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The impact of health literacy-sensitive design and heart age in a cardiovascular disease prevention decision aid: randomised controlled trial and end user testing

Carissa Bonner1, Carys Batcup1, Julie Ayre1, Erin Cvejic1, Lyndal Trevena1, Kirsten McCaffery1, Jenny Doust1 •
University of Sydney1
22 Sep 2021-medRxiv (Cold Spring Harbor Laboratory Press)-
TL;DR: In this article, the authors developed and evaluated the first literacy-sensitive CVD prevention decision aid (DA) developed for people with low health literacy, and investigated the impact of literacy sensitive design and heart age.
Abstract: Introduction: Shared decision making is as an essential principle for cardiovascular disease (CVD) prevention, where asymptomatic people are considering lifelong medication and lifestyle changes. This project aimed to develop and evaluate the first literacy-sensitive CVD prevention decision aid (DA) developed for people with low health literacy, and investigate the impact of literacy-sensitive design and heart age. Methods: We developed the standard DA based on international standards. The literacy-sensitive version included simple language, supporting images, white space and a lifestyle action plan. A randomised trial included 859 people aged 45-74 using a 3 (DA: standard, literacy-sensitive, control) x 2 (heart age: heart age + percentage risk, percentage risk only) factorial design, with outcomes including prevention intentions/behaviours, gist/verbatim knowledge of risk, credibility, emotional response and decisional conflict. We iteratively improved the literacy-sensitive version based on end user testing interviews with 20 people with varying health literacy levels. Results: Immediately post-intervention (n=859), there were no differences between the DA groups on any outcome. The heart age group was less likely to have a positive emotional response, perceived the message as less credible, and had higher gist/verbatim knowledge of heart age risk but not percentage risk. After 4 weeks (n=596), the DA groups had better gist knowledge of percentage risk than control. The literacy-sensitive decision aid group had higher fruit consumption, and the standard decision aid group had better verbatim knowledge of percentage risk. Verbatim knowledge was higher for heart age than percentage risk amongst those who received both. Discussion: The literacy-sensitive DA resulted in increased knowledge and lifestyle change for participants with varying health literacy levels and CVD risk results. Adding heart age did not increase lifestyle change intentions or behaviour but did affect psychological outcomes, consistent with previous findings. Key words: decision aids, shared decision making, risk communication, heart age, cardiovascular disease prevention, behaviour change, health literacy MeSH Terms: Health Literacy, Cardiovascular Diseases, Decision Making (Shared), Life Style, Decision Support Techniques

Summary (4 min read)

Jump to: [METHODS] – [Design] – [Recruitment] – [Measures] – [A priori sample size calculations determined that 85 participants per randomised group (total n=510)] – [850 to account for potential attrition of up to 30% between the intervention and follow-up.] – [3. Adding heart age to absolute risk will be more effective than absolute risk alone.] – [RESULTS] – [Demographics] – [At follow-up after 4 weeks, there were no significant differences between the control and decision] – [4 week differences between heart age groups] – [DISCUSSION] – [Strengths and limitations] and [Conclusion]

METHODS

  • The literacy-sensitive design included simple language, supporting images and white space to improve readability and understandability 28 , and a novel action plan format their team developed that has been shown to reduce unhealthy lifestyle behaviours amongst people with low health literacy29.
  • The authors added options for physical activity and smoking to the existing tool to reduce unhealthy snacking, drawing on previous literature on effective if-then plans in these areas39,40. .
  • CC-BY-NC-ND 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint.
  • The copyright holder for thisthis version posted September 22, 2021.

Design

  • The randomised trial was based on a 3×2 factorial design to test the effect of literacy-sensitive design (literacy-sensitive DA, standard DA, or control: Heart Foundation patient information) and risk format (explaining CVD risk only (as a percentage risk), or CVD risk percentage + heart age) on psychological and behavioural outcomes.
  • The snacking action plan was previously developed by their team 29, and the exercise and smoking plans were in the same style using research in those areas 39,40 .

