That “Can Do” Attitude

Companies that are committed to patient-centered healthcare must incorporate the patient’s voice in all stages of a product’s lifecycle—from preparing the clinical trial program to commercialization and market access. This commitment requires application of behavioral science metrics and predictors to drive product development, treatment compliance, and integrated solutions.

Pharma companies including Johnson & Johnson, Pfizer, Merck, and Sanofi are building—or have already built—behavioral science capabilities, according to published articles and press releases. For instance, Sanofi strengthened its ties with behavioral health company, Evidation Health.

Evolution of Behavioral Science

Behavioral science continues to evolve and now there is an emerging area in this field for life science companies that has the potential to advance clinical research and disease management, specifically self-efficacy and health locus of control (HLOC). Self-efficacy is defined as a feeling of “do-ability” and plays a major role in a patient’s proactivity with their healthcare and adherence to treatment. HLOC is the extent to which individuals attribute their health outcomes to their own actions (internal LOC) vs. believing that actions of influential individuals affect health (external LOC).

These two behavioral drivers can be used to help companies understand how much control patients perceive they have over their own health vs. how much of their health outcomes are controlled by their clinicians. Companies will also understand an important predictor of adherence with prescribed prescription treatments; specifically, the patients’ levels of confidence in their ability to manage their chronic disease. “By applying both these approaches to healthcare interventions, companies can develop communications and initiatives for clinical investigators as well as healthcare providers to better understand, interact, and communicate with patients,” explains Michael (Mike) Peterson, Professor & Chair, Department of Behavioral Health and Nutrition at the University of Delaware.

For example, clinical study participants with internal LOCs and high self-efficacy scores may be more likely to remain in a trial and follow instructions. Patients on approved therapies with internal LOC and high self-efficacy scores may be more likely to cooperate with their physician’s treatment recommendation(s) as well as comply with their treatment regimen. Insights such as these would help:

  • Advance a company’s clinical development program.
  • Develop state-of-the-art patient engagement initiatives for a brand or therapeutic category.
  • Collect, publish, and present data that fosters the industry’s commitment to patient-centered healthcare and that demonstrates the role of important behavioral predicators.
  • Address payer demands for improved outcomes at lower costs.

Implications for Chronic Disease and Payers

According to the Centers for Disease Control and Prevention (CDC), chronic disease accounts for approximately 75% of the nation’s aggregate healthcare spending—or an estimated $5,300 per person in the U.S. each year. More than 117 million people in the U.S. (about half of all adults) have at least one chronic condition. In terms of public insurance, treatment of chronic disease constitutes an even larger proportion of spending—96 cents per dollar for Medicare and 83 cents per dollar for Medicaid. As people live longer with chronic conditions, payers need new ways to reduce healthcare use and costs, including compliance with prescribed prescription treatments which mitigate long-term complications.

Behavioral support based on a patient’s self-efficacy and HLOC helps patients develop the skills and confidence to self-manage their diseases (e.g., take the prescribed therapy recommended by the doctor). At the same time, HCPs can more effectively communicate with and coordinate the care of patients with diabetes or cardiovascular disease when they understand how these patients view their own role in managing these chronic conditions and disease-related problems.

Pilot studies show that HCPs are willing to spend more time with patients who are actively managing their own health. If a patient has been found to experience low self-efficacy and has an external HLOC, the healthcare system would be alerted to the need for additional care coordination (e.g., health coach) to help improve communications between patient and clinician.

Opportunity to Build on Existing Evidence

Self-efficacy and HLOC predictors have been applied to weight loss, smoking cessation, and mental health—independent of one another. Other areas of study include the following conditions:

Cancer survivors (mostly breast): It is important to consider variations in an individual’s self-efficacy for self-managing different problems associated with cancer and its treatment, rather than viewing individuals as having confidence or not in a general sense. Identification of low self-efficacy in specific behaviors could facilitate targeted support for cancer survivors to better self-manage consequences of cancer and treatment.

Breast Cancer: High levels of self-efficacy can reduce psychological distress and symptoms and increase quality of life in patients with breast cancer; women who practice self-care strategies experience fewer side effects.

Multiple Sclerosis: MS patients with an internal locus of control had a higher awareness of their disease, were more informed, and practiced more self-care than those with an external locus of control.

Epilepsy: Patients demonstrated higher medication compliance as well as higher quality of life with a higher self-efficacy. Development of a patient’s self-efficacy can increase adherence to treatment plans and medication compliance.

“Now experts have combined two predictive behavioral factors into a single assessment tool that would take 10 to 15 minutes to complete,” says Dr. Peterson. By utilizing this assessment during the traditional clinical trial intake process, sponsors could support patients in a number of ways including, but not limited to, helping trial participants overcome decisional regret and ensure a complete understanding of the trial’s requirements.

By including a short behavioral assessment for self-efficacy and HLOC in a patient starter kit, companies can customize patient engagement communications. These behavioral findings augment other assessments designed to help industry map the patient journey. For example, Mayo Clinic has advanced a patient-centered service experience using four components, including patient journey maps to understand different mental states across the healthcare experience; behavior mapping charts to cross-reference user state with needs; and multi-user schematics to map out goals across audiences.

“In an era of patient centricity, measuring locus of control and self-efficacy can provide important data for researchers and medical affairs professionals to maximize engagement, improve clinical trial participation, and adhere with treatment regimens,” explains Robert J. Matheis*, licensed Clinical Psychologist and Executive Director, Global Scientific Communications with Celgene Corporation. “The existence of a comprehensive predictive instrument to assess self-efficacy provides an important tool to further clinical research and patient care.”

The U.S. Food and Drug Administration’s (FDA’s) patient-focused drug development program (integrating the “patient voice”) creates a ripe environment for behavioral science. The 21st Century Cures Act creates a window of opportunity to develop rigorous evidence-based standards that allow reliance on data developed in less traditional forms, most notably patient experience data.

*The thoughts, views, and opinions are those of Robert J. Matheis, PhD, MA and are not reflective of the perspectives represented by his employer, Celgene Corporation.

  • Michael Varadian

    Michael S. Varadian is Former Executive Director, RI Department of Health, RI Department of Behavioral Healthcare. Michael is a nationally recognized leader and innovator of progressive private and public sector healthcare systems, health reform, health regulations and law, mergers and acquisitions, value-based services, and integrated physical/behavioral health systems. 

    • Ilyssa Levins

      Ilyssa Levins is President and Founder of Center for Communication Compliance (CCC). Ilyssa helps manufacturers and their promotional agencies save time, money and manage risk, when promoting drugs and devices. She combines her regulatory compliance, marketing communications, and change management expertise to help clients achieve their goals.

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