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Trial registered on ANZCTR


Registration number
ACTRN12619001014145
Ethics application status
Approved
Date submitted
1/07/2019
Date registered
15/07/2019
Date last updated
27/03/2023
Date data sharing statement initially provided
15/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving Quality of Care Through Detection of Complexity Amongst Older People in a Community Setting: Pragmatic Randomised Controlled Trial Protocol.
Scientific title
Does the Patient Complexity Instrument (PCI) in addition to usual care, enhance nurses’ detection of complexity and delivery of appropriate allocation of care for community dwelling patients aged 65 and over?
Secondary ID [1] 298632 0
nil known
Universal Trial Number (UTN)
U1111-1236-2073
Trial acronym
ImPaCt
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Complexity of health conditions and healthcare status in geriatrics 313503 0
Condition category
Condition code
Public Health 311930 311930 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An introduction to the project will be provided as a 15 min powerpoint delivered 3 times or until all staff have been included. Delivered by the researcher and in groups, consent will be obtained at this point. An information sheet on the PCI and how to use it will be provided as part of this session, given to staff once. All staff receive this, it is not specifically part of the intervention. Staff will be asked to complete a pre-trial survey once to gather information about current knowledge of complexity.
Usual care: the documentation, questioning and assessment that would normally occur will continue to occur.
The intervention is usual assessment plus the PCI. The registered nurses will complete their usual care and on return to the office collect the randomized envelope. The intervention group will complete a survey regarding their current interpretation of the usual care, then complete the PCI for each admission in the intervention group, could be daily. They then redo the survey to identify a change.
The intervention is delivered to each admission allocated to this group, this may be daily.
The trial is conducted in a regional Victorian community nursing service, the intervention is physically administered in an office.
Intervention code [1] 314894 0
Early detection / Screening
Comparator / control treatment
The ImPaCt study is a pragmatic parallel group blocked randomised controlled trial in which the PCI plus usual assessment of patient complexity will be compared to usual assessment method alone. The control group: an assessment will be completed following the current usual process. The nurse conducting the assessment will be asked to rate and justify the patient’s complexity using judgment as usual and will not be prompted in any way.
Usual care: the documentation, questioning and assessment that would normally occur will continue to occur.
Control group
Active

Outcomes
Primary outcome [1] 320595 0
Detected patient complexity as assessed by nurses using low, moderate or high. 3 point Likert scale,: low (1), medium (2) or High (3). study-specific questionnaire.
Timepoint [1] 320595 0
data is collected at the point of initial assessment for each client.
Secondary outcome [1] 372156 0
Interventions (care tasks) allocated to clients using a drop down box including medication support, wound care, referrals & Liaison, hygiene and other as options to select. this is a composite secondary outcome. This is assessed using a study specific questionnaire.
analysis will be conducted using comparison Chi-square between control and intervention
Timepoint [1] 372156 0
data is collected at the point of initial assessment for each client.
Secondary outcome [2] 372423 0
time allocated to client care. this is assessed using the predetermined (service data base) time allocated to each task which is added together to determine total time.
analysis will be conducted using Linear regression analysis will be performed for total time allocated to patients as the dependent variable
Timepoint [2] 372423 0
data is collected at the point of initial assessment for each client.

