Reducing the Burden of Treatment: Addressing How our Patients Feel about What We Ask of Them

Patients with multiple chronic conditions (MCCs) face enormous challenges in terms of adherence to guideline-driven care, especially when there are individual guidelines for each of their chronic conditions. While physicians are knowledgeable of challenges faced by patients with MCCs, they are less aware of the severity of these challenges, and when patients may be contemplating reducing their medication adherence due to these challenges. Shippee and colleagues’ Cumulative Complexity Model¹ and Leppin and colleagues’ discussion of Minimally Disruptive Medicine² highlight the importance of helping patients balance care demands with their individual capacity (or self-defined capability) to perform the work needed to care for their conditions. In specific, Leppin asks clinicians to promote feasibility, use available resources, respond, and then monitor the outcomes.² Spencer Bonilla and colleagues³ note how reducing treatment burden may require policy changes supporting individualized care in order to help patients avoid being overwhelmed by their care; their article promotes measuring both a clinical outcome (such as Hemoglobin A1C) and the burden of treatment, to more completely portray how a patient might be doing in terms of managing their care. Finally, there are issues that result from a model of health care that prioritizes productivity and rapid throughput of patients rather than the care that patients need and the time needed to provide that care.⁴ This emphasizes the importance of a supportive work environment that allows time for clinicians and patients to listen and formulate thoughtful, patient-centered plans together which could allow important discussions about risks and benefits of de-complicating care. In these contexts, both burden of treatment measurement and healthcare policy assume prominent roles and drive the discussion below.

Our research over the past 8 years has focused on developing valid and clinically useful measures of the Burden of Treatment (BoT). BoT⁵ refers to the workload of treatment and self-management (e.g., taking medications, monitoring health, keeping medical appointments, and attending to diet and exercise), the impact of the workload on day-to-day functioning, and stressors that exacerbate the burden (e.g., medical expenses, and challenges with healthcare services). With support from the NIH, we have developed and validated a comprehensive measure of BoT, the Patient Experience with Treatment and Self-management (PETS) measure, which addresses several domains of this multi-faceted construct.⁵ Other brief measures are also available, such as the Treatment Burden Questionnaire (TBQ) by Tran and colleagues⁶ and the Multimorbidity Treatment Burden Questionnaire (MTBQ) by Duncan and colleagues.⁷ Culturally-adapted translations of these measures make valid assessment of BoT possible in the US, Europe and China.^8,9

Why does this matter?

We often have little sense of the complexity of our patients’ lives, and even less insight into how the treatments we provide (to reach goal-directed guidelines) fit within the web of our patients’ daily experiences. Indeed, “less may be more” here, with trade-offs and challenges that prompt discussions around the best ways forward. Furthermore, when patients take matters into their own hands (arguably, the hands that matter most), they may stop medications that are most troubling (a “rationalized non-adherence” from the patient perspective), rather than ones that are least important. Thus, vibrant discussions surrounding BoT are likely to be meaningful.

When does treatment burden matter?

One can make the case that we should always be aware of how our patients feel about our treatment proposals, and what might happen if they find them too challenging. But one can also propose a more targeted approach, episodically measuring and addressing BoT in patients with MCCs who are at particularly high risk (e.g. those with congestive heart failure, patients after a disabling stroke, or those with complex social determinant of health. such as food insecurity, that may exacerbate treatment burden).

How often will clinicians and patients agree on changes in treatment regimens due to BoT, and how stable are these agreements?

This remains to be determined. In part, this may be intricately related to the social and financial context of care; allowing sufficient time for such discussions, and sufficient leeway to make decisions based upon patient preference, will allow more concordance and, we anticipate, more durability in the results of these discussions.

Once we know it is present, how can we address it?

While this question may inform the next phase of BoT studies, we propose several mechanisms, beginning with either informally asking the patient a question such as: “what challenges do you experience in your treatment and self-management?”, or using a standardized set of questions such as those available in the existing validated measures. Here are some options of shared paths forward:

1. De-prescribing. This can reduce complexity in elderly patients with complex medication regimens. Making regimens less complex (with combined medications, or stopping medications of little utility) can pay dividends in adherence and outcomes. Clinicians, however, may have concerns about raising this, and policy recommendations allowing de-complicating regimens should be encouraged.

2. Shared decision making (SDM). This is an important contributor to discussions of regimen simplification. The movement toward “minimally disruptive medicine”² is built around minimizing complexity, in part through SDM. Studies show that patients prefer SDM and when it occurs, it improves their participation in their care.¹⁰

3. Medication and therapeutic management (MTM). While the role of pharmacists in primary care has expanded exponentially, MTM referrals for regimen simplification are underutilized. Consistent reimbursement by insurers could expand opportunities for this valuable process.

4. Referring to primary care behavioral health. Difficulties in chronic disease management may be more likely to surface in a visit with a clinical psychologist than in primary care, in part due to short visits in primary care⁴ and the potential reluctance by patients to acknowledge to their clinician the challenges of maintaining treatment regimens.

5. Virtual visits. During the COVID-19 pandemic, primary care changed to virtual care. After the pandemic, patients with MCCs may not want all their visits to be in-person. Patients may feel less burdened if they see their clinician once per year in person, with the other 3–5 visits via video or telephone. Efforts should be made to assure these options are available to all patients, including racial and ethnic minorities, those with limited English proficiency, and those of limited income.

6. Re-negotiating treatment guidelines on a person-centered basis. Not all guidelines work for all patients. Patients have an interest in being involved in choosing targets with respect to the day-to-day implications of accepting a more stringent approach (more medications, more dietary adjustments, more visits and lab checks). Trade-offs between attaining optimal clinical outcomes regardless of the personal costs and having a more reasonable quality of life with less treatment burden can be discussed. We accept these discussions at the end of life in negotiating goals of care, but we need not wait until the end of life to address the issues of quality of life related to BoT.

7. Referral to social work or community resources. These resources can support patients in navigating other life stressors that compete with their ability to self-manage their care. This could include support in addressing housing, insurance, transportation, food insecurity or interpersonal challenges.

The past two years brings a sense of urgency to better understanding and addressing BoT. In recovering from the pandemic, there will be pressure to resume care for issues not addressed for many months; not attending to treatment burden risks overwhelming patients and providers. Engaging patients in choices of how to resume care, with which medications, at what follow-up frequency, and in office or virtually, may contribute to care outcomes.

There are barriers to reducing BoT. Because clinicians are judged on the quality of their care, not aggressively pursuing quality measures, for example, Hemoglobin A1c < 8% or systolic BP < 130 mm Hg, might raise concern that a clinic is not providing high quality care. And there are many unanswered questions, including what is the incremental benefit of adding a BoT metric to typical measures of quality of clinical care? In return, we offer favorable consequences of a “less is more” approach: that less burdened patients are more likely to adhere to targets. Providing patient-centered care and focusing on targets most important to the patient might allow patients to gradually develop needed supports to eventually reach these high-quality goals. To reach our ultimate quality goals, we may need to step back to first address BoT.

Conclusion:

Burden of treatment is an emerging construct that adds the patient’s voice to decisions of clinical care. With multiple available measures, and several mechanisms to address it, BoT offers new and meaningful ways to harmonize perspectives of clinicians and patients on the journey to more patient-centered care.

Abbreviations used at least 3 times:

BoT

Burden of treatment

MCCs

Multiple chronic conditions