TITLE

Utilization of Medesto™ to Improve Medication Adherence: Protocol for a Non-Randomized Pilot

SPONSOR

Perigon Health 360

340 N Main St., Suite 300 Plymouth, MI 48170 USA

PRINCIPAL INVESTIGATOR

Michael DePaz

OTHER INVESTIGATORS

Chris Antypas, Melissa Marchetti, Elizabeth Petkac

STUDY-RELATED PHONE NUMBERS

Perigon Pharmacy 360™ Support Line  844.698.2533

INTRODUCTION

Thank you for considering participating in the following study: Utilization of Medesto to Improve Medication Adherence: Non-Randomized Study.  This consent form will provide you with additional information on this study for purposes of informing your participation decision. 

Should you elect to participate in the above-referenced study you will be provided a Medesto™ Health Platform which includes a Class-1 medical device medication dispenser which will be used to dispense prescription medication pods fulfilled by Pharmacists at Perigon Pharmacy 360. The medication pod will be filled with your once daily prescribed medication, as is prescribed by your Physician and as identified by you in your completed study intake form. The medication prescribed by your Physician will be filled and delivered to your home by Perigon Pharmacy 360 and is intended to be dispensed using the Class-1 medical device dispenser.  Through the above-referenced study, we will track your medication adherence through our Medesto Health Platform.

If you agree to participate in the above-referenced study we ask that you sign the within consent form and return it to us.  By signing the consent form, you are agreeing that you have read and understand this entire document and have asked us any and all questions you may have concerning your participation in the study. Should you have any questions concerning your participation in the above-referenced study, please contact our Study Support Line at 844.698.2533.

PURPOSE OF THE STUDY

Perigon Health 360 is conducting this study to determine whether the use of the Medesto Health Platform improves medication adherence for patients taking prescription medications, when supported by Perigon Pharmacy 360. To participate in this study, you will need to dispense your medication from the medication dispenser daily for a minimum of 120 consecutive days. 

PROCEDURES

Subject Responsibilities:

While participating in this study, you will need to:

• Be willing and able to follow the study directions and procedures as outlined.
• Have the ability to complete 120 consecutive days (i.e., 4-months) of the study. 
• Upon successful transfer of your prescription from your current pharmacy, and in collaboration with your Physician, allow future prescription refills to be managed through Perigon Pharmacy 360. 
• Inform the Perigon Pharmacy 360 care team about any issues with the Medesto™ Health Platform, the class-1 medical device dispenser, the dispensing of your medication, your use of the Medesto patient application, or any other issues you identify during your participation in the study. 
• Have daily access to an IOS/Android mobile device and Wi-Fi connection for the duration of the study.
• Agree to only use the Medesto Health Platform’s medication dispenser for dispensing your daily prescription(s) within the Perigon Pharmacy 360 medication pods provided, as prescribed by your Physician.

WHAT WILL HAPPEN DURING THE STUDY

Study Procedures:

You will dispense appropriate doses of your prescription regimen throughout the duration of the study at the time prescribed via the medication dispenser.  This will include dispensing your very first dose of your prescription regiment on day 1 of the study. You will receive training reference materials on the device prior to day 1 of the study and can obtain study-related support by contacting our Study Support Line at 844.698.2533.  

Dosing Period:

You will use the medication dispenser to receive your daily prescription regimen for days 1-120 of the study.  

• You will be the only person consuming the prescription medications as prescribed by your physician.  Note: The class-1 medical device dispenser and your prescription medication should be kept out of reach of children and should not be shared with any other person. 
• You should notify the Perigon Pharmacy 360 care team immediately if any of your prescriptions change during the study period or if you have any issues related to your prescriptions. 
• Should you encounter any issues with dispensing your medication through the provided pod or the Class-1 medical device dispenser (ex. not receiving the full regimen, having no medication dispensed, device piercing a used cell, etc.) please contact the Perigon Pharmacy 360 care team immediately by calling: 844-698-2533 for further instructions.

Study Completion:

Your participation in the medication usage portion of the study will be completed on day 120.  A study completion questionnaire will be sent to you on day 121. We ask that you complete the study completion questionnaire promptly following your receipt of the same.  For your reference, our review of information and data derived from your participation in the study will not end on day 120, but rather only your participation in the medication usage portion of the study will end at such time.

TIME DURATION OF THE STUDY

The study will last 120 days. Throughout the duration, your medication adherence will be monitored and managed through Perigon Pharmacy 360.

POTENTIAL SIDE EFFECTS AND RISKS

Similar to any other clinical study, potential risks and side effects may result from your participation in the study and could lead to injury or other harm. While there are no known side effects or risks associated with use of the Medesto Health Platform, the medication dispenser or the medication pod itself, study personnel will be monitoring participants carefully during the study. Potential side effects and risks will vary based on individual attributes, prescription medication, and medication adherence. If you do not understand the potential for risks or side effects or what these terms mean, please consult with the Pharmacists at Perigon Pharmacy 360 to explain these terms to you. 

POTENTIAL BENEFITS OF THE STUDY

There may be no direct benefit to you from this study. The platform adds convenience to do your daily medication regimen, meaning no more pill bottles or sorting medications. The automated reminders and notifications may also result in an improvement in your medication adherence.