Eligibility
Key inclusion criteria
The inclusion criteria are new referrals of patients aged 65 and over and meet the criteria for Commonwealth home support program (CHSP) funded services. This criteria is that the care is delivered to support the client to remain in their home and active in the community. Recently discharged patients falling under the episodic Post-Acute-Care (PAC) will be included if they require continuing care which is eligible for CHSP funding.
All Registered Nurses employed as District Nurses in the community nursing service and are assigned to perform new patient assessment during the trial period will be included. Assessments will be those performed during weekdays as those occurring on weekends are invariably Post Acute Care episodic care that are not eligible for CHSP funded care.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusions will be patients referred for specific episodic care such as anti-coagulant therapy or eye drops post-eye surgery. Patients who are due for follow up and re-assessment during the trial period will also be excluded. Nurse participation is voluntary therefore, assessments completed by a nurse who declines to participate in the study will not be considered. The relationship with the nurse, other staff and the organisation will not be affected by their decision.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study randomisation schedule will be designed by an independent person who will not be implementing the study procedures. Randomisation will occur at the level of the type of assessment (PCI plus usual assessment vs usual assessment alone) using 45 blocks of 4 block sizes.
The type of assessment will be concealed in sequentially numbered, sealed opaque envelopes prepared by an independent person. An envelope will be sequentially drawn from a closed box and opened to reveal the type of assessment; each time a new assessment needs to be performed. Once opened the allocation cannot be re-used if for whatever reason it is not used for that assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
nested feasibility
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Participant characteristics data will be analysed and presented using descriptive statistics such as mean and standard deviation for continuous data, median and interquartile range for ordinal data and percentage and 95% confidence interval for categorical data.
Chi-square independence test will be used for comparison of distribution of nurses detected patient complexity (categorised as low, moderate or high) between control and intervention groups. This method will also be used to look at comparison of nursing care medication support, wound care, referrals & Liaison, hygiene, other, allocated between control and intervention groups. The same comparison will also be conducted within the intervention group between level of complexity pre and post PCI.
Fisher’s Exact test will be used to analyse the pre and post survey data due to the low number of nurses in the study. This will allow for the Likert responses. The text responses analysis will be conducted using narrative descriptions.
Linear regression analysis will be performed for total time allocated to patients as the dependent variable with patient age, gender, reason or referral, staff years of experience, and level of complexity service as independent variables.
All data analysis will be carried in IBM SPSS Statistics Version 24 (IBM Corp, NY). Although the study may not be sufficiently powered to test for effect, nonetheless the level of statistical significance will be set at p>0.05.
A qualitative summary description of surveys and additional information regarding nursing interventions, rationale for complexity rating will be completed, barriers and enablers to detecting complexity. Content analysis will be used to report the findings of staff feedback, field notes and observations recorded by the researcher. This will be done using manifest analysis for feedback and latent analysis for field notes and observations. Themes will be coded, categorised and themed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/07/2019
Date of last participant enrolment
Anticipated
27/09/2019
Actual
30/10/2020
Date of last data collection
Anticipated
4/10/2019
Actual
30/10/2020
Sample size
Target
138
Accrual to date
Final
107
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14127 0
Bendigo Health Care Group - Anne Caudle campus - Bendigo
Recruitment postcode(s) [1] 26933 0
3550 - Bendigo

Funding & Sponsors
Funding source category [1] 303172 0
Hospital
Name [1] 303172 0
Bendigo Health
Country [1] 303172 0
Australia
Primary sponsor type
Individual
Name
Jennifer Boak
Address
Bendigo Health
37 Havlin st east, Bendigo, Vic 3550
Country
Australia
Secondary sponsor category [1] 303179 0
University
Name [1] 303179 0
La Trobe Univeristy
Address [1] 303179 0
Edwards Rd, Flora Hill VIC 3552
Country [1] 303179 0
Australia
Other collaborator category [1] 280826 0
Individual
Name [1] 280826 0
Irene Blackberry
Address [1] 280826 0
La Trobe University
133 McKoy Street, West Wodonga Victoria 3690
Country [1] 280826 0
Australia
Other collaborator category [2] 280827 0
Individual
Name [2] 280827 0
Tshepo Rasekaba
Address [2] 280827 0
La Trobe University
133 McKoy Street, West Wodonga Victoria 3690
Country [2] 280827 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303734 0
Bendigo Health HREC
Ethics committee address [1] 303734 0
Ethics committee country [1] 303734 0
Australia
Date submitted for ethics approval [1] 303734 0
14/06/2019
Approval date [1] 303734 0
28/06/2019
Ethics approval number [1] 303734 0
LNR/19/BHCG/54227

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

Contacts
Principal investigator
Name 94610 0
Mrs Jennifer Boak
Address 94610 0
Bendigo Health
37 Havlin st East, Bendigo, Vic 3550
Country 94610 0
Australia
Phone 94610 0
+61 439496924
Fax 94610 0
Email 94610 0
jboak@bendigohealth.org.au
Contact person for public queries
Name 94611 0
Jennifer Boak
Address 94611 0
Bendigo Health
37 Havlin st East, Bendigo, Vic 3550
Country 94611 0
Australia
Phone 94611 0
+61 439496924
Fax 94611 0
Email 94611 0
jboak@bendigohealth.org.au
Contact person for scientific queries
Name 94612 0
Jennifer Boak
Address 94612 0
Bendigo Health
37 Havlin st East, Bendigo, Vic 3550
Country 94612 0
Australia
Phone 94612 0
+61 439496924
Fax 94612 0
Email 94612 0
jboak@bendigohealth.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
participants will not be identifiable in the analysis.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2677Study protocol  jboak@bendigohealth.org.au 377888-(Uploaded-01-07-2019-10-19-48)-Study-related document.docx
2678Informed consent form  jboak@bendigohealth.org.au 377888-(Uploaded-01-07-2019-10-22-37)-Study-related document.docx
2679Ethical approval  jboak@bendigohealth.org.au 377888-(Uploaded-01-07-2019-10-22-37)-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.