Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000244505
Ethics application status
Approved
Date submitted
18/01/2024
Date registered
13/03/2024
Date last updated
13/03/2024
Date data sharing statement initially provided
13/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Testing the Deterioration Early Warning System (DEWS) for residential aged care: a feasibility study
Scientific title
Testing the Deterioration Early Warning System (DEWS) for residential aged care: a feasibility study
Secondary ID [1] 311294 0
Nil known
Universal Trial Number (UTN)
U1111-1302-4734
Trial acronym
DEWS: a feasibility study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute deterioration 332533 0
Condition category
Condition code
Public Health 329226 329226 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Trial: Type two hybrid feasibility testing study of 1) a newly developed tool (DEWS) designed to support staff to recognize and respond to acute deterioration of people living in residential aged care (RAC) and 2) the quality improvement processes designed to support tool implementation.

Rationale: DEWS was developed using best available national and international evidence, It was co-designed to work in the RAC environment. Both DEWS and the implementation processes need small scale testing in the real-world environment before any recommendation for use can be made.

Method: Adaptation of the quality improvement (QI) implementation processes used during the New Zealand (NZ) hospital based Deteriorating Patient program. We will recruit three to five RAC facilities from across NZ to implement DEWS. They will be supported to set up QI teams to implement and test DEWS in day-to-day practice. Researchers will be providing a standardized support package of a) all QI tools, project initiation document, data collection tools, education package, DEWS tools, DEWS tools guideline. b) initiation education workshop about DEWS tools and QI processes, c) site visits to establish baseline and support local QI teams to promote implementation and tackle roadblocks and progress visit at approx. 3 months d) regular (fortnightly) video conference support meetings to problem solve, collect data, continue impetus.

Support Package details:
The DEWS tools consist of three parts that reflect the existing RAC processes for recognizing and responding to acute deterioration.
i) Quick DEWS for use by healthcare assistant is a nine-item clinical indicator check list of signs that are significantly associated with acute deterioration. It is for completion once per shift (3x a day). The clinical indicators are observable during routine care provision. The presence of one indicator triggers a nurse assessment
ii) DEWS-RN is a chart including observable clinical indicators and vital signs. The chart is structure is based on Te Whare Tapa Wha holistic model of health. The chart has colors and numbers that indicate the degree of urgency associated with each measure. The chart is scored and triggers a mandatory clinical escalation pathway (same concept as hospital based early warning scores).
iii) SBARR-DEWS is a handover and critical thinking tool that structures clinical communication, it includes the score from DEWS-RN and uses the well know situation, background, assessment, recommendation and response communication process. This supports RN handover to next responder.
iv) The tools come with a user guide and standard presentation

Wrapped around DEWS implementation is a quality improvement process
i) Implementation guide and project charter, includes measurement suggestions, such as how often GP is call out of hours, hospital presentation, cost of implementation, staff time (to be refined with facilities as access to data varies across the different providers)

Education package detail
i) one full day face to face workshop for up to 5 members of each RAC quality team. First half of day includes DEWS tools (development process, train the trainer how to use DEWS in practice, small group familiarity with tools, copyright, IP and boundaries of use) Second half of day Quality improvement focus, Health and Disability Commission present on importance of recognizing acute deterioration in consumers in RAC. Then small group activities mapping current processes and where DEWS fits, Deciding from available data what can be measured. Setting task timeline to lead up to DEWS launch in practice. Teams will be provided with "train the trainer" materials to provide education about DEWS in their own facilities. Following this fortnightly zoom meetings 2 hours duration problem solve, support, assist processes need to launch DEWS. Then meetings will track DEWS use. One site visit by researchers during testing to support teams, check progress, talk to staff, provide data so far and celebrate.


The research team includes a primary care provider, nurse practitioner, and quality improvement practitioners and data analyst and is supported by Te Taha Hauora Health Quality and Safety Commission New Zealand. The research team will be supported by an expert advisory group to help manage the wider implications of the project (for instance unintended impact on service providers external to RAC) and cultural (Maori indigenous New Zealanders) and consumer considerations.

