Condition category
Respiratory
Date applied
22/09/2010
Date assigned
26/10/2010
Last edited
26/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

https://optima.mda.ch

Contact information

Type

Scientific

Primary contact

Dr Werner Albrich

ORCID ID

Contact details

Kantonsspital Aarau
Aarau
5001
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NA

Study information

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

Study hypothesis

A double biomarker interdisciplinary risk-assessment bundle reduces length of stay without excess adverse events and without patient dissatisfaction.

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)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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 patient’s 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

27/09/2010

Overall trial end date

26/09/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant 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)

Recruitment start date

27/09/2010

Recruitment end date

26/09/2011

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

Government

Funder name

Kantonsspital Aarau (Swizterland) - investigator-driven

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Canton Aargau Health 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