The New Statin Choice Decision Aid

By Victor M. Montori

With a new interface that includes versions in English, Spanish, and Chinese, the Statin Choice decision aid (http://statindecisionaid.mayoclinic.org) is out. With over 70,000 uses worldwide year-to-date and new policy endorsements for its use (JAMA Article), the Statin Choice decision aid is helping patients and their clinicians have meaningful conversations about whether to use statins to reduce cardiovascular risk. It helps them adhere to the new guidelines, in a patient-centered manner. And with new work to integrate the tool into all major EHR providers, it may be the best demonstration of meaningful use.

Enhancements from the first version also include two options for printing in the office: color and black-and-white, in addition to the existing option to emailing the tool after its use to the patient, a family member, or another clinician. In terms of new content, the biggest difference is the exclusion of the aspirin component (see below).  We have also beefed up the Documentation tab, an copy-and-paste interim solution before full integration into EHR to enable documentation of shared decision making, a key step toward advancing these conversations as a measure of quality of care.

This version is the result of hundreds of notes suggesting changes and enhancements that result form the experience of using it in practice. We hope to have responded properly. And thank you.

Why was aspirin removed from the latest version of the Statin Choice decision aid?

In response to the new AHA/ACC guidelines for cardiovascular prevention, there has been renewed interest in using the Statin Choice decision aid to translate the recommendations in a patient-centered way.  With this attention, there has been interest from preventive cardiologists in using this tool. They brought to our attention that indeed the evidence about efficacy of aspirin for the primary prevention of cardiovascular disease is inconsistent: clearer effect in men in relation to heart attacks but not stroke, in women about preventing strokes but no so much heart attacks and a series of negative trials in patients with diabetes and peripheral vascular disease have made it difficult to provide a simple message to all at-risk patients: a baby aspirin can reduce your risk of cardiovascular events. Also, emerging evidence suggests that the risk of bleeding with aspirin goes up as the risk of cardiovascular events, such that those who may benefit the most are also most likely to be harmed (although most aspirin bleeds are relatively inconsequential compared to a heart attack or a stroke).

This inconsistency is reflected, for example, in the US Preventive Services Task Force guidelines: http://www.ahrq.gov/professionals/clinicians-providers/resources/aspprovider.html.

Concerns are best reflected in this FDA advisory against primary prevention with aspirin from May 2014: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm390574.htm

It is telling when experts are talking more about using aspirin to prevent colon cancer than to prevent cardiovascular events (to our knowledge no one is yet recommending it for this purpose).

We will continue to monitor this evidence as we, the producers of Statin Choice, thought the evidence was good enough to add to and keep in the tool, and we will have a low threshold to put it back in as new evidence emerges, both of its efficacy and harm.

Communication is a challenge

Submitted by Jennifer Barton, M.D.

Communication is a challenge in my practice. As a rheumatologist in a busy, public hospital clinic, I had the privilege of caring for patients who spoke Spanish (a third), Cantonese (a third), Vietnamese, Russian, Lao, Tagalog, or English. Much can be conveyed in a smile or a warm handshake, but this is insufficient when  patient and doctor need to make decisions about a complex chronic condition like rheumatoid arthritis (RA). In particular, it was hard to identify how best to manage their conditions with one of  over a dozen available treatments.  In my toolbox, there was a gaping hole with no tools available to facilitate RA treatment conversations for this needy population.

Sitting at my desk on a Sunday afternoon drafting a grant proposal to create tools for shared decision making for diverse populations with RA, I came across a paper describing a clinical trial of a decision aid for diabetes. Diabetes and RA share many similarities:

  • both are chronic diseases,
  • both have many options for treatment with differing risks and benefits and costs, and
  • both require substantial patient self-management.

This decision aid was colorful, broken out into “issue” cards – like baseball cards (except not by player, or in this case by drug, but by feature), which I thought would be a great template for an RA decision aid, one that could be presented in different languages for patients with limited health literacy.

On a whim, I wrote to the corresponding author to see if I could learn more about the process and perhaps even use their tool as a template. Within hours, I received an enthusiastic reply from Victor Montori at the Mayo Clinic. This led to a phone call, the proposal, funding, and the work generated from fruitful collaboration and inspiration.

Patient Advisory Board

The journey from grant writing to project completion was filled with many adventures. I had never worked with designers or with patients in research. I looked forward to the meetings of our patient advisory board. They were full of laughter and shared  stories. Thanks to them I  learned about real life with RA. I got a chance to listen to the patients share experiences living with RA, getting tips, and finding value and support in one another. Working with patients was hands down the most satisfying and humbling part of the process for me.

Our most recent paper describes the results of a pilot study of 166 patients with RA from vulnerable populations (racial/ethnic minority, age >65, limited health literacy, immigrant status, non-English language) that tested a low literacy RA medication summary guide and RA Choice, the decision aid. We showed that the tools improved knowledge and reduced decisional conflict in this diverse population.