Recruitment

  • A national sample was recruited through Qualtrics, an online social research agency, with stratified sampling based on gender/age groups (5 year age groups from 45-74 years).
  • Participants completed a CVD risk assessment based on Australian guidelines and the New Zealand approach to calculating heart age1,38.
  • If blood pressure or cholesterol were not known, the average by age/gender based on non-diabetic participants in the AusDiab cohort was used (accessed via JD), and all participants were advised to see a GP for a more accurate risk assessment.
  • Those with established CVD or taking CVD prevention medication were excluded.
  • Duplicate IP addresses were replaced, and stratified sampling was relaxed with additional quality checks added if hard to reach groups did not reach quota after 2 weeks.

Measures

  • Established measures were used for the primary outcome of behavioural intentions (validated Theory of Planned Behaviour scale applied to smoking, diet, exercise and GP visit) 45–47 .
  • CC-BY-NC-ND 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint.
  • The copyright holder for thisthis version posted September 22, 2021.

A priori sample size calculations determined that 85 participants per randomised group (total n=510)

  • Would yield 90% power to detect a moderate effect size of d=0.5 (standardised difference) in the primary outcome of intention to change lifestyle or any of the secondary outcomes, assuming a twosided alpha of 0.05.
  • The authors aimed to recruit 20% more cases to account for potential missing values, totalling 600 participants (100 per group) at follow-up.
  • This sample was inflated for recruitment to.

850 to account for potential attrition of up to 30% between the intervention and follow-up.

  • Continuous outcome variables were modelled using linear regression.
  • Dichotomous outcomes were analysed using modified Poisson regression (using a log-link function with robust error variances).
  • All regression models included decision aid group (literacy-sensitive decision aid; standard decision aid; or basic Heart Foundation patient information) and risk format (CVD risk only, or CVD risk + heart age) as categorical variables and controlled for health literacy adequacy (categorical based on the Newest Vital Sign (NVS) measure51,52: low; moderate; adequate) and absolute risk .
  • CC-BY-NC-ND 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint.
  • The copyright holder for thisthis version posted September 22, 2021.

3. Adding heart age to absolute risk will be more effective than absolute risk alone.

  • Iterative end user testing with varying health literacy levels Participants in the trial were invited to opt-in to a “think aloud” interview to provide further end user testing and feedback for the literacy-sensitive version of the intervention, also known as Stage 3.
  • Participants went through the risk calculator in full, while saying out loud everything they were thinking, for example any areas of confusion.
  • Transcripts were thematically coded and discussed after each set of 4-5 interviews, and improvements were made to the intervention before the next set of interviews.
  • The copyright holder for thisthis version posted September 22, 2021.

RESULTS

  • The authors used the question format and style of the current national heart age calculator as the basis for the risk factor questions in all groups, and also based the heart age presentation on that tool.
  • The CVD risk results and decision aid were presented based on: 1) their existing GP decision aid tool 37 (standard decision aid group); 2) a simplified version of the standard decision aid with supporting images ; and 3) the current risk calculator from the National Vascular Disease Prevention Alliance41.
  • The copyright holder for thisthis version posted September 22, 2021.
  • The authors recruited 859 participants for the intervention (including the 100 in the soft launch), with a target of 600 at 4 week follow-up, for which they recruited 596.
  • CC-BY-NC-ND 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint.

Demographics

  • . CC-BY-NC-ND 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint.
  • The copyright holder for thisthis version posted September 22, 2021.
  • For Hypothesis 2, there was no difference between the standard and literacy-sensitive decision aids for any outcome (Table 6).
  • There were significant interactions between decision aid and health literacy for intention to talk to a doctor about medication (p=0.019) and emotional response (positive p=0.010; negative p=0.006).

At follow-up after 4 weeks, there were no significant differences between the control and decision

  • There were significant differences between decision aid groups by health literacy levels for self-reported calls to the Heart Foundation helpline (p<0.001) and verbatim knowledge of CVD percentage risk at follow up (p<0.001).
  • CC-BY-NC-ND 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint.

