Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001009505p
Ethics application status
Not yet submitted
Date submitted
5/07/2024
Date registered
20/08/2024
Date last updated
20/08/2024
Date data sharing statement initially provided
20/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a transition of care service to reduce hospital readmissions for high-risk cardiology patients.
Scientific title
The efficacy of a transition of care service to REduce hospital readmissions for high-risk CARDiology patients (RECARD): a pre-post interventional trial.
Secondary ID [1] 312468 0
MRFMMIP000044
Universal Trial Number (UTN)
Trial acronym
RECARD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute myocardial infarction 334305 0
Cardiac surgery 334306 0
Condition category
Condition code
Cardiovascular 330961 330961 0 0
Coronary heart disease
Public Health 331181 331181 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pharmacist-led interdisciplinary transition of care service that will incorporate the following:
The provision of written materials to patients, such as an updated discharge medication list, along with consumer medication information leaflets on newly prescribed medications. A senior pharmacist will lead the service and provide in-patient activities to the patient on discharge that will include medication review and reconciliation, discharge planning and organisation, supply of medications, medication counselling, and communication of any medication changes to primary care providers (i.e., community pharmacist or general practitioner). The pharmacist will also provide an out-patient follow-up consultation, which will also involve medication review and medication counselling after the patient has been discharged. The pharmacist will be supported by a nurse and indigenous healthcare worker who may also provide support in medication review and progress assessments. The pharmacist will be a senior clinician (Queensland Health practitioner level HP4) with a minimum of 3-4 years experience, the nurse will also be a senior practitioner (Grade 6) with a minimum of 3 years experience, and the indigenous healthcare worker will be an identified position to provide culturally safe care where it is needed.
The mode of delivery will be face to face whilst the patient is in hospital. After they are discharged, the mode of delivery will mainly be through telephone or video for follow-up consultations. The option for a home visit to provide a face to face follow-up consultation will be provided on the basis of feasibiltiy and patient preference. The pharmacist will provide the service/intervention at least once during the patient's inpatient stay, and prior to discharge (e.g., 1 x 1 hour face to face consultation), and the follow-up consultation will be provided at least once (e.g., 30 mins to 1 hour for a telephone or video consultation, and up to 2 hours for a home visit) within 1 to 2 weeks post-discharge. The nurse and indigenous health worker will provide support in the inpatient setting where they are needed through 30min to 1 hour in-person consultations with the patient. The location of the intervention will be at the three hospital sites for the study setting (Princess Alexandra Hospital, Royal Brisbane and Womens Hospital, and Townsville Univeristy Hospital) for inpatient care, and over telephone or video for outpatient follow-up consultations post-discharge. Follow-up consultations may be completed in the participant's home if this is appropriate and preferred. If the participant is identified as a First Nation's patient, the indigenous healthcare worker may be required to support the pharmacist consultation as care will need to be adapted to ensure a culturally safe and appropriate transition of care service.
Intervention code [1] 328983 0
Treatment: Other
Comparator / control treatment
Usual care will include participants that do not receive the pharmacist-led transition of care service, as determined through a historical cohort control group. The data collected for this historical control group will be from June 2024 to June 2025, approximately 1 year before the service (intervention) will be implemented (pre-post trial design). Usual care means that participants may still be provided with a consultation from a general ward pharmacist; however, no consultation with the transition of care pharmacist as described above will be provided.
Control group
Historical

Outcomes
Primary outcome [1] 338726 0
30-day medication related readmissions
Timepoint [1] 338726 0
30 days after discharge
Secondary outcome [1] 437172 0
30-day all cause readmissions
Timepoint [1] 437172 0
30 days after hospital discharge.
Secondary outcome [2] 437173 0
60-day all cause readmissions
Timepoint [2] 437173 0
60-days after hospital discharge
Secondary outcome [3] 437174 0
90-day all cause readmissions.
Timepoint [3] 437174 0
90 days after hospital discharge.
Secondary outcome [4] 437178 0
Type of harm in terms of severity of medication-related readmissions.
Timepoint [4] 437178 0
30-days from discharge.
Secondary outcome [5] 437181 0
Patient satisfaction of the transition of care service.
Timepoint [5] 437181 0
30-days after discharge and after receiving the transition of care service.
Secondary outcome [6] 437187 0
Cost-effectiveness of the transition of care service.
Timepoint [6] 437187 0
30-days after discharge.
Secondary outcome [7] 437990 0
Type of harm in terms of the preventability of medication-related readmissions.
Timepoint [7] 437990 0
30-days from discharge.

