By John Seaner
Health Literacy Is the Hidden Enrollment Barrier:
How a PXO Closes the Comprehension Gap
Every clinical trial requires informed consent. Every regulatory body mandates that patients understand what they’re signing up for. Every sponsor claims that education materials are “clear and easy to follow.”
But here’s the operational reality:
- Up to 40% of trial participants don’t fully understand the purpose of the study they’re enrolled in.
- One in three adults in the US has low health literacy and that number climbs in high-need, underserved, or non-English-speaking populations.
- Trials often use materials written at a 10th–12th grade reading level, while best practice is to use 6th grade or below.
- Low comprehension leads to higher screen failure, early withdrawal, and reduced data quality.
This isn’t a side issue. It’s a foundational weakness in how clinical trials communicate, enroll, and retain patients.
Health literacy isn’t just about words. It’s about meaning, context, and confidence.
And that’s exactly where a Patient Experience Organization (PXO) like Jumo Health creates strategic advantage.
The Myth of “Plain Language” Consent
Most trial consent materials claim to use “plain language.” But when we test these materials with real patients across language, age, race, and education level, three things become clear:
Language alone isn’t enough:
Patients also need visuals, analogies, repetition, and real-world relevance.
Comprehension is contextual:
What makes sense on paper doesn’t always resonate emotionally or cognitively during a vulnerable decision.
One-size-fits-all fails:
A first-time participant deciding on a Phase I trial isn’t the same as a parent weighing a pediatric study for a rare condition.
A PXO treats health literacy as a behavioral science problem, not just a copywriting task.
The PXO Approach to Health Literacy: 4 Dimensions of Design
At Jumo Health, our Patient Experience (PX) model incorporates a layered approach to health literacy, addressing not just what is said, but how, when, and why it’s communicated.
Our 4 pillars:
1. Cognitive Load Reduction
2. Emotional Framing
3. Contextual Anchoring
4. Iterative Comprehension Measurement
Let’s explore each one.
1. Cognitive Load Reduction: Say Less, Mean More
When patients are overwhelmed, scared, or unfamiliar with medical language, even “simple” sentences can be hard to process.
A PXO reduces cognitive burden with:
Information chunking: Breaking complex concepts into digestible sequences
Visual storytelling: Using illustrations, animations, or timelines to explain process and risk
Progressive disclosure: Revealing detail in layers, so patients aren’t bombarded upfront
Behavioral default design: Highlighting the key decisions clearly (eg, participation, withdrawal, follow-up), not burying them in pages of regulatory language
In one inflammatory disease trial, this approach raised comprehension from 62% to 89% in low-literacy participants.
2. Emotional Framing: Trust Starts Before Understanding
Even the most understandable content fails if it triggers fear, confusion, or distrust.
A PXO reframes trial participation emotionally:
Leads with “why,” not “what”: Anchoring the trial in patient-centered benefits (eg, “help others,” “contribute to science,” “better options”)
Acknowledges risk honestly: Trust is built when risks are described clearly, not minimized
Integrates stories from prior participants: Lived experiences increase resonance and reduce anxiety
Uses patient-preferred language: No one wants to be called a “subject.” Patients want to be seen as people.
This framing increases both recruitment intent and consent quality, especially in populations historically excluded from research.
3. Contextual Anchoring: Help Patients See Themselves in the Process
Understanding isn’t abstract, it’s personal.
A PXO uses tools that help patients see how the trial fits into their lived reality, including:
Visit walkthroughs: What will happen, where, with whom, and for how long
Decision maps: Helping patients identify what matters most to them: time, side effects, location, contribution
Daily life integration planners: Showing how the trial will impact work, school, family, or routine care
Caregiver overlay materials: Enabling shared understanding across family systems
This turns consent into a two-way conversation, not a document drop.
4. Iterative Comprehension Measurement: What Gets Measured Gets Improved
A PXO doesn’t assume comprehension. We measure it, continuously.
Our tools include:
Comprehension check-ins: Integrated into eConsent flows using short, emotionally neutral assessments
Informed Engagement Quality Score (IEQS): A metric that tracks how well patients grasp trial goals, procedures, and rights
Consent dropout heatmaps: Analyzing where patients disengage during the decision process
Mid-trial reinforcement modules: Revisiting key concepts at critical points, such as first dosing or protocol changes
One oncology sponsor using PXO methods saw a 36% reduction in early screen failure due to poor understanding.
Real-World Example: Health Literacy in a Rare Disease Trial
A global rare disease study for a metabolic condition faced high screen failure due to participants not fully understanding eligibility requirements.
A PXO implemented:
- A comic-book style consent tool co-created with advocacy partners
- Pre-consent coaching modules for caregivers, delivered via video
- Progressive disclosure materials explaining the difference between research and treatment
- Real-time IEQS dashboards for sites, flagging at-risk participants
Result: Comprehension scores rose by 42%, and early withdrawal dropped by 29% in the first 12 weeks.
Special Considerations by Trial Type
A PXO tailors health literacy solutions by trial category:
- Common diseases: Combat message fatigue, normalize participation as part of standard care
- Specialty diseases: Emphasize benefit framing and clarity around eligibility complexity
- Rare diseases: Prioritize shared decision-making, caregiver education, and advocacy partnerships
- Pediatric trials: Use age-appropriate tools, narrative visualizations, and separate caregiver/child materials
In every case, a PXO ensures comprehension is earned, not assumed.
Operational Benefits: Why Health Literacy Is a Business Driver
Improving comprehension does more than help patients, it drives trial success:
Higher enrollment rates from underserved, skeptical, or marginalized populations
Reduced screen failure, especially where eligibility is strict
Better retention, because patients know what to expect
Improved site efficiency, with fewer repeated questions and less emotional labor
Lower regulatory risk, with cleaner consent audits and participant-reported clarity
Put simply: Health literacy reduces trial risk at every level.
PXO Metrics for Health Literacy Impact
Our outcomes include:
- PXCI (Patient Experience Composite Index): Combines comprehension, confidence, and emotional readiness
- IEQS (Informed Engagement Quality Score): Tracks pre-enrollment understanding and post-enrollment reinforcement
- Enrollment Friction Index (EFI): Measures where comprehension barriers stall progress
- Retention Risk Score (RRS): Includes understanding as a predictive dropout factor
These are not vanity metrics. They guide operational decisions, site training, and resource allocation in real-time.
Conclusion: If Patients Don’t Understand, They Don’t Stay
We cannot ask patients to make life-altering decisions based on 15-page PDFs written at a 12th-grade reading level with no visuals and no emotional support.
That’s not informed consent. That’s informed confusion.
With a PXO you can redefine the trial experience with clarity, empathy, and context, not just better brochures.
In a world where health equity is a mandate, not a buzzword, health literacy is the single most important lever for inclusion, compliance, and retention.
Want to know how this PX model can improve comprehension across your pipeline? Let’s start the conversation.