PRIVACY AND CONFIDENTIALITY

By signing this informed consent document, you are acknowledging your participation in this study and understand that through the patient app, your information provided will be collected and recorded electronically, and used by Perigon Health 360 and Perigon Pharmacy 360 in the context of the study. Once collected, your personal information will be stored by Perigon Health 360 and Perigon Pharmacy 360 in an anonymous manner. Information and data collected through your participation (such as adherence and journal entry responses) will be made available only to the sponsor of the study for the purposes of evaluation. In the event of any publication or presentation resulting from the study, no personally identifiable information will be shared. Your personal information will not be shared with any third party or any other person except as authorized by applicable law and regulation.

USE OF PRIVATE HEALTH INFORMATION

Health information about you will be collected if you choose to be part of this study. Health information is protected by law, and will be used only as explained in study materials related to health information privacy such as the Perigon Pharmacy 360 Privacy Notice and Medesto App Privacy Notice. If you have not received these notices, please request a copy from the investigator. At Perigon Health 360 your information will only be used or shared as explained and authorized in this consent form or when required by law. It is possible that some of the other people or groups who receive your health information may not be required by Federal privacy laws to protect your information and may share it without your permission. 

To participate in this study, you must allow the study team to use your health information. If you do not want us to use your protected health information, you may not participate in this study.

Your permission for the use, retention, and sharing of your identifiable health information will continue for the period necessary for completion of the study and the preparation of a related follow-up research study.  Once this study and preparation for the follow-up research study are complete, information identifying you will be removed from the study results maintained at Perigon Health 360 and Perigon Pharmacy 360. Any study information in your medical record will be kept indefinitely.

If you choose to participate in this study, you are free to withdraw your permission for the use and sharing of your health information at any time. You must withdraw your permission for the use and sharing of your health information in writing. To do so, please write to Pharmacist in Charge, Michael DePaz, Pharm D, and let him know that you are withdrawing from the study. His mailing address is 250 Mt. Lebanon Blvd. #208, Pittsburgh, PA 15234.

If you withdraw your permission: 

• You will be immediately terminated from and unable to participate in the study;
• We will no longer use or share medical information about you for this study, except when the law allows us to do so;
• We will be unable to take back anything we have already done or any information we have already shared in reliance upon your permission; 
• We may continue using and sharing the information obtained prior to your withdrawal if it is necessary for the soundness of the overall study; and 
• We will keep our records of the care that we provided to you as long as legally required.

By participating in the study you authorize study personnel to use the following sources of health information:

• Clinical Chart Documentation; 
• Laboratory results related to dispensed medication or additional comorbidities;
• Verbal communications from prescribers, patients and caregivers;
• Health plan documentation (i.e., prior authorization documentation, MTM communications, etc.); and
• Health information that can be collected from the original date of diagnosis and ending 90 days after the close of the study.

Representatives of the following people or groups within Perigon Health 360 or Perigon Pharmacy 360 may use your health information and share it with other specific groups in connection with this study:

• The principal investigator, Michael DePaz;
• Perigon Health 360 Financial Analyst for Clinical Research; and
• Others within Perigon Health 360: those part of the study team, the study coordinator who might need to use and/or disclose the participant’s information in connection with this study.

The above people or groups may share your health information with the following people or groups outside Perigon Health 360 and Perigon Pharmacy 360 for their use in connection with this study. These groups, while monitoring the study, may also review and/or copy your original Perigon Pharmacy 360 records: 

• The Office of Human Research Protections in the U. S. Department of Health and Human Services; and
• The Food and Drug Administration.

IN CASE OF STUDY RELATED INJURY

As is the case with any prescription medication, you may experience potential risks or side effects. If complications occur, participants should immediately contact the Perigon Pharmacy 360 care team for further instructions at 844.698.2533. Pharmacists are on call 24 hours a day, 7-days a week, 365 days a year.

LEGAL RIGHTS

You will not lose any of your legal rights by signing this consent form.

COMPENSATION FOR PARTICIPATION

You will not receive any compensation for being in this study.

VOLUNTARY PARTICIPATION

Taking part in this study is voluntary. If you choose to take part in this study, your major responsibilities will be to take your medication as prescribed using the Medesto medication dispenser, maintain Wi-Fi internet connection for your Medesto Medication dispenser, and to maintain a connection between your medication dispenser and the Medesto App on your mobile device. You do not have to participate in this study. If you choose to take part, you have the right to stop at any time. If you decide not to participate or if you decide to stop taking part in the study at a later date, there will be no penalty or loss of benefits to which you are otherwise entitled. 

CONTACT INFORMATION

If you have questions, concerns, or complaints about this study or to report a study related event, contact:

Perigon Pharmacy 360, LLC

844.698.2533 Monday-Friday 9:00a.m.-6:00p.m. (EST)

If you are unable to reach anyone at the number(s) listed above and you need medical attention, please call 911 or go to the nearest emergency room.

SIGNATURE AND CONSENT/PERMISSION TO BE IN THE STUDY

Before making the decision regarding enrollment in this study, you should have:

• Discussed this study with a study investigator or other study personnel; 
• Reviewed the information in this form; and
• Had the opportunity to ask any questions you may have. 

Additionally, by agreeing to participate in this study you are also agreeing that:

• You are not traveling during the 120-day study period, thus preventing you from completing your daily medication regimen pursuant to the study terms.
• If at any time during this period you need to travel, you agree to notify the study staff and take the dispenser with you; and
• You understand that the medication pod is in non-child safe packaging and are agreeing to store it out of the reach of children and other persons.

Participant: By signing this consent form, you indicate that you are voluntarily choosing to take part in this study. 

Your signature below means that you have received this information, have asked questions you currently have about the study, and have received sufficient answers to those questions. You will receive a copy of the signed and dated form to keep for future reference.