4 week differences between heart age groups

  • At 4 week follow-up there were no significant differences between the heart age groups in terms of lifestyle behaviour change, seeing a doctor for a Heart Health Check or gist knowledge of risk level (Table 7).
  • The copyright holder for thisthis version posted September 22, 2021.
  • From this pool, 20 were selected to represent a range of ages, genders, risk levels, and health literacy.

DISCUSSION

  • The authors used both a mixed methods development and evaluation process to produce a CVD decision aid that is effective for improving verbatim and gist knowledge of CVD risk and fruit consumption after 4 weeks.
  • The results show literacy-sensitive decision aids can support people with lower health literacy to make informed decisions, while still being suitable for the general population.
  • CC-BY-NC-ND 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint.
  • The copyright holder for thisthis version posted September 22, 2021.
  • Analyses of people who received an older heart age result suggests it may be useful as a marketing tool to get attention and initiate behaviour change, but knowledge of heart age did not translate to knowledge of risk.

Strengths and limitations

  • The authors had sufficient follow-up to run the study per protocol despite COVID-19 disruptions, and observed no difference in dropouts for key variables.
  • A limitation is that the online panel sample may not be representative of the general population, and may better reflect users of online heart age tools than patients presenting to primary care for CVD risk assessment.
  • Different countries use also different CVD risk models/heart age algorithms, which may affect the results given the differences the authors observed in the older heart age sample.
  • Finally, the authors used validated outcomes where possible, but behaviour change was self-reported.

Conclusion

  • This study shows the value of combining health literacy-sensitive design with best practice risk communication and behaviour change tools.
  • This approach improved knowledge of CVD risk and heart age, and behaviour, in a sample with varying health literacy levels.
  • Further research should investigate implementation pathways for integrating such consumer tools with clinical practice, and distinguish between older and younger heart age results.
  • CC-BY-NC-ND 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint.
  • The copyright holder for thisthis version posted September 22, 2021.

