Condition category
Respiratory
Date applied
09/12/2009
Date assigned
17/02/2010
Last edited
17/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Werner Albrich

ORCID ID

Contact details

Kantonsspital Aarau
Tellstrasse
Aarau
5001
Switzerland

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

http://www.ksa.ch/

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

Publication citations

Additional files

Editorial Notes