Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617001141336
Ethics application status
Approved
Date submitted
13/01/2017
Date registered
4/08/2017
Date last updated
20/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Early Nurse Initiated Fascia Iliaca Regional Nerve Blocks for Fractured Neck of Femur in Elderly Emergency Department Patients: an Implementation and Generalisability Study
Scientific title
Early Nurse Initiated Fascia Iliaca Regional Nerve Blocks for Fractured Neck of Femur in Elderly Emergency Department Patients: an Implementation and Generalisability Study
Secondary ID [1] 290910 0
Nil
Universal Trial Number (UTN)
U1111-1191-6173
Trial acronym
ENI-FIB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fractured neck of femur (# NOF) 301631 0
Oligoanalgesia 301632 0
Condition category
Condition code
Injuries and Accidents 301336 301336 0 0
Fractures
Anaesthesiology 301337 301337 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Implementation study examining nurse-led and nurse administered Fascia Iliaca (femoral nerve) Blocks for pain management of #NOF among elderly patients in the Emergency Department. Importantly, this is purely observing the efficacy of nurse lead Fascia Iiliaca Blocks, which is being implemented into Royal North Shore Hospital, regardless of this study.
Trained senior nurses will administer 80 mg of Ropivacaine as soon as practicably possible after a patient is triaged and deemed likely to have a #NOF, ideally within one hour of presentation.
Nurse training will be
a) one full day didactic and practical session at the Medical Simulation Centre in the Kolling Institute
b) a minimum of four quarter-yearly three-hour didactic and practical sessions in the Emergency Department. Following the minimum attendance, further quarter yearly practical sessions will continue to be held for new Nurses wishing to partake in the study, as well as any Nurses who feel as though they need more practical sessions before performing a supervised block on a real patient.
c) all nurses need to perform a minimum of three procedures under the direct supervision of an ultra-sound qualified Senior Staff Specialist
d) the training will be co-ordinated by an ultra-sound qualified Senior Staff Specialist

When a nurse operator has been credentialed to perform ENI-FIB autonomously and have done a minimum of ten successful procedures, they will be credentialed to train other nurses who have undergone the didactic/practical sessions listed above.
The anticipated start date for the Gosford ENI-FIB session will be May 10 2017.

Strategies used to monitor the adherence to the intervention include continuous logging of all procedures and continuous scrutiny of the effectiveness of the blocks and of any implementation issues, safety issues, or other issues as part of the bi-weekly steering group meeting. Evaluating the sustainability of the implementation is a core focus of the study and will be undertaken at the end of the study by comparing data on rates of ENI-FIB at the commencement and at the end of the study term.

Small-scale follow-up will enquire into recovery rates after surgical repair and discharge to home.
Intervention code [1] 298658 0
Not applicable
Comparator / control treatment
Study is internally controlled: any patients not captured by the nurse-led initiative will act as the control. Standard care for these patients could involve a medical block later in the patient journey, and/or the administration of other analagesic agents including opioids and/or ibuprofen and/or paracetamol.
Pre-implementation practices (ie prior to the adoption of nurse-led FIBs as standard prcatice) will be audited retrospectively and these data will act as comparator data.
Control group
Active

