Developing Trial Protocols (Part 2 of 3)
(Week of January 6, 2025)
(Week of January 6, 2025)
Module 7-2: Operationalizing Your Pragmatic Trial Protocol Using SPIRIT (10-Minute Video)
In this module, we continue with Part 2 of the three-part series on developing a pragmatic clinical trial protocol using the updated SPIRIT 2025 checklist. Building on the foundational elements covered in Module 7-1, we walk through SPIRIT items that operationalize your trial, including recruitment, assignment of interventions, data collection, and data management. You will learn how to describe recruitment strategies, specify randomization approaches and allocation concealment, and clearly document roles and responsibilities for trial implementation. We also discuss what should be specified in the protocol regarding blinding, data collection methods and sources, participant retention and follow-up, and data management practices to ensure high-quality, reliable trial data.
** The video's content and narration were generated with the assistance of artificial intelligence, with human guidance and oversight throughout the process. **
Cost analysis and efficacy of recruitment strategies used in a large pragmatic community-based clinical trial targeting low-income seniors: a comparative descriptive analysis
Abstract: This paper evaluates which recruitment strategies were most effective—and most cost-efficient for enrolling low-income seniors into the ACCESS pragmatic randomized trial in Alberta, Canada. Using data from the first 4013 enrolled participants (of 12,342 callers), the authors classified recruitment into five overarching approaches (health-care providers, paper mail, media, seniors outreach, and word of mouth) and estimated detailed costs (supplies/services + staff time) for 14 substrategies. Recruitment consumed $354,330 CAD (about 20% of the operating budget during the period), averaging $88 CAD per enrolled participant. Health-care provider approaches enrolled the largest share (38%), with pharmacies recruiting the most participants (n=1217) at $128/enrolled, while other health professionals were low cost ($12/enrolled). Paper-mail strategies enrolled 34% overall ($78/enrolled), but yield varied widely depending on targeting and active follow-up. Media strategies were least efficient: paid media cost $808/enrolled (with very high per-enrollee costs for some channels), produced only brief recruitment spikes, and contributed little overall; in contrast, unpaid media and word of mouth were extremely low cost (~$3 and $7/enrolled). Different strategies reached different subgroups (e.g., seniors outreach reached lower-income and lower quality-of-life participants; word of mouth captured lower educational attainment), and no single strategy adequately recruited all priority groups supporting a diversified, multi-channel recruitment plan anchored in trusted health-care referrals.
Interactive group-based orientation sessions: A method to improve adherence and retention in pragmatic clinical trials
Abstract: This paper evaluates whether mandatory, pre-enrollment, interactive group orientation sessions (delivered before informed consent and randomization) were associated with improved adherence and retention in a pragmatic trial testing an intensive behavioral intervention for chronic pain patients on long-term opioids. Using a pre–post design at one trial site (Kaiser Permanente Northwest), the authors compared participants enrolled before implementation (Apr 2014–Dec 2015; n=209) versus after (Jan 2016–Feb 2017; n=258), examining intervention adherence (meetings attended) and retention (completion of quarterly assessments over 12 months), and also whether enrollment rates changed.
After implementation, adherence increased (mean 7.6 vs 5.6 meetings; mean difference 2.0) and the odds of completing quarterly assessments were higher (OR 2.8), but enrollment dropped substantially (38.1% vs 70.8%), with no meaningful differences in enrolled patient characteristics. The authors conclude that orientation sessions can be a feasible, low-resource strategy to improve engagement, but programs should plan for reduced enrollment and consider barriers to attending in-person sessions, particularly in medically complex populations
Recruiting for a pragmatic trial using the electronic health record and patient portal: successes and lessons learned
Abstract: This paper describes an EHR-based recruitment workflow used at UNC for the ADAPTABLE pragmatic trial, combining an EHR computable phenotype with outreach via in-clinic coordinators, letters, direct email, and patient-portal messages, with REDCap tracking and an encrypted MRN crosswalk to link invitations to enrollment. Electronic outreach (email + portal) reached 12,254 people, with 13.5% visiting the enrollment site and 4.2% enrolling; letters had lower yield (3.3% enrolled), while in-clinic recruitment had the highest yield (16.8% enrolled) but smaller scale. The authors conclude that electronic messaging can efficiently recruit at scale, but a mixed approach is needed, and portal-only recruitment may limit representativeness because only a minority of patients are active portal users.