MedicalResearch: What is the background for this study?
A real-world case study measuring the impact of Short Messaging System (SMS) or “Text Messaging” on clinical trial patient recruitment using an interactive two-way patient engagement platform by Mosio, Inc., which provides clinical research services designed to increase patient recruitment, engagement and retention, found that use of text messaging alone can be an effective means of patient engagement that results in clinical trial patient enrollment.
Patient recruitment, retention and medication adherence continue to be challenges in conducting effective clinical trials. While clinical trials often rely on email recruitment, recent studies suggest that only 22% of emails are read.1 Alternatively, 98% of text messages are read1 and 90% of text messages are read within the first three minutes of receipt.2
Recent research has evaluated the impact of Short Messaging System (SMS) or “Text Messaging” in healthcare settings, such as appointment reminders and medication adherence. Results have demonstrated that SMS intervention significantly improved patient behavioral outcomes: patients who received SMS reminders were more likely to show up to appointments on time,3 and patients who received SMS reminders were more adherent to medications.4 However, only limited research is available on the effect of SMS on clinical trial subject enrollment.
Johnson County Clin-Trials (JCCT), a clinical research facility that specializes in executing 10-15 vaccine clinical trials per year, was facing issues with enrolling patients rapidly in a tight time frame using email. To access a more effective strategy to better engage patients, JCCT employed two-way SMS/text messaging solutions, and this study assessed the impact of SMS/text messaging on patient recruitment and enrollment.
MedicalResearch: What are the main findings?
Response: Overall, SMS/text messaging alone produced an immediate response that resulted in more optimized clinical trial enrollment outcomes in comparison to JCCT’s previous experiences using email. JCCT remarked that the response was five times the response compared to e-mail and that enrollment results exceeded the trial sponsor’s expectations.
Use of two-way SMS/text messaging achieved a 1% increase in research subjects enrolled for every 1.5% increase in text messages sent. Over an 8-week enrollment period, a total of 1,541 text messages sent resulted in screening of 795 patients and enrollment of 265 patients.
MedicalResearch: What should clinicians and patients take away from your report?
Response: This case study suggests that two-way text messaging through a strategic and interactive patient engagement platform is an effective tool to captivate potential study participants by reaching them on the mobile devices they carry. JCCT found that patients responded positively to receiving SMS/Text Messages.
In this case, we have found that two-way SMS/Text Messaging solutions enable researchers to enroll patients in clinical trials. It is important to emphasize that IT systems utilization in clinical trials require validated systems that are HIPAA and 21 CFR Part 11 compliant; the two-way SMS system we used was validated for clinical trial use.
It is also important to note that FCC regulations require that any SMS/text message recipient opt in to receiving SMS from the deliverer. Many study sites have patient email lists; I recommend that study sites consider building their own SMS/text message database, so that they can send mobile communications to patients and comply with FCC regulations. Taking the effort now can save study sites time in the long run, while boosting enrollment performance, and available technologies can facilitate the process.
For example, the Mosio platform used by JCCT in the case study includes technology and tools to assist with developing communications content that can convert patients to opt in to receiving SMS/text messages, such as opt-in web widgets, opt-in wording templates in consent forms, and opt-in email blast templates to send out to existing patient databases.
Further, I want to indicate that many patients tend to respond to SMS/text messages by texting back with questions and more information. Mosio’s technological platform is capable of having interactive and automated conversations with patients, which can be used to qualify patients while enhancing patient engagement and reducing the work burden on study sites.
MedicalResearch: What recommendations do you have for future research as a result of this study?
Response: This real-world case study, conducted during an actual vaccine clinical trial, strongly suggests that a bilateral two-way SMS/text messaging platform can boost trial recruitment, with implications for cost savings, study timing and quality of results. Future prospective studies should compare SMS/text messaging with other common recruiting approaches via random subject assignment to groups to quantify levels of response with each approach and its resulting effectiveness and cost efficiency.
New approaches will be key in meeting trial retention, compliance and adherence challenges. In rigorous investigational product trials, non-adherence rates of 20%-30% require a 50% increase in sample size to maintain equivalent statistical power, while a 50% non-adherence rate requires a 200% increase in sample size.5
Conducting additional studies to evaluate the impact of SMS/Text Messages on medication adherence and other areas such as patient retention, study compliance, appointment reminders, and patient reported outcomes data collection will bring us closer to finding useful and cost effective solutions in clinical trials.
- Frost & Sullivan 2010, Epsilon 2009
- Use of mobile telephone short message service as a reminder: the effect on patient attendance, Sumanth Prasad and Richa Anand, International Dental Journal 2012; 62: 21-26
- Sahar Khonsari, et al., Effect of a reminder system using an automated short messaging service on medication adherence following acute coronary syndrome. Eur J Cardiovasc Nurs. published 02, February 2014
- Smith, Dorothy PharmD, Patient Nonadherencein Clinical Trials: Could There Be a Link to Post Marketing Patient Safety?, Consumer Health Information Corporation, October2011
Text Messaging Enhances Clinical Trial Enrollment with Mobile Solutions from Mosio
Applied Clinical Trials
Publish date: Nov 3, 2014