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

From: An organizational framework and strategic implementation for system-level change to enhance research-based practice: QUERI Series

1. Hands-off implementation research, in contrast to hands-on implementation research, is often demonstrated by the following, i.e., researchers:
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:
  1. **A hybrid design combines the use of formative evaluation with an experimental study, quasi-experimental study or other appropriate real world design for the question/targeted innovation at hand, within QUERI's framework, i.e., a continuum of pilot to national rollout phases [12].