Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000792224
Ethics application status
Approved
Date submitted
7/05/2018
Date registered
10/05/2018
Date last updated
24/04/2020
Date data sharing statement initially provided
30/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Emergency Nurse Practitioners use of Point of Care Ultrasound as a diagnostic tool for adult patients with skin and soft tissue infections.
Scientific title
Emergency Nurse Practitioners use of Point of Care Ultrasound as a diagnostic tool for adult patients with skin and soft tissue infections.
Secondary ID [1] 294810 0
Nil Known
Universal Trial Number (UTN)
U1111-1213-5455
Trial acronym
NPPoCUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin and soft tissue infections 307731 0
Abscess
 307733 0
Cellulitis 307734 0
Infection 307753 0
Boil 307754 0
Folliculitis 307756 0
Lesion 307757 0
Wound infection 307758 0
Discharging wound 307760 0
Skin infection 307762 0
Condition category
Condition code
Skin 306796 306796 0 0
Other skin conditions
Emergency medicine 306797 306797 0 0
Other emergency care
Infection 306808 306808 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Skin and soft tissue infections (SSTI) are a common emergency department (ED) presentation with a differential diagnosis of cellulitis or abscess resulting in differing treatment strategies. Diagnosis of an abscess requires surgical consultation, incision and drainage, cellulitis requires antibiotics. The use of ultrasound as a diagnostic tool to determine the diagnosis of SSTI has emerged as an adjunct to emergency clinician practice. Nurse Practitioner’s (NP's) are an integral part of health care delivery in Australia and as advanced senior clinicians are a vital part of the ED team, their use of ultrasound as an adjunct to their diagnostic skills in SSTI is inevitable.

This research will explore the hypothesis: ED NP's after completion of the Point of care ultrasound training and accreditation will improve the time taken to make a diagnosis of adult emergency patients with skin and soft tissue infections.

Quantitative research in the form of a pre and post intervention design, by means of chart audit of electronic medical records and patient’s records. Data will be collected for 6 months pre intervention and 6 months post intervention, intervention is NP standardized training in PoCUS.
Intervention code [1] 301121 0
Diagnosis / Prognosis
Comparator / control treatment
The study will be conducted at Nepean Hospital Emergency Department.
May 2018 intervention of Nurse Practitioners (NP's) Course in Point of care ultrasound (PoCUS) covering skin and soft tissues.
The Retrospective chart audit six months prior to intervention will commence in June 2018 and collect data for a 6 month period prior to May 2018.
Accreditation of all eight emergency NP's in PoCUS is expected to take 3-6 months, NP's will become proficient in skin and soft tissue PoCUS and document findings in electronic medical records.
Prospective chart audit at of similar time of year is intended for 2018- 2019. A 6 month time frame is given for data collection and analysis.
Control group
Historical

Outcomes
Primary outcome [1] 305783 0
Time to diagnosis of skin and soft tissue infections as assessed by data linkage to medical records
Timepoint [1] 305783 0
Retrospective chart audit six months prior to intervention and Prospective chart audit six months after intervention. Using the same data collection tool including data collection of time taken from assessment to PoCUS performance.
Primary outcome [2] 305797 0
Emergency nurse practitioner’s use of point of care ultrasound as assessed by audit of patient medical records
Timepoint [2] 305797 0
Measured through the collection of data from patient’s charts including electronic medical record and hard copy notes. Using the same data collection tool including data collection of time taken from assessment to treatment.
Primary outcome [3] 305798 0
Length of stay in Emergency department as assessed by audit of medical records
Timepoint [3] 305798 0
Retrospective chart audit six months prior to intervention and Prospective chart audit six months after intervention. Using the same data collection tool including data collection of length of stay in the Emergency Department.
Secondary outcome [1] 346587 0
nil
Timepoint [1] 346587 0
nil

Eligibility
Key inclusion criteria
Adult patients over 16 years of age that present to Nepean emergency department with Skin and soft tissue infections of limbs including axilla and groin and are assessed through Fast Track area of the emergency department.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children under 16 years of age. Patients unstable or with signs and symptoms of septic shock who require resuscitation and or monitoring in either the acute care or resuscitation areas of the emergency department. Deep space hand infections. Prior imaging confirming a diagnosis.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Statistical Package for the Social Sciences (SPSS) software program will be used for statistical analysis, data management and data documentation. SSPS statistics will be used to analyze the data collected to achieve study aims.

