de030 450 551102

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026