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Trial registered on ANZCTR
Registration number
ACTRN12623000378628
Ethics application status
Approved
Date submitted
16/03/2023
Date registered
14/04/2023
Date last updated
14/04/2023
Date data sharing statement initially provided
14/04/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
The effect of consumer led teach-back on recall and retention of health information: A mixed methods randomised controlled trial
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Scientific title
The effect of consumer led teach-back on recall and retention of health information in adult patients: A mixed methods randomised controlled trial
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Secondary ID [1]
308140
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Patient-provider miscommunication
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Condition category
Condition code
Public Health
324939
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Check back: Check back is a co-designed online module publicly available at https://checkback.org/. The module aims to raise awareness and educate patients about how they can communicate and ask questions in interactions with healthcare professionals in order to check that they have understood information and instructions. Check back is a self-directed web resource that comprises small videos and written content demonstrating how to use check back in clinical communication scenarios. It also has resources on how to address common barriers to communicating with healthcare professionals. The resource takes approximately 15 minutes, and is self-directed. On follow-up, participants will be asked whether they accessed the intervention prior to their health consultation.
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Intervention code [1]
324596
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Treatment: Other
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Comparator / control treatment
Standard care. Participants in the control arm will not receive any education on communication with health professionals or information on how they can ask questions in interactions with health professionals.
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Control group
Active
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Outcomes
Primary outcome [1]
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Correct recall of information discussed in a specialist outpatient consultation assessed by follow-up telephone call using binary (yes/no) standardised questions.
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Assessment method [1]
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Timepoint [1]
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36 hours post-consultation
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Secondary outcome [1]
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Correct recall of information discussed in a specialist outpatient consultation assessed by follow-up telephone call using binary (yes/no) standardised questions.
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Assessment method [1]
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Timepoint [1]
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7 days post-consultation
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Secondary outcome [2]
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Measure of patients’ ability to communicate with clinician, tested using questions from the Health Literacy Questionnaire (HLQ). The answers collected at 36 hours post-consultation will be compared to answers collected at baseline to measure change in patients’ ability to communicate with clinician.
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Assessment method [2]
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Timepoint [2]
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Baseline (pre-intervention) and 36 hours post-consultation.
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Secondary outcome [3]
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Correct understanding of information discussed in a specialist outpatient consultation assessed by follow-up telephone call using open-ended questions regarding information discussed in the consultation.
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Assessment method [3]
414603
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Timepoint [3]
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36 hours post-consultation
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Secondary outcome [4]
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Patient perspectives on usability, relevance and value of the intervention. An investigator will telephone the participants in the intervention arm to investigate their perspectives on using the intervention. Semi structured interviews will be conducted and will be recorded and transcribed verbatim by the investigator.
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Assessment method [4]
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Timepoint [4]
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36 hours post-consultation.
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Eligibility
Key inclusion criteria
Adults (18+ years); initial appointment in specialist outpatient clinic; English speaking; Cognitively able to provide consent and participate; to internet-connected electronic device with a compatible web browser.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Hearing impairment
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random block allocation
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/05/2023
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Actual
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Date of last participant enrolment
Anticipated
24/04/2024
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Actual
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Date of last data collection
Anticipated
1/05/2024
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Actual
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Sample size
Target
90
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Northern Hospital - Epping
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Recruitment postcode(s) [1]
38729
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3076 - Epping
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Monash University
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Address [1]
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15 Sargeant Street
Warragul, Victoria, 3820
Australia
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Monash University
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Address
15 Sargeant Street
Warragul, Victoria, 3820
Australia
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
314367
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Country [1]
314367
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Northern Health Low Risk Ethics Committee
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Ethics committee address [1]
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185 Cooper Street, Epping Vic 3076
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
310994
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Approval date [1]
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15/03/2022
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Ethics approval number [1]
310994
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Summary
Brief summary
The primary aim of this study is to determine whether a patient-led communication intervention can improve recall of health information following a healthcare interaction. This study follows a mixed-methods design whereby quantitative and qualitative data will be collected and analysed. A prospective, single centre, two arm RCT will determine the proportion of information recalled at two time points. A qualitative evaluation will be conducted parallel to the RCT, exploring patient perspectives on usability, relevance and value of the intervention through semi-structured interviews. These interviews will only be conducted among participants who have been randomised to the intervention arm of the RCT.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Alison Beauchamp
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Address
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Monash University
15 Sargeant Street
Warragul, Victoria, 3820
Australia
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Country
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Australia
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Phone
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+61 3 9902 7310
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Alison Beauchamp
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Address
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Monash University
15 Sargeant Street
Warragul, Victoria, 3820
Australia
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Country
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Australia
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Phone
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+61 3 9902 7310
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Alison Beauchamp
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Address
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Monash University
15 Sargeant Street
Warragul, Victoria, 3820
Australia
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Country
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Australia
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Phone
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+61 3 9902 7310
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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