Table 2 Summary of study components
Aim | Research question | Unit analysis | Analysis methods | Outcome |
|---|---|---|---|---|
1. Identify the organizational factors associated with the effective implementation of the intervention in VA facilities. | How do VA site leaders foster organizational readiness to implement the intervention? What VA clinic policies and practices are needed to support intervention use? Do VA clinics with a stronger implementation climate show more consistent, high-quality, appropriate intervention? | Organization (e.g., physicians, administrators, IT, nurses) | Qualitative/quantitative methods | An organizational model of implementation suitable for complex innovations and adapted to the context of clinical practice. While there are a number of methods available for implementing successful interventions, there lacks adequate examination of the most efficient methods for implementing this knowledge. An additional product of this phase of the study will be an evaluation of approaches to implementation of the behavioral intervention |
2. Evaluate the clinical impact of the intervention when implemented outside the context of a randomized controlled trial. | What is the impact, in terms of average systolic BP improvement, of having implemented the behavioral intervention versus not having implemented the intervention as a facility-wide (i.e., clinical-level) program? Within sites that have implemented the behavioral intervention, what is the impact, in terms of average systolic BP improvement, of having received the intervention versus not having received the intervention? | Change in BP among those who receive the intervention relative to a comparison group of usual care | Quantitative methods | Demonstrate improved systolic BP in clinics using the intervention relative to clinics who did not receive the intervention |
3. Assess the organizational factors associated with the sustained delivery of the intervention over time. | How do the perceived benefits and costs of the intervention affect the sustained use of the intervention by VA clinics? What policies and practices are necessary to support sustained use by clinics? How do organizational factors like staff turnover, competing priorities, and organizational changes affect sustained use by clinics? | VA clinics serve as the units of analysis. Focus on six VA clinics implementing the intervention. Data from the six VA clinics in the comparison group used to account for secular trends | Qualitative methods | Assess what implementation policies and practices are necessary to support sustainability and how organizational factors affect sustainability. |
4. Calculate the cost of the intervention as implemented by VA facilities. | Do costs decline as the intervention moves from start-up and implementation to a steady state? Is the intervention cost-neutral or cost-saving? What is the value of implementing the intervention in VA clinics and the possible value of disseminating the intervention to other primary care settings. | Same sample used in study two to estimate costs | Quantitative methods | Detailed cost and resource estimates needed to implement the intervention will be available for all VA facilities. |