Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001028796
Ethics application status
Approved
Date submitted
11/07/2022
Date registered
22/07/2022
Date last updated
11/10/2023
Date data sharing statement initially provided
22/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the feasibility and acceptability of a discharge medication literacy intervention (the CHAT study)
Scientific title
What is the effect of QR codes and websites on patients' hospital discharge medication literacy and communication? A feasibility trial
Secondary ID [1] 307330 0
Nil known
Universal Trial Number (UTN)
U1111-1279-1793
Trial acronym
CHAT Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medication communication 326614 0
Medication literacy 326968 0
Condition category
Condition code
Public Health 324148 324148 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a poster (size A3) placed in the patient’s room, plus an A4 copy of the poster is given to the patient to keep. The poster has 3 QR codes which when scanned link the patient to three intervention components:

1. The NPS Medicine Wise finder: https://www.nps.org.au/medicine-finder

2. A webpage specifically designed for this study that has information to support patients with managing their medications once home, including: the NPS Medicine Wise app: https://www.nps.org.au/medicinewiseapp, who to contact in the community such as NPS Medicine Line https://www.nps.org.au/medicines-line, and trusted sources of information including NPS Medicine Wise website and Health Direct website.

3. A question builder website specifically designed for this study that prompts patients to ask more questions about their medications in hospital

The intervention education session will be delivered by a Research Nurse, one-on-one with the patient. It will be delivered in a single session while the patient is in hospital. We anticipate that it will take the nurse 10 minutes or less to deliver the intervention education session. In this single session, the nurse will provide an overview of the intervention, by showing the patient the poster, and verbally instructing them that they can scan any of the 3 QR codes that are relevant to them, at any time during their hospital admission (thus, they can choose what components they engage with). The intervention education session will be scheduled at any time prior to discharge depending upon patient availability, etc. It will then be up to the patient how they engage with the intervention for the remainder of their hospitalization. The patients will use their own smart phone/device to access the intervention.

The Research Nurse will keep a log about fidelity to intervention delivery.
Intervention code [1] 323995 0
Behaviour
Intervention code [2] 324033 0
Treatment: Devices
Comparator / control treatment
Participants in the control group will not have access to the intervention. All participants (intervention group and control group) will receive usual care. Usual care at the site includes:
* Sporadic discharge medication conversations during routine tasks (for example bedside handover and ward rounds), dependent on patient and HCP communication skills
* Pharmacist consult on admission and discharge, dependent on pharmacist workload and timing of patient admission/discharge
We will not monitor adherence to usual care.
Control group
Active

Outcomes
Primary outcome [1] 331962 0
Recruitment and resources: the proportion of patients admitted to the units who meet the eligibility criteria determined by an audit of study screening logs, consent rate determined by an audit of study screening logs, reasons for declined consent and recruitment duration determined by an audit of study screening logs.
Timepoint [1] 331962 0
Recruitment and resources: cumulative data will be collected until the end of the study.
Primary outcome [2] 331963 0
Fidelity: Research Nurse adherence to intervention delivery determined by the Research Nurse completing a self-report log created by the research team and asking patient’s survey questions designed by the research team about the intervention education session.
Timepoint [2] 331963 0
Fidelity: after intervention delivery and 7-days post hospital discharge
Primary outcome [3] 332022 0
Retention: number of patients at 28-day follow-up who provide complete data. This will be determined by the Research Nurse completing a self-report log created by the research team. Open-ended notes will be kept about challenges in following-up patients will also be recorded.
Timepoint [3] 332022 0
Retention: at 28-days post hospital discharge
Secondary outcome [1] 411737 0
Medication literacy using the Medication Understanding Questionnaire (MUQ)
Timepoint [1] 411737 0
At baseline and 7-days post hospital discharge
Secondary outcome [2] 411738 0
Medication self-efficacy and adherence using the Medication Understanding and Use Self-Efficacy Scale (MUSE)
Timepoint [2] 411738 0
At baseline and 7-days post hospital discharge
Secondary outcome [3] 411739 0
Medication-related healthcare visits 28-days post hospital discharge including:
- Medication-related visit to an emergency department
- Medication-related admission to hospital
- Medication-related visit to General Practitioner
- Medication-related visit to Pharmacist
This is a composite secondary outcome that will be assessed by surveying patients using a study specific survey.
Timepoint [3] 411739 0
28-days post hospital discharge
Secondary outcome [4] 411919 0
This is a primary outcome
Data collection and resources: time to deliver the intervention and collect each outcome measure. This will allow our team to monitor participant burden, ease of implementation and study logistics. This will be determined by the Research Nurse completing a self-report log created by the research team.
Timepoint [4] 411919 0
Data collection and resources: cumulative data will be collected until the end of the study
Secondary outcome [5] 411920 0
This is a primary outcome.
Contamination: researchers will ask patients in the usual care group if they know about the intervention. This will be determined by asking patient’s survey questions designed by the research team about whether they knew about the intervention.
Timepoint [5] 411920 0
Contamination: at 7-days post hospital discharge
Secondary outcome [6] 411924 0
This is a primary outcome.
Intervention acceptability using the generic form of Theoretical Framework of Acceptability (TFA) questionnaire (for patients).
Timepoint [6] 411924 0
7 days post-hospital discharge
Secondary outcome [7] 411926 0
This is a primary outcome.
10 healthcare professionals on the participating units will also be given a questionnaire to explore their perceptions of intervention acceptability. This questionnaire has been designed by the research team. Healthcare professionals are not the target population for this intervention, however the intervention may result in patients asking healthcare professionals more questions. Thus, we will also seek healthcare professionals' views on acceptability. In terms of sampling, the first 10 healthcare professionals to consent to completion of the questionnaire will be participants.
Timepoint [7] 411926 0
At a time convenient for the healthcare professional while the patient is hospitalized or up to 7-days post the patient's hospital discharge.
Secondary outcome [8] 412152 0
This is a primary outcome
Fidelity: Patient adherence to the intervention will be determined by analysing the frequency that QR codes were accessed, analysing data the patient input into the Question Builder website, and asking patient’s survey questions designed by the research team about what intervention components they used.
Timepoint [8] 412152 0
Fidelity: Cumulative data will be collected until the end of the study and 7-days post hospital discharge.

