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Testing different ways to explain coronary calcium artery scoring for support of shared decision making in adults who do not have a history of cardiovascular disease

Testing different ways to explain coronary calcium artery scoring for support of shared decision making in adults who do not have a history of cardiovascular disease: A Study on Participant Understanding of cardiovascular disease risk

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623001246673
Enrollment
1629
Registered
2023-12-01
Start date
2023-12-04
Completion date
2023-12-12
Last updated
2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to improve knowledge of consumers about new and emerging CVD risk assessment methods, addressing different levels of health literacy; and to improve the uptake of evidence-based risk assessment methods by health professionals by providing them with communication tools that allow them to quickly and automatically apply the evidence to their patients. This project will use a novel approach to: 1) identify the best way to communicate the known benefits/harms and uncertainties of these tests, for patients with varying health literacy levels; and 2) develop novel patient decision aids on these issues to support revised national guidelines before they are implemented.

Interventions

Design: The study will be a randomised experiment. We will conduct a national survey recruited through Dynata to experimentally test different content options amongst consumers with varying health literacy. A 2 x 2 factorial design will test how to present risk assessment and management options (basic vs detailed) and uncertainty (implicit vs explicit) to enhance understanding. Methods: A national sample will be recruited for an online survey through Qualtrics, with stratified education, gender

Design: The study will be a randomised experiment. We will conduct a national survey recruited through Dynata to experimentally test different content options amongst consumers with varying health literacy. A 2 x 2 factorial design will test how to present risk assessment and management options (basic vs detailed) and uncertainty (implicit vs explicit) to enhance understanding. Methods: A national sample will be recruited for an online survey through Qualtrics, with stratified education, gender and age groups (45-79 years). Participants will complete a 10-minute survey where they will: 1) respond to questions about demographics and health literacy; and 2) respond to various information: group 1 and 3 will receive basic description of CVD risk factors/management options, group 2 and 4 will receive detailed description of the triage method and intervention effects. We will also compare standard presentation of probabilities with a version that has explicit information about different types of uncertainty: aleatory (randomness of future events, represented implicitly via probabilities) for group 1 and 2; and epistemic (with explicit statements about uncertainty around numeric estimates and the quality of underlying evidence) for group 3 and 4. There will be two outcome scenarios within each of the four groups. Participants will be shown a hypothetical scenario of a person receiving an intermediate result for their heart disease risk, which will be reclassified as either low risk or high risk. Participants will receive a debriefing document at the end to explain the aims of the study and that the data is based on a hypothetical scenario which do not apply to their own situation. The survey is anonymous. The eight groups participants can be randomised to are summarised below: 1a. Information: Basic; Uncertainty: Implicit; Final risk: Low 1b. Information: Basic; Uncertainty: Implicit; Final risk: High 2a. Information: Detailed; Uncertainty: Implicit; Final risk: Low 2b. Information: Detailed; Uncertainty: Implicit; Final risk: High 3a. Information: Basic; Uncertainty: Explicit; Final risk: Low 3b. Information: Basic; Uncertainty: Explicit; Final risk: High 4a. Information: Detailed; Uncertainty: Explicit; Final risk: Low 4b. Information: Detailed; Uncertainty: Explicit; Final risk: High

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention

Eligibility

Sex/Gender
All
Age
45 Years to 79 Years
Healthy volunteers
Yes

Inclusion criteria

Individuals will be eligible if they are aged 45-79; living in Australia, able to communicate and read English; never had a heart attack or stroke nor been diagnosed with a CVD.

Exclusion criteria

None

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026