Stage 1: STUDY PREPARATION 1www.ihpa.gov.au

STUDY PREPARATION OVERVIEW Steps required to prepare for the study implementation. Includes: Research ethics/site specific approval – Immediate Initial site set up visit by FMT Study website setup Progress reporting arrangements Study site database set up Submission Part A (Service level data) – 8 April 2016 Decisions on data collection processes Decide on when data collection will occur Review data already routinely collected Identify additional items that will need to be collected Decide on appropriate data collection processes, including for clinician time Train staff in data collection processes

RESEARCH ETHICS/ SITE SPECIFIC APPROVAL The study has ethics approval: This is through the South Australian Department for Health and Ageing Human Ethics Committee (SA HREC) (granted on 1 December 2015, HREC reference No.: HREC/15/SAH/165) The SA HREC is a lead HREC, able to approve multi-site studies. However, acceptance of the approval outside of SA is at the discretion of local research governance offices. In addition to ethics approval, local authorisation to conduct the study is also required: This is through the completion of a site specific assessment (SSA) form.

RESEARCH ETHICS/ SITE SPECIFIC APPROVAL If a state/territory health authority is seeking independent approval, this process should already be underway. For sites completing a site specific assessment, processes must commence immediately.

INITIAL SITE VISIT BY FMT The initial FMT site visit has three major goals: 1.Formal introduction of the FMT to onsite study staff (site co-ordinator and other project staff) 2.Provide education and training to onsite staff (site co- ordinator and other project staff) on: Data requirements and timing Study website Study site data management system 3.Check site progress Setup Submissions A1-9

WEBSITE – LOGIN Access protected area Username and password will be provided by FMT prior to initial visit Login

PROGRESS REPORTING Will occur at regular intervals tied in with submission due dates for the project. Will allow FMTs, state/territory health authorities and project management can monitor progress at a glance. Will be completed by site coordinators through the secure section of the website.

WEBSITE – PROGRESS REPORTING

WEBSITE – PROGRESS REPORTING

WEBSITE – PROGRESS REPORTING A user can add in new activities if and when required

STUDY SITE DATA MANAGEMENT SYSTEM SET UP The Study site data management system is available to be downloaded from the project web site. Hardware requirements include: Dual core processor 8G memory At least 50G free disk storage Part of the database set up will be the collection and entry of Submissions A1-A9.

STUDY SITE DATA MANAGEMENT SYSTEM PART A DATA SUBMISSIONS The main role of the system is to collate and process data extracts related to data collection and costing phases of the study. Information regarding the data submissions, timing and content can be found in the Data submissions and transfer module as well as the Data request specification document available for download form the website.

DATA COLLECTION Working with FMTs, sites will need to determine exact dates for data collection as well as the best way for this to occur at the specific site

DATA COLLECTION – TIMING Data collection must start between 1 April and 1 June Part C collection must be carried out over 1 calendar month 2.Part B collection will be carried out over 16 days inside the Part C collection period. The 16 days is made up of 2 days lead-in time, plus 2 weeks data collection.

DATA COLLECTION – DATA ELEMENTS Presenting problem/complaint: Already collected by many emergency departments. Sites need to check mapping of local codes to the code set specified for the study. Additional diagnoses: These are often available in local systems, but not necessarily collected. Collection needs to be priority for the study. Procedures: Already collected by some emergency departments. Sites need to check mapping of local codes to the code set specified for the study.

DATA COLLECTION – DATA ELEMENTS Diagnosis modifiers: Some of these may already be routinely collected (e.g. as additional diagnoses). Some diagnosis modifiers may be better collected at triage and or discharge/ transfer of care. Some sites may decide to undertake retrospective coding from the electronic/paper record to collect some of the diagnosis modifiers. Allied health times/procedures: May already be collected.

DATA COLLECTION – DATA PLAN Sites will need to develop a plan Assisted by FMT and state/territory health authority Should include: what data are already routinely collected, and what data will need to be collected specifically for the study how data already collected will be extracted from local systems and uploaded to the Study site data management system how data not already collected will be collected during the study.

APPROACH TO CAPTURING CLINICIAN TIME Patient attributable time will need to be captured in this study, for a two- week period. This is the time that clinicians spend attending to patients, either at the bed side or undertaking specific tasks in relation to a patient (e.g. interpreting and acting on test results). This is a challenging undertaking. Depending on a sites’ capabilities, two approaches may be adopted by sites: A:Total clinical time method Collect data from all clinicians during the two-week period related to time associated with individual patients, and the related procedures/activities. B:Specific activity/procedure method Collect data on clinical time associated with specific activities/ procedures. For each activity/procedure, a sample of 30 instances is required.

APPROACH TO CLINICAL TIME A:Total clinical time method 24 hours per day collection by all clinicians, over two weeks. Collect time attributable to patients and the procedures carried out. B:Specific activity/procedure method Collection based on discrete activities/ procedures. Uses the list of activities/ procedures detailed in the Data request specification (Submission B3). ‒ At least 30 observations required for each procedure/activity, capturing clinician time to undertake these activities/ procedures. Collection for longer than two weeks may be necessary to capture 30 observations Specific information on technology to capture clinician time can be found in the Clinician time capture module