Novel approaches to recruiting clinical sites for embedded pragmatic clinical trials: Insights from the AIM-back trial

Tyler L Cope; Steven Z George; S Nicole Hastings; Courtni France; Christa Tumminello; Cynthia J Coffman; Ashley Choate; Trevor A Lentz

doi:10.1016/j.conctc.2025.101483

Novel approaches to recruiting clinical sites for embedded pragmatic clinical trials: Insights from the AIM-back trial

Contemp Clin Trials Commun. 2025 Apr 11:45:101483. doi: 10.1016/j.conctc.2025.101483. eCollection 2025 Jun.

Authors

Tyler L Cope^{1

2}, Steven Z George^{1

2

3}, S Nicole Hastings^{2

4

5}, Courtni France⁴, Christa Tumminello⁴, Cynthia J Coffman^{4

6}, Ashley Choate⁴, Trevor A Lentz^{1

3

7}

Affiliations

¹ Duke Clinical Research Institute, Durham, NC, USA.
² Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, USA.
³ Department of Orthopaedic Surgery, Duke University School of Medicine, Durham, NC, USA.
⁴ Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veteran Affairs Medical Center, Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, USA.
⁵ Department of Medicine, Duke University School of Medicine, Durham, NC, USA.
⁶ Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA.
⁷ Duke-Margolis Institute for Health Policy, Duke University, Durham, NC, USA.

Abstract

Background: Embedded pragmatic clinical trials (ePCTs) assess interventions in real-world settings. Best practices for recruiting clinical sites for ePCTs are unknown, especially for sites that aren't known to the study team or familiar with clinical research. We describe the site recruitment process for AIM-Back, an ePCT of two nonpharmacologic pathways for low back pain within the Veterans Health Administration (VA).

Methods: During the planning phase of the AIM-Back trial, we aimed to recruit 18-20 sites. Eligible sites required provider capacity, administrative support, and geographic separation to avoid contamination. Our three-step approach involved: (1) lead (VA personnel) identification through existing VA contacts, data repositories of VA clinicians, and promotional outreach at events and listservs; (2) lead engagement via tailored communications emphasizing participation benefits; and (3) virtual meetings with administrators and clinicians.

Results: We identified 184 leads across 53 VA healthcare systems. Leads from 40 systems responded to outreach, and recruitment meetings were conducted with 23 systems involving primary care, physical therapy, research staff, and leadership. We met our recruitment goal, securing participation agreements from 19 sites, with a median timeline from outreach to participation agreement of 3.7 months. Common reasons for non-participation included infrastructure and resource constraints, resistance to new clinical programs, and competing programs.

Conclusion: AIM-Back's recruitment highlights ePCT site recruitment complexities for trials engaging new clinical research sites. Our innovative three-step recruitment approach provides an example for similarly designed trials. Future ePCTs should consider comprehensive recruitment strategies to ensure clinician buy-in, study feasibility, and broaden existing networks for completing ePCTs.