Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001354774
Ethics application status
Approved
Date submitted
7/09/2022
Date registered
21/10/2022
Date last updated
30/10/2023
Date data sharing statement initially provided
21/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
eConsent for haemodialysis: impact on the patient experience
Scientific title
Effect of a digital platform on communication and safety for patients undergoing haemodialysis (eConsent-HD)
Secondary ID [1] 307140 0
None
Universal Trial Number (UTN)
U1111-1278-3250
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End stage kidney disease 326321 0
Haemodialysis 326322 0
Informed consent 326323 0
Condition category
Condition code
Public Health 323627 323627 0 0
Health service research
Renal and Urogenital 324794 324794 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants assigned to the intervention group will be coached to navigate the online digital eConsent HD. The consent animation will be a user-friendly animation featuring human figures role-playing an interaction between a patient and a doctor. The audio narrative will guide participants through the content presented in the video, while written subtitles and captions will further enhance the visual content. The script will cover various topics including treatment options for advanced kidney disease; what HD involves, its potential benefits and risks, likely survival with or without HD, and the process of making an informed choice about HD. The animation will be co-designed with consumers (patients, family, carers, and kidney patient advocates).
eConsent HD places control of uptake of information and consent with the participant. At the start of the animation participants will select language and literacy level. Participants can alter the speed of navigation through the animation at any time. Participants will complete teach-back exercises, a cyclic process to assess and reinforce understanding, and will have the option to go back and revisit specific points in the animation. The process finishes with signing of the electronic consent form which is date- and time-stamped and is compliant with international requirements for electronic signatures (i.e., the U.S. Food and Drug Administration Code of Federal Regulations Part 11 eSignature requirements). It is anticipated that navigation through the animation and questions will take up to 15 minutes.
Intervention code [1] 323595 0
Treatment: Other
Intervention code [2] 324411 0
Prevention
Comparator / control treatment
Participants assigned to the control group will undergo the usual method of obtaining informed consent at the trial site. The process may involve either a medical or nursing clinician consenting the participants, followed by signing a paper-based informed consent form.
Both groups: To ensure both groups have access to a minimum standard information, pre-consent information booklets will be provided to all participants. In cases where English is not the participants’ first language, interpreters will be accessed to facilitate communication, following usual practice at the trial site. Regardless of the assigned group, all participants will have the opportunity to discuss any questions or concerns they may have with their clinicians before giving their consent for HD treatment. This ensures that participants in both groups have the opportunity for clarification and to address any uncertainties prior to making their decision.
Control group
Active

Outcomes
Primary outcome [1] 331387 0
Decision regret (assessed by a validated decision regret scale)
Timepoint [1] 331387 0
Data collection will occur at informed consent and after 12 months of HD treatments.
Secondary outcome [1] 409681 0
Patient reported experience measure (modified Kidney PREM) - The Kidney PREM has been adopted as a key element of service review by the NHS (UK). It aims to provide patients’ insights that informs and supports better kidney care. Participants will answer questions about their experience with the renal unit with regards to the HD procedure. All the questions are answered on a scale of 1 to 7, where 1 is negative and 7 is positive. For each question, there is also a “don’t know” option.
Timepoint [1] 409681 0
Immediately after signing the consent form.
Secondary outcome [2] 409682 0
Patient anxiety levels (six-item short form of the Spielberger State-Trait Anxiety Inventory (STAI Y-6 Item) - participants in both intervention and control groups will be asked to rate their degree of anxiety on a numerical scale using 6 short questions. A greater numerical score equates to a greater level of anxiety. This will be administered before and immediately after consent and a comparison will inform us of how the consent process has changed patients’ anxiety levels. The STAI is a well-published measure of anxiety and has been validated by several studies. The short form that will be used in this current study has shown good psychometric properties and has also been used in previous studies to assess changes in patient anxiety levels impacted by the consent process.
Timepoint [2] 409682 0
At 2 timepoints:
Baseline- immediately before watching the consent animation (intervention group) or immediately before talking with their doctor (control group)
Immediately after signing the consent form
Secondary outcome [3] 409683 0
Patient satisfaction (five-point Likert scale) - a Likert scale is a psychometric scale commonly used in research to assess participant attitudes. In this survey, participants will be given several statements regarding their satisfaction and confidence with their decision making and asked to rank each of these on a scale of 1 (strongly disagree) to 5 (strongly agree). This survey was used in a previous study from our group and was able to show statistically significant differences between control and intervention participants consented for a dermatological procedure.
Timepoint [3] 409683 0
Immediately after signing the consent form.
Secondary outcome [4] 409684 0
Qualitative feedback via consumer’s involvement - a free text comment box will be available at the end of the post-consent survey asking for any additional feedback/comments. The clinical research nurse will also encourage participants to provide feedback on the consent process, and this will be documented. Translation to English will be carried out in case feedback is provided in other languages.
Timepoint [4] 409684 0
Immediately after signing the consent form.
Secondary outcome [5] 409685 0
Recorded time taken to consent (in minutes), as measured by a digital stopwatch.
Timepoint [5] 409685 0
Control group: from when the participant begins their consultation with their doctor to when they sign the consent form.
Intervention group: from when the participant begins to watch the animation video to when they sign the consent form.
Secondary outcome [6] 428292 0
Patient’s comprehension, measured using an 18-point questionnaire, which will evaluate the extent to which the four main elements of informed consent are met: (1) provision of relevant information, (2) capacity, (3) understanding and (4) voluntary nature (Wainstein M. et al. Journal of Law and Medicine, July 2018). Given the close relationship between capacity and understanding and the limitation of assessing the existence of the former retrospectively, these two elements were grouped together in this questionnaire.
Timepoint [6] 428292 0
Secondary outcome [7] 428293 0
Patient’s comprehension, measured using an 18-point questionnaire, which will evaluate the extent to which the four main elements of informed consent are met: (1) provision of relevant information, (2) capacity, (3) understanding and (4) voluntary nature (Wainstein M. et al. Journal of Law and Medicine, July 2018). Given the close relationship between capacity and understanding and the limitation of assessing the existence of the former retrospectively, these two elements were grouped together in this questionnaire.
Timepoint [7] 428293 0
Immediately after signing the consent form.
Secondary outcome [8] 428294 0
Dialysis continuation/withdrawal (extracted from data submitted by each site to the Australian and New Zealand Data Registry)
Timepoint [8] 428294 0
Immediately after signing the consent form.
Secondary outcome [9] 428295 0
Dialysis continuation/withdrawal (extracted from data submitted by each site to the Australian and New Zealand Data Registry)
Timepoint [9] 428295 0
12 months after signing the consent form.
Secondary outcome [10] 428296 0
Changes in treatment modality (extracted from data submitted by each site to the Australian and New Zealand Data Registry)
Timepoint [10] 428296 0
12 months after signing the consent form.
Secondary outcome [11] 428297 0
Changes in treatment modality (extracted from data submitted by each site to the Australian and New Zealand Data Registry)
Timepoint [11] 428297 0
12 months after signing the consent form.