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1
Title: The impact of health literacy-sensitive design and heart age in a cardiovascular disease
prevention decision aid: randomised controlled trial and end user testing
Authors
: Carissa Bonner, Carys Batcup, Julie Ayre, Erin Cvejic, Lyndal Trevena, Kirsten McCaffery,
Jenny Doust
Affiliations
: The University of Sydney, Faculty of Medicine and Health, School of Public H ealth
Correspondence
:
Dr Carissa Bonner
Rm 128A, Edward Ford Building A27 | The Univer sity of Sydney | NSW | 2006
T +61 2 9351 7125 | F +61 2 9351 5049
E carissa.bonner@sydney.edu.au
Acknowledgments
:
This study was funded by a Vanguard Grant from the National Heart Foundation of Australia (ID
102215)
Ethics approval:
This study has ethics approval fr o m the University of Sydney Human Research Ethics Committee (ID
2019/774).
Trial registration:
The trial protocol was pre-registered at ANZCTR (Trial number ACTRN12620000806965).
. CC-BY-NC-ND 4.0 International licenseIt is made available under a
is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint
The copyright holder for thisthis version posted September 22, 2021. ; https://doi.org/10.1101/2021.09.20.21263868doi: medRxiv preprint
NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.
2
ABSTRACT
Introduction:
Shared decision making is as an essential principle for cardiovascular disease (CVD)
prevention, where asymptomatic people are considering lifelong medication and lifestyle changes.
This project aimed to develop and evaluate the first liter acy-sensitive CVD prevention decision aid
(DA) developed for people with low health literacy, and investigate the impact of literacy-sensitive
design and heart age.
Methods:
We developed the standa rd DA based on international standards. The l iteracy- sensitive
version included simple language, supporting images, white space and a lifestyle action plan. A
randomised trial included 859 people aged 45-74 using a 3 (DA: s tandard, literacy-sensitive, control)
x 2 (heart age: heart age + percentage risk, percentage risk only) factorial design, with outcomes
including prevention intentions/behaviours, gist/verbatim knowledge of ri sk, credib ility, emoti onal
respon se and deci sional con flic t . We iterativel y improved the literacy- sen si tive ve rsion ba sed on end
user testing interviews with 20 people with varying health literacy levels.
Results
: Immediately post-intervention (n=859), there were no differences between the DA groups
on any outcome. The heart age group was less likely to have a positive emotional response,
perceived the message as less credible, and had higher gist/verbatim knowledge of heart age risk
but not perc en tage risk. After 4 week s (n=5 96), the DA groups had better gist k no wled ge of
percentage risk than control. The literacy-sensitive decision aid group had higher fruit consumption,
and the standard decision aid gr oup had better verbatim knowledge of percentage risk. Verbatim
knowledge was higher for heart age than percentage risk amongst those who received both.
Discussion
: The literacy-sensitive DA resulted in increased knowledge and lifestyle change for
participants with varying health literacy levels and CVD risk results. Adding heart age did not
increase lifestyle change intentions or behaviour but did affect psychological outcomes, consistent
with previous findings.
. CC-BY-NC-ND 4.0 International licenseIt is made available under a
is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint
The copyright holder for thisthis version posted September 22, 2021. ; https://doi.org/10.1101/2021.09.20.21263868doi: medRxiv preprint
3
Key words:
decision aids, shared decision making, ris k communication, heart age, cardiovascular
disease prevention, behaviour change, health literacy
MeSH Terms:
Health Literacy, Cardiovascular Diseases, Decision Making (Shared), Life Style,
Decision Support Techniques
. CC-BY-NC-ND 4.0 International licenseIt is made available under a
is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint
The copyright holder for thisthis version posted September 22, 2021. ; https://doi.org/10.1101/2021.09.20.21263868doi: medRxiv preprint
4
INTRODUCTION
Prevention of cardiovascular disease (CVD) includes lifestyle interventions and medication for those
at highest risk who are most likely to benefit. An “absolute risk” approach is supported by clinical
evidenc e and endor sed by most nation al guideline s around the world
1–5
. The absolute risk of a heart
attack or stroke in the next 5-10 years can be asses sed using widely available calculators
1
, but there
is substantial underuse of these tools in practice
6–11
. Providing medication to high risk and not low
risk patients is a cost-effective approach
6
. However, up to 75% of high risk patients are not receiving
recommended medication to prevent death and disability from CVD, while 25% of low risk patients
are taking medication they are very unlikely to benef it from
7
. Recent guideline chan ges have led to
calls for a shared decision making appr oach, to ensure medication prescribing for blood pressure
and cholesterol is more in line with patient values
12–14
.
We also know that health literacy plays a role in CVD prevention. Low health literacy is common in
many countries, with estimates ranging from 36 – 60% of the population in Australia, Europe and the
US
15–17
. This is associated with poorer self- mana gement, less access to the health system, increased
chronic disea se including CV D, and incre as ed mortali ty
18
. It is therefore important to specifically
engage this group in communication s trategies about CVD prevention. This requires changes to the
design of online patient resources, since most consumers seek health information online, but f ewer
than 1% of health information websites meet recommended readability levels; Grade 8 is
recommended to mee t the needs of pe o ple with varyi ng health liter acy
19,20
.
Some countries have used online CVD risk assessment tools for absolute risk and heart age to
engage consumers in CVD prevention, with millions of users worldwide
21–24
. However, our
systematic review of 73 online CVD risk assessment tools available to consumers found they were
not suitable for people with lower health literacy: their readability level was too high; they
frequently used unexplained medical terms; few used best practice risk communication formats
such as frequencies in icon arrays; and they r ated poorly on actionability (i.e. clarity in instructions of
. CC-BY-NC-ND 4.0 International licenseIt is made available under a
is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint
The copyright holder for thisthis version posted September 22, 2021. ; https://doi.org/10.1101/2021.09.20.21263868doi: medRxiv preprint
5
what actions/steps to take), which makes it hard for the average person to know what to do about
the risk assessment result
25
. Our review of 25 online decision aids for CVD prevention found similar
