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

Area of Science:

• Clinical Trials
• Health Policy
• Patient Engagement

Background:

• The Health Insurance Portability and Accountability Act (HIPAA) aims to protect patient data.
• Complex legal language in HIPAA authorization forms can create barriers to clinical trial enrollment.
• Mistrust and confusion surrounding HIPAA forms may deter patient participation in research.

Purpose of the Study:

• To assess the impact of including a standard HIPAA authorization form in mailed survey packets on study enrollment rates.
• To evaluate the effectiveness of a standard HIPAA authorization within a pragmatic clinical trial setting.
• To identify potential barriers to research participation related to HIPAA documentation.

Main Methods:

• A pragmatic trial involving seriously ill, English and Spanish-speaking patients across 50 primary care clinics.
• Patients were randomized to receive (one-third) or not receive (two-thirds) the HIPAA authorization in their enrollment packet.
• Enrollment rates were compared at 3 months; HIPAA form readability, understandability, and actionability were assessed using established guidelines and tools.

Main Results:

• Patients who received the HIPAA form in their mailed packet had lower enrollment rates (10.2%) compared to those who did not (14.8%).
• The standard HIPAA form exhibited a 12th-grade reading level, with low understandability (42%) and actionability (40%) scores.
• The form met only 50% of the Federal Plain Language Guideline Checklist criteria, indicating poor accessibility.

Conclusions:

• The standard HIPAA authorization form, when mailed, significantly decreased study enrollment in a large pragmatic trial.
• Current HIPAA authorization forms present significant readability and understandability challenges for patients.
• Redesigning HIPAA authorization forms to be more patient-friendly is essential to reduce barriers and improve research participation.