Eligibility
Key inclusion criteria
Patients (the target group for the intervention):
* Patients greater than or equal to 45 years old
* Patients with greater than or equal to 1 chronic illness
* Patients with greater than or equal to 1 regularly prescribed medication that they manage at home
*Patients who have a smart device (I.e. tablet or phone)

Healthcare professionals:
*Doctor, nurse or pharmacist who was caring for patients in the intervention arm
*Work regularly on participating units
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients:
*Patients receiving end-of-life care
*Patients with planned discharge to an aged care facility
*Patients with cognitive impairments
*Patients with an inability to communicate in English

Healthcare professionals:
*N/A

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)
At the time of recruitment, the recruiter will access the Griffith University Randomization Service. The web-based service provides automated centralized randomization for research studies, overseen by experienced statisticians, researchers, and with the support of Griffith Information Services. This provides a completely independent randomization process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomized to the two study groups using simple random sampling in a 1:1 ratio. The randomization will be blocked (using randomly varying blocks of sizes 4 and 6).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sixty patient participants will be recruited to provide practical information about study processes, which is consistent with the median sample sizes for pilot studies. 10 Healthcare professionals will provide acceptability data.

For primary outcome measures, descriptive statistics will used to compute absolute (n) and relative (%) frequencies, and means and standard deviations or medians/interquartile ranges (IQR), depending on the level and distribution of data. The first question in the TFA questionnaire is a global rating scale for overall intervention acceptability, the median and interquartile range of global rating scale questions will be reported, and percentages will be calculated for the total number of participants deeming the intervention acceptable.
All percentages will be assessed against pre-specified criteria (based on previous pilot trials):
*Recruitment: >75% of eligible patients approached consent to participate
*Fidelity: >80% of patients receive the intervention as intended
*Retention: >80% of recruited patients provide complete outcome data at 28-days post-discharge
*Missing data: >80% of data collected is complete
*Contamination: >95% of the usual care group did not get the intervention
*Intervention acceptability: >80% of patients and healthcare professionals view the intervention as acceptable

The secondary outcome measures will be reported descriptively including absolute (n) and relative (%) frequencies, and means and standard deviations or medians/interquartile ranges (IQR), depending on the level and distribution of data. As this is a pilot study, hypotheses testing are not the focus; comparisons between the two groups will only be undertaken to obtain an indication of the general trends in the data as recommended in pilot study methodology. Statistical tests will be used to compare for significant differences in groups. Depending on the distribution of data parametric or non-parametric tests will be used. A p-value of less than .05 will be considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/10/2022
Actual
11/10/2022
Date of last participant enrolment
Anticipated
2/01/2023
Actual
22/05/2023
Date of last data collection
Anticipated
6/02/2023
Actual
17/07/2023
Sample size
Target
70
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22785 0
Gold Coast Hospital - Southport
Recruitment postcode(s) [1] 38071 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 311621 0
Hospital
Name [1] 311621 0
Gold Coast Hospital Collaborative Research Grant Scheme
Country [1] 311621 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast Hospital and Health Service
Address
Office Research Governance and Development
1 Hospital Blvd
Southport, Gold Coast, QLD, 4215
Country
Australia
Secondary sponsor category [1] 313288 0
None
Name [1] 313288 0
Address [1] 313288 0
Country [1] 313288 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311077 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 311077 0
Ethics committee country [1] 311077 0
Australia
Date submitted for ethics approval [1] 311077 0
15/04/2021
Approval date [1] 311077 0
31/05/2021
Ethics approval number [1] 311077 0
HREC/2021/QGC/74585
Ethics committee name [2] 311258 0
Griffith University HREC
Ethics committee address [2] 311258 0
Ethics committee country [2] 311258 0
Australia
Date submitted for ethics approval [2] 311258 0
14/06/2021
Approval date [2] 311258 0
24/06/2021
Ethics approval number [2] 311258 0
2021/436
Ethics committee name [3] 311259 0
Deakin University HREC
Ethics committee address [3] 311259 0
Ethics committee country [3] 311259 0
Australia
Date submitted for ethics approval [3] 311259 0
17/06/2021
Approval date [3] 311259 0
25/06/2021
Ethics approval number [3] 311259 0
2021-216

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

Contacts
Principal investigator
Name 119862 0
Prof Andrea Marshall
Address 119862 0
Gold Coast University Hospital
Block E, Room 2.015
1 Hospital Blvd,
Southport, Gold Coast, QLD, 4215
Country 119862 0
Australia
Phone 119862 0
+61756873235
Fax 119862 0
Email 119862 0
[email protected]
Contact person for public queries
Name 119863 0
Georgia Tobiano
Address 119863 0
Griffith University
G01 Room 2.05
Parklands Drive,
Parklands, Gold Coast, QLD, 4222
Country 119863 0
Australia
Phone 119863 0
+61755528180
Fax 119863 0
Email 119863 0
[email protected]
Contact person for scientific queries
Name 119864 0
Georgia Tobiano
Address 119864 0
Griffith University
G01 Room 2.05
Parklands Drive,
Parklands, Gold Coast, QLD, 4222
Country 119864 0
Australia
Phone 119864 0
+61755528180
Fax 119864 0
Email 119864 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
The sharing of patients' data has not been sought.


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.