Trial Review

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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] 289434 0
none
Universal Trial Number (UTN)
Trial acronym
MaP-RED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chest Pain 299120 0
Condition category
Condition code
Public Health 299140 299140 0 0
Health service research
Cardiovascular 299230 299230 0 0
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] 295026 0
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] 298621 0
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] 298621 0
Data were collected at the time of participant's discharge from the emergency department.
Secondary outcome [1] 324775 0
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] 324775 0
Data were collected at the time of participant's discharge from the emergency department.
Secondary outcome [2] 324776 0
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] 324776 0
Data were collected at the time of participant's discharge from the emergency department.
Secondary outcome [3] 324777 0
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] 324777 0
Seven-days after index presentation
Secondary outcome [4] 324778 0
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] 324778 0
Data were collected at the completion of the occasion-of-service with repeated measure 30-days after index presentation.
Secondary outcome [5] 324779 0
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] 324779 0
Baseline with repeated measure 30-days after index presentation
Secondary outcome [6] 325036 0
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] 325036 0
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?
No
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
62
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5979 0
Stanthorpe Hospital - Stanthorpe
Recruitment hospital [2] 5980 0
Warwick Hospital - Warwick
Recruitment hospital [3] 5981 0
Kingaroy Hospital & Community Health Centre - Kingaroy
Recruitment postcode(s) [1] 13402 0
4370 - Warwick
Recruitment postcode(s) [2] 13401 0
4380 - Stanthorpe
Recruitment postcode(s) [3] 13403 0
4610 - Kingaroy

Funding & Sponsors
Funding source category [1] 293845 0
University
Name [1] 293845 0
Queensland University of Technology
Country [1] 293845 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Victoria Park Road
Kelvin Grove Queensland 4059
Country
Australia
Secondary sponsor category [1] 292683 0
None
Name [1] 292683 0
Address [1] 292683 0
Country [1] 292683 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295251 0
Queensland Health Human Research Ethics Committee
Ethics committee address [1] 295251 0
Darling Downs Hospitals and Health Services
PO Box 405
Toowoomba Queensland 4350
Ethics committee country [1] 295251 0
Australia
Date submitted for ethics approval [1] 295251 0
21/07/2014
Approval date [1] 295251 0
28/08/2014
Ethics approval number [1] 295251 0
HREC/14/QHC\30
Ethics committee name [2] 295253 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [2] 295253 0
Ethics committee country [2] 295253 0
Date submitted for ethics approval [2] 295253 0
28/08/2014
Approval date [2] 295253 0
15/10/2014
Ethics approval number [2] 295253 0
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 66662 0
Mrs Tina Roche
Address 66662 0
C/O Professor Glenn Gardner
Queensland University of Technology
Victoria Park Road
Kelvin Grove 4059
Queensland
Country 66662 0
Australia
Phone 66662 0
+61 400 835 229
Fax 66662 0
Email 66662 0
tina.roche@hdr.qut.edu.au
Contact person for public queries
Name 66663 0
Mrs Tina Roche
Address 66663 0
C/O Professor Glenn Gardner
Queensland University of Technology
Victoria Park Road
Kelvin Grove 4059
Queensland
Country 66663 0
Australia
Phone 66663 0
+61 7 4683 3498
Fax 66663 0
Email 66663 0
tina.roche@hdr.qut.edu.au
Contact person for scientific queries
Name 66664 0
Mrs Tina Roche
Address 66664 0
C/O Professor Glenn Gardner
Queensland University of Technology
Victoria Park Road
Kelvin Grove 4059
Queensland
Country 66664 0
Australia
Phone 66664 0
+61 7 4683 3498
Fax 66664 0
Email 66664 0
tina.roche@hdr.qut.edu.au

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