Case Study

PTSD

Multi-Site Medical Device Study

The Challenge

A medical device company launched a multi-site study in the US to confirm the efficacy of its device for treating PTSD. The study’s enrollment goal was 100 patients. Three years later, only 30 patients had been recruited. The sites struggled to find patients since many suffered from disqualifying comorbidities. Many of the sites quickly exhausted their existing patient pool and had no way of expanding it. Since PTSD is a disorder involving intense suffering, and interferes with daily life, education about the disorder was not difficult. Nor was it a challenge to achieve interest in the study. However, finding patients with the proper diagnosis was challenging; prospective patients were often found to either have been misdiagnosed, have outdated diagnoses, or were not diagnosed by a medical professional. Further complicating recruitment efforts was the requirement to screen out those diagnosed with PTSD, a newly recognized form of PTSD associated with a history of multiple traumatic events occurring over a longer period of time.

Customized and Collaborative Approach

The nRollmed team built strong relationships with the staff at each site, listened to their specific challenges, and learned their preferences, availability, and capacity for receiving patient referrals. Based on the information garnered, nRollmed’s team was able to tailor the service to each site’s needs. Additionally, nRollmed consulted with each site to determine their level of comfort regarding patient referrals with an unclear diagnosis. Some sites were willing to perform a professional assessment. Other sites preferred prospective patients to see their own doctor for diagnosis before on-site screening. nRollmed’s team worked closely with the sites and sponsor to articulate a broad and carefully worded question that would be IRB-approved to screen out cPTSD patients. The pre-screening script was then updated to include this question, enabling the team to further optimize the screening funnel. The addition of this component saved sites valuable time.

The nRollmed Method

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Results

Recruitment for the PTSD trial was successfully completed with nRollmed’s participation. nRollmed
was active for only 30% of the total recruitment period and in that time brought in an additional 49
randomized subjects.

nRollmed’s active participation resulted in the recruitment of 50% of the study’s total patients.
When comparing the enrollment that took place without nRollmed’s participation, working with
nRollmed enabled the sponsor to complete the trial 24 months earlier.

66%

of subjects provided while active

months' recruitment time saved

patients recruited

In the time nRollmed was active, we recruited 66% of the patients.

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