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ISRCTN
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ISRCTN76703125
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ClinicalTrials.gov identifier
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Public title
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Optimised Patient Transfer using an Innovative Multidisciplinary Assessment in the Canton Aargau (OPTIMA)
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Scientific title
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Optimised Patient Transfer using an Innovative Multidisciplinary Assessment in the Canton Aargau (OPTIMA) : An observational quality control trial
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Acronym
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OPTIMA
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Serial number at source
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N/A
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Study hypothesis
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To develop appropriate triage pathways based on medical, nursing and psychosocial criteria in patients with lower respiratory tract infections
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Lay summary
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Ethics approval
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The Canton Aargau Cantonal Ethics Committee (Kantonale Ethikkommission Kanton Aargau) approved on the 10th of November (ref: EK 2009/074)
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Study design
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Observational quality-control analysis of current practice
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Countries of recruitment
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Switzerland
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Disease/condition/study domain
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Respiratory tract infections
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Participants - inclusion criteria
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1. Age ≥ 18 years
2. Admission to Emergency Department (ED) of acute care hospital (Kantonsspital Aarau, Klinik Barmelweid) for acute lower respiratory tract infections
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Participants - exclusion criteria
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Does not match inclusion criteria
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Anticipated start date
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10/11/2009
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Anticipated end date
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31/10/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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450
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Interventions
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Currently, most patients with lower respiratory tract infections, who are seen and evaluated in our Emergency Department, are generally admitted to hospital regardless of medical, nursing and psychosocial criteria. Clinical severity scores such as CURB65 and Pneumonia Severity Index (PSI), the levels of biomarkers, nursing risk assessments and patient's and relatives' preferences are not strictly applied and followed, but will be assessed in this observational analysis. Based on this patients will be classified into low, intermediate, high and very high risks corresponding to virtual triage into ambulatory, post-peracute care, spa treatment, nurse-led unit or traditional acute hospital care.
Patients will be followed up for 30 days after presentation.
The duration of the observation period is from November 2009 until May 2010.
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Primary outcome measure(s)
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To define the percentage of allocated patients into low, intermediate, high and very high risks based on medical, nursing and psychosocial criteria corresponding to virtual triage into ambulatory, post-peracute care, spa treatment, nurse-led unit or traditional acute hospital care
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Secondary outcome measure(s)
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1. Correlation of biomarkers, clinical and nursing scores (separately and in combination) with patients' outcomes (hospital mortality, ICU requirement and severe complications such as empyema, lung abscess, development of acute respiratory distress syndrome [ARDS], persistence or development of pneumonia) and site of care decisions
2. Identification and adaptation of medical, nursing and psychosocial criteria for triage decisions using biomarkers, clinical scores and functionality assessments, patients' and relatives` preferences
3. Testing the usefulness and feasibility of functional status and risk assessment tools as a surrogate marker for nursing requirements for risk-stratification
4. Comparison of the post-acute care discharge score with biomarkers and other clinical and functional assessment tools on day 3
5. External validation of the 5 day-1-items identified as predictive for post-acute care discharge
6. Identification of patients' and relatives' information needs
7. Cost-effectiveness of innovative pathways based on case-based lump sum (Fallpauschale) of entire treatment pathway on patient-level
8. Identification of patients' and families' preferences for site of care
9. Determination of current length of acute hospitalisation
10. Identification of medical and functional/nursing and psychosocial criteria to define stability for timely transfer to home or post-peracute care facilities (spa treatment or immediate post-peracute care in specialized facilities or NLU)
11. Determination of time to stability for transfer to post-peracute care facilities
12. Determination of proportion of patients eligible for pulmonary rehabilitation and time until eligibility
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Sources of funding
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1. Kantonsspital Aarau (Swizterland) - investigator-driven
2. Canton AargauHealth Department (Gesundheitsdepartement des Kantons Aargau) - local government grant
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Trial website
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Publications
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Contact name
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Dr
Werner
Albrich
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Address
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Kantonsspital Aarau
Tellstrasse
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City/town
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Aarau
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Zip/Postcode
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5001
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Country
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Switzerland
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Sponsor
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Kantonsspital Aarau (Switzerland)
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Address
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Tellstrasse
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City/town
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Aarau
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Zip/Postcode
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5001
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Country
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Switzerland
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Sponsor website:
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http://www.ksa.ch/
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Date applied
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09/12/2009
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Last edited
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17/02/2010
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Date ISRCTN assigned
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17/02/2010
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