Standard HIPAA Authorization Forms Decreased Response Rates for a Multi-site Pragmatic Trial.

Background: The Health Insurance Portability and Accountability Act (HIPAA) aims to safeguard patient information; however, complex legal language may lead to confusion and mistrust, and hinder enrollment in clinical trials.

Objective: To evaluate the effect of a standard HIPAA authorization included in mailed survey packets on study enrollment for a multi-site pragmatic trial.

Design: This study is nested within an advance care planning pragmatic trial at 50 primary care clinics across three University of California (UC) Health Systems.

Participants: We included English and Spanish-speaking seriously ill patients.

Interventions: One third of eligible patients received and 2/3 did not receive the HIPAA authorization in their enrollment packet.

Main Measures: We compared enrollment rates at 3 months and assessed the readability, understandability, and actionability of the standard HIPAA form using the Federal Plain Language Guidelines Checklist for Plain Language, the Automatic Readability Checker consensus calculator (grade 8 is the average reading level for US adults), and the Patient Education Materials Assessment Tool for Printable Materials (PEMAT-P, 0-100%, 70% considered the minimum).

Key Results: Of 4632 eligible patients (mean age 71, 48% women, 11% Spanish-speaking, 40% racial/ethnic minority); 1543 received a mailed enrollment packet with a HIPAA form and 3089 did not. Patients mailed the HIPAA form were less likely to enroll (10.2% vs. 14.8%, p < 0.001). The standard HIPAA form scored at the 12th grade reading level, had a PEMAT-P Understandability score of 42%, had an Actionability score of 40%, and only met 50% of Federal Plain Language Guideline Checklist items.

Conclusions: The inclusion of a standard HIPAA authorization in mailed enrollment packets for a large pragmatic trial led to lower rates of study enrollment. This study informs how HIPAA authorization forms should be redesigned to be more accessible to patients to prevent unnecessary barriers to research enrollment.