Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000780550
Ethics application status
Approved
Date submitted
29/05/2024
Date registered
25/06/2024
Date last updated
1/09/2024
Date data sharing statement initially provided
25/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a health literacy intervention to improve cardiac services for patients with coronary heart disease
Scientific title
Efficacy of a co-designed Patient Discharge Action Plan intervention to improve accessibility of cardiac services and health literacy levels for patients with coronary heart disease: A randomised-controlled trial
Secondary ID [1] 312194 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary heart disease 333865 0
Condition category
Condition code
Cardiovascular 330542 330542 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a Patient Discharge Action Plan co-designed with consumers and clinicians as part of The Equal Hearts Study (Monash Health HREC 88413). The 1-page Action Plan was developed to support patients to prepare for discharge. It is designed to ensure that patients know the next steps following discharge based on the information they are given as part of usual care, such as following up with a general practitioner and specialist, being referred to cardiac rehabilitation, what to do in the event of chest pain and what to do regarding medication. The action plan is also personalised for each patient with a section that addresses the patient’s individual concerns (e.g. about driving, exercise, work, etc.) and a section addressing any questions they may have. Links and QR codes to the health service's Patient Portal, and to information about recovery and cardiac rehabilitation (CR) are also provided in the action plan. The Patient Discharge Action Plan is intended to be filled out by the patient together with the CR clinician on the day of, or the day prior to, discharge and will take no longer than 30 minutes to complete. This intervention is delivered in addition to usual care, meaning that participants in the intervention group will receive all education that is provided as part of usual care, plus the Patient Discharge Action Plan. Face-to face training will be provided to CR clinicians by members of the research team about how to implement the Action Plan at least two weeks before commencement of the intervention.
Usual care treatment involves a one-on-one education session delivered by a CR clinician at the bedside, given on the day of, or the day prior to, discharge, and takes approximately 45 minutes to complete. Patients are educated about their condition, advised on management of chest pain and returning to activities, and provided with resources to aid their transition to at home care. These resources include a generalised chest pain management plan from the Heart Foundation. If further education is required, the CR clinician is able to refer patient to other services according to patient preferences.
Intervention code [1] 328644 0
Treatment: Other
Intervention code [2] 328767 0
Behaviour
Comparator / control treatment
The control treatment is the usual discharge education process for inpatients with coronary heart disease (CHD). It involves a one-on-one education session delivered by a CR clinician at the bedside, given on the day of, or the day prior to, discharge. This education process usually takes around 30 minutes and allows time for questions and two-way communication between the CR clinician and patient. Patients are educated about their condition, advised on management of chest pain and returning to activities, and provided with resources to aid their transition to at home care. These resources include a chest pain management plan which are standardised and based on the Heart Foundation guidelines. If further education is required, the CR clinician is able to refer patient to other services according to patient preferences.
Control group
Active

Outcomes
Primary outcome [1] 338307 0
Health literacy
Timepoint [1] 338307 0
Baseline, 2-weeks (primary timepoint) and 3-months after hospital discharge
Secondary outcome [1] 435374 0
Anxiety
Timepoint [1] 435374 0
Baseline, 2-weeks and 3-months after hospital discharge
Secondary outcome [2] 435375 0
Depression
Timepoint [2] 435375 0
Baseline, 2-weeks and 3-months after hospital discharge
Secondary outcome [3] 435376 0
Confidence to manage their heart condition
Timepoint [3] 435376 0
Three-months post hospital discharge
Secondary outcome [4] 435377 0
Ability to actively manage health
Timepoint [4] 435377 0
Baseline, 2-weeks and 3-months after hospital discharge
Secondary outcome [5] 435378 0
Ability to engage with the health system (healthcare providers)
Timepoint [5] 435378 0
Baseline, 2-weeks and 3-months after hospital discharge
Secondary outcome [6] 435379 0
Medication adherence
Timepoint [6] 435379 0
Three-months post hospital discharge
Secondary outcome [7] 435380 0
Physical activity
Timepoint [7] 435380 0
Baseline and 3-months post hospital discharge
Secondary outcome [8] 435381 0
Healthy eating
Timepoint [8] 435381 0
Baseline and 3-months post hospital discharge
Secondary outcome [9] 435382 0
Emergency department presentations
Timepoint [9] 435382 0
Three-months post hospital discharge
Secondary outcome [10] 435383 0
Attendance at cardiac rehabilitation
Timepoint [10] 435383 0
Three-months post hospital discharge
Secondary outcome [11] 435384 0
Uptake of the health service's Patient Portal
Timepoint [11] 435384 0
Three-months post hospital discharge
Secondary outcome [12] 435385 0
Patient and staff perspectives on the intervention
Timepoint [12] 435385 0
Three-months post hospital discharge
Secondary outcome [13] 436154 0
Ability to engage with the health system (health system navigation)
Timepoint [13] 436154 0
Baseline, 2-weeks and 3-months after hospital discharge
Secondary outcome [14] 436178 0
Hospital admissions
Timepoint [14] 436178 0
Three-months post hospital discharge

