OPTIMA II

Projektname
Optimized Patient Transfer using an Innovative Multidisciplinary Assessment - The development, implementation, and evaluation of a hospital based nurse-led unit for older patients at high biopsychosocial and low medical risk

Forschungsleitung
Beat Müller

Forschungsteam
Sabina De Geest; Antoinette Conca; Barbara Reutlinger; Maria Schubert; Petra Schäfer-Keller; Priska Scimonetti; Riat Bossart; Susanne Schirlo; Werner C. Albrich

Zusammenarbeit mit
Kantonsspital Aarau

Laufzeit
2011 bis 2013

Projektbeschreibung
Background: Lower respiratory tract infections (LRTIs) are the most impor-
tant drivers of hospitalization and antibiotic overuse. Due to ageing and changes in societal structure, patients with LRTI and low medical risk are hospitalized primarily based on psychosocial and functional factors, co-morbidities and anticipation of complications. Hospitalizations are associated with accelerated functional decline and nosocomial complications. An early, com-prehensive and adequate risk assessment combining medical, biopsychosocial and functional approaches will optimize patient care and the allocation of limited hospital beds and health care resources. Two of the CALC gene superfamily of peptides, procalcitonin (PCT) and proadrenomedullin (ProADM), appear to be superior diagnostic and prognostic tools.

Aim: To compare the effect of risk-based triage including a single biomarker (PCT) or a double biomarker (PCT and ProADM) in the implementation of an intensively reinforced, guideline-conform interdisciplinary medical, biopsychosocial and functional risk assessment bundle for site of care decisions, prediction of outcome in patients with LRTIs and patient satisfaction. We will also assess the feasibility of a nurse led unit (NLU) for patients with LRTI identified at low medical risk but high biopsychosocial and/or functional risk.

Design: Two separate interlinked designs: an experimental (randomized single-blinded effectiveness trial; primary aim) and an integrated mixed methods design (secondary aim).

Setting: Two mixed primary to tertiary care settings providing the entire patient treatment pathway from emergency department (ED) to discharge to non-hospital setting.

Patients: Consecutive adult patients with LRTI presenting to the ED who are able and willing to give informed consent.

Sample Size: A total of between 284-546 patients gives this study a power of 80% at the 2-sided 5% to detect a 1.5-2.0 days difference in time to hospital discharge (5-5.5 days in the intervention group, 7 days in the control group). Instead of a fixed sample size, we predefine a ­recruitment period of 9 months with the goal to randomize all eligible patients, with an extension if less than 400 patients are recruited.

Intervention: All patients will receive a guideline-based, multidisciplinary bundle of clinical, laboratory (PCT), nursing, functional and psychosocial care. This will be 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 will be recommended based on the expected risk as follows: i) high risk: hospital or intensive care; ii) intermediate risk: short hospitalization; iii) low risk: ambulatory care, post-peracute care (home health care, health resort) or a newly designed NLU. 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).

Endpoints: Primary aim: Primary endpoint is to compare the effectiveness of double (PCT and ProADM) vs single (PCT) biomarker risk assessment bundle regarding length of physician-led hospitalization. 

Secondary end point: a. other measures of resource utilization (different definitions of length of stay including rehospitalisation; treatment changes); b. adherence to triage algorithms; c. functional status and adverse events (i.e. mortality; rate of complications); d. patient satisfaction; e. quality of life assessment; f. effective and chargeable costs for treatment path. Endpoints will be assessed at discharge to non-hospital setting, 30 days and 3 months after admission. Secondary aim: Evaluation of the feasibility of an NLU on institutional, patient and nurse outcomes using a mixed methods approach.
Working hypothesis: A double biomarker interdisciplinary risk-assessment bundle reduces length of stay without excess adverse events and without patient dissatisfaction.

Ancillary projects: Two ancillary projects will synergize scientific efforts. We will assess a variety of diagnostic and prognostic biomarkers in patients with urinary tract infections and subsequently perform an intervention study using an interdisciplinary assessment.

Significance: The implementation of triage decisions must be improved to reflect true medical, biopsychosocial and functional risks. This study is a logical extension of successful and innovative studies combining an interdisciplinary risk assessment bundle with biomarkers.