96% of visits in window across a below-the-knee cardiovascular program

Complex imaging and assessment visits delivered in the community and at home for patients with chronic limb ischemia, with 99% of surveyed participants reporting they were very satisfied.

96%of study visits conducted in windowProtocol-compliant visit windows across the program

99%reported they were very satisfied2,000 participants surveyed

7 daysto schedule a visitStandard scheduling window from request

2 weeksto nurse readinessOnboarding and protocol training before first visit

of study visits conducted inside the protocol window

Across the program

reported they were very satisfied

2,000 participants surveyed

Visit-window adherence is the figure a sponsor models in feasibility. Participant satisfaction is the figure that predicts whether they stay in the study.

The situation

Sponsors running below-the-knee device studies in chronic limb ischemia were losing eligible patients before enrollment. The population skews older and less mobile, and the trial sites were often a long drive away. Patients who could benefit from the study were being excluded by geography and by the physical difficulty of getting to a site, not by the protocol.

What made it difficult

The visit schedule was not simple to move out of a hospital. It included duplex ultrasound imaging, wound assessment, ABI and TBI measurement, and PK blood draws.
Image and data quality had to hold to protocol standard wherever the visit happened, because duplex imaging is only useful to the sponsor if it is consistent.
Participating sites had limited staff and limited room to absorb additional visit volume.

What we did

Delivered study visits in the community and in participants’ homes using GCP-trained and protocol-trained nurses, with the same SOPs and documentation standards used at our sites.
Trained and readied nurses on the protocol within two weeks, and scheduled visits within a seven-day window.
Ran visits through a delivery platform that gave the study team real-time visibility into scheduling, completion, and data capture rather than a retrospective report.
Used the combined reach of our at-home nurse network across all 50 states and Labcorp patient service centers so that a visit location was within reach of most of the study population.

Result

96% of study visits were conducted inside the protocol window. Of 2,000 participants surveyed, 99% reported that they were very satisfied with their experience.

The program also reached patients who would not otherwise have been able to take part, which is the outcome the sponsor was buying. Mobility and distance stopped being enrollment criteria.

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Figures are Hawthorne Health operational data for the program, as of September 1, 2026. Sponsors are not identified under the terms of the applicable clinical trial agreements.

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The situation

What made it difficult

The visit schedule was not simple to move out of a hospital. It included duplex ultrasound imaging, wound assessment, ABI and TBI measurement, and PK blood draws.

Image and data quality had to hold to protocol standard wherever the visit happened, because duplex imaging is only useful to the sponsor if it is consistent.

Participating sites had limited staff and limited room to absorb additional visit volume.

What we did

Delivered study visits in the community and in participants’ homes using GCP-trained and protocol-trained nurses, with the same SOPs and documentation standards used at our sites.

Trained and readied nurses on the protocol within two weeks, and scheduled visits within a seven-day window.

Ran visits through a delivery platform that gave the study team real-time visibility into scheduling, completion, and data capture rather than a retrospective report.

Used the combined reach of our at-home nurse network across all 50 states and Labcorp patient service centers so that a visit location was within reach of most of the study population.

Result

96% of study visits were conducted inside the protocol window. Of 2,000 participants surveyed, 99% reported that they were very satisfied with their experience.

The program also reached patients who would not otherwise have been able to take part, which is the outcome the sponsor was buying. Mobility and distance stopped being enrollment criteria.