Eligibility
Key inclusion criteria
For patients, inclusion criteria are:
- Adults (18 years and older);
- Patients with first-time presentation of Acute Coronary Syndrome (ACS) (ICD-10 codes I200-I214);
- Able to understand English or one of the three top language groups admitted to the health service with CHD;
- Discharge to home is planned to occur within the next 48 hours.

For clinician interviews, inclusion criteria are a clinician working in the cardiac rehabilitation (CR) program at the health service.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For patients, exclusion criteria are:
- Cognitive impairment – this will be determined from the medical records or by the nurse in charge for that shift;
- Discharged home with diagnosis of heart failure, or on specific targeted therapy for heart failure;
- Other significant in-hospital complication including major stroke;
- Discharge to nursing home/long term care facility/other hospital.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block allocation (blocks of 6 participants).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
From previous work conducted by the research team, the sample size for this RCT is based on a 20% difference in HLQ scale scores in the intervention compared to the control group. With 80% power, a confidence level of 95%, and a standard deviation of 1.25, the required sample size is 50 (25 in each group), inflated to 60 to allow for attrition.
For the interviews with patients, we will aim for a sample size of 16, as between 9-17 participants is considered sufficient to achieve data saturation. For clinicians, all those who work in cardiac rehabilitation will be invited. This is expected to be up to 6 participants.

Data analysis will be conducted using Stata V18. A p-value of <0.05 will be used to indicate statistical significance. Patient demographics will be described by randomised group. The primary outcome will be changes in the HLQ scale 2: Having sufficient information to manage my health at 2-weeks post-discharge. Differences between the intervention and usual care groups will be compared using a two-sample t-test.
For secondary outcomes, differences between the two groups will be compared using t-tests for continuous data, or chi-squared tests for categorical data. Outcomes will be analysed using logistic and linear regression models for categorical and continuous variables, respectively. Where appropriate, 95% confidence intervals and effect sizes will be reported.
Qualitative interview data will be thematically analysed to identify key themes related to patient and clinician experience of the interventions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/09/2024
Actual
Date of last participant enrolment
Anticipated
3/03/2025
Actual
Date of last data collection
Anticipated
27/06/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316569 0
Government body
Name [1] 316569 0
Australian Government Department of Health and Aged Care - Medical Research Future Fund
Country [1] 316569 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Alison Beauchamp
Address
Country
Australia
Secondary sponsor category [1] 318764 0
None
Name [1] 318764 0
Address [1] 318764 0
Country [1] 318764 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315356 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 315356 0
Ethics committee country [1] 315356 0
Australia
Date submitted for ethics approval [1] 315356 0
22/05/2024
Approval date [1] 315356 0
16/07/2024
Ethics approval number [1] 315356 0

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

Contacts
Principal investigator
Name 134442 0
Dr Laveena Sharma
Address 134442 0
Victorian Heart Hospital, 246 Clayton Road, Clayton, VIC 3168
Country 134442 0
Australia
Phone 134442 0
+61 428337544
Fax 134442 0
Email 134442 0
[email protected]
Contact person for public queries
Name 134443 0
Associate Professor Alison Beauchamp
Address 134443 0
School of Rural Health, Monash University, 15 Sargeant St, Warragul, VIC 3820
Country 134443 0
Australia
Phone 134443 0
+610399027310
Fax 134443 0
Email 134443 0
[email protected]
Contact person for scientific queries
Name 134444 0
Associate Professor Alison Beauchamp
Address 134444 0
School of Rural Health, Monash University, 15 Sargeant St, Warragul, VIC 3820
Country 134444 0
Australia
Phone 134444 0
+610399027310
Fax 134444 0
Email 134444 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Contains sensitive health information


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23797Ethical approval    This will be available from alison.beauchamp@monas... [More Details]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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