NIH – Implementation of shared decision making for HLBS diseases and conditions (R01 Clinical Trial Optional)

The purpose of this new FOA is to support research that uses evidence-based, practical approaches to increase the uptake of shared decision making (SDM) into routine clinical practice. Proposed projects must consider using available, proven-effective SDM strategies, tools, and curricula to the extent feasible. Utilization of evidence-based theoretical or conceptual frameworks for implementation science (e.g., CFIR, RE-AIM, PRECEDE-PROCEED, K2A, etc.), and implementation research outcomes as primary outcome measures (e.g., acceptability, adoption, appropriateness, affordability, etc.) are encouraged. The use of a variety of novel implementation research study designs, including adaptive designs, is encouraged where appropriate to address issues such as heterogeneity of practices and providers, limited uptake, and to reduce implementation burden. This FOA seeks multi-disciplinary teams to conduct pragmatic research in clinical practice settings and other relevant settings such as community or public health clinics.


Shared decision making is a process in which clinicians and patients work together to make decisions and select tests, treatments, and care plans based on clinical evidence that balances benefits, risks and expected outcomes with patient preferences and values. SDM improves patient decisional satisfaction and engagement, reduces anxiety/regret, and has been shown to improve quality of care, adherence, and outcomes, and lower utilization rates and costs. SDM can reduce health disparities among underserved populations. It is especially important that SDM is used for preference sensitive conditions–those for which there is more than one reasonable option for screening or treatment; when no one option has a clear advantage; and/or when the possible benefits and harms of each option affect patients differently. In some cases, SDM visits are required by the Centers for Medicare and Medicaid Services (CMS); for example, prior to approval of lung cancer screening for asymptomatic former or current smokers, and for most implantable cardioverter defibrillator (ICD) patients.

Successful implementation of SDM into clinical practice requires interventions and approaches that are targeted to the patient, provider, and systems levels, and consider contextual factors. Although SDM models, frameworks, and curricula have been developed by governmental and non-governmental organizations, multi-level, comprehensive strategies and systematic approaches to implementing SDM in various types of clinical settings and networks are lacking, in part due to practical barriers such as clinical workflow, perceived lack of time, lack of physician training, and reimbursement issues.

Research areas of interest

Several recently-published clinical practice guidelines include specific SDM recommendations for decisions such as anticoagulation in atrial fibrillation, selection of type of prosthetic heart valve, implantable cardioverter defibrillators, and initiation of statin use in certain risk groups. Also, SDM is needed when there is little available clinical evidence, for example, in rare diseases or genetic disorders.

This FOA is intended to support projects that address patient, provider, contextual, and/or systems level factors including, but not limited to, healthcare provider education; assistance for patients with low health literacy skills; electronic healthcare record requirements to support SDM execution; clinical workflow issues that impede implementation of SDM; evaluation of SDM; and need for sustainable health care teams and models to implement SDM in real-world settings.

Selected Research Examples:

Examples of research that could be supported by this FOA include, but are not limited to, the following:

  • Projects that use tested, validated patient decision aids, training curricula, and/or novel approaches (e.g., use of community health workers, decision coaches, electronic health records, novel technologies) to implement evidence-based clinical guidelines recommendations (e.g., atrial fibrillation, heart failure, asthma, cholesterol, hypertension, sickle cell disease, obesity) into practice.
  • Implementation approaches that facilitate use of SDM in low-evidence contexts—for example in rare diseases, genetic findings, or other situations for which high quality evidence is not available—to support patient-centered decisions.
  • Studies that focus on using EHRs and other technologies to identify patients who need to make a medical or health decision and capture the encounter(s) and decision.
  • Hybrid implementation designs (Type III) testing SDM implementation strategies while observing and gathering information on the clinical intervention’s impact on relevant outcomes.
  • Research that focuses on strategies for increasing adoption of SDM curricula among medical, nursing, and allied health professionals in clinical or community settings.
  • Research that focuses on developing automated systems to support aspects of SDM such as identifying patients who face decisions; documenting SDM components such as decision aid used, clinical encounter, final decisions, care plan, and follow-up; and generating reminders for both patients and providers.
  • Research that includes use of telephonic/video communication, decision coaches, innovative and emerging technologies, and/or community health workers as part of a comprehensive team approach to facilitating utilization of SDM.
  • Strategies to effectively involve surrogates in SDM regarding treatment decisions for incapacitated mechanically ventilated patients.

Applications that propose to research the following are not appropriate for this FOA and will not be supported:

  • Projects to develop de novo decision aids with a primary aim of testing efficacy
  • Drug or device safety trials
  • Research that does not include an implementation framework
  • Studies that do not include a multidisciplinary team approach

Deadlines:  standard dates and standard AIDS dates apply