issues with understandability and actionability
26
, and few included lifestyle change as an option
reduce risk with many focusing on medication only.
There are several evidence-based strategies to address the issue of communicating CVD risk to
people with lower health literacy:
1) Use literacy-sensitive design to improve the readability of health information and reduce the
cognitive load of action plans for behaviour change
27–29
.
2) Use best practice risk communication formats to explain abstract probabilities (e.g. 16%) using
icon arrays and more concrete frequencies (e.g. 16 out of 100 people like you)
30–33
.
3) Use patient decision aids to improve understanding and decision making, including both lifestyle
change and medication as clear actions that patients can take to reduce their risk
27,34,35
.
This project aimed to develop and test a new consumer engagement tool for CVD prevention based
on the above strategies, to address the needs of Australians with different levels of health literacy. It
builds on our previous development of a GP-focused risk calculator and decision aid
36
, and
evaluation of the nationa l heart age calc ula tor
24
.
. CC-BY-NC-ND 4.0 International licenseIt is made available under a
is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint
The copyright holder for thisthis version posted September 22, 2021. ; https://doi.org/10.1101/2021.09.20.21263868doi: medRxiv preprint
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Dawn Stacey1, Dawn Stacey2, Krystina B. Lewis2, Michael J. Barry, Carol Bennett1, Karen Eden3, Margaret Holmes-Rovner4, Hilary A. Llewellyn-Thomas5, Anne Lyddiatt, Richard Thomson6, Lyndal Trevena7 •
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Abstract: Background Decision aids are intended to help people participate in decisions that involve weighing the benefits and harms of treatment options often with scientific uncertainty. Objectives To assess the effects of decision aids for people facing treatment or screening decisions. Search methods For this update, we searched from 2009 to June 2012 in MEDLINE; CENTRAL; EMBASE; PsycINFO; and grey literature. Cumulatively, we have searched each database since its start date including CINAHL (to September 2008). Selection criteria We included published randomized controlled trials of decision aids, which are interventions designed to support patients' decision making by making explicit the decision, providing information about treatment or screening options and their associated outcomes, compared to usual care and/or alternative interventions. We excluded studies of participants making hypothetical decisions. Data collection and analysis Two review authors independently screened citations for inclusion, extracted data, and assessed risk of bias. The primary outcomes, based on the International Patient Decision Aid Standards (IPDAS), were: A) 'choice made' attributes; B) 'decision-making process' attributes. Secondary outcomes were behavioral, health, and health-system effects. We pooled results using mean differences (MD) and relative risks (RR), applying a random-effects model. Main results This update includes 33 new studies for a total of 115 studies involving 34,444 participants. For risk of bias, selective outcome reporting and blinding of participants and personnel were mostly rated as unclear due to inadequate reporting. Based on 7 items, 8 of 115 studies had high risk of bias for 1 or 2 items each. Of 115 included studies, 88 (76.5%) used at least one of the IPDAS effectiveness criteria: A) 'choice made' attributes criteria: knowledge scores (76 studies); accurate risk perceptions (25 studies); and informed value-based choice (20 studies); and B) 'decision-making process' attributes criteria: feeling informed (34 studies) and feeling clear about values (29 studies). A) Criteria involving 'choice made' attributes: Compared to usual care, decision aids increased knowledge (MD 13.34 out of 100; 95% confidence interval (CI) 11.17 to 15.51; n = 42). When more detailed decision aids were compared to simple decision aids, the relative improvement in knowledge was significant (MD 5.52 out of 100; 95% CI 3.90 to 7.15; n = 19). Exposure to a decision aid with expressed probabilities resulted in a higher proportion of people with accurate risk perceptions (RR 1.82; 95% CI 1.52 to 2.16; n = 19). Exposure to a decision aid with explicit values clarification resulted in a higher proportion of patients choosing an option congruent with their values (RR 1.51; 95% CI 1.17 to 1.96; n = 13). B) Criteria involving 'decision-making process' attributes: Decision aids compared to usual care interventions resulted in: a) lower decisional conflict related to feeling uninformed (MD -7.26 of 100; 95% CI -9.73 to -4.78; n = 22) and feeling unclear about personal values (MD -6.09; 95% CI -8.50 to -3.67; n = 18); b) reduced proportions of people who were passive in decision making (RR 0.66; 95% CI 0.53 to 0.81; n = 14); and c) reduced proportions of people who remained undecided post-intervention (RR 0.59; 95% CI 0.47 to 0.72; n = 18). Decision aids appeared to have a positive effect on patient-practitioner communication in all nine studies that measured this outcome. For satisfaction with the decision (n = 20), decision-making process (n = 17), and/or preparation for decision making (n = 3), those exposed to a decision aid were either more satisfied, or there was no difference between the decision aid versus comparison interventions. No studies evaluated decision-making process attributes for helping patients to recognize that a decision needs to be made, or understanding that values affect the choice. C) Secondary outcomes Exposure to decision aids compared to usual care reduced the number of people of choosing major elective invasive surgery in favour of more conservative options (RR 0.79; 95% CI 0.68 to 0.93; n = 15). Exposure to decision aids compared to usual care reduced the number of people choosing to have prostate-specific antigen screening (RR 0.87; 95% CI 0.77 to 0.98; n = 9). When detailed compared to simple decision aids were used, fewer people chose menopausal hormone therapy (RR 0.73; 95% CI 0.55 to 0.98; n = 3). 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Barry D. Weiss1, Mary Z. Mays2, William Martz1, Kelley Merriam Castro1, Darren A. DeWalt3, Michael Pignone, Joy Mockbee1, Frank A. Hale1 •
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Hannah Farrimond, Paula Saukko, Nadeem Qureshi, Philip Evans 
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Dominique Alexandra Reinwand, Daniela N Schulz, Rik Crutzen, Stef P. J. Kremers, Hein de Vries 
Frequently Asked Questions (10)
Q1. What have the authors contributed in "Title: the impact of health literacy-sensitive design and heart age in a cardiovascular disease prevention decision aid: randomised controlled trial and end user testing" ?

