Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000425493
Ethics application status
Approved
Date submitted
18/03/2016
Date registered
4/04/2016
Date last updated
4/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prompting South Australian Baby Boomers to Complete Advance Directives: Randomised Controlled Trial of Electronic Interventions to Increase Completion Rates
Scientific title
RCT of Electronic Interventions to Increase Completion Rates of Advance Directives by South Australian Baby Boomers
Secondary ID [1] 288795 0
None
Universal Trial Number (UTN)
U1111-1180-9466
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
advance care directives 298061 0
Condition category
Condition code
Other 298222 298222 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This RCT consisted of 2 interventions: 1) electronic email prompting to nudge completion of advance care directive; 2) online educational module exposure to nudge completion of advance care directive. As this was a 2x2 factorial design there were 4 groups of the following make-up: 1) email prompting only group; 2) education module only group; 3)email prompting + education module group; 4) no prompt, no education module group.
Email prompting - this intervention consisted of a small survey of 7 questions asking participants if they had completed any of the 4 legal SA documents as well as other questions about whether they had acted as a substitute decision-maker and who they may have discussed advance directives with. Each email prompt began with a small paragraph of one - two lines about what advance directives are, how they could be used, and the types of conversations that may occur. The email prompts were sent 3 times during the period of the trial. The first email prompt was sent to the first set of participants in June 2013; those participants recruited after this date received the first email prompt within 2 weeks of recruitment between July 2013 to February 2014. The second email prompt was sent to all participants in January and February 2014 with those recruited during those months receiving the 2nd prompt 2 weeks after the first prompt. The final email prompt (#3) was sent to all participants in April 2014. The bulk of the participants were recruited in September 2013 (N=150) with the remaining 132 recruited between the months of July 2013 to February 2014.
Those participants in the online education module group received a link to a specifically designed education module focusing on the South Australian AD documents (EPG, EPA, MPA, Anticipatory Direction). This module identified what ADs are, what they look like in South Australia, why you might consider creating one, some of the barriers and facilitators to their creation and an alert that a new SA Advance Care Directive Form was going to come into play in the near future. The link was available for them to use throughout the study and was not accessible to the general public - only the participants in the education module had access to the link throughout the study, however at the end of the study, all participants were given access to the link in the post-survey. The education online module was housed in the CareSearch website in a non-publicly accessible domain and was available for 6 months after the conclusion of the trial. The module took approximately 10-30 minutes to review (depending on prior knowledge on the subject).
Participants in the email prompt + education module received materials at the same time as the single intervention groups. The control group (no interventions) and the intervention groups all received a Pre-survey with a number of questions about themselves, e.g. gender, age, location; questions about any documents they completed beyond the 4 legal ADs (Will, Statement of Choices, other non-legal AD documents); questions about substitute decision-making; questions about their use of the online environment, including comfort levels with the Internet and computers in general. All groups also received a Post-survey which repeated the same questions (excluding demographics) as well as their use of the online environment during the trial, any problems they had with the email prompting or the online education module, and specifically, whether they had completed any AD documents during the trial, acted as a substitute decision-maker, or discussed ADs with anyone. The control group did not receive any interventions during the trial other than the Pre- and Post-survey. Control group did not receive email prompting or the online education module during the course of the trial but did receive the education module after the trial. For the online education module groups, the education module was released via survey link in November - December 2013 for all those who had been recruited and were randomized into the education module groups by that time. As more participants were recruited and randomised into the online education module group, they received the link to the online education module at the first intervention time point (usually 2 weeks after the Pre-survey had been completed for those in recruited into the education module only group and the education + email prompt group).
This study did not monitor adherence to the education module (number of visits and pages viewed were not recorded). Email prompt adherence (views) were also not recorded. This is because the primary outcome of this trial was whether the information provided or the prompt induced change, i.e. an individual completing an AD. Secondary outcomes about useability, feasibility, language, and comfort with the online methods were identified through prevalence rates based on questions with pre-determined choices and open commentary.
Participants were able to email the researcher directly throughout the trial if they had any trouble with links or material being viewed. If participants queried whether their surveys lodged properly, the CareSearch monitor (an independent employee of CareSearch) forwarded the query by UID number to the researcher. The researcher then identified only if the survey had been lodged and responded to the participant directly by email. The researcher did not access any surveys lodged but only responded to the fact that the survey had been/had not been lodged. No data processing occurred during the duration of the trial to avoid any bias in any responses that the researcher may have had to provide to participants throughout the trial.
The researcher conducting this trial, at the time of the trial, had the following qualifications:
Bachelor of Science, Bachelor of English Writing, Bachelor of Nursing, Graduate Diploma in Higher Education, Masters of Research on advance directive decision-making by Baby Boomers (a classical grounded theory study exploring decision-making by a group of Baby Boomers). The researcher was the only person who provided and released the interventions.
