ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

ACTRN12616000823471

Ethics application status

Approved

Date submitted

15/06/2016

Date registered

23/06/2016

Date last updated

23/06/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

Effectiveness of an emergency nurse practitioner service for adults presenting to rural hospitals with chest pain

Scientific title

Effectiveness of an emergency nurse practitioner service for adults presenting to rural hospitals with chest pain: a multicentre, longitudinal nested cohort study

Secondary ID [1]

none

Universal Trial Number (UTN)

Trial acronym

MaP-RED

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chest Pain

Condition category

Condition code

Public Health

Health service research

Cardiovascular

Coronary heart disease

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

The independent variable is the service model involved in the management of patients presenting with undifferentiated chest pain - either ENP service or standard care model. In both models all clinicians work collaboratively and within their designated scope of practice.

For the purpose of this study the ENP model is operationally defined as follows:

* Emergency nurse practitioner model: The ENP manages the patient presenting with undifferentiated chest pain. The ENP delivers and coordinated care in the diagnosis, investigation, therapeutic treatment (including prescribing of medications and technical interventions) and referral. In this model ED nursing staff work with the ENP in providing nursing care to the patient.

As this research is an observational study, there will be no allocation of intervention; rather the care delivery model will follow the standard method of patient allocation. The current practice at these facilities involves the use of the Australasian Triage Scale to ensure that patients are treated in order of clinical urgency. The next available clinician (ENP or medical officer) is responsible for providing care to patients in order of clinical urgency. Medical and ENP service is provided in and out of hours.

At the index presentation, presenting patients who meet the inclusion criteria will be identified by the triage nurse or the treating clinician and invited to participate in the study. Participation in this research will involve the completion of a patient questionnaire at baseline, the researcher’s use of routinely collected data and completion of follow-up patient questionnaire. Potential participants will receive information and consent package, explaining the purpose of the research and procedures involved in completing the study. Trained research assistants will explain the study, enrol eligible consenting patients and assist with the completion of a baseline questionnaire. Patients will be advised that they may decline to engage in the study or withdraw from participation at any time without disadvantage.

Follow-up patient data was collected once only at 30-days after the initial presentation to ED.

Intervention code [1]

Not applicable

Comparator / control treatment

For the purpose of this study the standard care model is operationally defined as follows:

* Standard care model: In this traditional model, all care for the patient presenting with undifferentiated chest pain is delivered and coordinated by a medical officer. In this model ED nursing staff work with the medical officer in providing nursing care to the patient.
In both models all clinicians work collaboratively and within their designated scope of practice.

Control group

Active

Outcomes

Primary outcome [1]

Adherence to evidence based guidelines for management of patients presenting with suspected or confirmed acute coronary syndrome

Data were collected from the participant’s medical record using a tool that was designed for the study. The tool uses criteria from the Clinical Pathway currently in use in Queensland Health facilities. These clinical pathways are used in all participating study sites and are based upon the best practice recommendations of the National Heart Foundation/Cardiac Society of Australia and New Zealand Guidelines for suspected or confirmed acute coronary syndromes (Chew et al., 2011). Data were collected to evaluate clinician’s adherence to evidence-based guidelines, including pharmacological management, risk stratification and referral strategies. Where data were missing from the medical record (eg, evidence of administration of aspirin was not recorded) the intervention was assumed not to have occurred. For the purposes of this study, cardiac biomarker testing that occurs at any time during the ED stay was assessed as being ‘on arrival’ and in accordance with current guidelines.

Timepoint [1]

Data were collected at the time of participant's discharge from the emergency department.

Secondary outcome [1]

Diagnostic accuracy of ECG interpretation

A copy of the participant’s ECG/s was collected at the completion of the ED occasion-of-service. A blinded assessor who has specialist qualifications in emergency medicine examined the treating clinician’s interpretation of the diagnostic ECG for diagnostic accuracy.

Timepoint [1]

Data were collected at the time of participant's discharge from the emergency department.

Secondary outcome [2]

Service indicator of waiting time

Data abstraction tool for study cohort: A tool that utilises routinely collected data was developed for the study. Data collected includes Australasian Triage Score, treating clinician category, diagnosis at discharge and discharge destination, service indicators including waiting time, length-of-stay, did-not-wait and unplanned representations was also collected.

Descriptive statistics were used to present data for waiting time. Data were compared between service models and tested for significance using the Mann Whitney U test.

Timepoint [2]

Data were collected at the time of participant's discharge from the emergency department.

Secondary outcome [3]

Diagnostic accuracy as measured by rates of unplanned representation within seven-days.

Data were collected on unplanned representation by review of the electronic patient management system.

Timepoint [3]

Seven-days after index presentation

Secondary outcome [4]

Satisfaction with care

Patient-reported outcomes questionnaire: This study used an adaptation of the patient outcomes tools that were developed and/or incorporated from published work for the AusPrac Study (Gardner et al., 2010).