Recruited RAC facilities will have at least 50 bed capacity with a primary care provider with at least one year experience of working with that facility, they will need to agree to providing human resources necessary to complete project (including adequate release from clinical duties) and agree to abide by copyright rule for DEWS tools and processes. We aim to recruit a representative sample of RAC facilities, including all levels of care delivery.

Feasibility phases: PLAN: (approx. 2 months) facilities supported to understand their current state, gather base line data, establish their implementation team. PREPARE (approx. 3 months) attend workshop, establish escalation processes, socialize DEWS with staff teams, confirm data collection mechanisms. TEST (approx. 5 months) Use the DEWS tools, collect data, audit use of tools, provide narrative examples of tool use, collect data. EVALUATE (approx. 1 month) participate in qualitative interviews and survey about the DEWS tools and QI processes and thier view of whether is it feasible and worthwhile implementing DEWS. Researchers will collate data from across the 3-5 test sites, including hospital presentation data, primary care use data and clinical care study narrative of DEWS use. Research outcomes will include recommendations for change to DEWS tools and QI implementation processes and a recommendation for further implementation.
Intervention code [1] 327741 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337059 0
In residential aged care (RAC) is the implementation of a deterioration early warning system (DEWS) feasible?
Timepoint [1] 337059 0
From recruitment to completion will take 10 months.
The assessments above will be competed in October / November 2024 10 months from the first implementation of DEWS.
We plan to write an evaluation report by the end of the year (December 2024) that describe any changes deemed necessary to DEWS tools and implementation plan. The overall view of our participants about feasibility including risks and benefits for sharing with Te Tahu Hauora Health Quality and Safety Commission. The government agency charged with quality improvement in health.
Secondary outcome [1] 431822 0
Human resource costs incurred when implementing DEWS (composite outcome)
Timepoint [1] 431822 0
Baseline time out of hours primary care services (last 12 months).
Baseline ambulance services call outs (last 12 months)
Monthly collection of out of hours primary care service use (total collated end of project estimate Nov 2024)
Monthly collection ambulance call outs (total collated end of project estimate Nov 2021) Compare baseline use of primary care service out of hours consultations with primary care use each month of project (total at end of project). Data will be sourced from individual residential aged care records. Each facility will collect this using the most appropriate method (some facilities have electronic records they can search others use a diary system). There is no national data base for this information. We will seek monthly data (numbers) and compare month by month for the duration of the study (for example month May 2024, compared to pre-study May 2023) - anticipate 5-6 months of implementation data (May to September / October 2024)
2) Estimate additional staff time used during DEWS feasibility study. Each facility will complete a log of staff hours dedicated to DEWS implementation time. A xl spreadsheet has been developed that identifies staff type and hours, to be completed monthly from March to end of study anticipate September / October 2024).
act on primary care provision costs (any increase in out of hours or consultations not funded
3) Ambulance service use will be collected by each residential care facility. Facilities have to pay ambulance costs so this can be pulled from accounting data (again month by month comparison month by months comparison (for example month May 2024, compared to pre-study May 2023) anticipate 5-6 months of implementation data (May to October 2024)
4) Staff perception of additional workload will be established via semi-structured interviews October 2024
Secondary outcome [2] 432345 0
Understand the experience of the teams using and implementing DEWS tools (composite outcome)
Timepoint [2] 432345 0
a) Field notes: Collected on site visits by research team (one per site March 2024). Workshop notes collected by research during meeting (written notes). Zoom meeting notes (taken by researcher team), meetings are once every two weeks, 1 hour duration, from March 2024 to October 2024.
b) End of intervention for staff group this 5-6 months after DEWS is implemented (October 2024)
c) End of intervention for quality improvement team, same time as staff interviews but as this group started early this will be 8-9 months after the beginning of the project.. Anticipate interviews will take place in October 2024
Secondary outcome [3] 432346 0
Understand the challenges involved in implementing DEWS (composite outcome)
Timepoint [3] 432346 0
a) Weekly review from May 2024 for first month, reduced to review at fortnightly zoom meetings (1 hour duration) for the remainder of the project, 5-6 months after DEWS is implemented (no patient identifiers shared)
b) prospective weekly audit from beginning DEWs implementation to until end of project, anticipate from May 2024 (DEWS implemented) for or 5-6 months after implementation anticipated end October 2024 (brief online tool)
c) prospective issues log, that will be collected by researchers from start until end of project. This will be updated after site visits, workshop, and after each fortnightly one hour zoom meeting until end of project anticipate October 2024 (5-6 months post-implementation)

