Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000326897
Ethics application status
Approved
Date submitted
9/09/2020
Date registered
23/03/2021
Date last updated
9/03/2022
Date data sharing statement initially provided
23/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Relief of chest pain in the Emergency Department (RELIEF)
Scientific title
Relief of chest pain in the Emergency Department (RELIEF)
Secondary ID [1] 302267 0
None
Universal Trial Number (UTN)
Trial acronym
RELIEF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chest pain 318993 0
Condition category
Condition code
Emergency medicine 316961 316961 0 0
Other emergency care
Cardiovascular 317314 317314 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Recommended guidelines are based of current, evidenced-based guidelines. The documentation of pain scores should be documented as part of patient assessment, and ongoing observations. The Australian (NHMRC) guidelines recommend time to analgesic of <30 minutes after presentation. Further, the 2014 best practice guidelines from the UK College of Emergency medicine call for an analgesic medication to be administered within 20 minutes of ED arrival. For those with severe pain, the effectiveness of analgesics should be re-assessed within 30 minutes of receiving the first dose (The College of Emergency Medicine Best practice guideline, Management of pain in Adults, 2014). The type of analgesics included in the educational campaign are recommended in the Australian (NHMRC) guidelines, and include:
•GTN
• Simple analgesics – paracetamol and non-steroidal anti-inflammatory medications. Note
that aspirin will not be considered to be a simple analgesic as this is used for antiplatelet
effect and not as an analgesic in chest pain management)
• Narcotic analgesics – Morphine, Fentanyl
• Other agents – Antacid, Liquid xylocaine

In the pre-intervention stage, observational data on time to first analgesic, time to
analgesia, and study outcomes will be collected. Our previous work has demonstrated that
recruiting 100 patients will take approximately 8 weeks. The post-intervention stage will
be conducted one month after completion of the RELIEF campaign. Data collection will
be identical to the pre-intervention phase. This data will be used to identify the efficacy
of the intervention; whether the time to first analgesic and time to analgesia has been
reduced after a period of intense educational and training support and visual pain sign is
implemented at the site.

The CI will be responsible for ensuring that patients enrolled in the study meet inclusion criteria. The CI and AIs will also ensure that educational resources are available and that in-service teaching sessions occur.


• The education campaign: This campaign will incorporate information on the ‘why’; that is, it will provision education around the importance of early analgesic use for patients and in the process of assessment for chest pain specifically. Information will be provided about the importance of documenting pain scores in the patient notes, as this has been shown to improve the provision of timely analgesics.
• Clinical champions on the floor. The campaign will target both nursing and medical staff. Clinical champions (study AIs) will be recruited to disseminate the message during clinical shifts and during educational in-services. These clinicians will be experienced and well-known staff members who can motivate their colleagues to change practices around the provision of analgesics.
• Recommended guidelines for the provision of analgesics will be developed and provided to all clinical staff as educational material (e.g., posters). These guidelines will include information on the ‘how’: agents that may be given by nursing staff without medical prescription, and information about the agent’s mechanism of action in chest pain.
• Patient controlled sticker system. Pain has long been considered the ‘fifth’ vital sign (American Pain Society, Principles of analgesic use in the treatment of acute pain and cancer pain, 1999) . However, unlike other vital signs such as blood pressure and heart rate, pain does not have a simple, ongoing visual representation of monitoring display that is directly visible to clinicians. The RELIEF intervention proposes a novel approach to patient reported pain via a visual, deliberate representation of pain that is directly visible to clinicians. Patients will be provided with a red sticker (15 cm diameter) to place on their chest. They will be instructed to remove this sticker if they have no pain but are encouraged to place it on whenever they experience pain. This will be a visual prompt for clinical staff to complete a pain assessment, provide appropriate pain relief, and document the patient’s pain score.

In the pre-intervention phase, observational data will be collected. This will include time to first analgesic, time to analgesia and other study outcomes to determine a baseline for standard care for patients presenting to the ED with chest pain.