Timepoint [4]

Data were collected at the completion of the occasion-of-service with repeated measure 30-days after index presentation.

Secondary outcome [5]

Quality-of-life and functional status (composite outcome)

With permission of the authors, this study adapted the AusPrac patient outcomes scales to assess quality of life and functional status. Functional health and well-being were measured using the SF-12 Registered Trademark. Permission to use this instrument for the study has been provided by the copyright holder.

Timepoint [5]

Baseline with repeated measure 30-days after index presentation

Secondary outcome [6]

Service outcome of length-of-stay

Data abstraction tool for study cohort: A tool that utilises routinely collected data was
developed for the study. Data collected includes Australasian Triage Score, treating clinician category, diagnosis at discharge and discharge destination, service indicators including waiting time, length-of-stay, did-not-wait and unplanned representations was also collected.

Descriptive statistics were used to present data for length-of-stay. Data were compared between service models and tested for significance using the Mann Whitney U test.

Timepoint [6]

Data were collected at the time of participant's discharge from the emergency department.

Eligibility

Key inclusion criteria

Patients with chest pain who present participating EDs during the data collection period will be eligible for recruitment, if they:
1. Are at least 18-years old;
2. Have chest pain that is not the result of an acute injury;
Are capable (or have a legally acceptable representative) of providing informed consent

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Traumatic chest pain; not able to provide consent

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

The conventional 5% level of statistical significance will be used. All analyses will be conducted using de-identified patient data using SPSS software (IBM SPSS Statistics) V.22.
* Structural characteristics of the ENP service model: Descriptive statistics will be used to summarise the data for structural characteristics of the ENP service model. Categorical data will be displayed as a proportion for each of the components of the survey.
* Patient Demographic and clinical data: Baseline characteristics potentially associated with study outcomes (age, gender, education level, employment, ATSI status, previous health service usage) will be reported separately for each service model. The data collected will be analysed using descriptive statistics. Dichotomous and nominal data will be displayed as a proportion; comparison of clinical data will be examined and tested for significance using the chi-square test.
* Service indicators and unplanned representation within 7 days: Descriptive statistics will be used. Continuous data will be used for analysis of waiting times and length-of-stay. Normally distributed data will report means and standard deviations; comparisons between service models will be examined using the unpaired t-test. Data not normally distributed will be analysed using medians and IQR; comparisons between the two models will be tested for statistical significance using the Mann-Whitney test. The dichotomous data for unplanned representations will be displayed as an odds-ratio (OR); comparison between the service models will be examined and tested for significance using the chi-square test.
* Adherence to evidence-based guidelines: Descriptive statistics will be used to summarise the adherence to guidelines for patients with suspected or confirmed ACS. A blinded assessor who has specialist qualifications in emergency medicine will undertake independent interpretation of ECGs, which will be compared to the clinician’s interpretation. Dichotomous data will be displayed as a percentage of agreement proportion; comparisons between the service models will be examined and tested for significance using McNemar’s test.
* Patient-reported outcomes: Data will be summarized and measures of distribution for patient-reported health outcomes will be conducted. Nominal and ordinal data collected for analysis of patient satisfaction will be displayed as a proportion; comparisons between the two service models will be examined and tested for significance using the chi-square test. The data for the SF-12 Registered Trademark summary scores will be managed and analysed according to the guidelines from the SF tools and will be reported using means and standard deviations (for normally distributed data) or medians and IQR (for not normally distributed data). Comparisons between the service models will be tested for statistical significance. Regression analyses will evaluate the associations between functional status and other influencing factors.

The sample size calculations were based on 80% power and a type I error rate (two-sided) of 0.05. Sample size estimation was calculated for the nested cohort that will be used to evaluate the primary outcome of use of evidence based guidelines for patients with cardiac-related chest pain. This calculation was based on 1) perusal of prior research studies together with unpublished local data to determine the rate of protocol compliance expected in cardiac chest pain patients at an estimated 50%, 2) the proportion of cardiac chest pain patients who were seen by ENPs was identified as 25% and 3) the difference in protocol compliance between ENPs and doctors is expected to be larger than 20%. The sample size calculated for the primary outcome cohort study under these assumptions is 384 patients with cardiac related chest pain with an odds ratio of 2.25.

Recruitment

Recruitment status

Stopped early

Data analysis

Reason for early stopping/withdrawal

Date of first participant enrolment

Anticipated

Actual

25/11/2014

Date of last participant enrolment

Anticipated

Actual

9/02/2016

Date of last data collection

Anticipated

Actual

Sample size

Target

384

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Stanthorpe Hospital - Stanthorpe

Recruitment hospital [2]

Warwick Hospital - Warwick

Recruitment hospital [3]

Kingaroy Hospital & Community Health Centre - Kingaroy

Recruitment postcode(s) [1]

4380 - Stanthorpe

Recruitment postcode(s) [2]

4370 - Warwick

Recruitment postcode(s) [3]

4610 - Kingaroy

Funding & Sponsors

Funding source category [1]

