Calcitonin Gene derived peptides for an Optimized Patient Transfer using an Innovative Multidisciplinary Assessment in the Canton Aargau (OPTIMA II)

ISRCTN	ISRCTN62022490
DOI	https://doi.org/10.1186/ISRCTN62022490
Secondary identifying numbers	NA

Submission date: 22/09/2010
Registration date: 26/10/2010
Last edited: 18/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Werner Albrich
Scientific

Kantonsspital Aarau
Aarau
5001
Switzerland

Study information

Study design	Two separate interlinked designs: an experimental (randomised single blind effectiveness trial [primary aim]) and an integrated mixed methods design (secondary aim)
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
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
Study acronym	OPTIMA II
Study objectives	A double biomarker interdisciplinary risk-assessment bundle reduces length of stay without excess adverse events and without patient dissatisfaction.
Ethics approval(s)	The Ethics committee of the Canton of Aargau approved on the 14th of September 2010 (ref: EK 2010/045)
Health condition(s) or problem(s) studied	Lower Respiratory Tract Infection (LRTI)
Intervention	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 patients 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)
Intervention type	Other
Primary outcome measure	Physician-led length of stay during the index hospital exposure
Secondary outcome measures	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
Overall study start date	27/09/2010
Completion date	26/09/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	400
Total final enrolment	313
Key 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
Key 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)
Date of first enrolment	27/09/2010
Date of final enrolment	26/09/2011

Locations

Countries of recruitment

Switzerland

Study participating centre

Kantonsspital Aarau

Aarau
5001
Switzerland

Sponsor information

Kantonsspital Aarau (Switzerland)
Hospital/treatment centre

Tellstrasse
Aarau
5001
Switzerland

"ROR"	https://ror.org/056tb3809

Funders

Funder type

Government

Kantonsspital Aarau (Swizterland) - investigator-driven

No information available

Canton Aargau Health Department (Gesundheitsdepartement des Kantons Aargau) - local government grant

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2013	18/12/2020	Yes	No

Editorial Notes

18/12/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.