We are experiencing 4 week turn-around time in review of submissions and resubmissions. We recommend commencing this process concurrently with your ethics submission and allowing at least 8 weeks for registration to be completed from date of first submission. We currently do not have the capacity to expedite reviews.

Note also there are delays to review of updates. We appreciate your patience.

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
ACTRN12619000675123
Ethics application status
Approved
Date submitted
29/04/2019
Date registered
6/05/2019
Date last updated
9/03/2021
Date data sharing statement initially provided
6/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The InterACT (Intervention for Appropriate Care and Treatment) study: working with clinical teams in hospitals to trial a feedback loop approach to promoting appropriate care and treatment for elderly patients at the end-of-life.
Scientific title
A stepped-wedge randomised-controlled trial assessing the implementation, impact and costs of a prospective feedback loop to promote appropriate care and treatment for elderly patients in acute hospitals at the end of life.
Secondary ID [1] 296303 0
GNT1151923
Universal Trial Number (UTN)
U1111-1222-0173
Trial acronym
InterACT: Intervention for Appropriate Care and Treatment
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End of life care 312447 0
Aged care 312600 0
Condition category
Condition code
Public Health 310998 310998 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study intervention involves a prospective feedback loop to clinical teams, based on the outcomes of a twice-weekly patient record review process using the Criteria for Screening and Triaging to Appropriate aLternative Care (CriSTAL) tool and the Supportive and Palliative Care Indicators Tool (SPICT). The feedback provided to the clinical teams (the CriSTAL status and SPICT score) is intended to act firstly as a flag for the clinical team to review patient care activities and pathways, and to stimulate a tailored clinical response to promote appropriate patient care and treatment outcomes.
The study will be implemented in three acute Queensland hospitals. All hospitals commence the study at the same time point, and all complete a four-week site preparation and clinical team recruitment phase. Hospital 1 then sequentially completes a 16 week usual exposure phase, a four-week intervention establishment phase and a 34-week intervention exposure phase; Hospital 2, a 25-week usual exposure phase, a four-week establishment phase and a 25-week intervention exposure phase; and Hospital 3, a 34-week usual exposure phase, a four-week establishment phase and a 16-week intervention exposure phase.
The four-week intervention establishment phase will be used to prepare for the implementation of the feedback loop intervention, and tailor it to ensure it is feasible at each site and reflects local context and workflows. In this phase the the project team, study team, hospital executive advisory group and enrolled clinical teams will work together to:
- attend information sessions about the study, the tools being used, the background and evidence for non-beneficial treatment including risk factors and the range of options for responding to screened patients. these will be delivered by the project team. Number and duration will be tailored to reflect hospital requirements; will minimally include a 30 minute introduction session and a 30 minute evidence and rationale session.
- decide the process for the study team to provide the patient level screening outcomes to the clinical teams:
- pilot the proposed feedback mechanisms for one week with each clinical team, in the intervention establishment phase.
- decide the preferred clinical team responses to feedback. This will require agreement on how each clinical team will respond to feedback about the screening outcomes and the hospital inputs that will be provided to support this. Clinician response plans could include, but will not be limited to, palliative care referral, multidisciplinary team review, advance care planning consultation, and patient/carer meetings.

The record review will be performed by a trained auditor, employed as a Registered Nurse at the participating hospital and not part of the participating clinical team. A member of the study team will provide direct feedback to a nominated clinical team member of the outcomes of each record review. The study team will conduct a process evaluation to assess adherence and fidelity and support implementation.
The record review will occur throughout the usual exposure, intervention establishment and intervention exposure phases, with the feedback of the screening scores to clinical teams and a tailored clinical response part of the intervention phase only.
There are three participant populations across the study:
1: Clinical teams - who will be enrolled in the study and participate in the feedback loop intervention
2: Patients greater than 75 years of age, admitted under enrolled clinical teams
3: Members of the enrolled clinical teams, executive advisory group, site study team - who will be invited to participate in semi-structured interviews in the intervention establishment, intervention exposure and post-trial phases.
Intervention code [1] 314230 0
Behaviour
Comparator / control treatment
This is a stepped-wedge study design where each hospital and clinical team will act as their own control. Patient record review will occur throughout the study with the feedback loop and associated clinical response occurring in the intervention exposure phase. The length of the usual exposure and intervention exposure phases will be randomly allocated as per the stepped-wedge design for periods of 16, 25 or 34 weeks each.
During the usual exposure and intervention establishment phases all usual care will be provided by the clinical teams. Usual care in this case means the medical care that is typically provided by the clinical teams at the participating hospitals as part of their employment.
To check for potential seasonality or other confounders we will collect historical data about patient admission rates to the Intensive Care Unit (ICU) and length of hospital stay for the enrolled clinical teams at each hospital for the two years immediately prior to day 1 of the baseline phase.
