NIH - Improving Patient Adherence to Treatment and Prevention Regimens to Promote Health (R01, R21 Clinical Trial Optional)

The following description was taken from the R01 version of this FOA.

This funding opportunity announcement (FOA) is being issued by the NIH Adherence Network through the Office of Behavioral and Social Sciences Research (OBSSR) with participation from multiple NIH Institutes and Centers. This FOA calls for research grant applications which address patient adherence to treatment and prevention regimens in healthcare to promote health outcomes. This FOA accepts applications that either propose or do not propose a clinical trial(s).

Applications under this FOA are encouraged, but not required, to apply approaches and tools developed under the NIH Common Fund’s Science of Behavior Change (SOBC) Program. These include: use-inspired basic research on mechanisms of change at multiple levels of analysis; assays for self-regulation, interpersonal processes and stress that have evidence as malleable targets for behavior change (see https://osf.io/zp7b4) developed under the SOBC program; and an experimental medicine approach which requires a clear a priori specification of the intended mechanistic target(s) of an intervention, and methods that test the degree to which an experimental manipulation or intervention engages those targets. For more information about the SOBC program, please see: https://commonfund.nih.gov/behaviorchange.

Background

Increased patient adherence to recommended treatment and prevention regimens is an area of the behavioral and social sciences that promises substantial improvements in public health as well as savings in healthcare costs. For these reasons, improving adherence has been identified by the National Institutes of Health (NIH) Adherence Research Network as a top priority.

Poor adherence to healthcare regimens is common across many chronic illnesses and patient populations. This includes adherence to prescribed medications and other recommended prevention, screening, treatment, monitoring, and health behavior regimens. Research across many chronic illness areas has identified sub-optimal adherence to oral medications and even lower adherence to diet and exercise recommendations. Continued evidence of non-adherence in many chronic conditions and insufficient evidence for how to improve adherence highlights the need for transformative research in this area.

Adherence is increasingly understood as a multifaceted concept. First, adherence to a specific health care behavior (e.g., taking a medicine, deciding to follow a diet, or making dietary changes) can involve three dimensions: initiation (i.e., starting the regimen), implementation (i.e., executing the schedule), and persistence (i.e., length of time on regimen before discontinuation). Each dimension of adherence may have unique determinants, and each may require distinct behavioral and social interventions. Second, many recommended treatment and prevention regimens involve multiple health behaviors. For example, recommended treatment for Type 2 diabetes may include monitoring glucose, adjusting diet, increasing activity, and taking medicines to maintain health and quality of life. Third, many individuals experience multiple comorbid conditions which may require different and concurrent courses of therapy, or present unique cognitive, emotional, or social challenges that can interfere with adherence. Adherence may vary across different health behaviors, complex regimens, and comorbid conditions.

Adherence behavior is also dynamic with the potential to change over time. Some health care professionals and researchers may view adherence as a stable and dichotomous property of individuals; i.e., “there are adherent patients, and there are non-adherent patients.” This misses how adherence in chronic conditions may vary in response to disease activity, treatment methods, and the course of psychosocial or illness comorbidities. The dynamic nature of adherence underscores the need to improve routine monitoring of individual’s adherence to recommended healthcare regimens, and to re-examine or develop new interventions to support adherence over the course of care. Further, as more individuals live with long-term chronic conditions, adherence may be predicated on the complex interaction of the persons health needs and developmental factors.

Determinants of adherence and non-adherence span a broad ecologic spectrum. They may be influenced by the nature of the condition; the complexity of the regimen and concomitant treatments; individual factors such as sociodemographic characteristics, comorbidities, cognitive functioning, mental health status, health literacy, self-efficacy and motivation for self-management; aspects of the person-provider relationship; social and factors such as an individual’s access to social support, relationships and gender dynamics, and culture; and successively larger structural influences, including factors related to health economics (medication cost, insurance coverage, access to transportation, and cost-sharing) and the characteristics of health care organizations and healthcare delivery approaches. These multilevel adherence determinants invite a range of interventions that target individuals, families, caregivers, health-care providers, communities, and/or healthcare system delivery methods. They also invite careful consideration and assessment of the mechanisms of action in adherence intervention research.

New developments and innovations provide fresh opportunities to advance adherence research with the potential for real impact. Advances in mobile health (mHealth) technologies and informatics provide opportunities to monitor recommended healthcare regimen adherence, to improve measurement precision, and to deliver individualized interventions that are timely, tailored, and interactive. Attention to patient-centered care and shared decision-making models that include the person, family, and caregiver as part of the care team further broadens targets for improving adherence. Differentiated care models suggest matching individuals to different forms of adherence support based on demonstrated need. Growing attention to health behavioral economic approaches suggest new ways to “nudge” behavior in helpful directions. Additionally, healthcare coverage models that are designed to incentivize the delivery of high-quality and cost-efficient care are becoming increasingly common.