Now after all the hard work, and the results of the pilot study showing the tools worked in our patient population, we want to share the tools and improve conversations for patients with RA and their clinicians everywhere. RA is a chronic, disabling condition which leads to early mortality. Patients made vulnerable by how we deliver healthcare to them experience worse outcomes, and communication in these groups still needs work. Our hope is that with these tools and continued attention to the needs of all groups in the RA community, we can help reduce disparities and improve care for all patients with RA.

Jennifer Barton, MD
Associate Professor of Medicine, OHSU
Staff Rheumatologist, Portland VA Medical Center
Dr. Barton is an academic rheumatologist with a research focus on health communication and rheumatic diseases.

For more information on Rheumatoid Arthritis (RA) Choice, click here.

Fostering choice awareness for shared decision making

Marleen Kunneman, PhD; Megan Branda, MS; Ian Hargraves, PhD; Arwen Pieterse, PhD; Victor Montori, MD, MSc

Two roads diverged in a yellow wood,

And sorry I could not travel both

– Robert Frost “The Road Not Taken”

Although recommended, shared decision making (SDM) is still hard to implement in routine care. This is, we believe, in part because patients may not realize that there is more than one reasonable approach to address their situation, and that their involvement is critical in figuring out which care plan fits best. In other words, patients may lack ‘choice awareness’.

In a recently published paper, we aimed to assess the extent to which clinicians, using or not using conversation aids, foster choice awareness during clinical encounters. Also, we aimed to assess the extent to which fostering choice awareness, with or without conversation aids, is associated with greater patient involvement in SDM.

To this end, we randomly selected 100-video-recorded encounters from our database of 10 clinical trials of SDM interventions in 7 clinical contexts (low-risk acute chest pain, stable angina, diabetes, depression, osteoporosis, and Graves disease). Coders, unaware of our hypothesis, coded the recordings with the OPTION12-scale, which quantifies the extent to which clinicians involve patients in decision making (0-100 score, higher score is more involvement). Blind to these OPTION-12 scores, we used a self-developed coding scale to code whether and how choice awareness was fostered (see Table).

Fostering choice awareness behaviorN (%)
Choice awareness not fostered47
1. The clinician does not foster choice awareness; rather, the clinician informs on the next step in management without introducing other options for consideration34 (72)
2. The clinician does not foster choice awareness; rather, the clinician makes a recommendation that implies the existence of alternatives, but without explicit mentioning these13 (28)
Choice awareness fostered53
3. The clinician fosters choice awareness by listing relevant options followed by recommending one of these to the patient15 (28)
4. The clinician fosters choice awareness by listing relevant options without recommending one of these to the patient38 (72)

We found that clinicians fostered choice awareness in about half of the encounters, mostly by listing relevant options without providing a recommendation (see Table). If clinicians did not foster choice awareness, they mostly presented the next step in management without explicit or implicit suggestion that there are other options for consideration. Fostering choice awareness was associated with a higher OPTION12 score (20 points difference on 0-100 scale), regardless of whether conversation aids were used. Removing OPTION items that focus specifically on fostering choice awareness did not change the results (20 points vs 19 points difference).

Our study suggests that fostering choice awareness is associated with a better execution of other SDM steps, such as informing patients or discussing preferences, even when SDM tools are not available or not used. In future research, we will examine the causality of this association.

The full paper was published (Open access) in Mayo Clinic Proceedings: Innovation, Quality and Outcomes. (https://doi.org/10.1016/j.mayocpiqo.2017.12.002)

This study is part of the Fostering Fit by Recognizing Opportunity STudy (FROST) program.

Supporting Implementation of Shared Decision Making for Statin Therapy Initiation in Primary Care

Submitted by Aaron Leppin

Decisions on whether to initiate statin therapy for cardiovascular risk reduction should be based on individual patient risk and occur in the context of a shared decision making (SDM) conversation. The Statin Choice Conversation Aid is a web-based tool that incorporates patient variables to calculate and present an individual-level risk. It has been shown in multiple randomized trials to facilitate SDM when used in the clinical encounter.

Despite being freely available and well accepted by patients and clinicians, the Statin Choice tool had not been institutionally adopted and integrated into the clinical work flow at any site prior to 2014. This lack of implementation was and is representative of many SDM interventions which, in routine settings, are often not prioritized. The reasons for this are complex but, at least at some level, result from the competing priorities healthcare systems must address and the often-fixed resources they have to do this work. In this context, it stands to reason that health systems and other settings will be more likely to undertake the work of implementing SDM when it is understood clearly to be low.  Unfortunately, in most cases, the work of implementing any individual SDM intervention is poorly understood at the outset. The most effective and efficient strategies for facilitating implementation are often even more ambiguous.

In this study, we sought to address these foundational problems by both characterizing the work of implementing the Statin Choice tool and identifying the most useful strategies for doing this work. Specifically, we recruited 3 health systems in the Mayo Clinic Care Network and carefully observed and tracked their efforts to integrate the tool into their EHR and into routine use across all of primary care over an 18-month period.

We used Normalization Process Theory, an implementation theory that organizes the types of work required to embed new practices, to describe the implementation process at each site. We collected multiple types of data from many sources to track the success (or outcomes) of implementation as well. By carefully examining the things teams did (e.g. the strategies they used) to do the work of implementation and the results of this effort (e.g. the outcomes the work achieved), we were able to identify the most useful strategies for making SDM implementation happen. We were also able to gain a clear understanding of the types and amount of work that would be required.