Control group
Active

Outcomes
Primary outcome [1] 319792 0
Proportion of patients with one or more Intensive Care Unit (ICU) admission. This will be assessed via data linkage to patient medical records.
Timepoint [1] 319792 0
These data will be collected twice; once in week 1 of the usual exposure phase for the 2 years prior to day 1 of the usual exposure phase (historical data set), and once after week 58 (the end of all the trial phases).
Secondary outcome [1] 369538 0
Composite outcome of length of hospital stay and discharge outcome. This will be assessed via data linkage to medical records.
Timepoint [1] 369538 0
These data will be collected twice; once in week 1 of the usual exposure phase for the 2 years prior to day 1 of the usual exposure phase (historical data set), and once after week 58 (the end of all the trial phases).
Secondary outcome [2] 369540 0
Time to hospital re-admission. This will be assessed via data linkage to medical records.
Timepoint [2] 369540 0
These data will be collected once after week 70, which is the end of all the trial phases (week 58) and a 12 week allowance for re-admission. Data will be assessed for all patients identified and recorded in the record review activity during the usual exposure, intervention establishment and intervention exposure phases as having being 'high-risk CriSTAL or SPICT-positive' and will be assessed after week 70.
Secondary outcome [3] 369541 0
Time to first documented indications of clinician-led care review discussion. This will be assessed by patient record review while the patient remains an inpatient and under the care of the enrolled clinical team,
Timepoint [3] 369541 0
This will be assessed twice weekly from week 5 to week 58, while the patient remains an inpatient and under the care of the enrolled clinical team,
Secondary outcome [4] 369542 0
Time to care directive measures. This will be assessed by patient record review and will include advance care plans, statement of choices and acute resuscitation plans.
Timepoint [4] 369542 0
This will be assessed twice weekly from week 5 to week 58, while the patient remains an inpatient and under the care of the enrolled clinical team,
Secondary outcome [5] 369543 0
Time to palliative care referral. This will be assessed by patient record review while the patient remains an inpatient and under the care of the enrolled clinical team,
Timepoint [5] 369543 0
This will be assessed twice weekly from week 5 to week 58, while the patient remains an inpatient and under the care of the enrolled clinical team,
Secondary outcome [6] 369544 0
Time to medical emergency calls. This will be assessed via data linkage to medical records.
Timepoint [6] 369544 0
These data will be collected once, after week 58.
Secondary outcome [7] 369545 0
Changes in admission and treatment costs (composite outcome). This will be assessed using data linkage to medical records to identify treatments, tests, and procedures.
Timepoint [7] 369545 0
These data will be collected once, after week 58.
Secondary outcome [8] 369546 0
Cost of implementing the prospective feedback loop intervention. This will be assessed using prospective tracking records, including a time log and spreadsheet, to record time and resources used in delivering the intervention
Timepoint [8] 369546 0
These data will be recorded twice weekly throughout the intervention exposure phase, and collated by the project team monthly.
Secondary outcome [9] 369547 0
Process evaluation composite outcome: Extent and fidelity of implementation, impact, and contextual barriers and enablers of the feedback loop intervention
This will be assessed by:
- using templates based on the Consolidated Framework for Implementation Research (CFIR), including a context assessment, hospital specific implementation plan and an implementation record
- Semi-structured group or individual interviews based on CFIR
- Records of clinical team, study team and executive advisory group meetings (attendees, time, key points)
- records of communication and feedback using OneNote, based on CFIR constructs
Timepoint [9] 369547 0
Data about context, implementation planning and monitoring will be collected continually from week 1 to week 58. Data about meetings and communication and feedback will be collected continually from week 1 to week 58. Semi-structured group or individual interviews based on CFIR will be conducted between week 1 to 4 of the intervention establishment phase, at least once during the intervention exposure phase and, post-trial, in weeks 59 to 62.

Eligibility
Key inclusion criteria
Note that this study directly recruits clinical teams to participate not patients.
Inclusion criteria for Population 1, Clinical teams:
- be an established clinical team unit or specialty that routinely admits patients within the hospital
- include a nominated lead specialist consultant/s
- include a registrar/s and affiliated clinical nurse consultant or nurse unit manager
- have a clinical team structure and admission pattern typical of the hospital
- have a consistent history of admitting patients aged 75 years or over during a sample time period in the previous year
- participate in an information session with the project team.
Inclusion criteria for Population 2, patient data:
Patients admitted under the enrolled clinical teams and aged 75 years or over.