This study was funded by a Vanguard Grant from the National Heart Foundation of Australia ( ID 102215 ) Ethics approval: This study has ethics approval from the University of Sydney Human Research Ethics Committee ( ID 2019/774 ). It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. 

Further research should investigate implementation pathways for integrating such consumer tools with clinical practice, and distinguish between older and younger heart age results. 

up to 75% of high risk patients are not receiving recommended medication to prevent death and disability from CVD, while 25% of low risk patients are taking medication they are very unlikely to benefit from7. 

Low health literacy is common in many countries, with estimates ranging from 36 – 60% of the population in Australia, Europe and the US15–17. 

There are several evidence-based strategies to address the issue of communicating CVD risk to people with lower health literacy:1) Use literacy-sensitive design to improve the readability of health information and reduce the cognitive load of action plans for behaviour change27–29.2) 

Prevention of cardiovascular disease (CVD) includes lifestyle interventions and medication for those at highest risk who are most likely to benefit. 

their systematic review of 73 online CVD risk assessment tools available to consumers found they were not suitable for people with lower health literacy: their readability level was too high; they frequently used unexplained medical terms; few used best practice risk communication formats such as frequencies in icon arrays; and they rated poorly on actionability (i.e. clarity in instructions of. 

; https://doi.org/10.1101/2021.09.20.21263868doi: medRxiv preprint31A major strength of this study is that the authors were able to recruit a large, diverse sample in terms of health literacy and risk results. 

Recent guideline changes have led to calls for a shared decision making approach, to ensure medication prescribing for blood pressure and cholesterol is more in line with patient values12–14. 

As this sample was predominantly low risk, the authors would not want a decision aid to lead to greater actual medication uptake in this group, but speaking with a doctor about risk and how to reduce it may be a positive outcome in line with guidelines to assess risk in this age group1.