The Quality in Acute Stroke Care (QASC) Australasia Trial: Multi-national Translation of Fever, Sugar, Swallow (FeSS) Protocols

Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: The intervention is testing the amount of external remote facilitation (high, low or none) needed to improve implementation of the Fever Sugar Swallow (FeSS) Protocols for stroke patients admitted to stroke units/stroke services in Australia. Hospitals will be randomised to one of the three study groups – high intensity external remote facilitation intervention group, low intensity external remote facilitation intervention group, or a no facilitation control group. All participating hospitals will nominate at least one nurse currently working in the stroke unit/stroke service to act as a site clinical champion and will receive the intervention components depending on study group allocation as outlined below. High intensity external remote facilitation intervention group: Hospitals randomised to this group will receive: i) the FeSS Protocols (refined from the Quality in Acute Stroke Care (QASC) trial, ACTRN12608000563369) ii) the online FeSS education package consisting of three components which will be designed specifically for this study: a) an Online Education Resource Package: An online education resource package comprising a suite of short (3‐5 minute) videos and downloadable hard‐copy resources will be developed by the research team and provided to site champions. It is anticipated that the package will be hosted on the Australian Catholic University Open Learning webpage. Video topics will be based on case studies using role‐playing actors and animations. The video topics include: 1. Short introduction of the benefits of FeSS Protocols in stroke 2. Detailed video regarding FeSS Protocols 3. Fever Protocol 4. Hyperglycaemia or ‘Sugar’ Protocol 5. Swallow Protocol 6. Implementation and behaviour change ‐ The science behind i CONDITION: Stroke ‐ Haemorrhagic Stroke ‐ Ischaemic Stroke; ; Stroke SECONDARY OUTCOME: A qualitative exploration of participants’ experience of contributing organisational, contextual and structural factors that impacted successful/unsuccessful uptake of the intervention through: either individual face‐to‐face/virtual interviews or focus group interviews with stroke unit/stroke service nurses and doctors depending on clinician availability and preference.[Once all sites have completed post‐implementation data entry.] Additional cost per quality adjusted life year gained at 6 months post‐stroke due to implementation of the FeSS Protocols.[180 days post‐stroke. ] Comparison between metropolitan and rural/remote hospitals for composite outcome of adherence to each of the combined monitoring and treatment elements for: i) fever, ii) hyperglycaemia (sugar) and iii) swallowing, and to the individual elements that make up each of the FeSS Protocols: ; Fever Protocol ‐ Proportion of patients who had: ; • temperature monitored at least four times per day on day of admission (assessed via ; medical record audit) ; • temperature monitored at least four times per day on day two of admission (assessed ; via medical record audit) ; • temperature monitored at least four times per day on day three of admission (assessed ; via medical record audit) ; • paracetamol (or other anti‐pyretic) given for first temperature equal to or greater than ; 37.5°C (assessed via medical record audit) ; • paracetamol (or other anti‐pyretic) given with one hour from first temperature equal to ; or greater than 37.5°C (assessed via medical record audit) ; ; Hyperglycaemia (Sugar) Protocol ‐ Proportion of patients who had: ; • venous blood glucose level sample collected and sent to laboratory (assessed via ; medical record audit) ; • blood glucose levels (BGL) monitored at least four times per day on day of admission ; (assessed via medical record audit) PRIMARY OUTCOME: Composite outcome of overall adherence with all monitoring and treatment elements of the FeSS Protocols ‐ Proportion of patients who:; • had temperature monitored at least four times per day on day of admission (assessed ; via medical record audit); • had temperature monitored at least four times per day on day two of admission ; (assessed via medical record audit); • had temperature monitored at least four times per day on day three of admission ; (assessed via medical record audit); • had paracetamol (or other anti‐pyretic) given for first temperature equal to or greater; than 37.5°C (assessed via medical record audit); • had paracetamol (or other anti‐pyretic) given with one hour from first temperature; equal to or greater than 37.5°C (assessed via medical record audit); • had venous blood glucose level sample collected and sent to laboratory (assessed via ; medical record audit); • had blood glucose levels (BGL) monitored at least four times per day on day of; admission (assessed via medical record audit); • had BGL’s monitored at least four times per day on day two of admission (assessed via ; medical record audit); • had BGL’s monitored at least four times per day on day three of admission (if BGL’s; unstable) (assessed via medical record audit); • had insulin given for first BGL equal to or greater than 10mmol/L (assessed via medical ; record audit); • had insulin given within one hour from first BGL equal to or greater than 10mmol/L; • had formal swallow screen performed (assessed via medical record audit); • failed screen and subsequently had swallow assessment (assessed via medical record ; audit); • had swallow screen performed within 24 hours (assessed via medical record audit); • had swallow assessment recorded (assessed via medical record