Table 2 Operational definition of hands-on, action-oriented research on implementation

i) Allow sites to view the study as "your research;"

ii) Drop intervention/s into the site, then sit back and wait till the end of a trial to see progress and related factors;

iii) Delegate site activities to research assistants that would be critical to routine best practice maintenance after the study;

iv) Plan not to interfere with experimental interventions, or perhaps even explore fidelity or actual implementation (i.e., given need for maximum control); and

v) Are primarily concerned with statistical outcomes re: targeted variables rather than also understanding the complex black box of implementation.

2. Hands-on implementation research includes or is demonstrated by the following actions, i.e., researchers:

i) Engage in a strategic, collaborative relationship; i.e., they initiate a strategic effort to partner with relevant operational leadership by:

   ▪ Engaging key stakeholders in a mutual relationship regarding improvement needs,

   ▪ Enhancing partner commitment (as through evidence-based persuasion/gaps evidence, stakeholder needs assessment, and use of a business case); and

   ▪ Focusing the partner on the fact that this is not "research as usual," but rather a quality improvement effort with a rigorous study and evaluation approach to enable actual improvement and replication in other clinics/sites.

ii) Participate in the implementation process on site, as appropriate, in order to:

   ▪ Understand, real-time, the ongoing nature of implementation within the particular setting – but not to substitute for roles/activities that will need to be sustained/maintained as part of the routine delivery system or practice; and

   ▪ Provide formal facilitation to help overcome mutable problems and provide needed support [40].

iii) Utilize a hybrid study design which:**

   ▪ Involves the most realistically rapid timeline given the complexity of the implementation program,

   ▪ During the study, focuses on progress and identifies both potential and actual influences on the progress and effectiveness of implementation efforts through the use of formative evaluation [3], and

   ▪ Plans action during the study, as needed based on formative data, to refine the change intervention, resolve mutable barriers, and enhance available facilitators, in order to optimize:

∘ Actual implementation of the change intervention to achieve or at least assess its potential;

∘ The goal of clinically meaningful, not just statistically significant, evidence-based practice;

∘ Understanding of the black box of implementation, including cost-benefit;

∘ Identification of outstanding research questions; and

∘ Development of a replicable implementation program.

3. Summary: Key words which describe "hands-on" implementation research:

   ▪ STRATEGIZE

   ▪ ENGAGE/EDUCATE/PERSUADE

   ▪ PARTICIPATE

   ▪ FACILITATE

   ▪ OPTIMIZE