Eligibility
Key inclusion criteria
All consecutive incident haemodialysis patients will receive information about the study and be invited to participate. Prevalent haemodialysis patients, who have not been consented in the last 12 months, will also be invited to participate. Those that agree will be required to sign written informed consent to proceed into the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
< 18 years of age.
Individuals not competent to consent or refuse to consent to medical treatment.
Legally blindness (defined as having corrected acuity of no better than 6/60 and/or a vision field of no more than 10 degrees).

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation performed using a computerised sequence generation. Pre-generated centre-specific permuted block randomisation lists (one for incident and one for prevalent HD patients) will be used at each clinical site.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
eConsent HD is a distinctive first-of-its-kind study and there is no previous literature available to provide effect-size estimates for a similar intervention. Our sample size calculation was guided by a previous study that evaluated the effectiveness of a multimedia education format in assisting individuals with CKD to make treatment choices. In that study, the intervention group showed a significant reduction in decision regret. For our study, we aim to detect a 15% change in the primary outcome, which is decision regret, with a statistical power of 90% and a Type 1 error rate of 5% (two-tailed). Based on these parameters, a total sample size of 244 participants will be required, with 61 participants in each arm for the incident and prevalent cohort, respectively.
Randomisation: To mitigate the bias of previous knowledge from exposure to HD, participants will be stratified into incident and prevalent HD participant groups. Once eligibility is confirmed, and written research consent provided, participants will be assigned (by computer random sequencing software) to either the intervention or the control group in a 1:1 stratified block randomisation. A research officer (or an investigator) will assign participants to one of the study groups and will utilise an opaque sealed envelopes for each enrolled participant. To ensure balanced and comparable groups, stratification based on language background will be employed, distinguishing between English speakers and non-English speakers as a surrogate for people with CALD backgrounds. This approach controls for the major sources of bias between the two groups.
Data analysis plan: Data analysis will be on an intention-to-treat basis. Incident and prevalent HD participants will be kept separate in the data analysis. Descriptive statistics will be employed to summarise the characteristics of study participants, providing a clear overview of their demographic and clinical characteristics. For continuous measures, the differences between intervention and control group will use t-tests and Mann–Whitney U-test depending on distributions and appropriateness. Linear mixed models will be used to examine any group differences while accounting for potential confounding variables and repeated measurements over time. Statistical significance between the intervention and control groups will be considered when p-values are =0.05. Qualitative data, (written feedback from participants), will undergo Braun and Clarke’s thematic analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
244
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 22378 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 22379 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [3] 22380 0
St George Hospital - Kogarah
Recruitment hospital [4] 25783 0
Bundaberg Hospital - Bundaberg
Recruitment hospital [5] 25784 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 37542 0
4029 - Herston
Recruitment postcode(s) [2] 37543 0
3168 - Clayton
Recruitment postcode(s) [3] 37544 0
2217 - Kogarah
Recruitment postcode(s) [4] 41609 0