Mode of delivery was through the online environment only: email, survey data creation and distribution, data collection and analysis all conducted through the CareSearch Research Data Management System and Flinders University. All data held on password-protected computers in the Flinders University domain. All surveys were released through the Research Data Management System on a group level. As the group was formed, they were allocated to a separate file on the RDMS and then a group invitation to complete a survey was sent at the appropriate time.
Initially, it was anticipated that reminder prompts would be sent to those participants in the email groups to complete their email prompt surveys however after the first time this was done, many participants were confused as to whether they had completed the survey, it had lodged on the system, and other confounders, so it was determined not to provide any reminders to complete for subsequent email prompts. Those in the education module groupings did not receive reminder prompts.
At the time of Post-survey, all participants in all groups were sent a reminder to complete the Post-survey two weeks after the Post-survey was released. Only one such reminder prompt was sent so that data processing and analysis could begin. The end point for the RCT was June 2014 with regard to receipt of Post-surveys.
Total time of the trial was 12 months but individual participants may have been part of the trial from 3 – 12 months depending on when first recruited and completion of the Pre-survey as the Pre-survey completion information was used for randomisation. The bulk of recruitment occurred by September 2013 which was when the interventions were released. As more people were recruited, they were added to one of the randomised groups (based on the stratified randomisation process) and then sent the appropriate intervention (no intervention for controls).
The object of the trial was to see how many individuals in each of the groups completed any one of the 4 ADs from Pre-survey to Post-survey. This RCT was not sufficiently powered to explore time elements of completion, e.g. the number that completed after one, two or three prompts. Therefore, the timing of when an AD might have been completed was not relevant to the primary outcome of the study.
The location of the interventions was through the individual’s own computer resources whether personally owned or community-based and the surveys were completed at a location of the participant’s choosing.
Intervention code [1] 294245 0
Behaviour
Comparator / control treatment
For non-education module groups (including the control group) they had access to the online education module in a link within the Post-survey sent in May 2014 for completion by the end of June 2014. The link to the education module for all participants remained live until December 2014.
Control group
Active

Outcomes
Primary outcome [1] 297725 0
Individuals self-reporting completion of one of the 4 legal South Australian Advance Directive documents. The 4 legal South Australian Advance Directive documents are: Enduring Power of Attorney, Enduring Power of Guardianship, Medical Power of Attorney and Anticipatory Direction (at the time this study was conducted). Other advance directives that people may have completed such as a regular Power of Attorney or Will were assessed but did not form part of the primary outcome for this study. Although there are many documents that people may think are ADs, these 4 documents (EPG, EPA, MPA, and Anticipatory Direction) constitute the 4 legal ones for future financial and healthcare direction. The primary outcome was assessed through self-reporting in the online Post-survey of completion of any one or more of EPA, EPG, MPA, Anticipatory Direction.
Timepoint [1] 297725 0
The primary outcome for all participants was only assessed at the conclusion of the trial via a Post-survey conducted in June 2014 equivalent to 3-12 months (depending on recruitment) in the trial.
Secondary outcome [1] 322015 0
A secondary outcome included analysis of the completion of other documents outside the 4 legal ADs (EPA, EPG, MPA, Anticipatory Direction). These other documents included Wills, Power of Attorneys, advance care plans, statement of choices, life values statements, organ donation cards, psychiatric advance directive documents. These other documents were included as choices in the one question on which documents had been completed so represents a secondary analysis of this composite data set. This secondary analysis used descriptive statistics (frequency, univariate and binary logistical regression) for reporting purposes.
Timepoint [1] 322015 0
The secondary analysis for all participants was only assessed at the conclusion of the trial via a Post-survey conducted in May - June 2014 equivalent to 3-12 months (depending on recruitment) in the trial.
Secondary outcome [2] 322379 0
Secondary outcome: Why did you not complete AD documents? Multiple choice with pre-determined choices. Analysed using descriptive statistics - frequency of responses for each choice.
Timepoint [2] 322379 0
Post-survey, June 2014.
Secondary outcome [3] 322380 0
Whether assistance was sought for completion of AD and if so who assisted.Multiple choice with pre-determined choices. Analysed using descriptive statistics - frequency of responses for each choice.
Timepoint [3] 322380 0
Post-survey, June 2014.
Secondary outcome [4] 322381 0
Whether person had discussed ADs with anyone during trial and if so, with whom?Whether assistance was sought for completion of AD and if so who assisted. Multiple choice with pre-determined choices. Analysed using descriptive statistics - frequency of responses for each choice.
Timepoint [4] 322381 0
Post-survey, June 2014.
