Depending on how closely you follow politics, you might remember that the Obama campaign used text messaging quite successfully in 2008. Most famously, the campaign used a text message to announce Obama’s VP pick to people that had previously opted to receive messages.
In addition to building a lot of buzz, the announcement of VP over text turned out to be a highly successful grassroots organizing tool. Approximately 3 million people chose to receive text messages, allowing the Obama campaign to repeatedly mobilize (no pun intended) supporters via their mobile phones.
I recently became acquainted with a company that is bringing mobile solutions to the clinical research space. As it turns out, the team responsible for Obama’s text solution in 2008 is the same team behind this new company, Omniscience Mobile. They have some interesting mobile products, and I’d love to get some feedback, particularly from those that deal with patients directly.Omniscience Mobile offers three products: Omnicast, Omnipal, and Omnipro. I’ll describe each of them in more detail below.
Omnicast
Omnicast allows you to add a mobile call-to-action to your existing advertising. Potential patients enter the shortcode from your ad and they get a response confirming their interest in your study.
Then they answer pre-defined eligibility questions via text. If patients qualify, the appropriate research site is forwarded the information via a secure file. Alternatively, the Omnicast software can also call the research site and immediately connect it with the potential research participant. This demo is helpful for understanding the process:
The inclusion of a text message call-to-action has the potential to improve response rate. Because people often have different preconceptions or preferences, some will respond to a particular call-to-action better than another. A segment of the population would respond quite well to a text message call-to-action, and that segment would likely skew younger. In addition, I would not be surprised if the novelty factor of text messaging for study information also encouraged a better response rate.
Of course, the proof is in the data. It would be interesting to see a study analyzing response rate and enrollment numbers for studies utilizing a text call-to-action. Unfortunately, I didn’t find anything publicly available.
Omnipal
Omnipal sends actionable patient text messages at a designated time, and it supports appointment, medication, and diary reminders. While phone calls are an effective means of improving compliance, they can be extremely time consuming. Open/read rates of text messages hover between 90%-%100, so this solution may offer an efficient and effective alternative.
Given the success of text reminders in other areas of healthcare, there is reason to believe they could be an effective tool for improving patient compliance in clinical research. For example, one study of dermatology patients found that text reminders and information improved patient outcomes.
The research by the Center for Connected Health, Partners’ division that conducts and studies telehealth related initiatives, found that text messages to dermatology patients that reminded individuals to take or apply their medications, as well as provided them with educational information about their ailment, improved patient outcomes.
The 25 patients receiving the daily text messages for six weeks included teenagers and adults, with a mean age of 30.5 years for the group.
At the end of the study, there was a “statistically significant” improvement in the severity of patients’ skin conditions, said Dr. Joseph Kvedar, director of the center.
Omnipro
Omnipro transforms patient mobile phones into mobile diary devices, allowing patients to report information like dosing intervals and adverse events via their phone. The biggest advantage of the Omnipro is that patients would no longer need a secondary device to complete their electronic diaries. And since the diary is on a mobile device, syncing is not necessary.
Omniscience offers three different mobile diary products. First, their text message solution works well for brief diaries. Second, their web solution uses the phone’s mobile browser to reach an interface customized for each device. And third, the app solution uses native applications downloaded to each phone. For patients that do not have a mobile phone, Omniscience will dispense them.
Certainly, this new diary solution has the potential to offer significant advantages over current electronic diary devices, but adoption is likely to be slow. It was several years before the original electronic diaries were widely accepted by the industry. Though the electronic diaries we use now were once innovative, they haven’t notably improved over the years. Mobile phones certainly hold promise for innovation in capture of patient diary data.
What Do You Think?
Do you find any of this technology particularly exciting? Is there anything that concerns you? Please leave your feedback below.
I know there has been some success with text messaging in clinical trials – wondering what the FDA regulations/guidelines are for use of text?
Lu
Good question. I’m not seeing the FDA treat text messaging differently than other forms of communication. So, the standard rules apply regarding regulatory requirements related to patient recruitment, such as IRB approval of text messaging content.
There has been much discussion about text messaging compliance with HIPAA, but I’m not aware of HHS issuing formal guidance or directives on this topic. We designed our systems for HIPAA compliance, particular with regards to how the data is stored in our system, and the controls put in place to user access to our system.
The other major consideration with HIPAA is the patient’s ‘consent’ regarding how the information they provide will be used. The guidance we’ve received is that this formal consent is not required in the case of standard patient recruitment advertising. The respondent to the recruitment advertising is not a ‘patient’ of the study, and (depending on where they see the recruitment advertising) they don’t necessarily assume that they are communicating their information to a Covered Entity. A legal expert on this analogized this to a scenario where two strangers strike up a conversation in a Starbucks about their asthma. Neither one of them expects that information to be protected the way they would if they were communicating with their physician. So, as long as the patient recruitment advertising is not physically located in the provider setting, we don’t have to ask for consent as part of the text messaging dialogue that Rahlyn profiled above.
That stance has been acceptable to our commercial pharma sponsors, but if we did find a case where a consent was deemed as important, I believe that could be achieved simply via text message at the outset of the text messaging dialogue.