We anticipate that our pre-intervention data collection, our intervention period and post-intervention data collection periods will take 2 months each to complete.
Intervention code [1] 318554 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325066 0
Time to first analgesic defined as the time to provision of agents including:
1. Glyceral Trinitrate
2. Simple analgesic – paracetamol and non-steroidal anti-inflammatory medications. Note that aspirin will not be considered to be a simple analgesic as this is used for antiplatelet effect and not an analgesic in chest pain management)
3. Narcotic analgesics – Morphine, Fentanyl
4. Other agents – Antacid, Liquid xylocaine
Timepoint [1] 325066 0
This will be assessed when the patient leaves the Emergency Department. Data will be collected from patient medical records.
Primary outcome [2] 325067 0
Emergency Department length of stay.
Timepoint [2] 325067 0
Defined as the time between presentation to the Emergency Department and discharge from emergency department (where the patient was not admitted to short stay). This data will be collected from patient medical records.
Primary outcome [3] 326865 0
Short stay unit (SSU) length of stay. This data will be collected from patient medical records.
Timepoint [3] 326865 0
Defined as the time between arrival in the SSU and discharge from the SSU.
Secondary outcome [1] 386727 0
Time to adequate analgesia (defined as time to a patient stating their pain score is 0-1/10).
Timepoint [1] 386727 0
This will be determined by reviewing patient records.
Secondary outcome [2] 386728 0
Type of analgesic medication given to patient.
Timepoint [2] 386728 0
This will be determined by reviewing patient records.
Secondary outcome [3] 391326 0
Admission to an inpatient unit (excluding short stay units)
Timepoint [3] 391326 0
This will be determined by reviewing patient records.
Secondary outcome [4] 391327 0
Time to exercise stress test (EST)
Timepoint [4] 391327 0
This will be determined by reviewing patient records.
Secondary outcome [5] 391328 0
Proportion of patients categorised as high risk after serial troponin testing.
Timepoint [5] 391328 0
This will be determined by reviewing patient records.
Secondary outcome [6] 391329 0
Proportion of patients with a failed exercise stress test (EST), defined as ineligibility to complete an EST due to ongoing pain, or an equivocal or positive EST.
Timepoint [6] 391329 0
This will be determined by reviewing patient records.
Secondary outcome [7] 391330 0
Proportion of patients undergoing anatomical or invasive testing, including CTCA, myocardial perfusion scanning, echocardiography or angiography.
Timepoint [7] 391330 0
This will be determined by reviewing patient records.
Secondary outcome [8] 391331 0
Documentation of pain scores
Timepoint [8] 391331 0
This will be determined by reviewing patient records.
Secondary outcome [9] 391334 0
Cost of chest pain assessment
Timepoint [9] 391334 0
This data will be taken from the patient record, after the patient has left the department.
We will compare the ED and hospital costs in the pre- and post- implementation groups. This will provide an estimate of whether there are cost savings associated with the intervention.

Eligibility
Key inclusion criteria
Patient >18 years
Treating physician investigated for acute coronary syndrome
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients will be excluded if:
1. Have previously presented to the ED with suspected ACS within the study period
2. Are pregnant
3. Are unable to provide informed consent (e.g., language barriers)
4. Are unwilling to provide informed consent
5. Staff consider recruitment inappropriate (e.g., palliative patient)
6. They do not have pain suggestive of myocardial ischaemia (e.g. chest, jaw, neck, arm pain) on arrival to the ED

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Pre-Post intervention study
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In the pre-intervention stage, observational data on time to analgesia and study outcomes will be collected. Such data will be collected for 104 patients. The post-intervention stage will be conducted one month after completion of the RELIEF intervention program. Data collection will be identical to that performed in the pre-intervention phase and will again involve collecting data on 104 eligible patients. This data will be used to identify the efficacy of the intervention.
The time to and type of first analgesic will be collected from the patient medical notes. To identify time to analgesia, defined as a pain score of ‘0’, consenting participants will be sent an automated text message at 30 minutes, 60 minutes, 120 minutes and 240 minutes after presentation to the Emergency Department. This text will ask them to provide information about their current pain score (on a scale of 1 to 10). Where patients do not have a phone, a Department-owned iPad will be provided to them for this data collection. The text will state: “Please send us a message with your pain score now. Use the pain score from 0 to 10 that represents the intensity of your pain. 0 means no pain and 10 means the worst possible pain. The middle of the scale (around 5) is moderate pain. Thank you”.
Basic participant demographics, cardiac risk factors/stratification, additional analgesics given, cardiac tests received & results, hospital disposition, ED and total hospital length of stay will be collected from both the participant and relevant hospital databases (e.g. EDIS, HBCIS). Initially identifiable data will be recorded on a paper based case report form. De-identified data will be later entered into a password protected redcap database on a password protected computer in a locked research office.