4670 - Bundaberg
Recruitment postcode(s) [5] 41610 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 311444 0
Commercial sector/Industry
Name [1] 311444 0
Consentic
Country [1] 311444 0
Australia
Funding source category [2] 312221 0
Hospital
Name [2] 312221 0
Royal Brisbane and Women's Hospital
Country [2] 312221 0
Australia
Primary sponsor type
Individual
Name
Pedro Henrique Franca Gois
Address
Nephrology Department
Fraser Coast Hospital and Health Service
Cnr Nissen Street &, Urraween Rd, Pialba QLD 4655
Country
Australia
Secondary sponsor category [1] 312840 0
Individual
Name [1] 312840 0
Rebecca Saunderson
Address [1] 312840 0
Drummoyne Dermatology
Suite 1, 109 Victoria Road, Drummoyne NSW 2047.
Country [1] 312840 0
Australia
Other collaborator category [1] 282299 0
Individual
Name [1] 282299 0
Marina Wainstein
Address [1] 282299 0
Nephrology Department
West Moreton Health
Chelmsford Ave, Ipswich QLD 4305
Country [1] 282299 0
Australia
Other collaborator category [2] 282300 0
Individual
Name [2] 282300 0
Helen Healy
Address [2] 282300 0
Kidney Health Service
Metro North Hospital and Health Service
Level 9 Butterfield Street, Herston QLD 4029.
Country [2] 282300 0
Australia
Other collaborator category [3] 282301 0
Individual
Name [3] 282301 0
Ann Bonner
Address [3] 282301 0
School of Nursing and Midwifery
G16 Clinical Sciences 2, Level 2.15
Griffith University, Southport QLD 4215
Country [3] 282301 0
Australia
Other collaborator category [4] 282302 0
Individual
Name [4] 282302 0
Vera Yueyue Miao
Address [4] 282302 0
Drummoyne Dermatology
Suite 1, 109 Victoria Road, Drummoyne NSW 2047.
Country [4] 282302 0
Australia
Other collaborator category [5] 282303 0
Individual
Name [5] 282303 0
Matthew Damasiewicz
Address [5] 282303 0
Department of Nephrology, Monash Medical Centre
Department of Medicine, Monash University
246 Clayton Road, Clayton VIC 3168,
Country [5] 282303 0
Australia
Other collaborator category [6] 282304 0
Individual
Name [6] 282304 0
Chenlei-Kelly Li
Address [6] 282304 0
Nephrology Department
St George Hospital
Suite 1, 50 Montgomery Street, Kogarah NSW 2217
Country [6] 282304 0
Australia
Other collaborator category [7] 282305 0
Individual
Name [7] 282305 0
Martin Wolley
Address [7] 282305 0
Kidney Health Service
Metro North Hospital and Health Service
Level 9 Butterfield Street, Herston QLD 4029.
Country [7] 282305 0
Australia
Other collaborator category [8] 282419 0
Individual
Name [8] 282419 0
Kirsten Hepburn
Address [8] 282419 0
Kidney Health Service
Metro North Hospital and Health Service
Level 9 Butterfield Street, Herston QLD 4029.
Country [8] 282419 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310919 0
Metro North Health Human Research Ethics Committee
Ethics committee address [1] 310919 0
Ethics committee country [1] 310919 0
Australia
Date submitted for ethics approval [1] 310919 0
07/09/2022
Approval date [1] 310919 0
06/03/2023
Ethics approval number [1] 310919 0
HREC/2022/MNHB/86890

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

Contacts
Principal investigator
Name 119346 0
A/Prof Pedro Henrique Franca Gois
Address 119346 0
Nephrology Department, John Hunter Hospital, 1 Lookout rd, New Lambton Heights, NSW 2305
Country 119346 0
Australia
Phone 119346 0
+61 249213545
Fax 119346 0
Email 119346 0
[email protected]
Contact person for public queries
Name 119347 0
Pedro Henrique Franca Gois
Address 119347 0
Nephrology Department, John Hunter Hospital, 1 Lookout rd, New Lambton Heights, NSW 2305
Country 119347 0
Australia
Phone 119347 0
+61 249213545
Fax 119347 0
Email 119347 0
[email protected]
Contact person for scientific queries
Name 119348 0
Pedro Henrique Franca Gois
Address 119348 0
Nephrology Department, John Hunter Hospital, 1 Lookout rd, New Lambton Heights, NSW 2305
Country 119348 0
Australia
Phone 119348 0
+61 249213545
Fax 119348 0
Email 119348 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
This matter will be discussed with HREC.


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.