Balancing Flexibility and Fidelity in Pragmatic Trials

Determining how to maintain fidelity to the research plan while enabling flexibility in implementation can be a challenge in pragmatic trials. It is important to “build flexibility into how one thinks about fidelity,” says Jeanne Hoffman, PhD.

Hoffman and co-principal investigator Jesse Fann, MD, MPH direct the BRITE Study, a pragmatic trial that aims to determine which transitional care model is most effective for improving outcomes of importance to patients after discharge from inpatient rehabilitation for a traumatic brain injury (TBI). The study examines two existing approaches— the CARF (Commission on Accreditation for Rehabilitation Facilities) standard rehabilitation discharge planning (RDP) approach already in place in many rehabilitation facilities, and a rehabilitation transition plan (RTP) model based on the model in use at the Veterans Health Administration (VHA).

An initial challenge the study team faced was determining how to monitor fidelity to two models in a real world context when neither had previously been studied. In addition, both approaches allow for flexibility in implementation based on patient-specific factors such as the severity of injury, current needs, and the amount of available caregiver support, making it challenging to define and monitor fidelity. According to Hoffman, the team struggled with these issues for both study arms.

“The study team has been trained primarily in controlled trials– which have more strict control over study implementation– and are therefore more comfortable with that structure,” says Hoffman. “We had to wrap our heads around how to approach fidelity in the real world, and what that means.”

Interventions need to be adapted for the real world context in order to make them implementable and scalable, suggests Fann. Developing a strategy to monitor fidelity to the RTP model posed an additional challenge, as it had not previously been implemented outside of the VHA and needed adaptation for a civilian population.

The study team initially created a structured checklist of components of the RTP model that study investigators tracked while listening to recordings of sessions between the TBI Care managers and study participants. Although this process provided investigators an opportunity to closely monitor the intervention and provide detailed supervision and feedback to care managers, the process ran counter to the pragmatic nature of the study and the RTP model’s emphasis on flexible, person-centered care. The team realized that it needed to take a more practical and pragmatic approach and worked closely with the care managers and stakeholders in the Study Advisory Committees (SAC) to adapt the process of tracking fidelity.

From Fann’s perspective, the goal of a truly pragmatic trial is to achieve fidelity without being intrusive or burdensome. “You want fidelity to be a naturalistic process and not an artificial one defined by the research process,” says Fann.

The investigators also emphasize the importance of applying implementation principles in pragmatic studies and considering outcomes such as feasibility, acceptability, and sustainability.