Regardless of focus or approach, the next generation of adherence research will benefit from improved scientific rigor. Future studies should clearly define adherence, address intervention mechanisms of action, and compliment self-reported measures with objective assessment of behavior. A Cochrane review of randomized controlled trials of medication adherence interventions in 2014 found many trials were compromised by low statistical power and/or biases resulting from use of self-reported adherence measures when trial participants were not blinded to treatment allocation. The adherence intervention evidence base will therefore require improved rigor and reporting: well-powered trials with appropriate sample sizes that employ and describe objective measures, centralized randomization procedures, and blinded outcome assessors. Randomized trials of interventions can target enrollment to individuals with prior adherence problems to help avoid ceiling effects. Adherence research may also benefit from novel research designs, including sequential randomized designs.

Non-adherence to medical regimens exemplifies the challenges in initiating and sustaining healthful behavior change. Researchers are beginning to make progress in understanding some of the basic mechanisms that account for less-than-optimal initiation and maintenance of behavior change. Applications under this FOA are encouraged, but not required, to apply approaches and tools developed under the NIH Common Fund’s Science of Behavior Change (SOBC) Program. These include: use-inspired basic research on mechanisms of change at multiple levels of analysis; assays for self-regulation, interpersonal processes and stress that have evidence as malleable targets for behavior change (see https://osf.io/zp7b4) developed under the SOBC program; and an experimental medicine approach which requires a clear a priori specification of the intended mechanistic target(s) of an intervention, and methods that test the degree to which an experimental manipulation or intervention engages those targets.

Adherence is pivotal to healthcare regimen effectiveness and can make important contributions to health outcomes. Research that pairs measures of adherence behaviors and social determinants of health with clinical outcomes will help advance the science. Research that demonstrates health benefits and cost-effectiveness of adherence interventions, and that reflects the priorities and considerations of real-world stakeholders (persons with the condition/illness; health care providers, care systems, etc.) can additionally promote intervention dissemination and implementation.

Research Objectives

This FOA calls for research applications that address individual adherence to recommended treatment and prevention regimens to promote health, health outcomes, and quality of life. Many NIH Institutes, Centers and Offices have joined together to support this initiative. Applications should be relevant to both the general objectives of the FOA and to the specific research interests of at least one participating Institute or Center. Brief descriptions of the specific interests of the Institutes and Centers follow the cross-cutting list provided below.

Potential study topics and intervention approaches may include, but are not limited to:

Research to develop novel tools or modify existing approaches to monitor adherence and facilitate delivery of targeted interventions to improve adherence
Research testing innovative approaches for monitoring and maintaining individual or caregiver adherence to complex health care regimens
Research to target groups at high risk for non-adherence such as adolescents/young adults and individuals with cognitive impairment, complex illnesses and health regimens, mental health comorbidities, and/or substance abuse
Studies of adherence-promoting interventions that are delivered through technological tools, such as mobile health technologies and electronic health records, to target health care provider behaviors, patient behaviors, both, and/or provider-patient interactions and feedback
Research examining interventions designed to optimize adherence through caregivers, peers, or social support networks
Research to examine the role of shared decision making on adherence
Research testing the efficacy of interventions at the health care system level that target, for example, health care provider practices (i.e., decision tools, access to resources such as medication plans, electronic medical record practices) as facilitators of patient adherence
Research to address social and structural determinants of health contributing to racial and ethnic disparities in adherence and associated health outcomes
Interventions that test multi-level and multi-component interventions (e.g., at the individual, health care provider, and community level) to improve adherence behavior
Studies that identify competing behaviors, psychosocial concerns, and/or social issues that contribute to non-adherence and associated changes in health outcomes, to inform future interventions and science

Descriptions of the specific interests of the Institutes and Centers follow.