Outcomes
Primary outcome [1] 300741 0
Demonstrate the safety of Nurse initiated Fascia Iliaca Block to medically initiated blocks. We will assess this outcome by documenting and statistically comparing (using a two tailed T test) number of (if any) adverse events observed post block, Monitoring for adverse events will continue for 60 minutes post block, this includes monitoring of vitals (BP/HR/RR/SpO2/Temp) and neurovascular observations
Timepoint [1] 300741 0
15 minutes post block, then again 60 minutes post block
Primary outcome [2] 300742 0
Evaluate the ability of trained nursing staff to safely 'pass on' this knowledge to other nursing staff at both the primary and secondary site using a 'train the trainer' approach. This will be assessed by statistical comparison (two tailed T test) of data relating to any adverse events following the FIB within the nursing staff at each site and between the sites as well. The data will be collected by review of medical records.
Timepoint [2] 300742 0
Two years after staff familiarisation and training is completed at both sites.
Primary outcome [3] 302773 0
Observe whether nurses can establish equal levels of analgesia compared to medically initiated fascia iliaca blocks. This will be evaluated by statistically comparing (using a two tailed T test) ten point numerical ratings of pain scores reported by patients post block
Timepoint [3] 302773 0
Pain score recorded 60 minutes post block
Secondary outcome [1] 330770 0
Evaluate the effects that early Fascia Iliaca Blocks has on subsequent opioid use during a #NOF patient's hospital stay. This will be asses by comparing average dosage of opioids between patients by review of medical records
Timepoint [1] 330770 0
From administration of block until hospital discharge
Secondary outcome [2] 330771 0
Compare the waiting time of a patient to receive a Fascia Iliaca Block when presenting to ED with a #NOF if the block is performed by a nurse vs medical staff. This will be done by comparing the mean time before administration of a Fascia Iliaca Block can be performed between the two groups by review of medical records
Timepoint [2] 330771 0
This will be done retrospectively at the completion of the study
Secondary outcome [3] 336984 0
Compare the number of adverse events occurring between the patients receiving FIB and those who receive traditional opioid analgesia. Data will be collected retrospectively from medical records
Timepoint [3] 336984 0
From administration of analgesia until hospital discharge

Eligibility
Key inclusion criteria
Patients over the age of 65 years who have a suspected #NOF and who consent to a nurse-initiated Fascia Iliaca Block
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Absolute Contraindications

• Inability to cooperate with procedure
• Medical or behavioural reasons (agitation, dementia, etc)
• Known allergy to local anaesthetics
• Any Ropivacaine contraindications
• Adult that weighs less than 40kg
• Localised injection site infections
• Inability to identify the femoral artery with ultrasound

Relative Contraindications
• Documented hepatic disease
• Known bleeding problems
• Documented evidence of second or third-degree heart block on ECG (unless patient has a personal pacemaker)
• On anticoagulants

Study design
Purpose
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample size: all patients who present to ED with a #NOF and is eligible for a Fasica Iliaca Block will be recruited to the study
Primary Outcomes:
1. Determine whether Nursing staff can perform a Fasicia Iliaca block to provide safe and eqi-analgesia compared to medical administration of the block
- Statistical Analysis: Two Tailed T-Test comparing number of adverse events and the mean numerical pain score between nurse, and medical administration of the Fascia Iliaca Block
2. Demonstrate that safe and effective Nurse administered Fascia Iliaca Blocks can be taught and performed at a secondary site using a “train the trainer” approach
- Statistical Analysis: Two Tailed T-Test comparing number of adverse events, time to block, and the mean numerical pain score between nurses who performed the Fascia Iliaca Block at the primary site compared to nurses at the secondary site.

Secondary Outcomes
1. Compare waiting time to receive a Fascia Iliaca Block in the patient's journey through ED when the block is administered by a nurse vs medical staff
- Statistical Analysis: Two Tailed T-Test of average time to block
2. Demonstrate that early application of Fascia Iliaca Block can reduce total opioid use during a patient's hospital stay and reduce delirium
- Statstical Analysis: Two Tailed T-Test comparing opioid use of patients and number of diagnosed cases of delirium following a #NOF in patients who received early nurse initiated Fascia Iliaca Block vs standard medical care
3. Determine long term outcomes of patients in comparing residual post operative pain, as recorded in a numerical rating scale of 1-10, and current activities of daily living between those that received early Nurse Initiated Fascia Iliaca Block against those who received standard care
- Statistical Analysis: Two Tailed T-Test comparing numerical Pain scales between groups and a chi squared test of differences in activities of daily living between groups in regards to whether the tasks are completed alone or with aid, using variables including: foot care, showering/bathing, laundry, cleaning, shopping, cooking, transport, gardening, doctor appointments

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/02/2017
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
31/12/2019
Actual
Sample size
Target
350
Accrual to date
40
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7301 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 7302 0
Gosford Hospital - Gosford
Recruitment postcode(s) [1] 15074 0
2065 - St Leonards
Recruitment postcode(s) [2] 15075 0
2250 - Gosford

