Overview
Digital recruitment of patients for clinical trials is an efficient, effective way to enroll patients more quickly in clinical trials for inflammatory bowel disease (IBD).
Organization Name
Mount Sinai IBD Center, additional Mount Sinai Health System Clinics
Organization Type
- Academic Hospital
- Academic Medical Center
National/Policy Context
- Approximately 8 out of 10 clinical trials are delayed or left incomplete due to challenges with patient recruitment. Currently, recruitment of patients requires face-to-face visits and is inefficient.
- Digital platforms have the potential to increase both the reach and efficiency of recruitment efforts to fill clinical trials, particularly in chronic diseases.
- Inflammatory bowel disease (IBD) is an often-debilitating prototypical chronic disease where trial optimization may be beneficial.
Local/Organizational Context
- The Sinai AppLab serves as the data-supporting arm of the Mount Sinai Crohn’s and Colitis Registry, which is a database for clinical information and biological specimens maintained by the hospital.
- In this context, the Sinai AppLab was able to identify the pain points of trial recruitment and develop Health, an EHR-integrated digital medicine platform, to deliver educational content, health information, and other materials to patients. This platform was designed such that it could also be utilized to address inefficient trial recruitment.
Patient Population Served and Payor Information
- The majority of the patients in the Mount Sinai IBD center have private insurance. There are limited patients with Medicare due to the younger patient population.
- In the registry, of the 1100 patients who had reliable health insurance, 1000 have private, 200 have Medicare, and 65 have Medicaid, with some overlap.
Leadership
- Technical leadership was provided by the Sinai AppLab.
- Atreja led the implementation on the clinical side with support from the principal investigator for the study.
Funding
- Internal funding for the AppLab’s day-to-day functions supported all activities, requiring no separate or external funding.
- The AppLab has received funding from NIH, national societies, and industry for various projects but is a self-supporting entity within Mount Sinai.
Research + Planning
- The RX. Health Digital Medicine Platform, the main infrastructure for implementation, existed prior to this project.
- However, this utilization of the platform required cleaning patient data, programming the content, and setting rules for sending. These tasks were conducted by data scientists employed by the AppLab.
Tools or Products Developed
- The Rx.Health Digital Medicine Platform and IBD registry had both been in existence for over a year prior to this intervention, but this was the first time that the platform was customized for trial recruitment. These tools had previously been used for patient education, communication and research.
Training
- The project required trained data scientists to clean the patient data, though this is likely already within the area of expertise of any data scientist.
- Programming the rules to use Rx.Health platform for trial recruitment does not require coding expertise, but there is initial training for how to utilize the application when an institution licenses the technology.
Team Members Involved
- Data Analyst
Workflow Steps
- The principal investigator for the research study generated the text message language to be delivered through the digital platform.
- Patients who were enrolled in the Mount Sinai Crohn’s and Colitis Registry (which had been enrolling patients for years by physicians at the IBD center) and had opted into trial enrollment were contacted about clinical trial opportunities via text message and asked whether they were interested in enrolling in a particular trial.
- Patients who received the text message could reply “yes” or “no” directly to indicate whether or not they were interested in the trial.
- 270 patients indicated interest in the trial, and they were given additional information about the trial as well as contact information to email the research coordinator. Many of these patients reached out on their own to the research coordinator.
- If patients who indicated interest via text did not contact the coordinator independently, their contact information was given to the coordinator, who reached out to the remaining patients.
- 240 patients responded to the text and indicated that that they were not interested.
- 270 patients indicated interest in the trial, and they were given additional information about the trial as well as contact information to email the research coordinator. Many of these patients reached out on their own to the research coordinator.
- Patients who corresponded with the research coordinator and were interested in the trial were included in a secure file that was shared with the principal investigator.
- The trial was then enrolled with patients from this pool.
Budget Details
Funding for the AppLab covered all expenses:
- <100 hours of total team time for cleaning of the patient data to feed it into the platform, time programming the rules for this use of the application.
- Message sending cost: approximately $1,000
- Health Platform license cost: this is an enterprise solution for institutions that support multiple use cases, so cost varies by institution based on the use cases. It is currently licensed to eight institutions in the North America (for prescribing apps, engaging patients to prevent readmissions, sending educational content, preparing patients for procedures, etc.) and is available for use by other institutions through Rx.Health.
Where We Are
- The completed pilot took place in March 2018.
- This was the first utilization of the Rx.Health platform for trial recruitment. The platform is also used to support and collect PRO data from 65 center National Fecal Transplant Registry led by American Gastroenterological Association (AGA). There are plans to expand the features with telemedicine, messaging and wearables integration to create a comprehensive virtual clinical trials suite by Q3, 2019.
Outcomes
- Contact Rate: 1364 IBD patients were contacted digitally, 1309 patients had confirmed delivery of message, while 55 messages were rejected.
- Response Rate: Of those contacted, 510 patients responded through text/email within same day and 270 patients indicated interest in study participation.
- Response Time: Most patients responded within 2 hours of notification. It is anticipated that a similar trial without digital recruitment would have taken months to years to recruit.
- Responder Characteristics: Patients who opted in were more likely to have less control over their IBD (25.64% vs. 18.97% in those who opted out) and recent history of depression (15.38% vs. 8.4% in those who opted out). While not significant, patients opting in were more likely to be female, younger, and have Crohn’s rather than UC.
Future Outcomes
- Additional Responder Characteristics: In the future, the team plans to investigate patient socioeconomic indicators and other predictors of response as part of this method of trial recruitment.
Benefits
- Time to recruitment was reduced to days instead of month by using the campaign feature of secure EHR-integrated Digital Medicine Platform, Rx.Health.
Unique Challenges
- The key challenge was having an excess of patients who responded, as the trial was quickly over-enrolled within a single day.
- Patients had previously consented to be re-contacted as part of prior enrollment into the research registry, which required IRB compliance prior to rollout.
Sources
- Internal abstract drafts
- https://rx.health/
Innovators
- Ashish Atreja, MD, MPH
Editors
- Katherine Rowe, BA
Location
New York, NY
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