Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Optimised Patient Transfer using an Innovative Multidisciplinary Assessment in the Canton Aargau (OPTIMA) : An observational quality control trial
Acronym
OPTIMA
Study hypothesis
To develop appropriate triage pathways based on medical, nursing and psychosocial criteria in patients with lower respiratory tract infections
Ethics approval
The Canton Aargau Cantonal Ethics Committee (Kantonale Ethikkommission Kanton Aargau) approved on the 10th of November (ref: EK 2009/074)
Study design
Observational quality-control analysis of current practice
Primary study design
Observational
Secondary study design
Other
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Respiratory tract infections
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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
Secondary outcome measures
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
Overall trial start date
10/11/2009
Overall trial end date
31/10/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age ≥ 18 years
2. Admission to Emergency Department (ED) of acute care hospital (Kantonsspital Aarau, Klinik Barmelweid) for acute lower respiratory tract infections
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
450
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
10/11/2009
Recruitment end date
31/10/2010
Locations
Countries of recruitment
Switzerland
Trial participating centre
Kantonsspital Aarau
Aarau
5001
Switzerland
Sponsor information
Organisation
Kantonsspital Aarau (Switzerland)
Sponsor details
Tellstrasse
Aarau
5001
Switzerland
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Kantonsspital Aarau (Swizterland) - investigator-driven
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Canton AargauHealth Department (Gesundheitsdepartement des Kantons Aargau) - local government grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary