There are many different ways to prepare for implementation, including partnering with those who create policy and guidelines, those who can implement legislative changes, and those conducting quality improvement and public health initiatives. PCT researchers can also make targeted tools to bolster implementation. We will describe examples of each of these strategies in this section.

Changes to Policy and Guidelines

One way to ensure that the intervention under study can drive positive changes in care is to partner with those who create policy and/or guidelines at the planning stage to ensure that the study is a priority and relevant to care. Partnering with guideline developers can help investigators get the research question and study design right so that the evidence produced can be used to drive change.

Case Example: Trauma Survivors Outcomes and Support Trial (TSOS)

An explicit goal of the TSOS trial was to provide the college with multisite pragmatic trial evidence that could further inform regulatory policy. The clinical goal of TSOS was to coordinate care and improve outcomes for trauma survivors with PTSD and comorbidity. The trial was conducted at 25 US level 1 trauma centers, and frontline providers received intervention training at each center. Sites were asked to recruit 40 patients over the course of the 4-year study, and patients underwent a baseline electronic health record PTSD screen, were randomized, and then completed 3-, 6-, and 12-month follow-up assessments (Zatzick et al. 2016).

After 6 months, but not at 3 or 12 months, the intervention group experienced a significant reduction in PTSD symptoms as compared with the control group. The treatment effect was greater for patients with higher baseline PTSD risk and for patients treated at sites with good or excellent protocol implementation. The subgroup of patients who had firearm injuries and who were treated at sites with good or excellent protocol implementation had among the largest 6-month treatment effects and had significant treatment effects at 12 months (Zatzick et al. 2021).

Along with other evidence, these findings led to the following policy change requiring protocols at trauma centers nationally to identify and refer patients at high risk for psychological sequelae after injury.

With TSOS, nearly all the clinical investigators were front-line trauma center providers who understood that if the College issues the requirement, they are required to perform those mandated screening and intervention procedures at their trauma centers. When the research team was developing the screening and intervention process, they remained focused on the ultimate implementation. The clinical and policy team developed a unique set of methods for understanding implementation mechanisms: these methods begin with immersive participant observation by study team members at training site visits, over the telephone, and in their own clinical activities. Team members record field observations in real time—in ways that don’t drive up the cost of the trial—and these notes, logs, and other observations are reviewed with a mixed-methods expert. These field observations gave the team preliminary information regarding the implementation science constructs informed sustainable implementation and acute care regulatory policy.

Researchers in Australia examined the feasibility of implementing an enhanced version of the TSOS collaborative care intervention for patients at risk of PTSD and pain symptoms after major traumatic injury (Giummarra et al. 2024). They found the intervention was highly valued by most participants and could be implemented at low cost in the trauma system in Victoria, Australia.

The TSOS diffusion, dissemination, implementation, and sustainability strategy is shown below.

Legislative Changes

Legislation can be an important way both to generate interest in a particular trial and to sustain its impacts. Investigators can include legislators as part of a steering committee to ensure that the research question can help drive change in policy.

Case Example: STOP CRC

At the onset of the Strategies and Opportunities to Stop Colorectal Cancer (STOP CRC) in Priority Populations trial, colorectal cancer screening was adopted as an incentive metric for Oregon’s Coordinated Care Organizations (CCOs, the Oregon equivalent of Accountable Care Organizations). This meant that Medicaid Health Plans and CCOs would receive incentives for reaching performance or improvement targets for colorectal cancer screening. The initial performance target was set at 47%, and the improvement target was set at 3%. Over the subsequent years, additional state legislation was passed to reduce patient out-of-pocket costs for colorectal cancer screening, in part, because a legislator was included as part of the study team. In 2014, Oregon passed legislation required that a colonoscopy initiated as a screening procedure be billed as a screening procedure—even when polyps were removed. Legislation passed in 2015 further required payers to cover the cost of a follow-up colonoscopy (with no out-of-pocket costs) among patients who screened positive on fecal testing. This policy was adopted nationally in 2023.

Creation of Targeted Tools

To help speed implementation and translation of research findings into practice across the nation, tools, such as online materials, training videos, etc., can be created. Materials developed to train the sites participating in the PCT are good starting places for materials for a broader audience.

Case Example: REDUCE MRSA and ABATE Infection Trials

The REDUCE MRSA trial was a large, cluster-randomized pragmatic trial of 43 hospitals (74 adult ICUs) that demonstrated that universal bathing with chlorhexidine and universal nasal decolonization with mupirocin significantly reduced MRSA clinical cultures and all-cause bloodstream infections in adult ICUs.

To support broad implementation and facilitate rapid integration of techniques into routine care in ICUs across the country, investigators made the toolkit with educational materials and documentation widely available (Universal ICU Decolonization: An Enhanced Protocol), offered standardized support, and encouraged local adaptation and collaboration. Septimus et al. note several contributing factors that influenced the success of implementation: “(1) a well-designed toolkit with proven success in a pragmatic clinical trial; (2) a program team, experienced in implementing evidence-based practices, that is responsive to local needs; and (3) an established infrastructure for implementing large quality improvement projects (Septimus et al. 2016)."

The implementation of the REDUCE MRSA trial was informed by Pronovost’s 5 key components of effective translation of knowledge into practice:

• A focus on systems rather than the care of individual patients
• Engagement of local interdisciplinary teams to assume ownership of the improvement project
• Creation of centralized support for the technical work
• Encouraging local adaption of the intervention
• Creating a collaborative culture within the local unit and larger system (Pronovost et al. 2008; Septimus et al. 2016)

The successful and rapid implementation of the toolkit used in REDUCE MRSA demonstrates the ability to rapidly integrate research into clinical care, which is the foundation of a learning health system.

The Active Bathing to Eliminate Infection (ABATE) Trial is a sister trial of REDUCE MRSA, conducted in non-ICU settings. Universal decolonization did not reduce multidrug-resistant bacteria or bloodstream infection in the overall non-ICU population. However, in a post hoc analysis of patients with medical devices, decolonization was associated with a significant 32% reduction in all-cause bloodstream infections and a significant 37% reduction in MRSA or vancomycin-resistant Enterococci (VRE) clinical cultures attributable to participating units. Targeting patients with devices may be particularly valuable because they represented 10% of the non-ICU population but were responsible for 37% of all MRSA and VRE clinical cultures and 56% of all bloodstream infections in non-ICU patients. Therefore, the team developed a Toolkit for Decolonization of Non-ICU Patients With Devices.

The diffusion, dissemination, implementation, and sustainability strategy for the ABATE Infection trial is described in the table below.

Targeted tools can also be created to help implement the intervention during the trials itself.  For example, the STEP-2 trial is developing and refining a practice facilitation guide with debriefing sessions, clinician webinars, and FAQ tip sheets to support implementation of in-clinic HPV self-sampling in Federally Qualified Health Centers.

As another example, the RAMP study created a spreadsheet to systematically make decisions about potential areas of optimization of the intervention and study processes, using multi-level, feedback, according to our guiding models and framework. The team also created REDCap data management forms to systematically capture multi-level stakeholder feedback.

Partnering With Quality Improvement and Population Health Initiatives

When developing and conducting a PCT, it may be useful to partner with quality improvement and population health personnel at sites; if the results of the PCT are positive, the results may align with organizational goals for improving care. Tools and technologies can be developed so they are easily adaptable for use in various departments.