Phase 2 involves an initial test of the intervention in comparison with an appropriate alternative. This article examines the key challenges in and progress of behavioral intervention research, the trajectory of introducing a new behavioral intervention with potential for implementation, and key considerations in developing an intervention protocol. Research team members as well as study participants remain unaware of group allocation. Second, theories often lack a strong empirical foundation, and their application to an intervention can be difficult. Building the health care workforce. In Phase 2, monitoring of feasibility, acceptability, and safety continues, and investigators examine the theoretical basis for observed changes. Also, new evidence may emerge from practice or additional research testing the intervention, and this new evidence may lead to enhancements of the original tested intervention.
Nevertheless, although these interventions have been shown to be effective, they are mostly out of reach to the public, primarily because of the complexities of biiobehavioral preparatory needs and the fiscal constraints of care settings.
Introducing a New Intervention: An Overview of Research Phases and Common Challenges
National Institutes of Health; Figure 1 presents an adaptation of the traditional four-phase sequence for developing an intervention: Figure 2 graphically displays a task analysis for a depression intervention protocol as an example Gitlin et al.
Identifying a base in theory or theories is critical to inform an understanding and evaluation of literaature mechanisms by which an intervention may have its desired effect. New hybrid models that blend test phases and involve biobehaviooral and end users up front in developing and testing interventions may shorten this time frame and enhance adoption of a proven intervention.
The latter is particularly important because it informs sample size calculations and other design elements of a Literaature 3 efficacy trial.
Discovery is guided by theory and involves identifying a clinical problem, target population, and existing evidence e. Understanding organizational factors affecting knowledge literaure 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. Knowledge generated from activities tailorex this phase can advance a working intervention prototype and treatment manual.
Behavior change and health behavior theories tend to explain behavioral intentions tailoed motivation but do not explain or predict actual behavior or behavior change, which is typically the intent of an intervention. HHS action plan to reduce racial and ethnic health disparities: The Issue Is—How do we synthsis practice when we have the evidence? National Academies Press; Combining elements of clinical effectiveness and implementation research to enhance public health impact.
No consensus exists, and researchers need to offer justification for any type of control group. How can research organizations more effectively transfer research knowledge to decision makers? Several challenges are encountered at the discovery stage. This analysis entails breaking down the intervention by detailing its theory base, treatment goals, objectives and specific activities, and hypothesized primary proximal and secondary distal outcomes to ensure alignment of elements.
Because efficacy trials are typically dependent on study volunteers and focus on internal versus external validity, inclusion criteria usually delimit a homogeneous population. Department of Health intervemtions Human Services. Retooling for an aging America: Even then, most interventions are not integrated into practice.
In addition to these considerations, conducting a task analysis of an intervention is a useful exercise. An active intervention, however, should not include any active ingredients being tested in the treatment group.
One approach is inclusion of economic analyses in Phase 2 or Phase 3, or both, to evaluate the implementation potential of an intervention from a cost perspective.
Tailored biobehavioral interventions: a literature review and synthesis.
These developments are positively changing the conduct of behavioral intervention research. Second, theories often lack a strong empirical foundation, and their intervejtions to an intervention can be difficult.
Department of Health and Human Services, Description of the Beat the Blues randomized trial and intervention costs. Integrating cost analyses early on and using hybrid models also hold promise for closing the research—practice gap. Funding for the discovery stage is scarce. Although interventions needed to improve the public’s health are complex and funding lags behind, introducing new interventions remains a critical and most worthy pursuit. This article has been cited biobehaviiral other articles in PMC.
Designing and evaluating interventions to eliminate racial and ethnic disparities in health care. Another consideration in this phase is monitoring fidelity in literaturw the intervention and control groups.