University

Name [1]

Queensland University of Technology

Address [1]

Victoria Park Road
Kelvin Grove Queensland 4059

Country [1]

Australia

Primary sponsor type

University

Name

Queensland University of Technology

Address

Victoria Park Road
Kelvin Grove Queensland 4059

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Queensland Health Human Research Ethics Committee

Ethics committee address [1]

Darling Downs Hospitals and Health Services
PO Box 405
Toowoomba Queensland 4350

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/07/2014

Approval date [1]

28/08/2014

Ethics approval number [1]

HREC/14/QHC\30

Ethics committee name [2]

Queensland University of Technology Human Research Ethics Committee

Ethics committee address [2]

Ethics committee country [2]

Date submitted for ethics approval [2]

28/08/2014

Approval date [2]

15/10/2014

Ethics approval number [2]

1400000709

Summary

Brief summary

The overall aims of this study were to examine the effectiveness of the rural ENP service model.  Specific aims were to:
i)	Examine the safety and quality of the ENP service model in the provision of care in the rural environment, and
ii)	Evaluate the effectiveness of ENP service in the management of patients presenting with undifferentiated chest pain.

In order to achieve the study aims we investigated  several outcomes in order to address the following research questions:
* What are the health service structures that influence the ENP delivery of safe, quality care for patients presenting to rural EDs with chest pain?
* Are the processes of care for patients who present to rural EDs with chest pain equivalent for patients managed by an ENP service to those managed in the standard model of care?
* Are the comparative outcomes for patients who present to rural EDs with chest pain equivalent for patients managed by an ENP service to those managed in the standard model of care?

To address the research questions the following null hypotheses were tested:

Hypothesis One – Primary outcome
For patients presenting to rural emergency departments with suspected or confirmed acute coronary syndrome who are managed by the ENP service or standard medical care, there will be no difference in: 
(i)	Use of evidence based guidelines for management of care as measured by the extent to which this is demonstrated in the clinical record and, 
(ii)	Diagnostic accuracy as measured by accuracy of electrocardiogram (ECG) interpretation.

Hypothesis Two
For patients presenting to rural emergency departments with undifferentiated chest pain who are managed by an ENP or standard medical care, there will be no difference in:
(i)	Service indicators of 
a.	Median waiting times
b.	Overall Length-of-stay in the emergency department for all patients presenting with chest pain
c.	Did-not-wait rates 
(ii)	Diagnostic accuracy as measured by rates of unplanned representation within seven-days

Hypothesis Three
For patients presenting to rural emergency departments with undifferentiated chest pain who are managed by ENP service or standard care there will be no difference in levels of patient-reported outcomes related to:
i)	Satisfaction with care
ii)	Quality-of-Life (QoL)
iii)	Functional status

Trial website

Trial related presentations / publications

Public notes

The major limitation of our study is the small sample size.  We initially expected to include a much greater number of participants; however, patient recruitment was fraught with difficulty.  A multisite strategy was utilised for this study as a measure to increase sample size to ensure that the research was completed in a reasonable time frame by decreasing patient recruitment time.  Medical students and nurses working at each site were invited to participate as research assistants for the project. Whilst rural clinicians were enthusiastic to be involved in this research there were no staff who had previously been involved the research processes for a cohort study.  The consequence of this approach was that it proved difficult to provide support local research champions because of the distance between study sites made onsite support prohibitive in terms of cost and time constraints.  Despite this, the greatest impedance to increased patient recruitment was the difficulties experienced in balancing service delivery with research requirements.  Although the concept of using medical students and nurses as research assistants seemed the most feasible method to recruit patients at each site, invariably in the resource poor rural areas these staff were front-line clinicians with busy workloads.  This meant that by incorporating research processes into service delivery there was competing responsibilities with the timely delivery of patient care, especially when potentially acutely unwell like those patients presenting with undifferentiated chest pain.

Consideration was given toward performing a retrospective power calculation but the idea was rejected in order to ensure research fidelity.  Data analysis was performed as published in the study protocol that was previously published.

Contacts

Principal investigator

Name

Mrs Tina Roche

Address

C/O Professor Glenn Gardner
Queensland University of Technology
Victoria Park Road
Kelvin Grove 4059
Queensland

Country

Australia

Phone

+61 400 835 229

Fax

tina.roche@hdr.qut.edu.au

Contact person for public queries

Name

Tina Roche

Address

C/O Professor Glenn Gardner
Queensland University of Technology
Victoria Park Road
Kelvin Grove 4059
Queensland

Country

Australia

Phone

+61 7 4683 3498

Fax

tina.roche@hdr.qut.edu.au

Contact person for scientific queries

Name

Tina Roche

Address

C/O Professor Glenn Gardner
Queensland University of Technology
Victoria Park Road
Kelvin Grove 4059
Queensland

Country

Australia

Phone

+61 7 4683 3498

Fax

tina.roche@hdr.qut.edu.au

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically