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Calcitonin Gene derived peptides for an Optimized Patient Transfer using an Innovative Multidisciplinary Assessment in the Canton Aargau (OPTIMA II)
ISRCTN ISRCTN62022490
DOI 10.1186/ISRCTN62022490
ClinicalTrials.gov identifier
EudraCT number
Public title Calcitonin Gene derived peptides for an Optimized Patient Transfer using an Innovative Multidisciplinary Assessment in the Canton Aargau (OPTIMA II)
Scientific title Calcitonin Gene derived peptides for an Optimized Patient Transfer using an Innovative Multidisciplinary Assessment in the Canton Aargau (OPTIMA II): A trial using two separate interlinked designs
Acronym OPTIMA II
Serial number at source NA
Study hypothesis A double biomarker interdisciplinary risk-assessment bundle reduces length of stay without excess adverse events and without patient dissatisfaction.
Lay summary
Ethics approval The Ethics committee of the Canton of Aargau approved on the 14th of September 2010 (ref: EK 2010/045)
Study design Two separate interlinked designs: an experimental (randomised single blind effectiveness trial [primary aim]) and an integrated mixed methods design (secondary aim)
Countries of recruitment Switzerland
Disease/condition/study domain Lower Respiratory Tract Infection (LRTI)
Participants - inclusion criteria 1. Patients 18 years of age or older
2. Admitted from the community or a nursing home with acute (i.e. symptoms less than 28 days) Lower Respiratory Tract Infection (LRTI) as main diagnosis. LRTI will consist of at least one respiratory symptom (cough, sputum production, dyspnea, tachypnea, pleuritic pain) and one auscultatory finding or systemic inflammatory signs (core body temperature >38.0° C, shivers, leukocyte count >10 or <4 x 109 cells/ L) independent of antibiotic pretreatment.
3. Ability to understand verbal and written instructions and informed consent by patient or available relatives
Participants - exclusion criteria 1. Patients permanently unable to give written informed consent, e.g. with severe dementia, if no relative and an independent physician (not part of the study team) are available to provide consent for the patient
2. Patients without command of the German, English, French, Italian, Turkish or Serbian language, who will not be able, within reason, to get translators (e.g. family members) during admission, hospitalization and follow-up telephone interview
3. Terminal and very severe disease or medical co-morbidity where death is imminent and comfort therapy is provided
4. Severe immunosuppression, foreseeable non-compliance for follow-up (e.g. current drug use)
Anticipated start date 27/09/2010
Anticipated end date 26/09/2011
Status of trial Completed
Patient information material Not available in web format, please use contact details below to request a patient information sheet
Target number of participants 400
Interventions All patients receive guideline-based, multidisciplinary bundle of clinical, laboratory (PCT), nursing, functional and psychosocial care, enforced with high-intensity and include clinical (CURB65 and medical stability), biopsychosocial and functional scores, and structured discharge planning while strongly considering patientís preferences and current living situation.
Site of care recommendation will be based on the guideline-conform risk algorithm without (control) or with a second biomarker (ProADM) on days 0, 2 and 5 (+/-1).
Sites of care are recommended as follows:
1. High risk: hospital or intensive care
2. Intermediate risk: short hospitalization
3. Low risk: ambulatory care, post-peracute care (home health care, health resort) or a newly designed Nurse-Led Unit (NLU)
Primary outcome measure(s) Physician-led length of stay during the index hospital exposure
Secondary outcome measure(s) 1. Primary Aim:
1.1. Other measures of resource utilization (different definitions of length of stay including rehospitalisation; treatment changes)
1.2. Adherence to triage algorithms
1.3. Functional status and adverse events (i.e. mortality; rate of complications)
1.4. Patient satisfaction
1.5. Quality of life assessment
1.6. Effective and chargeable costs for treatment path.
Endpoints will be assessed at discharge to non-hospital setting, 30 days and 3 months after admission.
2. Secondary aim:
2.1. Evaluation of the feasibility of an NLU on institutional, patient and nurse outcomes using a mixed methods approach
Sources of funding 1. Kantonsspital Aarau (Swizterland) - investigator-driven
2. Canton Aargau Health Department (Gesundheitsdepartement des Kantons Aargau) - local government grant
Trial website https://optima.mda.ch
Publications
Contact name Dr  Werner  Albrich
  Address Kantonsspital Aarau
  City/town Aarau
  Zip/Postcode 5001
  Country Switzerland
Sponsor Kantonsspital Aarau (Switzerland)
  Address Tellstrasse
  City/town Aarau
  Zip/Postcode 5001
  Country Switzerland
Date applied 22/09/2010
Last edited 26/10/2010
Date ISRCTN assigned 26/10/2010
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