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Life sciences organizations are reevaluating their approaches to patient engagement and outdated workflows in clinical trials, largely due to low enrollment rates and growing concerns about data integrity. Solutions utilizing voice and chat technologies, such as Alexa and Amazon Lex, a fully managed conversational artificial intelligence (AI) service, can significantly enhance the patient experience and boost engagement.
Around 48% of clinical trials fail to meet their patient recruitment goals, with 80% experiencing delays due to insufficient enrollment, leading to increased time and costs. Furthermore, the quality of trials is jeopardized, as approximately 30% of participants withdraw after signing up, underscoring the necessity for positive patient experiences to ensure trial success.
According to clinicaltrials.gov, there are nearly 130,000 studies registered in the U.S., with around 20,000 actively recruiting participants. Each of these studies typically aims to enroll between several hundred and 3,000 participants. This data highlights the considerable impact that a solution focused on patient experience can achieve.
By leveraging AWS’s preferred cloud technologies, including Amazon Lex and Amazon SNS, our solution aimed to facilitate remote patient access, deliver proactive reminders, and capture real-time responses to daily questionnaires.
Summary of Challenges
- Patient Experience with Questionnaires: Participants may opt out of a clinical trial if answering questionnaires is inconvenient or if guidance on the questions is insufficient.
- Questionnaire Data Quality and Timeliness: Without timely reminders, participants might fail to provide accurate responses, leading to potential data quality issues.
- Study Results: Participants may forget to take their medications as scheduled if they do not receive reminders, which can affect the study’s usability.
- Data Analysis: Clinical trial administrators lack automated methods for gathering and analyzing trial data.
Solution Objectives
Utilizing cutting-edge voice and chat technology, we sought to:
- Provide remote access for patients through Amazon Alexa and SMS text messaging for:
- FAQs
- Site information
- Patient medication diaries
- Questionnaires
- Transportation details to clinical trial sites
- Send proactive reminders to patients for:
- Medication adherence
- Completion of their patient diaries
- Capture patient responses in near real-time through:
- Daily questionnaires using Alexa and text
- A dashboard for immediate reporting and intervention
Solution Overview
Clinical trial questionnaires have long been employed to evaluate drug efficacy and patient quality of life where objective measurements are lacking. These questionnaires feature various question types, including multiple choice and numeric responses, and are administered on specific dates to accurately capture data.
A web interface allows study administrators to create questionnaires with multiple questions and set schedules for their administration. The notification process checks scheduled activities and generates an Amazon Pinpoint segment to update the respective campaign. Participants receive SMS reminders to complete their questionnaires on the scheduled date.
Responses are facilitated through Amazon Lex, with message management handled by Amazon SNS. Questions are retrieved from Amazon Simple Storage Service (Amazon S3), while Amazon DynamoDB serves as the interface database, recording responses via Amazon Kinesis Data Streams and Amazon Kinesis Firehose.
When patients activate Alexa, an Alexa skill checks for any scheduled questionnaires and begins asking the relevant questions. The skill logs responses through the response API, streaming data into Amazon S3, with DynamoDB facilitating real-time data exchanges.
Reporting
Responses stored in Amazon S3 are queried by Amazon Athena to create a dashboard in Amazon QuickSight. Amazon Glue provides necessary data integration services. Clinical trial sponsors can generate reports to assess response rates and delve into patient-level data. A lack of engagement, indicated by unanswered questionnaires or signs of non-adherence to medication, suggests the risk of potential dropouts. Near real-time reports enable timely interventions to assist such patients in remaining in the trial.
For instance, a dashboard displaying patient responses about their medications can help clinicians identify engagement levels and take necessary actions.
Additionally, FAQs play a significant role in addressing patient inquiries about the trial, covering topics such as study drugs, duration, phases, screening, and objectives. The web interface allows administrators to configure FAQs tailored to individual trials. The Alexa skill interacts with the FAQ search API, triggering an AWS Lambda function to query Amazon OpenSearch Service for appropriate responses.
Reminders
One of the primary goals of this solution is to enhance patient adherence and ensure timely questionnaire responses, thereby improving data quality. This solution can also deliver reminders via chat for medication, alongside prompting patients to respond to daily questionnaires.
Conclusion
Incorporating voice and chat technologies into patient engagement during trials can enhance the patient experience and reduce dropout rates. The financial burden of replacing participants during trials is threefold the cost of initial recruitment, which impacts overall data quality. Thus, improving patient experience yields benefits by minimizing dropouts, ensuring timely data capture, and enhancing data quality. This solution is applicable for pharmaceutical companies conducting trials or organizations overseeing them.
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