Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000444189p
Ethics application status
Submitted, not yet approved
Date submitted
8/03/2019
Date registered
18/03/2019
Date last updated
18/03/2019
Date data sharing statement initially provided
18/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Using teach-back to improve recall of discharge information in patients with arthroplasty
Scientific title
Using teach-back to improve recall of discharge information in patients with arthroplasty
Secondary ID [1] 297667 0
None
Universal Trial Number (UTN)
U1111-1229-7641
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthroplasty 311946 0
Condition category
Condition code
Musculoskeletal 310528 310528 0 0
Other muscular and skeletal disorders
Public Health 310622 310622 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
‘Teach-back’ involves health providers asking patients to explain in their own words what they have just been told and then working with that patient to clarify any misunderstandings. The intervention is the addition of teach-back to usual education about activity, medication and prevention of dislocation that is provided before discharge to patients with arthroplasty. This usual education is currently provided on a one-to-one basis by a clinician (usually a physiotherapist) using written resources and verbal instruction. The time taken is approximately 10-15 minutes. For the teach-back intervention, clinicians will summarise the pre-discharge information into 2-3 standardised key points and then check the patient's understanding by asking them to explain back in their own words what they have understood. The clinician will then work with the patient to clarify misunderstandings. The intervention is expected to add approximately 5 minutes to the education session. To support fidelity of the intervention, the education content will be standardised and training and resources will be provided to all staff. Staff will also be asked to record which patients received teach-back. The patient participant group are not randomised. A comparison group will comprise eligible patients admitted to the orthopaedic unit prior to staff being trained in standardised use of teach-back (i.e. 'pre-intervention'). Following staff training and implementation of teach-back, eligible patients will be allocated to the post-intervention group.
Intervention code [1] 313904 0
Behaviour
Comparator / control treatment
Usual care will comprise the standard pre-discharge education about activity, medication and prevention of dislocation (the latter for total hip replacement (THR) patients only) that is provided before discharge to patients. his usual education is currently provided on a one-to-one basis by a clinician (usually a physiotherapist) using written resources and verbal instruction. The time taken is approximately 10-15 minutes.
Control group
Active

Outcomes
Primary outcome [1] 319392 0
% of patients who can correctly recall discharge information about:
Three symptoms to see the doctor or the emergency department for.
How many times a day should they complete their rehabilitation exercises.
How long before exercising should they take pain medication

Responses will be yes/no for having answered correctly (based on the standardised education given to arthroplasty patients prior to discharge). These items are designed specifically for this study.
Timepoint [1] 319392 0
2-days post-discharge
Primary outcome [2] 319394 0
Confidence of staff to undertake teach-back. This is a composite outcome derived from the Teach-Back Conviction and Confidence Scale and the validated Perceived Knowledge and Self-confidence of Paediatric Nurses as Patient Educators scale.
Timepoint [2] 319394 0
Pre- and post-intervention (approximately 4 months between)
Secondary outcome [1] 368002 0
Patient's level of pain, using the Numeric Pain Rating Scale
Timepoint [1] 368002 0
2-days post-discharge
Secondary outcome [2] 368003 0
Patient's self-efficacy to manage their condition at home using the Self Efficacy Expectation Scale
Timepoint [2] 368003 0
2-days post-discharge
Secondary outcome [3] 368012 0
To assess staff satisfaction with using teach-back and barriers/enablers to its uptake, staff will be invited to a 45-minute focus group(s) at the end of the intervention period. For staff who are unable to attend the focus group due to availability, a 15-minute telephone/face-to-face interview will be offered.
The focus group/interviews will be semi-structured, and facilitated/conducted by a researcher. Both will be audio-recorded and transcribed.
There are between 6-10 eligible staff who will be invited to participate in either the focus group or interviews.
Timepoint [3] 368012 0
Within 2-4 weeks of completion of the intervention period.

Eligibility
Key inclusion criteria
Group one - patients: Will be discharged directly home following an elective arthroplasty. Cognitively able to receive pre-discharge education on activity, medication, (+/- prevention of dislocation for patients with total hip replacement); are able to provide informed consent; able to communicate in English.
Group two - Clinicians (nursing, allied health or medical) within the Williamstown orthopaedic unit who routinely provide pre-discharge information to patients with elective joint surgery (approximately six to ten eligible staff).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Group one - Patients who are not considered to be clinically or otherwise appropriate for inclusion based on their treating clinician’s opinion will be excluded from this study.
Group two - clinicians. No exclusion criteria

Study design
Purpose of the study
Educational / counselling / training
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2019
Actual
Date of last participant enrolment
Anticipated
1/02/2020
Actual
Date of last data collection
Anticipated
5/02/2020
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13345 0
Williamstown Hospital - Williamstown
Recruitment postcode(s) [1] 25944 0
3016 - Williamstown

Funding & Sponsors
Funding source category [1] 302197 0
University
Name [1] 302197 0
University of Melbourne
Country [1] 302197 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Department of Medicine - Western Health
WCHRE Building, Level 3 / 176 Furlong Road, St Albans VIC 3021
Country
Australia
Secondary sponsor category [1] 302049 0
None
Name [1] 302049 0
Address [1] 302049 0
Country [1] 302049 0
Other collaborator category [1] 280584 0
Hospital
Name [1] 280584 0
Western health
Address [1] 280584 0
Sunshine Hospital
176 Furlong Road, St Albans VIC 3021
Country [1] 280584 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302876 0
Western Health Human Research Ethics Committee
Ethics committee address [1] 302876 0
Ethics committee country [1] 302876 0
Australia
Date submitted for ethics approval [1] 302876 0
04/03/2019
Approval date [1] 302876 0
Ethics approval number [1] 302876 0

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

Contacts
Principal investigator
Name 91698 0
A/Prof Cathy Said
Address 91698 0
Physiotherapy, The University of Melbourne
Level 3, Western Centre for Health Research and Education
Sunshine Hospital
176 Furlong Rd, St Albans
Vic 3021
Country 91698 0
Australia
Phone 91698 0
+61 383958106
Fax 91698 0
Email 91698 0
[email protected]
Contact person for public queries
Name 91699 0
Alison Beauchamp
Address 91699 0
Department of Medicine - Western Health
Level 3, Western Centre for Health Research and Education
Sunshine Hospital
176 Furlong Rd, St Albans
Vic 3021
Country 91699 0
Australia
Phone 91699 0
+61 414 411 296
Fax 91699 0
Email 91699 0
[email protected]
Contact person for scientific queries
Name 91700 0
Alison Beauchamp
Address 91700 0
Department of Medicine - Western Health
Level 3, Western Centre for Health Research and Education
Sunshine Hospital
176 Furlong Rd, St Albans
Vic 3021
Country 91700 0
Australia
Phone 91700 0
+61 414 411 296
Fax 91700 0
Email 91700 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
These data are considered as patient data maintained by Western Health and individual data will not be publicly available


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.