Recruiting US veterans with chronic low back pain in a multisite randomized pragmatic trial

Area of Science:

• Clinical trial recruitment strategies
• Veterans Health Administration (VA) research
• Pragmatic clinical trials (PCTs)

Background:

• Limited evidence exists on effective recruitment strategies for VA pragmatic clinical trials (PCTs).
• This study addresses the need to compare multiple recruitment approaches for engagement, efficiency, and representativeness within the VA's integrated care setting.

Purpose of the Study:

• To compare the engagement, efficiency, and representativeness of different recruitment strategies in a VA PCT.
• To evaluate the effectiveness of existing referrals, electronic health record (EHR) prescreening, and self-referral methods.
• To assess the impact of communication methods (postal mail, email, virtual visits) on recruitment outcomes.

Main Methods:

• Examined recruitment and screening processes for the Veterans Response to Dosage in Chiropractic Therapy (VERDICT) PCT across 4 VA facilities.
• Utilized three primary recruitment strategies: existing referrals, EHR prescreen, and self-referral.
• Employed sequential screening steps including identification, phone screening, consent, eligibility questions, and chiropractic consultation.

Main Results:

• Screened 3667 veterans; 91% identified via existing referrals, 7% via EHR prescreen, 2% via self-referral.
• Existing referrals were most efficient (23 days median time to randomization); emailed invitations had faster response times (16 days).
• Existing referrals improved minority recruitment (33%), while EHR prescreening yielded more female veterans (79%).

Conclusions:

• Multifaceted recruitment strategies, including email and virtual methods, can successfully overcome challenges in VA PCTs.
• Adaptable approaches are crucial for improving recruitment engagement and diversity in clinical trials.
• Findings can inform recruitment strategies for trials in other VA-based and real-world healthcare settings.