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Trial registered on ANZCTR


Registration number
ACTRN12618002014235
Ethics application status
Approved
Date submitted
6/12/2018
Date registered
14/12/2018
Date last updated
16/10/2019
Date data sharing statement initially provided
14/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Choosing Wisely Australia® 5 Questions resource and a shared decision-making preparation video: Protocol for an online experiment
Scientific title
Evaluation of the Choosing Wisely Australia® 5 Questions resource and a shared decision-making preparation video: Protocol for an online experiment
Secondary ID [1] 296864 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health Literacy 310600 0
Shared Decision Making 310601 0
Condition category
Condition code
Public Health 309313 309313 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study seeks to compare the relative effectiveness of multiple shared decision making interventions (1: a preparation video alone vs. 2: enablement intervention alone vs. 3: preparation video and enablement intervention vs. 4: no intervention) on consumer outcomes. It will also assess whether the level of health literacy (adequate or inadequate) will impact the two primary outcomes: the intention and the self-efficacy of participants to use shared decision making.

Participants will be randomised into one of four intervention groups using randomisation embedded in Qualtrics, stratified by level of health literacy.

Each participant will then be randomly assigned to one of the four interventions and asked to complete an online questionnaire based around a hypothetical healthcare scenario to measure primary and secondary outcomes in regard to use of shared decision making. Mixed qualitative and quantitative methods will be used.

Using Qualtrics to monitor link usage, we will assess the proportion of participants who click on a link to their intervention at 2-weeks follow-up.

PREVENTION INTERVENTION
The preparation intervention is a short 3 minute video we developed, which will be given to survey participants via a link. Participants will have access to the video once within the post-intervention survey and only permitted to progress with the intervention once 3 minutes have elapsed to ensure adherence. The preparation video script was developed via an iterative process drawing upon existing shared decision making literature to inform, encourage and clarify the rights of participants to engage in this process.

ENABLEMENT INTERVENTION
The enablement intervention is a question prompt list developed by Choosing Wisely Australia. It will be included in single page graphic form within the survey given to participants. Participants will only be permitted to progress with the intervention once a minute has elapsed to ensure adherence. The question prompt list consists of five questions which patients can ask their healthcare professionals in order to make informed, shared decisions.

The interventions will be displayed to participants within the survey platform. To ensure intervention exposure, a timer has been added to the pages displaying the video (3 minutes) and 5 Questions resource (1 minute), preventing participants from progressing to the next survey page until the specified time has elapsed. In the preparation video and 5 Questions resource arm, the video will be presented before the 5 Questions resource. Participants will not be prevented from exposure to any other care or interventions prior to or during the study.
Intervention code [1] 313055 0
Behaviour
Comparator / control treatment
Four different combinations of interventions will be compared to each other in a parallel group comparison. The fourth combination is an active control in which participants randomised to this arm will receive no intervention.
Control group
Active

Outcomes
Primary outcome [1] 308278 0
Self-efficacy to ask questions and be involved in healthcare decision making - measured in three components:

a) self-efficacy to ask questions: participants are asked to rate their degree of confidence to ask questions of their healthcare provider by recording a number from 0 (cannot do at all) to 100 (highly certain can do).
b) self-efficacy to be involved in healthcare decision-making: participants are asked to rate their degree of confidence to be involved in decisions with their healthcare provider by recording a number from 0 (cannot do at all) to 100 (highly certain can do).
c) self-efficacy to ask questions and be involved in healthcare decision-making: composite measure based on two individual items (see above)

These measures of self-efficacy are developed from Bandura's (2006) self efficacy theory. Bandura A. Chapter 14: GUIDE FOR CONSTRUCTING SELF-EFFICACY SCALES. In: Pajares F, Urdan TC, editors. Self-efficacy beliefs of adolescents. Greenwich, Conn: IAP - Information Age Pub., Inc; 2006.
Timepoint [1] 308278 0
Assessed at:
a) pre-intervention questionnaire
b) immediate post-intervention questionnaire
c) 2-week follow-up questionnaire
Primary outcome [2] 308279 0
Intention to engage in shared decision making:

Self-reported measure of intention to engage in SDM will be measured using a validated three-item scale (Cronbach alpha = 0.8) developed by Couet et al. (2015).

Items measure participants'
(i) likelihood of engaging in shared decision-making, from very unlikely (-3) to very likely (+3)
(ii) odds of engaging in shared decision-making, from very weak (-3) to very strong (+3) and
(iii) agreement with the statement 'I intend to engage in shared decision-making', from total disagreement (-3) to total agreement (+3).