With this knowledge, we were able to develop a multi-component toolkit that could be provided to other settings to support implementation of the tool. As part of this toolkit, we were also able to provide a brief organizational readiness and context assessment. More clearly, because we had observed the implementation process, we were able to provide an assessment that would guide clinical stakeholders in thinking about the specific things they would need to be able to do (e.g. integrate into the record, train clinicians), the ways in which these things can be done (e.g. workflow examples, training methods), and whether the provided toolkit resources (e.g. EHR code language, implementation team manuals, educational templates) was sufficient support to justify going forward.

Importantly, our study identified several strategies that were judged to be of low value in facilitating implementation. This knowledge was critical to the development of the toolkit and to stakeholders as it allowed us to avoid inclusion of things that will only cause more work for clinical teams with little to no benefit.

The conceptual advancements of our research to the field of implementation science include (1) a theoretical connection between the work that stakeholders do to implement SDM and the outcomes this achieves and (2) an appreciation of the need to develop useful toolkits that can support clinical settings in understanding and doing the work of implementation.

It is not our impression, however, that the toolkit we developed will be necessarily appropriate for other SDM interventions. Rather, we believe our research should be used as a template that can be replicated by other teams in other settings and for other interventions.

The full paper was published in BMC Health Services Research and can be found here. This study was made possible by a CTSA Grant (UL1 TR000135) from the National Center for Advancing Translational Sciences (NCATS), a component of the National Institutes of Health (NIH).

Decision aids that facilitate elements of shared decision making in chronic illnesses

Submitted by Thomas Wieringa

Shared decision making (SDM) is a patient-centered approach in which clinicians and patients work together to find and choose the best course of action for each patient’s particular situation [1]. This approach is pertinent to the care of patients with chronic conditions [2]. Six key elements of shared decision making can be identified [1-4]:

  1. situation diagnosis (understanding the patient’s situation and establishing the aspects require action)
  2. choice awareness (indicating that multiple options are available and highlighting the
  3. importance of the patient’s preferences in deciding on the course of action)
  4. option clarification (explaining the available options)
  5. discussion of harms and benefits (explaining the harms and benefits of each option)
  6. deliberation of patient preferences (discussing the preferences of the patient)
  7. making the decision (clinician and patient making together the decision)

Decision aids
SDM can be facilitated by decision aids that have been developed for use by clinicians and patients, either during or in preparation of the clinical encounter [5-7]. Decision aids can help patients choose an option that is congruent with their values, reduce the proportion of patients remaining undecided and/or who play a passive role in the decision-making process, and improve patient knowledge, decisional conflict, and patient-clinician communication [7-11].

The International Patient Decision Aid Standards (IPDAS) Collaboration developed a minimal set of standards for qualifying a tool as a decision aid, which require that a decision aid support all key elements but making the decision [12].

Systematic review
We conducted a systematic review to assess the extent to which decision aids support the six key SDM elements and how this relates to their impact.

We found 24 articles reporting on 23 RCTs of 20 DAs (10 DAs for cardiovascular disease, two DAs for respiratory diseases, and eight DAs for diabetes). With the exception of one, all studies have an unclear or high risk of bias for all outcomes assessed in this review. The option clarification element (included in 20 of 20 DAs; 100%) and the harms and benefits discussion (included in 18 of 20 DAs; 90%; unclear in two DAs) are the elements most commonly clearly included in the DAs. The other elements are less common and more uncertainty is present whether these elements are included, especially with regard to choice awareness (uncertain in 14 out of 20 DAs; 70%). All elements were clearly supported in four DAs (20%). We found no association between the presence of these elements and SDM outcomes.

Conclusion
Thus, despite the IPDAS minimal set of qualifying criteria, our systematic review showed that decision aids for cardiovascular diseases, chronic respiratory diseases, and diabetes mostly support the option clarification and the discussion of harms and benefits elements of SDM, while the other SDM elements are less often incorporated.

Future research
Possibly, some SDM elements may be left out of decision aids by design. This choice may depend on what features were thought most important by the developers (e.g., patient education, risk communication, preference elicitation, or patient empowerment). The importance of incorporation of SDM elements in decision aids may be situation-dependent, but the way this works is unclear. Therefore, future research should clarify this situation-dependence and eventually inform possible reconsideration of the IPDAS minimum standards for decision aid qualification. The relationship between the extent to which decision aids support SDM elements and outcomes is yet unknown and should be studied in future research as well.

The full paper was published in Systematic Reviews and can be found here: https://systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-019-1034-4.

Thomas Wieringa is a post-doc researcher at the department of Epidemiology at the University Medical Center Groningen (UMCG), the Netherlands. He did his PhD, focused on shared decision making and patient-reported outcomes in type 2 diabetes, at the VU University Medical Center. He visited and collaborated with the Knowledge and Evaluation Research (KER) Unit of the Mayo Clinic in the context of his PhD.

References

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