Health Ahead Comparative Effectiveness Study
Purpose
The Health Ahead Comparative Effectiveness Study is a pragmatic, parallel-arm interventional platform that systematically compares successive changes to preventive health screening - each isolated as a single variable against current practice - on the path toward a fully automated screening system deployable in any environment, including the most isolated and resource-limited communities. Each comparison is evaluated with a common set of engagement, behavior-change, experience, cost, and longitudinal outcome measures, allowing results to accumulate on a consistent yardstick across the life of the platform. The first comparison evaluates static versus interactive personalized health report delivery. Subsequent pre-planned comparisons, added by protocol amendment, evaluate mobile community versus fixed laboratory screening; and a hybrid medical-droid plus human-delivery model versus human-only screening. All participants are simultaneously enrolled in the 100-Year Human Aging Study and the Human Observatory Study, contributing individual longitudinal and population-level causal inference data through those protocols.
Conditions
- Health Services Accessibility
- Rural Health
- Medically Underserved Area
- Preventive Health Services
- Patient Participation
- Health Behavior
- Aging
- Cardiovascular Diseases
- Metabolic Syndrome
- Cognitive Dysfunction
- Frailty
- Activities of Daily Living
- Health Related Quality of Life
- Health Equity
- Telemedecine
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Age 18 years or older - Willing and able to provide written informed consent, or enrollment with consent of a legally authorized representative - Willing to participate in longitudinal follow-up.
Exclusion Criteria
- Age under 18 years.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Factorial Assignment
- Intervention Model Description
- This is a multi-domain comparative-effectiveness platform study of how health screening is delivered. Each domain compares two conditions: (1) Report format - static vs. interactive personalized health report; (2) Screening setting - fixed-site vs. mobile community-based screening; (3) Delivery model - human-delivered vs. hybrid medical-droid-and-human-delivered screening. Domains open over the course of the study and additional domains may be added by amendment. A participant may receive interventions from more than one domain. Allocation is randomized within a domain whenever operationally feasible (e.g., report format) and otherwise follows setting and availability (e.g., screening setting determined by location and participant presentation). Allocation procedures for the delivery-model domain will be finalized by protocol amendment.
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
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Active Comparator Static Personalized Health Report |
Participants complete comprehensive multi-system health screening and receive a standard static personalized health report. |
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Experimental Interactive Personalized Health Report |
Participants complete identical comprehensive multi-system health screening and receive an interactive personalized report allowing real-time adjustment of behaviors and diagnostic inputs to visualize projected changes in composite scores, estimated biological age, and aging trajectory. |
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|
Active Comparator Fixed-Lab Health Screenings |
Health screenings performed at fixed-lab site. |
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|
Experimental Mobile Lab Health Screenings |
Health screenings performed in remote locations using a mobile lab |
|
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Active Comparator Human Delivered Health Screenings |
Health screenings delivered by human operators only |
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Experimental Hybrid Medical Droid and Human Delivered Health Screenings |
Health screenings delivered by a hybrid model using medical droid and human operators |
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Recruiting Locations
Boulder, Colorado 80301
More Details
- Status
- Recruiting
- Sponsor
- William Brandenburg, MD
Detailed Description
Access to comprehensive preventive health screening is profoundly unequal. Geographic, economic, and systemic barriers leave medically underserved populations - including rural, frontier, and isolated communities - with little or no access to the depth of preventive screening that identifies disease before symptoms occur. The long-term aim of this work is a fully automated preventive screening system that can be deployed anywhere people live. Reaching that aim safely and credibly requires testing each change to the screening model one variable at a time, against current practice. The Health Ahead Comparative Effectiveness Study is therefore designed as a standing sequential comparative-effectiveness platform. Each phase is a parallel two-arm comparison that isolates a single change while holding all other elements of the screening experience constant, and each is evaluated with the same core outcome set. As one comparison concludes, the next is opened by protocol amendment. Throughout, all participants are concurrently enrolled in the 100-Year Human Aging Study and the Human Observatory Study, so that short-horizon comparative findings are linked to lifelong individual and population-level outcomes. Two design principles govern every comparison. First, allocation is randomized wherever randomization is feasible and non-randomized only where participant-level random assignment is not possible (for example, comparisons of screening location such as mobile versus fixed laboratory). Second, every comparison is registered with non-inferiority as the primary hypothesis: each evolutionary change toward a more automated and more broadly deployable model must demonstrate that it does not degrade outcomes relative to current practice, by more than a pre-specified margin. The unifying thesis is that quality is preserved as the platform evolves. Superiority is assessed as a pre-specified secondary in a hierarchical (gatekeeping) test and reported whenever non-inferiority is established and the data support a superiority claim. The same core outcome set is applied to every comparison to the greatest extent each comparison allows. The planned comparison sequence is: - Comparison 1: Static versus interactive personalized health report delivery. Both arms complete identical comprehensive multi-system screening and differ only in the report they receive. The interactive report allows participants to adjust their own behaviors and diagnostic inputs in real time and visualize the projected effect on their composite scores, estimated biological age, and aging trajectory. Assignment is randomized. The primary hypothesis is that the interactive report is non-inferior to the standard static report on health activation and behavior change. - Comparison 2: Mobile community screening versus fixed laboratory screening in medically underserved populations. The question is whether mobile delivery achieves engagement and outcomes equivalent or superior to a fixed laboratory setting (an equivalence/non-inferiority question). - Comparison 3: A hybrid delivery model combining medical droids, one registered nurse, and remote physician oversight, versus human-only screening. - Future: Fully automated screening performed by medical droids with remote physician review versus hybrid model. The platform launches in Colorado, chosen as the founding geography for its exceptional diversity of medically underserved communities - high-altitude frontier towns, rural agricultural communities, mining corridors, and isolated mountain communities - within a well-characterized geography with established academic research infrastructure. Findings are designed to generalize to medically underserved populations nationally, internationally, and to inform federal health policy on mobile and automated preventive health delivery.