Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000365965
Ethics application status
Approved
Date submitted
21/02/2020
Date registered
16/03/2020
Date last updated
16/03/2020
Date data sharing statement initially provided
16/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Emergency Department and hospital adverse events in Aotearoa New Zealand
Scientific title
Emergency Department (ED) and hospital adverse events in Aotearoa New Zealand: A multicentre, prospective cohort study of adverse events experienced by adults and children presenting to participating EDs on randomised study shifts
Secondary ID [1] 300544 0
None
Universal Trial Number (UTN)
U1111-1227-1271
Trial acronym
Emergency Department Safety Aotearoa New Zealand (EDSANZ)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adverse events 316271 0
Condition category
Condition code
Emergency medicine 314550 314550 0 0
Other emergency care

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Weeks
Description of intervention(s) / exposure
To estimate the frequency of emergency department (ED) adverse events (AEs) in patients treated in Aotearoa New Zealand (NZ) EDs, by determining the proportion of patients who experience an AE related to ED care within 3 weeks of an ED visit, using the NZ Health, Quality and Safety Commission (HQSC) AE definition. Participants or whanau/family will be asked to consent to access medical records. Trained research nurses will contact the majority of patients/whanau via telephone follow-up, or in person if still admitted, at 21 days using a structured interview to identify patients with flagged outcomes. The duration of the interview is estimated to be between 5-15 minutes.
Intervention code [1] 316848 0
Not applicable
Comparator / control treatment
Observational study - no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322873 0
The proportion of patients who experience an AE related to ED care within 3 weeks of an ED visit, using the New Zealand Health, Quality and Safety Commission (HQSC) AE definition: "an event with negative or unfavourable reactions or results that are unintended, unexpected or unplanned (in practice this is most often understood as an event which results in harm or has the potential to result in harm to a consumer)".

Participants will be contacted at 21 days via telephone using a structured interview with built in 'trigger tools' to identify flagged outcomes that may indicate a potential AE. Participants will be considered to have a flagged outcome if they experience any of the following: new symptoms, worsening symptoms, new exacerbation of a chronic underlying illness, unscheduled medical visit, unscheduled admission, racism or death. Previous studies have also demonstrated that patients/families may also identify AEs not detected by the above categories, therefore we will specifically ask about and consider the following additional flagged outcomes: patient report of a possible medication problem, complication of care, miscommunication between staff, miscommunication between staff and patient, equipment problem, or other issues that may have been deemed to harm the patient. For patients admitted at their index visit the medical records will be screened for triggers. Triggers in adult patients (greater than or equal to 18 years) will be via the IHI Global Trigger Tool and for paediatric patients via a modified version (for NZ clinical terminology) of the Paediatric Trigger Tool from the NHS Institute for Innovation and Improvement in the United Kingdom, and the Canadian Pediatric Trigger Tool, both of which have been modified from the adult orientated IHI Global Trigger Tool.. Any patient who dies in the ED will be considered to have a flagged outcome and their medical record will be reviewed for an AE.

Any patient with a flagged outcome/trigger will have a narrative case summary prepared by a research nurse. Three emergency physicians, blinded to site, will independently review the case summaries and additional material if required, of each patient with a flagged outcome/trigger to determine if an AE(s) occurred. The reviewers will then be asked to independently determine whether the flagged AE may be associated with health care management and rate their certainty of this determination on a 6-point Likert scale (1 means flagged outcome/trigger was most certainly due to disease and 6 means was most certainly due to care) with AEs classified as associated with health care management if two reviewers have a certainty greater than or equal to 4. If one reviewer reports a level of certainty 5 or more, while the remaining report less than 4 the reviewers will re-consider and reach a conclusion based on consensus. Similarly, reviewers will determine whether the AEs were preventable using a 4-point Likert scale, with AEs classified as preventable if two reviewers have a certainty greater than or equal to 3. We will use three reviewers as studies of the reliability of the peer review process in AE reporting have suggested that three reviewers are required to achieve a sensitivity of 95% for the outcome of an actual AE. A single reviewer will classify the AE type/s, severity, and system response required.
Timepoint [1] 322873 0
21 days (approx)
Secondary outcome [1] 380099 0
Types of AEs in the study population (category). Identified AEs will be classified as:
a) Diagnostic issue: documented signs, symptoms, laboratory tests or imaging not acted on, or an indicated diagnostic test not ordered;
b) Management issue: suboptimal management plans despite accurate diagnosis, or based on an inaccurate diagnosis;
c) Unsafe disposition decision: patient placed at unnecessary risk of experiencing death or major disability by being discharged from the ED or hospital;
d) Suboptimal follow-up: problems with follow-up arrangements led to the development of new symptoms, unnecessary prolongation of symptoms, an unscheduled return visit to the ED, or a subsequent unscheduled hospital admission (this could be due to inadequate availability of follow-up or due to inappropriate follow-up arrangements);
e) Medication adverse effect: patient experiences a symptom related to a medication regardless of whether the medication was appropriately prescribed or taken;
f) Procedural complication: patient experiences adverse consequences of a procedure; g) Nosocomial infection: infection acquired in ED or in hospital

