A study of implementation factors for a novel approach to clinical trials: constructs for consideration in the coordination of direct-to-patient online-based medical research

Abstract

Background: Traditional medical research infrastructures relying on the Centers of Excellence (CoE) model (an infrastructure or shared facility providing high standards of research excellence and resources to advance scientific knowledge) are often limited by geographic reach regarding patient accessibility, presenting challenges for study recruitment and accrual. Thus, the development of novel, patient-centered (PC) strategies (e.g., the use of online technologies) to support recruitment and streamline study procedures are necessary. This research focused on an implementation evaluation of a design innovation with implementation outcomes as communicated by study staff and patients for CoE and PC approaches for a randomized controlled trial (RCT) for patients with vasculitis.

Methods: In-depth qualitative interviews were conducted with 32 individuals (17 study team members, 15 patients). Transcripts were coded using the Consolidated Framework for Implementation Research (CFIR).

Results: The following CFIR elements emerged: characteristics of the intervention, inner setting, characteristics of individuals, and process. From the staff perspective, the communication of the PC approach was a major challenge, but should have been used as an opportunity to identify one "point person" in charge of all communicative elements among the study team. Study staff from both arms were highly supportive of the PC approach and saw its promise, particularly regarding online consent procedures. Patients reported high self-efficacy in reference to the PC approach and utilization of online technologies. Local physicians were integral for making patients feel comfortable about participation in research studies.

Conclusions: The complexity of replicating the interpersonal nature of the CoE model in the virtual setting is substantial, meaning the PC approach should be viewed as a hybrid strategy that integrates online and face-to-face practices.

Trial registrations: 1) Name: The Assessment of Prednisone In Remission Trial - Centers of Excellence Approach (TAPIR).

Trial registration number: ClinicalTrials.gov NCT01940094 . Date of registration: September 10, 2013. 2) Name: The Assessment of Prednisone In Remission Trial - Patient Centric Approach (TAPIR).

Trial registration number: Clinical Trials.gov NCT01933724 . Date of registration: September 2, 2013.

Keywords: Advertising; Clinical trial; Direct-to-consumer; Granulomatosis with polyangiitis; Research subject recruitment; Social media.

Fig. 1

Organizational Structure and directive framework for the development and implementation of the study. Notes: CoE = Center of Excellence; DMCC = Data Management and Coordinating Center; PI = Principal Investigator; NIH = National Institutes of Health; VCRC = Vasculitis Clinical Research Consortium; SAE = Serious Adverse Events; * = VCRC Lead; § = DMCC Lead; # = Work ended upon finalization of consent process