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Kidney Week

Abstract: PO2403

Opt-In vs. Opt-Out Approach for Kidney Disease Education and Associated Research

Session Information

Category: CKD (Non-Dialysis)

  • 2102 CKD (Non-Dialysis): Clinical, Outcomes, and Trials

Authors

  • Shukla, Ashutosh M., VA North Florida South Georgia Veterans Health System, Gainesville, Florida, United States
  • Shell, Popy, VA North Florida South Georgia Veterans Health System, Gainesville, Florida, United States
  • Fu, Devin S., VA North Florida South Georgia Veterans Health System, Gainesville, Florida, United States
  • Purvis, Zachary Pitt, VA North Florida South Georgia Veterans Health System, Gainesville, Florida, United States
  • Orozco, Tatiana, VA North Florida South Georgia Veterans Health System, Gainesville, Florida, United States
  • Chamarthi, Gajapathiraju, University of Florida, Gainesville, Florida, United States
Background

Clinical research mail-invites require patients to call back for their ability to participate (opt-in). This patient-initiative need reduces efficiency, requires more effort, and limits external validity. Opt-out approach, where research team actively contacts those not choosing to call back, can improve efficiency, especially when evaluating recommended but uncommonly used interventions. Current guidelines recommend comprehensive pre-end stage kidney disease (ESKD) education (CPE) for all advanced, stage 4/5 CKD patients but, CPE is uncommonly used prompting patient preference research. Evaluating enrollment statistics for the initial year of randomized controlled Trial to Evaluate and Assess the effects of CPE on Home dialysis among VETerans(TEACH-VET), we report the effectiveness and efficiency of the ‘opt-out’ approach in CKD education research.

Methods

TEACH-VET (NCT04064086) aims to evaluate universal CPE strategy on Veteran outcomes, including home dialysis. It uses an EHR-based source cohort to mail-invite advanced CKD Veterans; those who do not call-back within 15 days to opt-out, are telephoned for upto 3 times for their interest. Staff surveys(n=6) are used to determine effort (time) associated with each study activity and aggregated for opt-in/opt-out processes. We examined approach success rates, and study enrollments and efficiency(time per enrollments) as outcomes.

Results

Of the total of 226 randomly selected Veterans mail-invited for study participation over the initial 15 months, approach success rate was 3.9%(n=9) for opt-in method, resulting in 2(22%) enrollments, while 4(44.3%) requested additional time for decision. Of the remaining 217, study staff were able to approach 157 invitees(success rate of 72.4%), resulting in 86(54.8%) enrollments, while 18(10.8%) requested additional time. Significant differences in personnel efforts were seen with an estimated 147±69.2 and 183±70 min, minutes per enrollments(p<0.05) in the opt-in vs. opt-out respectively though, efficiency for enrollment was signficantly better for opt-out vs. opt-in (60.2 vs. 30.7min) approach.

Conclusion

Patient driven opt-in approaches are less effective and efficient for enrollments in clinical and research activities involving the universally recommended services like kidney disease education.

Funding

  • Veterans Affairs Support