Three emergency physicians, blinded to site, will independently review the case summaries and additional material if required, of each patient with a flagged outcome/trigger to determine if an AE(s) occurred. The reviewers will determine whether the flagged AE may be associated with health care management and categorise this accordingly based on the above schedule
Timepoint [1] 380099 0
21 days (approx)
Secondary outcome [2] 380698 0
Clinical severity of AEs in the study population. For all patients, severity will be classified according to schema developed for studies of out-patients and reported as:
a) an abnormality on laboratory testing,
b) less than or equal to 1 day of symptoms, c) >1 day of symptoms,
d) non-permanent disability (temporary impairment of function lasting less than 3 months)
e) permanent disability (permanent impairment of function)
or
f) death.
For admitted patients, clinical severity according to categories used by the IHI Global Trigger Tool:
a) temporary harm to the patient requiring intervention,
b) temporary harm to the patient requiring initial or prolonged hospitalisation,
c) permanent patient harm,
d) intervention required to sustain life, or
e) death.
Both assessment systems can be used to define the HQSC SAC severity codes which range from 1) severe to 4) minimal/minor.
Timepoint [2] 380698 0
21 days (approx)
Secondary outcome [3] 380699 0
Proportion of patients experiencing a preventable AE. Proportion of preventable AEs will be determined by classifying all identified AE using a 4-point Likert scale, with AEs classified as preventable if two reviewers have a certainty greater than or equal to 3.
Timepoint [3] 380699 0
21 days (approx)
Secondary outcome [4] 380700 0
Classification of the system response required to address the study AEs. Identified AEs will be classified to reflect the effect of the AE at both a patient and population and health systems level as requiring:
a) No treatment;
b) Intervention;
c) GP visit;
d) ED visit;
e) Admission.
Timepoint [4] 380700 0
21 days (approx)
Secondary outcome [5] 380701 0
Proportion of patients for whom the AE is related to ED specific care vs. other hospital teams care in ED or care provided after ED visit. The proportion of patients will be determined by classifying identified AEs according to location of patient and team leading the care at the time of the AE.
Timepoint [5] 380701 0
21 days (approx)
Secondary outcome [6] 380702 0
The frequency of AEs not related to care received in ED (in-hospital care or primary care). The proportion of patients will be determined by classifying identified AEs according to location of patient and team leading the care at the time of the AE.
Timepoint [6] 380702 0
21 days (approx)
Secondary outcome [7] 380703 0
Days alive out of hospital to 90 days for the study population. Survival rates will be determined by collecting 90 day mortality data for each patient in the study population. Days alive out of hospital (DAOH) at 90 days post randomisation. Participants who die during the index admission will be assigned zero hospital-free days.
Timepoint [7] 380703 0
90 days
Secondary outcome [8] 380704 0
Variables related to AE preventability.
Variables will include:
a) Demographic and patient data for the study population: age, gender, ethnicity, Australian Triage Scale category, time of day of presentation, weekday vs. weekend, discharge disposition, complex medical illness
b) System level factors at patient and hospital level on study enrolment shifts.
ED/hospital level factors include: Australasian College of Emergency Medicine (ACEM) role delineation of hospital ED, number of patients waiting in hour of arrival, number of patients waiting in-patient beds in hour of arrival, degrees of access block in hour of arrival, proportion of ED bed occupancy in hour of arrival, average ED length of stay (LOS) of all patients in ED in hour of arrival, proportion of patients with ED LOS less than 4 hours in hour of arrival, proportion of ED patients with ED LOS < 6 hours in hour of arrival, number of ventilated patients in ED in hour of arrival, number of ED beds.
Patient/ED factors include:
Referral status, presentation to clinician assessment time, ED LOS, number of care providers involved in patient care, involvement of other hospital teams, number of hand-overs of care, level of initial clinician assessing patient (consultant, nurse practitioner, trainee etc.).

