|- candidate number||29474|
|- NTR Number||NTR7452|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-aug-2018|
|- Secondary IDs||2017.503 METc VUmc registratienummer|
|- Public Title||Bedside testing for lower respiratory tract infections in nursing homes.|
|- Scientific Title||Using Point-of-care C-reactive protein to guide Antibiotic prescribing for Respiratory tract infections in Elderly nursing home residents|
|- hypothesis||Antibiotics are over-prescribed for lower respiratory tract infection (LRTI) in nursing home (NH) residents due to diagnostic uncertainty. Inappropriate antibiotic use is undesirable both on patient level, considering their exposure to side-effects and drug interactions, and on societal level, given the potential development of antibiotic resistance. The diagnosis of LRTI is challenging in NHs, as NH residents often lack typical symptoms, and because cognitive disabilities can impede communication of experienced complaints. ln addition, diagnostic tools are often not well-applicable or not directly available in the NH setting. C-reactive protein (CRP) point-of-care testing (POCT) may be a promising diagnostic tool to reduce unnecessary antibiotic use for LRTI in NHs. |
The overarching aim of the UPCARE study is to achieve better antibiotic stewardship by introducing a cheap, quick and easy-to-use diagnostic tool for the evaluation of LRTI in NHs: CRP POCT.
|- Healt Condition(s) or Problem(s) studied||Pneumonia, Lower respiratory tract infections, Lung inflammation|
|- Inclusion criteria||- Residence at a nursing home;|
- Residence at a psychogeriatric, somatic, or geriatric rehabilitation department
- A new diagnosis 'suspected lower respiratory tract infection'
|- Exclusion criteria||- The patient no longer wishes to be treated with antibiotics in case of a lower respiratory tract infection;|
- Recent use of antibiotics (oral, intravenous, or intramuscular) in the week preceding the current respiratory tract infection;
- Recent infection, other than a respiratory tract infection, in the week preceding the current respiratory tract infection;
- The patient receives palliative or terminal care.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||Single arm|
|- planned startdate ||1-sep-2018|
|- planned closingdate||1-mrt-2020|
|- Target number of participants||588|
|- Interventions||A cluster randomized controlled trial (cRCT) will be conducted in NH organizations. Participating NHs will be randomized to the intervention or control group. ln the control group, care as usual is provided. ln the intervention group, physicians provide care as usual including C-Reactive Protein (CRP) Point-Of-Care-Testing (POCT) for patients who are diagnosed with 'suspected LRTl'. Elderly care physicians consider CRP POCT results along with the clinical features of the patient in their decision to prescribe or not prescribe antibiotics.|
|- Primary outcome||The central research question is whether the use of CRP POCT results in a reduction in antibiotic prescribing for NH residents with suspected LRTl, without any negative consequences for patient recovery
The primary outcome is antibiotic prescribing for suspected LRTl at index consultation (yes/no).
|- Secondary outcome||Secondary research questions:|
1) Associations between CRP POCT values and:
a. signs and symptoms in NH patients with suspected LRTI
b. antibiotic treatment (yes/no)
2) Cost-effectiveness and cost-benefit of the use of CRP POCT compared to usual care for NH patients with suspected LRTI.
|- Timepoints||During the study period (September 2018-March 2020), data collection occurs through an electronic patient file. For each diagnosis “suspected LRTI” entered by a physician in the electronic patient file, a screen will pop-up with questions about study eligibility and informed consent. In a subsequent screen the physician can fill out the research questionnaire. Follow-up information on patient recovery and changes in policy is asked one and three weeks later. In addition, pharmacy data will be collected on total antibiotic use in the NH during the study period.
|- Trial web site||-|
|- CONTACT FOR PUBLIC QUERIES||Drs. Tjarda M. Boere|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. Cees M.P.M. Hertogh|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|Saltro/Orion Diagnostica, ZonMw|
|- Brief summary||A cluster Randomized Controlled Trial (cRCT) will be conducted in NH organizations in the Netherlands, with the NH as the unit of randomization. NHs in the intervention group will use CRP POCT, and NHs in the control group will provide care as usual for NH residents with (suspected) LRTI.|
|- Main changes (audit trail)|
|- RECORD||29-aug-2018 - 9-sep-2018|