Solving Clinical Trial Patient Communication Challenges
- Forgotten Study Visits
- Non-Compliance (Medication Adherence)
- Misunderstood Expectations/Information
- Inefficient Communications
- Lack of Feeling Appreciated
- Appointment Reminders
- Dosing Reminders
- Information Delivered in Real-Time
- Positive Messaging, Incentives
- Automated Messaging and Responders
- Improve Patient-Centricity
Improve Patient Engagement Without Mobile Apps
Mobile App Management is a Problem
- Discoverability (100,000 mHealth apps in the app store)
- Device Variation (108 mobile phone brands, hundreds of types)
- Operating Systems (22 mobile operating systems currently)
- Version Control (27 different version of Android alone)
Text Messaging is Ubiquitous
- 98% of mobile phones have text messaging.
- It’s the “app” on nearly every mobile phone.
- Text messaging is the number one data service in the world.
Why Text Messaging In Research?
Email and phone calls are not as effective for engaging patients.
- 23% of phone calls go straight to voicemail.
- 30% of voicemails linger unheard for 3 days or longer.
- 90% of emails are spam.
Text messaging enables patients to use their own mobile devices.
- 91% of mobile users keep phones within arm’s reach 24/7.
- 90% of text messages are opened and read within 3 minutes.
- Text messaging is the most-used channel on mobile phones.
With text messaging, there is nothing to download, no app versions to update, and no device “tech support” requirements by research staff.
Benefits to Sponsors
BYOD (Bring Your Own Device)
- Cost efficient, no phones to provision.
- User friendly, patients know how to use their own phones.
- Accessible to everyone on every mobile device.
- Dosing reminders.
- Improve site visit and appointment attendance.
- ePRO link delivery with “nudge” completion reminders.
- Automated messages and reminders.
- Easy subject enrollment for study staff.
- Pre-scheduled coordinator check-ins to improve engagement.
21 CFR Part 11 and HIPAA
FDA 21 CFR Part 11
Mosio is compliant to FDA 21 CFR PART 11 along with supplemental documents:
– Guidance For Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application
– Guidance for Industry Computerized Systems Used in Clinical Investigations.
Mosio meets the needs of clients and regulation in critical specified areas such as: role based limited access, validation, data protection, data retrievability, audit trials, date/time stamps, and system training documentation. Data backup and production systems are in geo-diverse locations for added protection. Mosio adheres to a defined SDLC and Quality Policy for ongoing updates and customer support.
Hosted on HIPAA-compliant servers. All data collected by the Mosio platform (PHI or non-PHI) receives the same safeguards for security, privacy and breach notification applied to our clients covered under HIPAA rules and stipulated by a client BAA.
Medication Adherence and Compliance Reminders
Keep tight dosing schedules and ensure desired actions are completed.
Medication adherence or compliance reminders help patients stay “on task” with protocol requirements.
Notifications are sent via text message. Patients can then login to the Patient Engagement Portal (PEP) for additional private information or to have two-way communications with the site regarding dosage administration.
Ensure Patients are Informed and Compliant:
- Reminder and confirmation of dosage administration.
- Recording of taken and missed doses.
- Tracking of other medications being taken.
- Guides or instructions on taking medications properly.
- Code phrase messaging for patient privacy.
- Quick access to helpful information.
- Secure, two-way messaging for the patient to ask questions.
Fix your “no show” rate.
- Merge Field™ technology enables you to inject patient (or study coordinator) first names in the message.
- Schedule single appointments or in batches.
- “Nudge” reminders can be sent for non-responses.
- Notifications to study staff when cancellations occur for quick rescheduling.
“The solution offered unprecedented benefits in operational efficiency including a 91.6% reduction in resources used to remind patients of their study screening visits, and an ability to optimize study screening department resources because of visit confirmations.”
– Quintiles Case Study (published in Applied Clinical Trials)
Support, encourage, and motivate.
Automated coordinator check-ins are the perfect way to keep patients engaged without additional work required from study staff. For example, monthly messages can be pre-scheduled and personalized using a study coordinator’s name, automating outreach.
- Improve the feeling of value by showing subject appreciation.
- Automating study coordinator outreach.
- Keep patient contact information up to date.