Eligibility
Key inclusion criteria
Recruiting RAC facilities (not people) to implement DEWS; facilities 50 beds or more with contract primary care provider with at least one years' experience at facility.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
RAC facilities less than 50 beds. RAC with primary care providers of less than one years' experience working with that facility.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
We have landed on recruitment numbers as RAC facilities because there is no national staff (healthcare assistant or registered nurse) to resident ratio. We are unable therefore to predict staff numbers that will be recruited to study. As this is a staff process change (using a standardized tool DEWS to identify acute deterioration) recruited RAC leadership will require staff to use DEWS for the duration of the study, this will not be an individual staff decision as running two parallel systems (DEWS and usual process) carries too much risk.

We have stipulated that RAC facilities must have a minimum of 50 beds (no maximum) and we are planning to recruit one RAC facility that has a high concentration of Maori staff, ideally that facility will have a Maori centered approach to care.

As we have recruited a range of RAC facilities (those with corporate ownership and those in individual ownership) the project teams at the facilities differ. Corporate groups have national quality improvement advisors, regional risk managers and clinical leadership, small facilities simply do not have those roles / resources. More than half the RAC facilities in NZ are run by small owner / operators so we need to include them to be representative of the sector. This mean we were unable to use quality team size / roles a number.

So that is why we settled on number of facilities as "number of participants"

Recruiting: we have now recruited our facilities (visited and consented). The workshop will be held 29 February 2024 this is the first action of the research.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
5/02/2024
Date of last participant enrolment
Anticipated
Actual
16/02/2024
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
5
Accrual to date
Final
6
Recruitment outside Australia
Country [1] 26068 0
New Zealand
State/province [1] 26068 0

Funding & Sponsors
Funding source category [1] 315549 0
Government body
Name [1] 315549 0
Te Tahu Hauora Health Quality and Safety Commission
Country [1] 315549 0
New Zealand
Primary sponsor type
Individual
Name
Dr Michal Boyd
Address
University of Auckland, 85 Park Road, Grafton, Auckland
Country
New Zealand
Secondary sponsor category [1] 317636 0
None
Name [1] 317636 0
Address [1] 317636 0
Great South Road, Auckland
Country [1] 317636 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314448 0
Auckland Health Research Ethics Committee
Ethics committee address [1] 314448 0
Ethics committee country [1] 314448 0
New Zealand
Date submitted for ethics approval [1] 314448 0
27/11/2023
Approval date [1] 314448 0
15/12/2023
Ethics approval number [1] 314448 0
AH26938

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131618 0
A/Prof Michal Boyd
Address 131618 0
University of Auckland, Faculty of Medical and Health Sciences, School of Nursing, 85 Park Road, Grafton, Auckland, 1023
Country 131618 0
New Zealand
Phone 131618 0
+64 9 373 7599
Fax 131618 0
Email 131618 0
michal.boyd@auckland.ac.nz
Contact person for public queries
Name 131619 0
Michal Boyd
Address 131619 0
University of Auckland, Faculty of Medical and Health Sciences, School of Nursing, 85 Park Road, Grafton, Auckland, 1023
Country 131619 0
New Zealand
Phone 131619 0
+64 9 373 7599
Fax 131619 0
Email 131619 0
michal.boyd@auckland.ac.nz
Contact person for scientific queries
Name 131620 0
Michal Boyd
Address 131620 0
University of Auckland, Faculty of Medical and Health Sciences, School of Nursing, 85 Park Road, Grafton, Auckland, 1023
Country 131620 0
New Zealand
Phone 131620 0
+64 9 373 7599
Fax 131620 0
Email 131620 0
michal.boyd@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We will not be collecting individual participant data, this is a process feasibility study.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21383Study protocol  michal.boyd@auckland.ac.nz 387140-(Uploaded-14-01-2024-12-32-47)-Study-related document.docx
21384Ethical approval  michal.boyd@auckland.ac.nz 387140-(Uploaded-14-01-2024-12-31-13)-Study-related document.pdf



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.