Total scores will be rescaled on a scale of 0-6 and the sum of the items divided by three to derive the total score of intention.

Couët N, Labrecque M, Robitaille H, Turcotte S, Légaré F. The impact of DECISION+2 on patient intention to engage in shared decision making: secondary analysis of a multicentre clustered randomized trial. Health Expectations. 2015;18(6):2629-37.
Timepoint [2] 308279 0
Assessed at:
a) pre-intervention questionnaire
b) immediate post-intervention questionnaire
c) 2-week follow-up questionnaire
Secondary outcome [1] 354498 0
Attitudes towards shared decision making:

Attitudes towards SDM are measured with a three-item validated scale (developed by Dormandy et al. 2006) and adapted for use in this context. It assesses participants' perceptions of shared decision-making as beneficial/not beneficial, worthwhile/not worthwhile and important/unimportant. Each item has seven response options, forming a scale from 3 to 21. Scores will be re-coded such that higher scores indicate more positive attitudes towards shared decision-making. Participants responding with the highest possible score on all three questions will be classified as having positive attitudes.

Dormandy E, Michie S, Hooper R, Marteau TM. Informed choice in antenatal Down syndrome screening: A cluster-randomised trial of combined versus separate visit testing. Patient Education and Counseling. 2006;61(1):56-64.
Timepoint [1] 354498 0
Assessed at: immediate post-intervention questionnaire
Secondary outcome [2] 354499 0
Preparedness for shared decision making:

Preparedness for shared decision-making will be measured using an 8-item version of the Preparation for Decision Making Scale (PrepDM), adapted from Graham and O’Connor (2005).

The PrepDM scale was developed to assess a participants' perception of how useful a decision support intervention is in preparing them to communicate with their practitioner at a consultation visit and to make a health decision.

Items are scored on a 5-point Likert scale, from 'not at all' (1) to 'a great deal' (5), with higher scores indicating higher perceived level of preparation for decision-making. Items will be summed, and the total score divided by 8.

Graham ID, O’Connor AM. Preparation for Decision Making Scale. University of Ottowa; 1995 [Updated 2005].
Timepoint [2] 354499 0
Assessed at: immediate post-intervention questionnaire
Secondary outcome [3] 354500 0
Knowledge of patient's rights in regards to share decision-making:

Knowledge will be measured using four questions adapted from Halaway et al. (2016) and applied to the Australian Charter of Healthcare Rights (second edition).

Participants will indicate 'yes', 'no' or 'unsure' to show whether they think the following are patient rights:
a) ask questions and be involved in open and honest communication
b) make choices with your healthcare provider
c) include the people that you want in planning and decision-making
d) get clear information about your condition, including the possible benefits and risks of different tests and treatments.

A foil question will be included to detect if participants are arbitrarily selecting 'yes' to all questions. Scores are dichotomised into a) all questions correct, or b) not all questions correct.

Halawany HS, AlTowiher OS, AlManea JT, Abraham NB, Jacob V, AlMaflehi N. Awareness, availability and perception of implementation of patients’ rights in Riyadh, Saudi Arabia. The Saudi Journal for Dental Research. 2016;7(2):132-7.

Australian Commission on Safety and Quality in Healthcare. Australian Charter of Healthcare Rights 2008 [Available from: https://www.safetyandquality.gov.au/national-priorities/charter-of-healthcare-rights/.
Timepoint [3] 354500 0
Assessed at:
a) pre-intervention questionnaire
b) immediate post-intervention questionnaire
Secondary outcome [4] 354502 0
Healthcare questions:

Participants will be asked to write down 5 questions they would ask the doctor given the hypothetical healthcare scenario. The content of individual responses will be anaysed via content analysis using inductive and deductive approaches. The mean number of questions that map onto the Choosing Wisely 5 Questions will be calculated.
Timepoint [4] 354502 0
Assessed at:
a) immediate post-intervention questionnaire
b) 2-week follow-up questionnaire
Secondary outcome [5] 354503 0
Acceptability:

Adapted from Shepherd et al. (2016) participants in each intervention group will be asked to rate on a 4-point scale from 1 (definitely not) to 4 (yes, definitely) if they would:
a) recommend the material/s to others, or
b) use the intervention again

Recommendations are dichotomised into would recommend (3 and 4) and would not recommend (1 and 2).