Three emergency physicians, blinded to site, will independently review the case summaries and additional material if required, of each patient with a flagged outcome/trigger to determine if an AE(s) occurred. The reviewers will determine whether the flagged AE may be associated with health care management and categorise this accordingly based on the above schedule
Timepoint [8] 380704 0
21 days (approx)

Eligibility
Key inclusion criteria
All patients presenting to ED on the randomised study days will be eligible for recruitment.
Eligibility assessments will determine whether the patient or whanau/family/parents are approached for consent to participate in the study
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Insurmountable language barrier that prevents informed consent or follow-up.
2. Patients initially triaged in Emergency Department (ED) but then transferred to a Medical or Surgical or Paediatric Admission Unit to see an inpatient specialty team. Patients referred to inpatient specialty teams but triaged to ED will be included in the study.
3. Patients unavailable for telephone follow-up in the 3 weeks after their ED visit (e.g. overseas). Every attempt will be made to include all patients resident in NZ.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
For the primary outcome of adverse event (AE) rate, descriptive statistics (proportion with 95% confidence intervals) will be used.
The association of AEs and preventable AEs with patient and system level characteristics will be explored with multiple logistic regression and survival analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/03/2020
Date of last participant enrolment
Anticipated
28/02/2021
Actual
Date of last data collection
Anticipated
31/08/2021
Actual
Sample size
Target
6336
Accrual to date
69
Final
Recruitment outside Australia
Country [1] 22362 0
New Zealand
State/province [1] 22362 0

Funding & Sponsors
Funding source category [1] 304957 0
Government body
Name [1] 304957 0
Health Research Council of New Zealand
Country [1] 304957 0
New Zealand
Primary sponsor type
Government body
Name
Auckland District Health Board
Address
Level 7/214 Green Ln W, Greenlane, Auckland 1051, New Zealand
Private Bag 92024, Wellesley Street, Auckland 1142, New Zealand
Country
New Zealand
Secondary sponsor category [1] 305315 0
None
Name [1] 305315 0
Address [1] 305315 0
Country [1] 305315 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305367 0
Northern A Health & Disability Ethics Committee
Ethics committee address [1] 305367 0
Ministry of Health
PO Box 5013
Wellington 6011
Ethics committee country [1] 305367 0
New Zealand
Date submitted for ethics approval [1] 305367 0
Approval date [1] 305367 0
20/12/2019
Ethics approval number [1] 305367 0
19/NTA/21/AM01

Summary
Brief summary
This is a multicentre, prospective cohort study of ED Adverse Events (AEs) in 6,336 eligible patients from 9 NZ Emergency Departments(EDs) presenting over 1 year. A stratified cluster sampling scheme will be used to randomly select 18 shifts within each ED in which to enroll patients. At each ED, trained research assistants will be present for each randomised shift, and will aim to enroll and prospectively consent consecutive patients presenting to the ED who are not critically unwell. For these patients, research assistants will collect baseline patient and systems data, and will contact enrolled patients 21 days after this index visit for a follow-up phone-call interview using a structured questionnaire aiming to identify outcomes of interest or AE triggers. A 21 day follow-up phone interview was chosen because previous international studies suggest that consumers can reliably report AEs, and the majority of ED AEs occur within 72 hours of the ED visit, with the remainder by 3 weeks. For critically unwell patients, approach for enrollment/consent will be deferred until patient has improved. For deceased patients baseline data will be collected as per clinical audit and HQSC processes, and the medical records will be reviewed for AE triggers. Admitted patients will also have medical records examined for AE triggers. Once research nurses have finished the interviews and review of medical records, for those patients who have an AE trigger or flagged outcome present, clinical summaries will be created, and these will be examined by the emergency physician reviewers to determine presence of AEs, and their classification and preventability.
The primary objective is to estimate the frequency of ED AEs by calculate an event rate . Secondary outcomes include assessing types, severity and preventability of AEs, as well as patient and system factors associated with AEs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100134 0
Prof Stuart Dalziel
Address 100134 0
Director of Emergency Medicine Research and Paediatric Emergency Physician,
Children’s Emergency Department,
Starship Children’s Hospital,
Auckland 1023
Country 100134 0
New Zealand
Phone 100134 0
+64 93074902
Fax 100134 0
Email 100134 0
s.dalziel@adhb.govt.nz
Contact person for public queries
Name 100135 0
Ms Nina Baker
Address 100135 0
Children’s Emergency Department,
Starship Children’s Hospital,
Auckland.1023
Country 100135 0
New Zealand
Phone 100135 0
+64 93074902
Fax 100135 0
Email 100135 0
NBaker@adhb.govt.nz
Contact person for scientific queries
Name 100136 0
Prof Stuart Dalziel
Address 100136 0
Director of Emergency Medicine Research and Paediatric Emergency Physician,
Children’s Emergency Department,
Starship Children’s Hospital,
Auckland 1023
Country 100136 0
New Zealand
Phone 100136 0
+64 93074902
Fax 100136 0
Email 100136 0
s.dalziel@adhb.govt.nz

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


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.