De-identified data will be entered into a redcap database and exported to Stata for analysis. To identify the baseline time to first analgesic, time to analgesia and type of first analgesic (aim 1), we will provide descriptive statistics and present the data graphically. If all patients have data for time to first analgesic, standard descriptive statistics will be reported. However, there may be some patients who do not receive an analgesic at all before discharge. In this instance, median time to analgesic (with IQR) will be calculated using survival analysis.
To examine the relationship between time to first analgesic, time to analgesia, and outcomes (aim 2), regression models will be utilised. Regression models will be fit with an appropriate error distribution for the outcome of interest (binomial for ordinal data and gaussian or gamma for continuous data). If there is censoring in the time to analgesic data (ie, patients left the department before an analgesic is provided), maximum likelihood methods will be used to estimate regression parameters (30) to ensure unbiased estimates. The regression models will incorporate control variables such as risk stratification on presentation, patient age, risk factors and prior cardiac history.
To examine the impact of the RELIEF intervention (aim 3), descriptive statistics will be reported for the outcome variables before and after the intervention. Cox regression analysis will also be performed to compare time to first analgesic in the pre- and post- cohorts, controlling for any potential baseline characteristics in the two groups and for time (as outlined in the confounders section). Time to analgesia will only be collected at specific timepoints, making this variable interval censored. As such, a proportional odds model will be fitted for this variable. All other endpoints will be compared using regression analyses (logistic, gaussian or gamma as appropriate).


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/05/2021
Actual
22/09/2021
Date of last participant enrolment
Anticipated
31/05/2022
Actual
Date of last data collection
Anticipated
31/05/2022
Actual
Sample size
Target
104
Accrual to date
44
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 17462 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 31194 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 306687 0
Charities/Societies/Foundations
Name [1] 306687 0
Emergency Medicine Foundation
Country [1] 306687 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butterfield st
Herston
QLD
4006
Country
Australia
Secondary sponsor category [1] 307242 0
Government body
Name [1] 307242 0
Queensland Health
Address [1] 307242 0
33 Charlotte Street
Brisbane
Queensland
4000
Country [1] 307242 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306864 0
Royal Brisbane & Women's Hospital, Human Research Ethics Committee
Ethics committee address [1] 306864 0
Ethics committee country [1] 306864 0
Australia
Date submitted for ethics approval [1] 306864 0
13/08/2020
Approval date [1] 306864 0
18/09/2020
Ethics approval number [1] 306864 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105278 0
Ms Emily Brownlee
Address 105278 0
c/o ETC
Dr James Mayne Building
RBWH
Butterfield st
Herston
QLD
4006
Country 105278 0
Australia
Phone 105278 0
+61 0736466262
Fax 105278 0
Email 105278 0
[email protected]
Contact person for public queries
Name 105279 0
Emily Brownlee
Address 105279 0
c/o ETC
Dr James Mayne Building
RBWH
Butterfield st
Herston
QLD
4006
Country 105279 0
Australia
Phone 105279 0
+61 0736466262
Fax 105279 0
Email 105279 0
[email protected]
Contact person for scientific queries
Name 105280 0
Jaimi Greenslade
Address 105280 0
c/o ETC
Dr James Mayne Building
RBWH
Butterfield st
Herston
QLD
4006
Country 105280 0
Australia
Phone 105280 0
+61 0736466262
Fax 105280 0
Email 105280 0
[email protected]

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


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.