Secondary outcome [5] 322382 0
Whether person had helped anyone else with AD during trial and if so, whom? Multiple choice with pre-determined choices. Analysed using descriptive statistics - frequency of responses for each choice.
Timepoint [5] 322382 0
Post-survey, June 2014.
Secondary outcome [6] 322383 0
Whether person had acted as a substitute decision-maker during the trial and if so under what legal document? Multiple choice with pre-determined choices. Analysed using descriptive statistics - frequency of responses for each choice.
Timepoint [6] 322383 0
Post-survey, June 2014.
Secondary outcome [7] 322384 0
Whether person would act as an SDM? Yes/No/Maybe response. Analysed using descriptive statistics - frequency of responses for each choice.
Timepoint [7] 322384 0
Post-survey, June 2014.
Secondary outcome [8] 322385 0
Which online formats participant felt helpful when wanting to learn more about ADs. Multiple choice with pre-determined choices. Analysed using descriptive statistics - frequency of responses for each choice.
Timepoint [8] 322385 0
Post-survey, June 2014.
Secondary outcome [9] 322386 0
Which online formats participant found helpful when they wanted to complete an AD.Multiple choice with pre-determined choices. Analysed using descriptive statistics - frequency of responses for each choice.
Timepoint [9] 322386 0
Post-survey, June 2014.
Secondary outcome [10] 322387 0
Which online hardware devices helped participant to learn more about or complete ADs. Multiple choice with pre-determined choices. Analysed using descriptive statistics - frequency of responses for each choice.
Timepoint [10] 322387 0
Post-survey, June 2014.
Secondary outcome [11] 322388 0
Which online software applications assisted participant to learn about ADs. Multiple choice with pre-determined choices. Analysed using descriptive statistics - frequency of responses for each choice.
Timepoint [11] 322388 0
Post-survey, June 2014
Secondary outcome [12] 322389 0
Which social networks participant would prefer reminders(prompts) sent to. Multiple choice with pre-determined choices. Analysed using descriptive statistics - frequency of responses for each choice.
Timepoint [12] 322389 0
Post-survey, June 2014
Secondary outcome [13] 322390 0
When would be the best time to send a reminder? Multiple choice with pre-determined choices. Analysed using descriptive statistics - frequency of responses for each choice.
Timepoint [13] 322390 0
Post-survey, June 2014
Secondary outcome [14] 322391 0
Did participant find the online surveys easy to use? Yes/No/Sometimes responses. Analysed using descriptive statistics - frequency of responses for each choice.
Timepoint [14] 322391 0
Post-survey, June 2014
Secondary outcome [15] 322392 0
How did participant think online information about ADs could be improved? Multiple choice with pre-determined choices. Analysed using descriptive statistics - frequency of responses for each choice.
Timepoint [15] 322392 0
Post-survey, June 2014
Secondary outcome [16] 322393 0
Was there anything participant experienced during course of trial that heightened awareness of ADs? Yes/No/Maybe response - open commentary box provided. Analysed using descriptive statistics - frequency of responses for each choice.
Timepoint [16] 322393 0
Post-survey, June 2014
Secondary outcome [17] 322394 0
How likely was participant to complete an AD in the 3 months following the end of the trial? Multiple choice with pre-determined choices. Analysed using descriptive statistics - frequency of responses for each choice.
Timepoint [17] 322394 0
Post-survey, June 2014
Secondary outcome [18] 322395 0
Open commentary on any other issues arising during or from participation in the trial. Analysed thematically using classical grounded theory method.