Shepherd HL, Barratt A, Jones A, Bateson D, Carey K, Trevena LJ, et al. Can consumers learn to ask three questions to improve shared decision making? A feasibility study of the ASK (AskShareKnow) Patient–Clinician Communication Model® intervention in a primary health-care setting. Health Expectations. 2016;19(5):1160-8.
Timepoint [5] 354503 0
Assessed at immediate post-intervention questionnaire
Secondary outcome [6] 354727 0
Indicator of proactive intervention use:

We will assess the proportion of participants who click on a link to their intervention (arms 1-3 only). We will use Qualtrics website analytics to monitor the number of link clicks.
Timepoint [6] 354727 0
Assessed at:
a) immediate post-intervention questionnaire
b) 2-week follow-up questionnaire
Secondary outcome [7] 375932 0
Intention to follow the treatment plan recommended by the doctor without further questioning.:

A single item on a 10-point scale adapted from Fisher et al., 2012 will asses hypothetical intention to follow the treatment plan recommended by the doctor without further questioning: 'Which best describes your intention to follow the treatment plan recommended by the doctor without asking further questions?' (1 = 'definitely will not' to 10 = 'definitely will').

Fisher A, Bonner C, Biankin A, Juraskova I. Factors influencing intention to undergo whole genome screening in future healthcare: a single-blind parallel-group randomised trial. Prev Med 2012 55:514–20.
Timepoint [7] 375932 0
Assessed at:
a) pre-intervention questionnaire
b) immediate post-intervention questionnaire
c) 2-week follow-up questionnaire

Eligibility
Key inclusion criteria
Participants must be aged 18 years or older, be an Australian citizen or permanent resident and possess sufficient self-assess English language skills to complete questionnaires in English.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Below 18 years

Not and Australian citizen or permanent resident

Insufficient English language skills to complete the questionnaires in English

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)
There will be no direct contact between researchers and participants. Rather, participants enter into the study via independent recruitment provider Dynata. Web based randomisation will be performed by Qualtrics separate from the research team and there will be no disclosure of the process to the team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised automatically using the Randomiser function included in Qualtrics, which utilizes the Mersenne Twister pseudorandom number generator. Participants and researchers will be blinded to the allocation sequence until data collection is complete.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
To randomised participants stratified by health literacy level, health literacy will be assess by the Newest Vital Sign (NVS), with participants categorised as inadequate (score 0-3 on NVS) or adequate literacy (score 4-6 on NVS). The NVS has been used in other online studies and is an objective, performance-based measure of health literacy skills.

Weiss BD, Mays MZ, Martz W, Castro KM, DeWalt DA, Pignone MP, et al. Quick assessment of literacy in primary care: the Newest Vital Sign. Ann Fam Med 2005;3(6):514-22.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
QUANTITATIVE ANALYSIS:

The study statistician will be blinded to the intervention allocation of participants and their level of health literacy until after completion of analyses; a research assistant who has no other involvement in the trial will remove all group identifiers prior to analysis. Quantitative primary and secondary outcome data will be analysed as intention-to-treat using appropriate regression models (i.e., linear regression for continuous outcomes, logistic regression for dichotomous categorical outcomes). Dichotomous variables representing the study factors (preparation video: provided, not provided; Choosing Wisely Australia 5 questions resource: provided, not provided; health literacy: adequate, inadequate) and their interactions will be included in models as between-subjects fixed effects, controlling for pre-intervention values (where available). Outcome data collected during the immediate post- and follow-up survey will be analysed in separate models. Any significant interactions will be followed-up by sub-group analyses based on potentially relevant demographic variables.

The use of an online survey platform minimises the risk of missing data; participants are required to provide responses to each question before moving on to subsequent items. As such, data is only missing in cases where participants discontinue prior to providing responses for outcome measures. Participants who discontinue the study before completion of the (immediate) post-intervention survey will be excluded from all analyses. Multiple imputation will be used to impute occasional cases of missing data (e.g. some outcome measures incomplete) or for missing responses for participants who complete the initial (pre- and post-) surveys, but do not return to complete the 2-week follow-up survey. If multiple imputation of missing data is utilised, sensitivity analyses will be performed comparing the outcome from complete-case with imputed analyses.

Sample size estimates were derived based on the primary outcome of intention score, with the estimates of effect based on previously published values (Couet et al., 2015) and refined considering pilot data. For each stratified analysis arm (i.e., inadequate health literacy, adequate health literacy), a sample of n=162 subjects per intervention group is expected to provide approximately 80% power to detect a small main effect (effect size of 0.10 or greater) of the Choosing Wisely Australia questions resource; and over 80% power to detect small main effects (effect sizes 0.20 or larger) of the preparation video intervention, and their interaction, at a p-value of 0.05 in primary analyses. As such, we aim to recruit a total sample size of N=1432 (i.e., 716 with inadequate health literacy and 716 with adequate health literacy; with n = 179 participants randomly allocated to each intervention group [preparation video alone, Choosing Wisely Australia 5 questions resource alone, both Choosing Wisely questions and preparation intervention, and control]). This will allow for a drop-out of approximately 10% of participants who discontinue the study before completing the (immediate) post-intervention survey measures.

