Patient Retention Management

Communicating with clinical trial patients is MMG’s specialty. With over 17 years of experience in health communications, we are experts in creating messages that resonate with patients. MMG’s clients include 7 of the top 10 pharmaceutical companies in the world. We have an established track record of providing clinical trial communications strategies that meet goals cost-effectively and quickly.

In most Clinical Studies, Patient Retention Management  will employ a two-pronged strategy for retrieving patients lost to follow-up. First, upon receiving available information on lost to follow up patients from study sites, Patient Locator will utilize their expertise to provide current location information on each LTFU patient. After confirming the contact and location data for the patients, MMG will reach out to patients with compelling messages designed to persuade them to return to the study.

Patient Locator’s investigation license allows them access to information databases and other resources that are only available to licensees and law enforcement. Death records are searched through the Social Security Death Index and state and county death indexes are accessed when available.
 

As a licensee, Patient Locator is required by law to maintain strict confidentiality with the

information they receive about a patient. Additionally, MMG is required to protect all information we find about the patient during our search. Patient Locator meets and maintains HIPAA compliance as well as patients’ right to privacy by completing a confidentiality agreement with the study sponsor, securing their mandate to maintain patient confidentiality. The sanctity of HIPAA compliance is secure with Patient Retention Management due to the experience of both MMG and Patient Locator of providing our services under HIPAA guidelines.

In preparation for the patient location process, MMG will work with local and central IRBs for the study sites to obtain the HIPAA waivers required to use patients’ contact information and contact patients directly. Once contact information for patients has been updated or confirmed as current, MMG will contact patients, attempting first via phone, then email, then direct mail. To ensure secure and expedient storage of data, MMG will use an extranet (see "MMGConneCT" below) to collect patients’ last known contact information.

Since our first contact with the lost-to-follow-up patients will be via phone, and will likely require a high volume of outbound calls, MMG will employ its in-house call center. Using customized scripts, MMG’s trained information specialists will contact the patients, determine the reason for their absence from the study, and encourage them to re-enter the study.

MMG’s in-house call center features:

and handling sensitive health privacy issues

• A staff that includes multi-lingual professionals

• A secure technological infrastructure with 100-seat capacity

• Sophisticated reporting capability that allows real-time tracking

MMG will work with your study to develop IRB and client-approved telephone scripts that

respectfully and sensitively determines patients’ reason for leaving the study and assesses their interest or ability to return. The questions will be incorporated into a study-specific database that allows us to track all calls. We will also incorporate FAQs (Frequently Asked Questions) into the script to ensure that all callers receive consistent responses. The outbound calls will be made by information specialists. MMG’s quality control measures for information specialists include protocol training, role-playing, database training, script review, spot-testing, and education and coaching to reinforce and evaluate their readiness. Outcomes will be forwarded to appropriate study sites on a regular basis.
 

MMG observes HIPPA-compliant, industry-specific procedures to ensure confidentiality of patient information, including blinding patient identities, password protection of databases, and regular data backup.

A percentage of patients (each clinical study differs)  will agree to return to the study based on receiving MMG’s phone call. For patients who require further follow-up and have an email address, MMG will write and send a personalized email that addresses our inability to contact them by phone and encourages them to reply.
 

If the patient does not respond to email MMG will make one final attempt via certified mail. The email and certified letter language will be submitted for both sponsor and IRB approval.
 

Endpoints – whether the patient has agreed to return to the study, has an issue with participating in the study or is no longer available to participate – will be reported as they are reached with individual patients. If a patient reports an issue preventing them from returning to the study, MMG will attempt to assist your clinical study in resolving the issue by acting as a liaison between the site and patient.

MMG focuses on strategic problem solving and close working relationships with all project partners. Our goal is to achieve successful performance metrics, to be monitored and shared with your clinical study in weekly reports ensuring that goals are being met. This timely, detailed tracking allows MMG to constantly assess strategy success and adjust implementation as necessary.
 

The metrics we generate allow us to document activities and track their success, keeping the sponsor and sites informed of every step of the campaign. MMG will report on relevant data captured through its, extranet (MMGConneCT), call center database and management database. At the project outset, MMG will confirm our understanding of the data collection and reporting activities that is required by your clinical study. MMG will incorporate these preferences into task-specific standard operating procedures to help guide the activities moving forward, and ensure that expectations are met.
 

MMG recommends implementing a study extranet – MMG ConneCT – for secure and centralized data transfer. MMG’s user-friendly extranet system facilitates task completion by allowing your study and MMG to share information in real time – keeping the process moving forward to meet tight timelines. This tool keeps all study collaborators connected and provides seamless project management and information-sharing capabilities, as real-time data are stored in one place. MMG’s new media team can create an extranet in one week, and will provide a user’s guide and ongoing support to all users during the course of the study.
 

For this project, MMG ConneCT will provide study collaborators with access to:

• IRB approvals tracking information

• Project team contact lists

• Frequently asked questions

• Communications and call notes from interactions among study sites and MMG support team

• Patient recovery tracking as reported by sites

MMG ConneCT will also be used to capture last known contact information of study patients lost to follow-up as reported by Patient Locator. In keeping with good clinical practice, the Study Sponsor will not have access to this information.
 

MMG ConneCT uses 128-bit encryption and two layers of security to protect data and control

access. Access to specific functionality can also be controlled by the user's profile and

permissions. These restrictions are managed using both security levels. For example, study sites are able to use MMG ConneCT to update patient recovery status for their sites only, but a Study Sponsor representative can access this information for all sites.

The Call center database captures data related to outbound calls in terms of:

• Patients called

• Patients reached

• Geographic information

• Reason for leaving the clinical study

• Follow-up action taken (i.e. email or letter)

Patient Retention Management's in-house capabilities through MMG are comprehensive, and our ability to locate and maintain patient location through the specialized expertise of Patient Locator provides a complete service. Depending on your needs, we enroll patients, locate patients, keep in contact with patients, see that they keep in touch with the sites and we report patient retention statistics.

By using Patient Retention Management your clinical study will rely on one site to maintain and regularly report on patient retention. The study sites are no longer burdened with the constant battle to maintain patient retention; with Patient Retention Management the clinical study site can fully focus on the clinical side of the study.

For More Information On
Patient Retention Management

Contact Kirk Rutherford - Patient Locator:
1-800-432-FIND (3463)
kirk@patientlocator.org

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