Inclusion criteria for population 3, (semi-structured interviews), Clinical teams, executive advisory group, site study team:
Enrolled clinical teams, hospital study executive advisory group and site study team members.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinical team exclusion criteria:
Excluded clinical teams will be those from the emergency department, any Intensive Care Units (ICUs), mental health units, and non-acute care and teams that do not meet all the inclusion criteria. While inappropriate treatment can occur in the ICU setting, we are choosing to study the feedback intervention with clinical teams that care for patients before they go to ICU.
Clinical teams that are already implementing an intervention or initiatives related to reducing non-beneficial treatments for older patients will be excluded.
Exclusion criteria patient data:
Patients <75 years of age or not admitted under the enrolled clinical teams.
Exclusion criteria, semi-structured interviews:
Clinical teams not enrolled in the intervention.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will not be concealed. This is a stepped-wedge study design and all participants receive the intervention at some stage.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratification pre-enrolment:
To inform a stratified ordering of clinical teams for purposive sampling that will maximise a sample of patients aged 75 years or over, we will firstly identify the number of patient admissions aged 75 years or over for 1 to 7 February, 1 to7 May, 1 to7 August, and 1 to 7 November in the previous 12 month period per eligible clinical team per hospital. Based on this information, we will develop an ordered sampling list that considers the average number of admissions per clinical team and prioritises medical specialties. A purposive sampling approach will be followed until the study team has recruited seven clinical teams at each participating hospital during the four-week recruitment phase.
The three participating hospitals will be randomly allocated to intervention timing through the allocation of hospital identifiers from 1 to 3 prior to commencement of the trial. These identifiers will dictate the allocation to the stepped-wedge study design. A study statistician will be responsible for computer generation of this study timing randomisation and the intra-hospital clinical team identifiers once all ethical and governance approvals are in place and all teams are enrolled at each of the three participating hospitals
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other
Other design features
Given the nature of the intervention, and the fact that each hospital receives the intervention, it is not possible to blind the clinical teams to the intervention. Concealment of allocation will occur in relation to the cross-over timing to the intervention phases. During the site preparation and clinical team recruitment phase the date the intervention exposure phase is commencing will be concealed from the hospital teams (including enrolled clinical teams, employed auditors, advisory group and site study team members). the project team will notify the hospital's advisory group, auditor and clinical team participants of their intervention establishment and intervention exposure phase activities. from this time point, the particular hospital's clinical teams will be aware of their allocation in the study.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size:
The sample size calculations were performed to ensure the study has sufficient statistical power for the analysis of the first outcome measure, the proportion of high-risk CriSTAL or SPICT-positive patients who had one or more ICU admissions (primary outcome). Simulation-based sample size calculations were used to determine adequate sample to power the analyses. Information used in the patient hospital episode simulation procedure was obtained from a previous study estimating the incidence and impact of non-beneficial treatment in three tertiary public hospitals in the same state. In particular, we calculated the proportion of patients aged 75 years or older who had one or more ICU admissions during their hospitalisation, stratified by their retrospectively identified non-beneficial treatment status.
Statistical analyses:
Outcome 1 will be analysed using a Binomial regression with the patient ICU admission as the binary response variable. The key variable is the timing of the switch from baseline to intervention phase, so the main result of this analysis will be the intervention effect on the proportion of patients with at least one ICU admission.
Outcomes 2 to 7 will use competing-risk, proportional hazards survival models.
Outcomes 8 and 9 will use statistical distributions to describe variability in all cost parameters.
Process evaluation outcomes will be subject to thematic analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13663 0
Gold Coast University Hospital - Southport
Recruitment hospital [2] 13664 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 13665 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 26345 0
4215 - Southport
Recruitment postcode(s) [2] 26346 0
4029 - Herston
Recruitment postcode(s) [3] 26347 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 300900 0
Government body
Name [1] 300900 0
National Health and Medical Research Council
Address [1] 300900 0
GPO Box 1421
Canberra ACT 2601
Country [1] 300900 0
Australia
Funding source category [2] 302620 0
Hospital
Name [2] 302620 0
Metro North Hospital and Health Service
