Trial Review

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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
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
Secondary ID [1] 308140 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patient-provider miscommunication 327858 0
Condition category
Condition code
Public Health 324939 324939 0 0
Health service research

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 324596 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 334418 0
Correct recall of information discussed in a specialist outpatient consultation assessed by follow-up telephone call using binary (yes/no) standardised questions.
Timepoint [1] 334418 0
36 hours post-consultation
Secondary outcome [1] 414600 0
Correct recall of information discussed in a specialist outpatient consultation assessed by follow-up telephone call using binary (yes/no) standardised questions.
Timepoint [1] 414600 0
7 days post-consultation
Secondary outcome [2] 414602 0
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.
Timepoint [2] 414602 0
Baseline (pre-intervention) and 36 hours post-consultation.
Secondary outcome [3] 414603 0
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.
Timepoint [3] 414603 0
36 hours post-consultation
Secondary outcome [4] 420053 0
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.
Timepoint [4] 420053 0
36 hours post-consultation.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hearing impairment

Study design
Purpose of the study
Treatment
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)
Random block allocation
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2023
Actual
Date of last participant enrolment
Anticipated
24/04/2024
Actual
Date of last data collection
Anticipated
1/05/2024
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23355 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 38729 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 311539 0
University
Name [1] 311539 0
Monash University
Country [1] 311539 0
Australia
Primary sponsor type
University
Name
Monash University
Address
15 Sargeant Street
Warragul, Victoria, 3820
Australia
Country
Australia
Secondary sponsor category [1] 314367 0
None
Name [1] 314367 0
Address [1] 314367 0
Country [1] 314367 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310994 0
Northern Health Low Risk Ethics Committee
Ethics committee address [1] 310994 0
185 Cooper Street, Epping Vic 3076
Ethics committee country [1] 310994 0
Australia
Date submitted for ethics approval [1] 310994 0
Approval date [1] 310994 0
15/03/2022
Ethics approval number [1] 310994 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119622 0
A/Prof Alison Beauchamp
Address 119622 0
Monash University
15 Sargeant Street
Warragul, Victoria, 3820
Australia
Country 119622 0
Australia
Phone 119622 0
+61 3 9902 7310
Fax 119622 0
Email 119622 0
[email protected]
Contact person for public queries
Name 119623 0
Alison Beauchamp
Address 119623 0
Monash University
15 Sargeant Street
Warragul, Victoria, 3820
Australia
Country 119623 0
Australia
Phone 119623 0
+61 3 9902 7310
Fax 119623 0
Email 119623 0
[email protected]
Contact person for scientific queries
Name 119624 0
Alison Beauchamp
Address 119624 0
Monash University
15 Sargeant Street
Warragul, Victoria, 3820
Australia
Country 119624 0
Australia
Phone 119624 0
+61 3 9902 7310
Fax 119624 0
Email 119624 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.