Timepoint [18] 322395 0
Post-survey, June 2014

Eligibility
Key inclusion criteria
1) South Australian resident (documents pertain to South Australian law)
2) Born 1946-1965 (represents Baby Boomer generation in Australia)
3) Access to Computer and Internet (trial was conducted only online)
4) Understand Written English well enough to understand online directions and documentation
5) Prepared to participate for up to 12 months and duration of study
Minimum age
47 Years
Maximum age
67 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Not born between 1946-1965
2) Already completed any one of the 4 legal SA Advance directive documents (Enduring Power of Attorney, Enduring Power of Guardianship, Medical Power of Attorney, Anticipatory Direction)

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)
Allocation was partially concealed: When the Pre-survey was returned, randomisation was conducted using a block randomisation generator with stratification based on three factors: age (first or second decade of Baby Boomers); gender (male/female); and location (metropolitan or rural). As the Pre-survey was submitted, the Research Data Management System (RDMS) of CareSearch generated an email to the researcher with details of the three factors, namely birth year (older decade 1946–1955, younger decade1956–1965), gender, location (metropolitan or rural). These factors allowed stratification of the sample such that equal numbers of each type of stratification would be placed in randomised groups. As the email came back without a name but only a unique identification number, the researcher was blind to individual responses and only knew the respondent by a UID. Allocation concealment involved contacting the holder of the allocation schedule (the Research Data Management System - computer data collection server) located in a central administration site at Flinders University.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block stratified randomisation using computerized sequence generation based on three factors: age (first or second decade of Baby Boomers); gender (male/female); and location (metropolitan or rural) was conducted. For example, as the Pre-survey was submitted, the Research Data Management System (RDMS) of CareSearch generated an email to the researcher with details of the three factors, namely birth year (older decade 1946–1955, younger decade1956–1965), gender, location (metropolitan or rural). The UID number was then allocated to a pre-determined computer generated randomized sequential block: e.g. group B - Male - Young - Rural - first UID coming back fitting these parameters was then allocated to computer generated category of B. Next Male - Young - Rural - UID coming back fitting these parameters was then allocated to computer generated category of group D. Thus, the computer decided the group allocation for received UIDs fitting the parameters of Male - Young - Rural. The researcher entered UID against group designation and was thus blinded to identification of participant other than UID.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample sizes were calculated according to Dupont and Plummer (1990) using their regression calculator (Dupont and Plummer 1998). to determine sample size, the following variables were considered: Effect size = 10% for each factor; Power = .80; Prospective; Uncorrected chi-square test; Two sided Type 1 error rate with alpha = .05. Sample size for uncorrected chi-square test = 101 cases per group to detect a 10% difference. There were 4 factors (independent variables) so total sample size was based on 4 parallel groups = 404. To adjust for a 2x2 design which increases the power of the study by assessing the main effects of the two groups with the same factor together, a variance inflation factor as described by Hsieh et al. (2011) was applied. This halved the initial total sample size required from 404 to 202 which it was felt was more achievable within the time constraints available to conduct the study. The sample size of 202 was then multiplied by 35% (to allow for refusals and attrition) which necessitated a minimum sample size of 272 participants (i.e. 68 participants per group).
Once the data was compiled and arranged for statistical analysis, datasets were uploaded to SPSS version 19 for exploratory, descriptive statistical analysis.
All analyses were conducted on an intention-to-treat basis; a two-sided probability value of .05 constituted statistical significance. Categorical variables were compared using chi-square in the first instance to determine any significant effect between documents for any group. Main effects and any interaction effects of the intervention and between group differences were assessed using binary logistic regression.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/05/2013
Date of last participant enrolment
Anticipated
Actual
28/02/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
272
Accrual to date
Final
282
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 12952 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 293160 0
University
Name [1] 293160 0
Flinders University of South Australia
Country [1] 293160 0
Australia
Funding source category [2] 293161 0
Government body
Name [2] 293161 0
Australian Government Department of Health
Country [2] 293161 0
Australia
Primary sponsor type
University
Name
CareSearch at Flinders University South Australia
Address
GPO Box 2100
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 291956 0
None
Name [1] 291956 0
Address [1] 291956 0
Country [1] 291956 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294654 0
Flinders University Social and Behavioural Ethics Committee
Ethics committee address [1] 294654 0
Ethics committee country [1] 294654 0
Australia
Date submitted for ethics approval [1] 294654 0
04/03/2013
Approval date [1] 294654 0
29/04/2013
Ethics approval number [1] 294654 0
Project No. 6069

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

Contacts
Principal investigator
Name 64498 0
Dr Sandra L Bradley
Address 64498 0
Flinders University South Australia
c/o CareSearch,
Health and Sciences Building, Repatriation General Hospital Campus
GPO Box 2100
Adelaide SA 5000
Country 64498 0
Australia
Phone 64498 0
61 8 7221 8231
Fax 64498 0
Email 64498 0
[email protected]
Contact person for public queries
Name 64499 0
Sandra L Bradley
Address 64499 0
Flinders University South Australia
c/o CareSearch,
Health and Sciences Building, Repatriation General Hospital Campus
GPO Box 2100
Adelaide SA 5000
Country 64499 0
Australia
Phone 64499 0
61 8 7221 8231
Fax 64499 0
Email 64499 0
[email protected]
Contact person for scientific queries
Name 64500 0
Sandra L Bradley
Address 64500 0
Flinders University South Australia
c/o CareSearch,
Health and Sciences Building, Repatriation General Hospital Campus
GPO Box 2100
Adelaide SA 5000
Country 64500 0
Australia
Phone 64500 0
61 8 7221 8231
Fax 64500 0
Email 64500 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseWhich online format is most effective for assisting Baby Boomers to complete advance directives? A randomised controlled trial of email prompting versus online education module.2017https://dx.doi.org/10.1186/s12904-017-0225-9
N.B. These documents automatically identified may not have been verified by the study sponsor.