Evidence map›Paper›PMID 39438380›Full record

Trial reportJournal of general internal medicine2025

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

Anne M Walling, Neil S Wenger, Aaron J Chau, Jennifer Reihm, Lisa Gibbs, Maryam Rahimi, Ron D Hays, Rebecca L Sudore

Abstract readMulticenter StudyPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of general internal medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Anne M WallingDepartment of Medicine, University of California, Los Angeles, Los Angeles, CA, USA. AWalling@mednet.ucla.edu.
Neil S WengerDepartment of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.
Aaron J ChauDivision of Geriatric Medicine, Department of Family Medicine, University of California, Irvine School of Medicine, Irvine, CA, USA.
Jennifer ReihmDivision of Rheumatology, University of California, San Francisco, San Francisco, CA, USA.
Lisa GibbsDivision of Geriatric Medicine, Department of Family Medicine, University of California, Irvine School of Medicine, Irvine, CA, USA.
Maryam RahimiDepartment of Medicine, University of California, Irvine, Irvine, CA, USA.
Ron D HaysDepartment of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.
Rebecca L SudoreDivision of Geriatrics, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.

Funding

Patient-Centered Outcomes Research Institute PLC-1609-36291
6 · The paper itself

Abstract

backgroundThe 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.

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

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

participantsWe included English and Spanish-speaking seriously ill patients.

interventionsOne 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

resultsOf 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.

conclusionsThe 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.

Indexed as

Health Insurance Portability and Accountability ActPatient SelectionPragmatic Clinical Trials as TopicAdultAgedFemaleHumansMaleMiddle AgedUnited Stateshealth literacy

Identifiers

PMID39438380
PMCPMC11968583

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.