Address [2] 302620 0
Royal Brisbane and Women's Hospital, 7 Butterfield St, Herston QLD 4029
Country [2] 302620 0
Australia
Funding source category [3] 302621 0
Hospital
Name [3] 302621 0
Gold Coast Hospital and Health Service
Address [3] 302621 0
Gold Coast Hospital and Health Service 1 Hospital Boulevard Southport Qld 4215
Country [3] 302621 0
Australia
Funding source category [4] 302622 0
University
Name [4] 302622 0
Queensland University of Technology
Address [4] 302622 0
GPO Box 2434
Brisbane, QLD 4001
Country [4] 302622 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
GPO Box 2434
Brisbane, QLD 4001
Country
Australia
Secondary sponsor category [1] 302532 0
None
Name [1] 302532 0
Address [1] 302532 0
Country [1] 302532 0
Other collaborator category [1] 280654 0
Other Collaborative groups
Name [1] 280654 0
Deeble Institute for Helath Policy Research, Australian Hospitals and Healthcare Association
Address [1] 280654 0
Unit 8, 2 Phipps Close Deakin ACT 2600
Country [1] 280654 0
Australia
Other collaborator category [2] 280655 0
Other Collaborative groups
Name [2] 280655 0
Palliative Care Australia
Address [2] 280655 0
Unit 8
113 Canberra Avenue
Griffith ACT 2603
Country [2] 280655 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301668 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 301668 0
HREC Office,Executive Suites, Lower Ground Floor, Dr James Mayne Building, RBWH
RGO Office, Level 4, UQCCR, RBWH
Butterfield Street, Herston Qld 4029
Ethics committee country [1] 301668 0
Australia
Date submitted for ethics approval [1] 301668 0
29/04/2019
Approval date [1] 301668 0
18/06/2019
Ethics approval number [1] 301668 0
HREC/2019/QRBW/51606
Ethics committee name [2] 304073 0
Queensland University of Technology (QUT) Human Research Ethics Committee
Ethics committee address [2] 304073 0
Level 4
88 Musk Avenue
Kelvin Grove QLD 4059
Ethics committee country [2] 304073 0
Australia
Date submitted for ethics approval [2] 304073 0
16/07/2019
Approval date [2] 304073 0
29/07/2019
Ethics approval number [2] 304073 0
1900000630

Summary
Brief summary
This study will work with clinical teams in three acute hospitals to trial a feedback loop approach to promoting appropriate care and treatment for elderly patients at the end-of-life. The feedback loop is intended to provide a ‘flag’ to increase clinician awareness of the risk profile of their patients, and to prompt a tailored care review activity.
It is expected that the use of this feedback intervention will improve care outcomes for elderly patients, specifically to increase appropriate care and treatment pathways and reduce the incidence of non-beneficial treatments. the study will report the impact on patients, and the costs and implementation issues of the feedback loop activity.
Trial website
http://www.aushsi.org.au/research/nhmrc-funded-research/the-interact-trial-intervention-for-appropriate-care-treatment/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87726 0
Prof Adrian Barnett
Address 87726 0
School of Public Health and Social Work
Institute of Health and Biomedical Innovation
Queensland University of Technology
GPO Box 2434
Brisbane, QLD 4001
Country 87726 0
Australia
Phone 87726 0
+61 7 31386010
Fax 87726 0
Email 87726 0
a.barnett@qut.edu.au
Contact person for public queries
Name 87727 0
Ms Alison Farrington
Address 87727 0
School of Public Health and Social Work
Institute of Health and Biomedical Innovation
Queensland University of Technology
GPO Box 2434
Brisbane, QLD 4001
Country 87727 0
Australia
Phone 87727 0
+61 7 3138 6132
Fax 87727 0
Email 87727 0
alison.farrington@qut.edu.au
Contact person for scientific queries
Name 87728 0
Prof Adrian Barnett
Address 87728 0
School of Public Health and Social Work
Institute of Health and Biomedical Innovation
Queensland University of Technology
GPO Box 2434
Brisbane, QLD 4001
Country 87728 0
Australia
Phone 87728 0
+61 7 31386010
Fax 87728 0
Email 87728 0
a.barnett@qut.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Non-identifiable final data sets for outcome 1-8
When will data be available (start and end dates)?
Data will be available once results have been published. No end date will be in place.
Available to whom?
Will be available to people who have ethical or other approvals to use the data sets, and as approved by the data custodian
Available for what types of analyses?
Will be available for analyses that reflect the original intent of the data collection, and have appropriate ethical or other approvals in place.
How or where can data be obtained?
Will be supplied by the data custodian, the Principal Investigator Adrian Barnett. Information about the data set, including a DOI, will be publicly available once data set is available.
What supporting documents are/will be available?
Study protocol
Ethical approval
Other
'Other' documents specified
Adding Participant information sheets for the intervention and interview components of the study.
How or where can supporting documents be obtained?
Type [1] 1956 0
Study protocol
Citation [1] 1956 0
Link [1] 1956 0
Email [1] 1956 0
Other [1] 1956 0
Protocol will be uploaded once ethical approvals in place.
Type [2] 4026 0
Ethical approval
Citation [2] 4026 0
Link [2] 4026 0
Email [2] 4026 0
Other [2] 4026 0
Type [3] 6750 0
Other
Citation [3] 6750 0
Link [3] 6750 0
Email [3] 6750 0
Other [3] 6750 0
Adding Intervention participant information sheet
Type [4] 6751 0
Other
Citation [4] 6751 0
Link [4] 6751 0
Email [4] 6751 0
Other [4] 6751 0
Add Interview participant information sheet
Summary results
No Results