Gaps between knowing and doing: Abstract This article examines the challenges in and progress of behavioral intervention research, the trajectory followed for introducing new interventions, and key considerations in protocol development. Also, in addition to institutional review board approval, a Phase 3 trial requires a data safety and monitoring board that provides oversight of recruitment and accrual progress, adverse events, interim analyses if part of the trial design, and stopping rules. Conclusion Introducing a new behavioral intervention is an important and exciting endeavor but is not without challenges. Phase 4 can be either an effectiveness or a replication trial in which the intervention is evaluated within the practice or service context and with a broader group of study participants.

Why behavioral and environmental interventions are needed to improve health at lower cost. Tailoring intervention protocols to the needs and preferences of diverse populations and testing cultural modifications may require additional research steps and further testing before rolling out and scaling up for a particular intervention. Similarly, evidence suggests that tailoring an intervention to specific needs or characteristics is more effective than taking a one-size-fits-all approach if the desired outcome is behavior change Richards et al. The latter is particularly important because it informs sample size calculations and other design elements of a Phase 3 efficacy trial. Combining elements of clinical effectiveness and implementation research to enhance public health impact. Phase 2 involves an initial test of the intervention in comparison with an appropriate alternative.

Domain Elements Target of intervention Individual Family and social network Physical environment Community Agency personnel Provider System of care Policy Area targeted Behavior Affect Knowledge Skills Social environment Physical environment Delivery technique Tailoring Risk assessment driven Prescriptive one size fits all Stage of intervening Prevention Stage of disease Disease management Delivery mode Face to face Group Telephone Literqture Technology-assisted devices computer, smart phone, Wii Dose and intensity Frequency of contact Length of time Immediate and potential delivery setting Home Community Agency Clinic inteventions medical office Legislative office Web-based literaturd technology Characteristics of interventionists Who can deliver the intervention Level of education, years of practice, or skill Previous training requirements Potential funding streams to support the intervention if proven effective Consideration of cost associated with training in using intervention and its delivery.


The Issue Is—How do we change practice when we have ajd evidence? Regardless of the pipeline followed, intervention development must begin with discovery preclinical phase. Understanding organizational factors affecting knowledge uptake and potential barriers to intervention adoption up front in the intervention development process may better inform trial designs that in turn advance integration of the intervention into practice if it is proven effective Cochrane et al.

tailored biobehavioral interventions a literature review and synthesis

A new health system for the 21st century. Journal of Continuing Education in the Health Professions. An iterative developmental model for building evidence for novel behavioral interventions and training the next generation in such approaches is critical.

Tailored biobehavioral interventions: a literature review and synthesis.

Research and Theory for Nursing Practice: In addition to these considerations, conducting a task analysis of an intervention is a useful exercise. A synthesis of the literature. New hybrid models that blend test phases and involve a team approach consisting of stakeholders and end users up front in developing and testing interventions may shorten the timeframe and enhance adoption.

Conclusion Introducing a new behavioral intervention is an important and exciting endeavor but is not without challenges.

Tailored biobehavioral interventions: a literature review and synthesis.

Also, intramural support through pilot study mechanisms and foundation support are feasible funding alternatives. The figure suggests that developing and testing health-related behavioral interventions involve an incremental, iterative process of building a robust body of evidence discovery, proof of concept, feasibility, safety, and efficacy, similar to the traditional phased approach followed by three additional phases—translation, implementation, and maintenance and sustainability—to embed a proven intervention and normalize it within a practice setting.


Trials are increasingly costly to conduct because of the need for diverse and large samples, repeated measures, skilled personnel intervening in both treatment and control groups, and extensive monitoring. Description of the Beat the Blues randomized trial and intervention costs. Effect of multicomponent interventions on caregiver burden and depression: Still, consideration of where and how an intervention will be embedded in the future, if proven effective, is important even at this early stage and helps establish feasibility.

tailored biobehavioral interventions a literature review and synthesis

A randomized trial of a multicomponent home intervention to reduce functional difficulties in older adults. A nation free of disparities in health and health care.

Department of Q and Human Services. Yet another approach is involvement of stakeholders and end users as research team members in early phases. This phase should also yield preliminary evidence that the intervention is efficacious and well-defined treatment manuals. Gene Ontology GO Terms.

Introducing a New Intervention: An Overview of Research Phases and Common Challenges

An essential question intrrventions this phase is, Why would the intervention work? Determining ways to monitor quality of and fidelity in delivery, receipt, and enactment of the intervention remains the primary focus of these three latter phases.

Journal of the American Geriatrics Society. Potential funding streams to support the intervention if proven effective. Occupational therapy biobehavioraal independent-living older adults: An opportunity for occupational therapy. Intramural funds and support from a professional association may be available. Built environments and obesity in disadvantaged populations. Theory, research, and practice.

tailored biobehavioral interventions a literature review and synthesis

In addition to the funding sources discussed above, activities for this phase can be supported taipored the NIH R21 mechanism. Advancing the health of our aging population: