Patient Services for a Post-Traumatic Stress Disorder (PTSD) Trial

Providing secure and consistent ground transport by trained professionals for adult PTSD patients.

The Challenge

When we began the Phase III Post-Traumatic Stress Disorder trial, we expected to face challenges. mdgroup was trusted by the client to provide ground transportation for every patient from home to site. Being unaware of the reasons behind each diagnosis, we knew that each patient would have a different set of needs, challenges, and requirements.

Fears: Building Trust

Gaining patient trust would be a challenge throughout the study. Some patients were afraid to drive themselves, or even be inside of a vehicle. Drivers would need to drive defensively, and ensure patients feel safe and comfortable on the road. Standard cadence, conversation topics, or body language from a driver could be perceived by a PTSD patient as threatening, uncomfortable, or intimidating. Lack of familiarity with a driver could also lead to distrust, and frequent patient requests were for either repeat drivers or for drivers to wait throughout appointment duration. Lack of a personalised or highly sensitive approach to the transportation experience would ultimately lead to patients avoiding their transportation method, distancing themselves from the site/study, and discontinuing their enrollment.

Traumas: Preferences and Compatibility

For a female patient whose PTSD was the result of possible abuse, to ride alone with a male driver may trigger traumas, stress, anxiety, and potentially panic. Certain patients would only enter a vehicle with a female, to ensure comfort and security. We planned accordingly for possible instances in which a female driver would be unavailable, as some patients confirmed in advance that they would be unable to ride with a male driver.

Comorbidities: Depression, Anxiety, and Beyond

Most PTSD patients also possess at least one additional comorbidity, with Major Depressive Disorder and Generalised Anxiety Disorder frequently seen in the study, among others. Both depression and anxiety play large roles in patient compliance. Patients have difficulty being proactive about their follow-ups, have a hard time building enough motivation to attend site visits, and can generally lose their drive for following through on long-term commitments. Requiring the patients to coordinate their own Taxis/App-based Car Services and reimbursements would lead to countless missed visits and dropouts. A hands-off approach would simply not work for this study. Accountability, relationships, and simplicity would need to be leveraged to make sure patients would leave their homes, accept transportation, and make it to their site visits.

The Solution

We truly went above and beyond as a team and were able to meet individual patient needs in a scalable manner. In addition to heavy involvement and personalised support, this included:

• Vetting and quality-checking each driver for driving records, backgrounds, and compatibility
• Providing driver training on patient population needs, such as behavior, approach, communication, and sensitivity
• Using a specialised ride service that provided tracking, reminders, follow-up on rides, repeat driver assignment, and pools of specialty drivers specific to thestudy (such as only female)
• Door-to-door service – driver notifications, profiles, and consistency for patients, with drivers waiting at the site for patients when necessary
• Heavy engagement with sites – transparency into patient scheduling, transport, location, and communication provided an extra layer of comfort for patients
• Relationships built with patients that developed accountability, trust, and the needed extra push of motivation for certain patients to get out of their home, into the car, and onto their visit

The Outcome

We will do everything possible to make our patients comfortable, and no ask is ever too tall for our team. We delivered every patient to the site with their personal needs fulfilled and ensured that not a single logistical task was left for the patient – the only thing they had to do was get in the car. Between both sponsor and patient feedback, we know that these patients would not have attended their visits, or even enrolled in the study, if we hadn’t provided this service.

Patients felt safe and cared for throughout their journey, and the consistency of their experience is what led to their ultimate study completion.

Our client was extremely happy with our efforts and delivery, and acknowledged that our service not only maintained retention, but ramped up recruitment as well. The promise of a personalised, clean, safe, door-to-door service without added logistics/responsibilities was able to remove the barrier for patients during the ICF process and led to higher, sustained enrollment rates.

Want to find out more about our patient services?

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Our approach to patient health drastically reduces patient drop-out rates, and prevents disruption to your clinical trial, getting products to market faster.

Get in touch to see how we can support your patients and boost the success of your clinical trial.