Sample size and statistical power
Sample size will reflect the number of adult patients that present to the Nepean emergency department with Skin and soft tissue infections in a designated 6 months pre and post times frames in 2017-2020. Electronic medical record will extract sample population with a presenting problem including cellulitis or abscess and/or diagnosis including cellulitis or abscess.

A sample of N=500 in the pre period and N=500 in the post period will provide over 80% power at the two-sided 5% level of significance to reject the null hypothesis of no difference in the rate (i.e. speed) of reaching a differential diagnosis if the true difference in the ratio of the rates between the groups is 20%.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2020
Actual
Date of last participant enrolment
Anticipated
1/11/2020
Actual
Date of last data collection
Anticipated
1/06/2021
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10854 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 22598 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 299406 0
University
Name [1] 299406 0
Western Sydney University
Country [1] 299406 0
Australia
Funding source category [2] 299407 0
Hospital
Name [2] 299407 0
Nepean Hospital
Country [2] 299407 0
Australia
Primary sponsor type
Hospital
Name
Nepean Hospital
Address
Centre of Nursing Research Western Sydney University & Nepean Blue Mountains Local Health District
Level 1 Court Building
Derby Street
Kingswood NSW 2747
Country
Australia
Secondary sponsor category [1] 298692 0
University
Name [1] 298692 0
Western Sydney University
Address [1] 298692 0
Centre of Nursing Research Western Sydney University & Nepean Blue Mountains Local Health District
Level 1 Court Building
Derby Street
Kingswood NSW 2747
Country [1] 298692 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300309 0
APPOLLO Nepean Blue Mountains Local health District
Ethics committee address [1] 300309 0
Nepean Hospital
Derby Street
Kingswood NSW 2747
Ethics committee country [1] 300309 0
Australia
Date submitted for ethics approval [1] 300309 0
11/04/2018
Approval date [1] 300309 0
19/04/2018
Ethics approval number [1] 300309 0
Study 18-25(A)

Summary
Brief summary
The research proposed will study the use of Point of Care Ultrasound (PoCUS) to differentiate the diagnosis of skin and soft tissue infections (SSTI). SSTI are a common emergency department (ED) presentation with a differential diagnosis of cellulitis or abscess and therefore differing treatment strategies. The use of ultrasound as a diagnostic tool to determine the subsequent treatment has emerged as an adjunct to emergency physician practice. Nurse Practitioners (NP) as an integral part of the Nepean ED team are expanding their Scope of Practice (SOP) to include the use of PoCUS. This research will look at the NP’s use of PoCUS in the ED to improve time to a diagnosis and the definitive management plan of patients with SSTI. The study will be undertaken using a pre and post intervention design with the intervention being Nurse Practitioners accreditation in the use of PoCUS.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2664 2664 0 0
/AnzctrAttachments/375046-Study 18-25(A) Apollo outright approval letter..pdf (Ethics approval)

Contacts
Principal investigator
Name 83242 0
Ms Robyn Totenhofer
Address 83242 0
C/- Centre Nursing and Midwifery Research (CNMR) Western Sydney University (WSU) & Nepean Blue Mountains Local Health District (NBMLHD)
Level 1 Court Building
Nepean Hospital
Derby Street
Kingswood NSW 2747
Country 83242 0
Australia
Phone 83242 0
+61 2 4734 3181
Fax 83242 0
Email 83242 0
Robyn.Totenhofer@health.nsw.gov.au
Contact person for public queries
Name 83243 0
Ms Robyn Totenhofer
Address 83243 0
C/- Centre Nursing and Midwifery Research (CNMR) WSU & NBMLHD
Level 1 Court Building
Nepean Hospital
Derby Street
Kingswood NSW 2747
Country 83243 0
Australia
Phone 83243 0
+61 2 4734 3181
Fax 83243 0
Email 83243 0
Robyn.Totenhofer@health.nsw.gov.au
Contact person for scientific queries
Name 83244 0
Ms Robyn Totenhofer
Address 83244 0
C/- Centre Nursing and Midwifery Research (CNMR) WSU & NBMLHD
Level 1 Court Building
Nepean Hospital
Derby Street
Kingswood NSW 2747
Country 83244 0
Australia
Phone 83244 0
+61 2 4734 3181
Fax 83244 0
Email 83244 0
Robyn.Totenhofer@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.