Eligibility
Key inclusion criteria
Inclusion Criteria
• Greater than or equal to 18 years of age (Adult participants).
• Discharge from Princess Alexandra Hospital (PAH), Royal Brisbane and Womens Hospital (RBWH), or Townsville University Hospital (TUH) for an index diagnosis of acute myocardial infarction (AMI).
• Discharged from PAH, RBWH or TUH for a planned cardiac surgery (CS) admission.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
• Patients who reside in a residential aged care facility (RACF).
• Patients who are palliative or receiving end of life care.
• Patients undergoing chemotherapy, radiation, or dialysis.
• Patients who are inter-hospital transferred to a site other than PAH, RBWH or TUH.
• Patients who discharge against medical advice.
• Patients who died during their admission

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Pre-Post Interventional trial with a historical control group.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An intention to treat (ITT) analysis will be conducted. Participants that are lost to follow up (do not complete the intervention, withdrawal of consent, death) will be included in the ITT analysis for the primary outcome. Participant characteristics will be summarised according to the pre- and post- study cohorts. Characteristics will be summarised and presented descriptively using means and standard deviations, medians and interquartile ranges and number and percentages, as required. Independent t-tests and chi-squared tests will be undertaken to determine if there are any differences in baseline characteristics between the pre- and post-study cohorts. The primary outcome is a comparison of 30-day medication related readmissions in the pre- and post-study cohort, with secondary outcomes compared between the pre- and post-study cohort as well. The results for these outcomes will be considered significant at the 5% level, with 95% confidence intervals reported. Subgroup analysis will also be undertaken to assess whether the clinical impact of the intervention varied by location (regional versus metropolitan site), or cohort (acute myocardial infarction and cardiac surgery).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
31/07/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
775
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26758 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 26759 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 26760 0
Townsville University Hospital - Douglas
Recruitment postcode(s) [1] 42807 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 42808 0
4029 - Herston
Recruitment postcode(s) [3] 42809 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 316883 0
Government body
Name [1] 316883 0
Medical Research Future Fund (MRFF), Department of Health and Aged Care.
Country [1] 316883 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 319130 0
None
Name [1] 319130 0
Address [1] 319130 0
Country [1] 319130 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315647 0
Metro North Health Human Research Ethics Committee A
Ethics committee address [1] 315647 0
Ethics committee country [1] 315647 0
Australia
Date submitted for ethics approval [1] 315647 0
31/08/2024
Approval date [1] 315647 0
Ethics approval number [1] 315647 0

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

Contacts
Principal investigator
Name 135362 0
Prof Michael Barras
Address 135362 0
Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba Queensland 4102
Country 135362 0
Australia
Phone 135362 0
+61 7 3176 7048
Fax 135362 0
Email 135362 0
[email protected]
Contact person for public queries
Name 135363 0
Michael Barras
Address 135363 0
Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba Queensland 4102
Country 135363 0
Australia
Phone 135363 0
+61 7 3176 7048
Fax 135363 0
Email 135363 0
[email protected]
Contact person for scientific queries
Name 135364 0
Dr Keshia De Guzman or Dr Chariclia Paradissis
Address 135364 0
The University of Queensland, School of Pharmacy, 20 Cornwall Street Woolloongabba Queensland 4102
Country 135364 0
Australia
Phone 135364 0
+61 7 3346 1980
Fax 135364 0
Email 135364 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


What supporting documents are/will be available?

No Supporting Document Provided



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.