audit); • had swallow screen recorded (assessed via medical record audit); • had swallow screen or assessment performed before being given oral medications ; (assessed via medical record audit); • had swallow screen or assessment performed before being given oral food or fluids ; (assessed via medical record audit); ; [Baseline and 6 months (primary timepoint) after intervention commencement date which will be negotiated with each hospital.; ] ; • BGL’s monitored at least four times per day on day two of admission (assessed via ; medical record audit) ; • BGL’s monitored at least four times per day on day three of admission (if BGL’s ; unstable) (assessed via medical record audit) ; • insulin given for first BGL equal to or greater than 10mmol/L (assessed via medical ; record audit) ; • insulin given within one hour from first BGL equal to or greater than 10mmol/L ; (assessed via medical record audit) ; ; Swallow Protocol ‐ Proportion of patients who: ; • had formal swallow screen performed (assessed via medical record audit) ; • failed screen and subsequently had swallow assessment (assessed via medical record ; audit) ; • had swallow screen performed within 24 hours (assessed via medical record audit) ; • had swallow assessment recorded (assessed via medical record audit) ; • had swallow screen recorded (assessed via medical record audit) ; • had swallow screen or assessment performed before being given oral medications ; (assessed via medical record audit) ; • had swallow screen or assessment performed before being given oral food or fluids ; (assessed via medical record audit) ; [Baseline and 6 months after intervention commencement date which will be negotiated with each hospital.. ; ] Composite outcome of adherence to the combined monitoring and treatment elements for the Fever Protocol, and to the individual elements that make up this protocol ‐ Proportion of patients who had: ; • temperature monitored at least four times per day on day of admission (assessed via ; medical record audit) ; • temperature monitored at least four times per day on day two of admission (assessed ; via medical record audit) ; • temperature monitored at least four times per day on day three of admission (assessed ; via medical record audit) ; • paracetamol (or other anti‐pyretic) given for first temperature equal to or greater than ; 37.5°C (assessed via medical record audit) ; • paracetamol (or other anti‐pyretic) given with one hour from first temperature equal to ; or greater than 37.5°C (assessed via medical record audit) ; [Baseline and 6 months after intervention commencement date which will be negotiated with each hospital.] Composite outcome of adherence to the combined monitoring and treatment elements for the Hyperglycaemia (Sugar) Protocol, and to the individual elements that make up this protocol ‐ Proportion of patients who had: ; • venous blood glucose level sample collected and sent to laboratory (assessed via ; medical record audit) ; • blood glucose levels (BGL) monitored at least four times per day on day of admission ; (assessed via medical record audit) ; • BGL’s monitored at least four times per day on day two of admission (assessed via ; medical record audit) ; • BGL’s monitored at least four times per day on day three of admission (if BGL’s ; unstable) (assessed via medical record audit) ; • insulin given for first BGL equal to or greater than 10mmol/L (assessed via medical ; record audit) ; • insulin given within one hour from first BGL equal to or greater than 10mmol/L ; (assessed via medical record audit) ; [Baseline and 6 months after intervention commencement date which will be negotiated with each hospital.] Composite outcome of adherence to the combined monitoring and treatment elements for the Hyperglycaemia (Sugar) Protocol, and to the individual elements that make up this protocol ‐ Proportion of patients who: ; • had formal swallow screen performed (assessed via medical record audit) ; • failed screen and subsequently had swallow assessment (assessed via medical record ; audit) ; • had swallow screen performed within 24 hours (assessed via medical record audit) ; • had swallow assessment recorded (assessed via medical record audit) ; • had swallow screen recorded (assessed via medical record audit) ; • had swallow screen or assessment performed before being given oral medications ; (assessed via medical record audit) ; • had swallow screen or assessment performed before being given oral food or fluids ; (assessed via medical record audit) ; [Baseline and 6 months after intervention commencement date which will be negotiated with each hospital.] INCLUSION CRITERIA: Hospitals To be eligible to participate in the study, hospitals must: ‐ have at least one staff member to fulfill the role of site clinical champion ‐ Advise on obtaining human research ethics and site‐specific governance approvals ‐ nominate staff to undertake patient medical record audits pre‐ and post‐intervention implementation and enter data into the Australian Stroke Data Tool ‐ grant permission to the researchers to obtain patient medical record audit data from the Australian Stroke Data Tool data custodian Patients The medical records of eligible patients will be audited by participating hospital staff. Patients will be eligib ‐ have a pre‐existing acute stroke unit (organised care within a specific ward in a hospital by a multidisciplinary team who specialise in stroke management) or a stroke service (no dedicated stroke unit but with integrated hospital stroke services based on agreed hospital service delineations)
Epistemonikos ID: 44ba92806067ad1add24c7e52906357d82461e92
First added on: Aug 25, 2024