The National Cancer Institute (NCI) seeks multi-level research from across the translational science continuum aimed at improving adherence to treatment and prevention regimens to reduce cancer risk, improve treatment outcomes, and lower cancer-related morbidity, mortality, and disability. Additional information about priority areas of research are described by the NCI’s Division of Cancer Control and Population Sciences.
The National Institute on Aging (NIA) seeks research on interventions to promote adherence to medical and behavioral regimens aimed at promoting healthy aging in Stages I through IV of the translational intervention development pipeline, as defined by the NIH Stage Model. NIA applications under this FOA are expected to articulate their research aims using the NIH Stage Model framework, identifying the Stage(s) of research proposed. In addition, applications are encouraged to apply the experimental medicine approach, i.e. articulate or test a hypothesis to identify an intervention’s principles/mechanism(s) of action, as described by SOBC. Areas of interest include those that leverage current understanding of psychology of aging or of behavioral and social contexts relevant to aging to promote adherence to exercise, healthful eating, prescribed medications, stress-reducing and/or positive affect inducing behaviors, and medical regimens. Of particular interest is the development of scalable principle-driven interventions that are highly relevant to the needs and capacities of individuals as they age and interventions that incorporate behavioral economic principles and/or technological innovations.
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is interested in supporting alcohol prevention research focused on incentives, barriers and disincentives to adherence to health promoting and harm reduction behaviors targeting multiple levels, including family-based, community-based, health care systems and other environmental-level policy-based interventions. NIAAA is also interested in alcohol treatment research focused on understanding the mechanisms that underlie adherence to engaging in and maintenance of behavior change within our empirically-supported alcohol behavioral treatments that target heavy and problematic alcohol use.
The National Institute of Allergies and Infectious Disease (NIAID) is interested in supporting programs that support the development of biomedical measures to improve adherence to ART, PrEP, and other HIV prevention interventions and strategies. NIAID is also interested in supporting basic and applied research in the behavioral and social sciences to inform the development of novel interventions that enable all HIV infected individuals to achieve durable viral suppression. With implementers, develop and pilot enhanced adherence interventions with demonstrated effectiveness.
The National Institute on Drug Abuse (NIDA) is interested in research on the development of optimal behavioral strategies to promote adherence to medications and substance use disorder (SUD) treatment. Applications are encouraged for studies that include, but are not limited to: improvements in drug abuse treatment adherence interventions for use in primary care; technologies to boost effects and increase efficiency of adherence interventions, and; interventions to promote adherence to HIV medications.
The National Institute of Mental Health (NIMH) has interest in adherence research in the context of mental health as well as HIV/AIDS. NIMH is interested in research on adherence interventions that support the NIMH Strategic Plan for Research. All applications that propose clinical trials to test adherence strategies are encouraged to follow the NIMH’s experimental therapeutics approach to intervention development and testing (see NIMH Clinical Trials FOAs). Examples of relevant research projects include but are not limited to the following: Adherence interventions capitalizing on innovations in technology, consistent with the NAMHC workgroup on technology report, Opportunities and Challenges of Developing Information Technologies on Behavioral and Social Science Clinical Research; applications that use existing patient-level data, such as electronic medical records and prescription refill data, to support adherence; adherence approaches to reduce empirically documented disparities in care and outcomes for racial and ethnic minorities and other underserved groups; adherence interventions that support shared decision making and patient engagement; adherence strategies that fit seamlessly into existing clinical practice; and strategies to support use of HIV/AIDS antiretroviral treatment and pre-exposure prophylaxis.
The National Institute on Nursing Research (NINR) is seeking research on patient-focused adherence strategies to engage individuals, caregivers and families and communities as active participants in self-management and wellness to improve quality of life while living with an acute or chronic condition or multiple conditions.
The National Institute of Minority Health and Health Disparities (NIMHD) is interested in supporting research and interventions considering determinants from more than one domain or level of influence (see NIMHD Research Framework). Intervention design should be based on theories from minority health and health disparities science. Research must focus on one or more minority or health disparity population (African Americans/Blacks, Hispanics/Latinos, American Indians/Alaska Natives, Asians, Native Hawaiians and Other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minority populations). Applications may include but are not limited to multi-disciplinary etiologic and intervention research projects that advance the understanding of the mechanisms, pathways, and processes operating within the domain of medication management, including but not limited to research on the behavioral, social, and structural determinants of medication adherence, medication safety, shared decision making, integrated medical team care, and resilience within home and community settings. Research may propose using available secondary data, health system data and/or collection of primary data.
The National Center for Complementary and Integrative Health (NCCIH) is interested in research studying mind-body approaches to improve adherence to treatment and prevention regimens to promote health outcomes, as well as research to improve adherence to mind-body treatment or health promotion approaches. Mind-body approaches include various meditation approaches (e.g., mindfulness), hypnosis or guided imagery, meditative movement approaches (e.g., yoga, tai chi, qi-gong), body-based approaches (e.g., spinal manipulation, massage, mobilization, acupuncture), a combination of these approaches (e.g., meditation and yoga, such as in mindfulness-based stress reduction MBSR), or complex interventions including music and art therapy. NCCIH will not fund multi-site efficacy or effectiveness research through this FOA (please see NCCIH Clinical Trial Funding Opportunities instead). Investigators are strongly encouraged to discuss their plans with NCCIH program staff prior to submitting their application.

Deadlines: standard dates and standard AIDS dates apply

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NIH – Improving Patient Adherence to Treatment and Prevention Regimens to Promote Health (R01, R21 Clinical Trial Optional)