Funding & Sponsors
Funding source category [1] 295334 0
Government body
Name [1] 295334 0
NSW Health
Country [1] 295334 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital
Address
Pacific Highway,
St. Leonards
NSW
2065
Country
Australia
Secondary sponsor category [1] 294160 0
None
Name [1] 294160 0
Address [1] 294160 0
Country [1] 294160 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296671 0
NSLHD HREC
Ethics committee address [1] 296671 0
Research Office

Level 13, Kolling Building
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 296671 0
Australia
Date submitted for ethics approval [1] 296671 0
06/06/2016
Approval date [1] 296671 0
07/09/2016
Ethics approval number [1] 296671 0
HREC/16/HAWKE/203

Summary
Brief summary
Fractured neck of femur (#NOF) is a common, painful condition in the elderly for which regional nerve block (RNB) techniques provide effective and safe analgesia. Presently, RNBs are administered by doctors, usually later in the patient journey.
RNB via Fascia Iliaca Nerve Block (FIB) has been demonstrated to be safe and effective when administered by trained nurses.

We hypothesise that early, nurse-initiated FIB (ENI FIB) can be successfully introduced and sustained within a tertiary level Emergency Department (ED) and can be generalised to a regional ED. We aim to demonstrate that ENI FIB can be delivered to a higher proportion of eligible patients than current practice, is at least equi-analgesic and equivalently safe with standard medical RNB, and can be delivered significantly earlier than medically-initiated RNB.

In the preparatory phase, data will be collected regarding current RNB/analgesic therapy whilst a core nurse FIB operator group is trained at RNSH. Subsequently the implementation phase will begin in early 2017 where ENI FIB will be introduced as the preferred RNB for #NOF. Data will be collected regarding enrollment rates, safety, pain levels and times to analgesia. Gosford ED will follow the protocol six months behind RNSH with implementation taking place in May 2017.

After twelve months, ENI FIB will be re-evaluated at both sites with respect to embeddedness, safety and effective practice. The Implementation Package will be refined as indicated.

Potential benefits are that significantly more patients with #NOF will have access to effective, safe and early pain relief. We aim to demonstrate that this model of care is generalisable to another ED whilst yielding similar positive clinical outcomes.
Assuming adoption and sustainability of ENI FIB at both sites, there is potential to roll out a standardised, proven ENI FIB program across a large number of the State’s EDs in an economical fashion, utilising a ‘train the trainer’ model and our refined Implementation Package.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1368 1368 0 0
/AnzctrAttachments/372161-HREC ENI FIB Protocol Version I 26.08.2016.docx (Protocol)
Attachments [2] 1369 1369 0 0
/AnzctrAttachments/372161-ENI FIB HREC approval letter v1 12.01.2017.pdf (Ethics approval)
Attachments [3] 1370 1370 0 0
/AnzctrAttachments/372161-Master Consent Form- ENI-FIB study Version I 26.08.2016.docx (Participant information/consent)

Contacts
Principal investigator
Name 71702 0
A/Prof Mark Gillett
Address 71702 0
Emergency Department,
Royal North Shore Hospital,
Pacific Highway,
St Leonards,
NSW 2065
Country 71702 0
Australia
Phone 71702 0
+61 2 9906 8123
Fax 71702 0
Email 71702 0
[email protected]
Contact person for public queries
Name 71703 0
A/Prof Mark Gillett
Address 71703 0
Emergency Department,
Royal North Shore Hospital,
Pacific Highway,
St Leonards,
NSW 2065
Country 71703 0
Australia
Phone 71703 0
+61 2 9906 8123
Fax 71703 0
Email 71703 0
[email protected]
Contact person for scientific queries
Name 71704 0
A/Prof Mark Gillett
Address 71704 0
Emergency Department,
Royal North Shore Hospital,
Pacific Highway,
St Leonards,
NSW 2065
Country 71704 0
Australia
Phone 71704 0
+61 2 9906 8123
Fax 71704 0
Email 71704 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.