QUALITATIVE ANALYSIS:

Assessment of healthcare questions deemed by participants as important to ask in their hypothetical scenario will be analysed via content analysis. Coding will first be done deductively based on concepts embodied in the Choosing Wisely Australia 5 Questions resource. Two double-blind coders will review all data and code any questions that fit broadly into 1 of 5 categories: Do I really need this test, treatment or procedure? What are the risks? Are there simpler, safer options? What happens if I don’t do anything? What are the costs? Any discrepancies will be resolved through discussion between coders. Remaining responses will be coded inductively with categories derived from the data. Inductive codes will be collected to form coding sheets and categories freely generated and grouped through the abstraction process. The coding scheme will revised over an iterative process of discussion and revision to ensure all themes are captured. Based on our previous work, data will be presented in the form of frequencies expressed as percentages and actual numbers of key categories. We will also report category names, definitions and data examples.

Couët N, Labrecque M, Robitaille H, Turcotte S, Légaré F. The impact of DECISION+2 on patient intention to engage in shared decision making: secondary analysis of a multicentre clustered randomized trial. Health Expect 2015;18(6):2629-37.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 301312 0
University
Name [1] 301312 0
University of sydney
Address [1] 301312 0
School of Public Health
Edward Ford Building A27
The University of Sydney
NSW
2006
Country [1] 301312 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
School of Public Health
Edward Ford Building A27
The University of Sydney
NSW
2006
Country
Australia
Secondary sponsor category [1] 300977 0
None
Name [1] 300977 0
Address [1] 300977 0
Country [1] 300977 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302054 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 302054 0
Ethics Office
Level 3, Administration Building (F23)
University of Sydney
NSW 2006
Ethics committee country [1] 302054 0
Australia
Date submitted for ethics approval [1] 302054 0
19/11/2018
Approval date [1] 302054 0
19/06/2019
Ethics approval number [1] 302054 0
2018/965

Summary
Brief summary
This study seeks to compare the relative effectiveness of a multiple shared decision making tools (a preparation video alone vs. enablement intervention alone vs. preparation video and enablement intervention) on consumer outcomes. It will also assess whether the level of health literacy will impact the primary outcomes.

Pre-intervention, post-intervention and 1 month follow-up surveys will be used to measure change in primary outcomes. Secondary outcomes will be measured at post-intervention and 1 month follow-up surveys.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88966 0
Prof Kirsten McCaffery
Address 88966 0
The University of Sydney
Rm 128B, Edward Ford Building A27
The University of Sydney
NSW 2006
Country 88966 0
Australia
Phone 88966 0
+61 2 9351 7220
Fax 88966 0
Email 88966 0
kirsten.mccaffery@sydney.edu.au
Contact person for public queries
Name 88967 0
Prof Kirsten McCaffery
Address 88967 0
The University of Sydney
Rm 128B, Edward Ford Building A27
The University of Sydney
NSW 2006
Country 88967 0
Australia
Phone 88967 0
+61 2 9351 7220
Fax 88967 0
Email 88967 0
kirsten.mccaffery@sydney.edu.au
Contact person for scientific queries
Name 88968 0
Prof Kirsten McCaffery
Address 88968 0
The University of Sydney
Rm 128B, Edward Ford Building A27
The University of Sydney
NSW 2006
Country 88968 0
Australia
Phone 88968 0
+61 2 9351 7220
Fax 88968 0
Email 88968 0
kirsten.mccaffery@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual participant data collected during the trial can be made available in de-identified csv or excel datasets, along with the data dictionary.
When will data be available (start and end dates)?
Data will be made available once the manuscript outlining results from the study has been published for up to 5 years after publication.
Available to whom?
Data will be made available upon request to anyone wishing to access it who provides a methodologically sound proposal to the principal investigator.
Available for what types of analyses?
Replication and meta-analysis.
How or where can data be obtained?
Data will be made available upon direct contact with the first/corresponding author. Contact details of the first author are danielle.muscat@sydney.edu.au
What supporting documents are/will be available?
No other documents available
Summary results
No Results