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Trial registered on ANZCTR


Registration number
ACTRN12618002014235p
Ethics application status
Submitted, not yet approved
Date submitted
6/12/2018
Date registered
14/12/2018
Date last updated
14/12/2018
Date data sharing statement initially provided
14/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Helping People to Choose Wisely: Evaluating Question Based Interventions to Support Shared Decision Making in Healthcare
Scientific title
Helping People to Choose Wisely: Evaluating the impact of Question Based Interventions on Self-Reported Efficacy and Intention to Use Shared Decision Making in Healthcare
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 (a preparation video alone vs. enablement intervention alone vs. preparation video and enablement intervention) on consumer outcomes (2 primary and 6 secondary). It will also assess whether the level of health literacy 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 three intervention groups using randomisation embedded in Qualtrics, stratified by level of health literacy.
 
Each participant will then be randomly assigned to one of the three 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.
 
Following this, the links to both interventions will be shared with the participant for one month and the frequency visited used as the basis for measuring a behavioral effect in the 1-month follow up survey. Link usage will be monitored online via Qualtrics. 
 
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.
 
PREVENTION INTERVENTION
The preparation intervention is a short 3 minute video 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 have access to it once within the post-intervention survey and only 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.
Intervention code [1] 313055 0
Behaviour
Comparator / control treatment
Three different combinations of interventions will be compared to each other in a parallel group comparison.
Control group
Active

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

Measures of self-efficacy 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
Upon completion of:
- Pre-intervention questionnaire
- Post-intervention questionnaire
- 1 month 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 scale developed by Couet et al. (2015).

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
Upon completion of:
- Pre-intervention questionnaire
- Post-intervention questionnaire
- 1 month follow-up questionnaire
Secondary outcome [1] 354498 0
Attitudes towards shared decision making

Attitudes towards SDM are measured with a validated scale developed by Dormandy et al. 2006) and adapted for use in this context.

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
At time of post-intervention questionnaire completion
Secondary outcome [2] 354499 0
Preparedness for shared decision making

Adapted from Graham and O’Connor (2005), participants will be asked to complete the Preparation for Decision Making Scale.

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

Knowledge of patient rights in regards to asking questions and sharing in health decisions are measured via questions adapted from Halawany et al. (2016) to include items from the Australian Charter of Healthcare Rights.

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
At time of post-intervention questionnaire completion
Secondary outcome [4] 354502 0
Healthcare questions

Post intervention, 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.
Timepoint [4] 354502 0
At time of post-intervention questionnaire completion
Secondary outcome [5] 354503 0
Likelihood of recommending the material/s to others

Adapted from Shepherd et al. (2016) participants in each intervention group will be asked to rate if they would recommend the material/s to others.

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
At time of post-intervention questionnaire completion
Secondary outcome [6] 354727 0
Behaviour

Patients will be sent an email with a link to the intervention they've been randomised to. The number of times each link has been clicked after one month will be monitored and recorded as a measure of behavioural effect.
Timepoint [6] 354727 0
At time of 1 month follow-up questionnaire

Eligibility
Key inclusion criteria
Above 18 years

Sufficient English language skills to complete the 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

Insufficient English language skills to completet 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 Research Now SSI. Web based randomization will be performed by Research Now SSI 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)
Qualtrics computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Not Applicable
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Quantitative data anlysed using linear regression

Qualitative data using framework analysis/content analysis using inductive/deductive methods

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)
NSW

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
Submitted, not yet 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
Ethics approval number [1] 302054 0

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)?
No
No/undecided IPD sharing reason/comment
Only de-identified data will be available
What supporting documents are/will be available?
Ethical approval
Summary results
No Results