Utilization of the TAD Device for Dispensing Pain Medications in Hospice Patients
Phase: NA
Conditions: Medication Adherence, Satisfaction, Personal
Sponsor: Intent Solutions, Inc.

Cover Page 
 
 
Title: Utilization of the TAD Device for Dispensing Pain Medications in Hospice Patients 
 
 
Date: 3/9/2018 
 

Utilization of the TAD Device for Dispensing Pain Medications in Hospice Patients 
 
Introduction 
 
It is well documented that medication adherence is of great concern in many patients including 
those taking opioid pain medication. Taking medications outside of the prescribed regimen can lead to 
adverse events and can lead to improper adjustments to medication regimens. Additionally, diversion 
issues continue to be a problem with opioid pain medications, and the hospice setting is not devoid of 
these issues in palliation of symptoms including pain. A novel device, TAD, has been developed to aid 
adherence to prescribed regimens and may have a roll in hospice pain management. The TAD device 
collects dose timing information that can help clinicians assess patient compliance and can be 
programmed to dispense a dose in a specific time frame. This device can operate with and without the 
assistance of a mobile device application. However, concerns about the ability of the hospice patient 
population to use the technology exist. 
 
This study aims to assess medication adherence relating to missed doses or improperly timed 
doses with and without the aid of a mobile device as a primary endpoint. Secondary endpoints will be 
patient, nursing, and provider satisfaction. 
 
Inclusion/Exclusion Criteria 
 
Inclusion criteria for the study are any Haven patient taking morphine ER or Oxycontin on one of 
three hospice home teams, Lake City, Palatka, or Gainesville. There will be no gender or racial bias in 
consideration for inclusion. Vulnerable patients will be included in this study as many of our patients 
suffer from dementia and are cognitively impaired. Inclusion in the study of a cognitively impaired 
patient will require the presence of a caregiver that is a legally authorized representative (LAR) of the 
patient. Exclusion criteria are age less than 18 and patient or caregiver inability to demonstrate 
competent use of the TAD device. Also, no pregnant women are under hospice care at Haven as they 
would not be appropriate for hospice. Patients that will be studied will primarily be in their own homes 
but may transition through Haven hospice care centers periodically. A patient’s capacity to consent will 
be determined from the patient’s medical assessment by the patient’s hospice provider. Reassessment 
of the patient’s understanding and willingness will occur with each phone call survey by asking the 
patient if they wish to continue the study. If the patient has been enrolled in the study without the 
capability to consent, the caregiver will be asked at every visit if they wish to continue the study. 
 
The study will aim to accumulate approximately 1600 patient days with 20 patients enrolled 
each for 12 weeks. Three sites will be used, and each should have 6 to 7 patients enrolled. 
 
Methods 
 
Potential subjects will be identified by observing Morphine ER and Oxycontin utilization reports 
at Haven. Once a patient is identified as taking one of these medications, they will be contacted by 
telephone by a study investigator to set up a visit time to discuss the study in the patient’s home or in a 
Haven inpatient care center if the patient is agreeable. All care centers have private rooms and provide a 
confidential environment for discussion. Upon, visiting the patient in person, written informed consent 
will be obtained and the patient will keep a copy for their records. Physicians, ARNPs, and nurses at the 
study sites will receive consent documentation via secure encrypted email but will not be required to 
sign the consent.   

 
Patients will be randomized in a cross-over design to either use the TAD device with a mobile 
device or without a mobile device for 2 weeks, and then, alternate to the opposite group, respectively, 
for an additional 2 weeks. After the initial 4 weeks, patients will be allowed to choose whether or not to 
use the TAD device with or without a mobile device for the remaining 2 months of the study. An 
investigator will then provide patient education on the TAD device using a demonstration device and 
document the patient’s ability to demonstrate proper use of the device. If a patient owns a mobile smart 
phone, the TAD application will run on the patient’s phone. If a patient does not own a mobile device, 
Intent Solutions will provide a mobile device to the patient for use with the TAD device. If the patient or 
caregiver are unable to operate the mobile device application properly after instruction by an 
investigator, the patient will be categorized as “failed” for the mobile device phase of the cross over 
period. Primary outcome data will be collected by Intent solutions from the TAD device. No PHI will be 
obtained by Intent solutions in the data collected. Patient, nursing, and prescriber satisfaction surveys 
will be filled out weekly for each patient for the first 4 weeks and then every 2 weeks thereafter. In the 
event that the patient has a LAR acting on their behalf, the LAR will answer the survey questions. 
 
 
The attending provider for the patient will send a prescription via fax to the mail order 
pharmacy for a 14-day supply. The mail order pharmacy staff will be adequately trained to place tablets 
inside simple gelatin capsules of appropriate size for the purpose of consistent dose delivery size 
pertaining to the TAD device. Also, the pharmacy staff will be trained on all functions of the TAD device 
including data collection. The TAD device filled with the patient’s medication will be mailed to the 
patient 3 days before the last dose of the medication with a return label and packaging for the TAD 
device via second-day delivery so that there is no delay in drug therapy. If the patient has partial fills left 
on the prescription 3 days before the last dose of the medication, the registered nurse will call the mail 
order pharmacy to send another supply of the medication to the patient. When the patient has taken 
the last dose of medication, the patient or caregiver will send the TAD device to the principle 
investigator who will then ship the device back to Intent Solution upon verification that no patient 
information is labeled on the device. If there are no partial fills left, the registered nurse will notify the 
provider to send a new prescription to the mail order pharmacy. Should the device fail for any reason or 
the patient is unable to access the medication using the device, the patient will be categorized as 
“failed” for duration of the study, the registered nurse will contact the provider, and the provider will 
fax a prescription immediately to a local pharmacy for the patient. In this scenario, the registered nurse 
would remove the medication from the TAD device using a proper tool and dispose of the medication 
stored in the device in the Rx Destroyer product. The patient and/or caregiver will witness the disposal 
as part of normal clinical practice when a nurse disposes of medication. The patient would then send the 
TAD device to the principle investigator who will then ship the device back to Intent Solution upon 
verification that no patient information is labeled on the device. If the patient passes away while the 
TAD device still contains medication, the registered nurse will empty the device of medication and send 
the device to the principle investigator who will then ship the device back to Intent Solution upon 
verification that no patient information is labeled on the device. The medication will be disposed of by 
the registered nurse if the nurse attends time of death or if asked by the caregiver. Otherwise, the 
caregiver will be responsible for disposal of the medication as the caregiver becomes the party 
responsible for the medication at the time of death. At the completion of the study or at any point 
during the study the patient chooses to withdraw from participation in the study, the nurse will dispose 
of the medication and send the TAD device to the principle investigator who will then ship the device 
back to Intent Solution upon verification that no patient information is labeled on the device. The 
patient will then have a prescription filled at a local pharmacy for the medication. 
 

Any patient safety issues reported to the investigators as concerns about the study protocol will be 
assessed monthly at the Haven patient safety committee meeting. 
 
Analysis of Results 
 
Demographic information such as birth date, race, sex, and hospice diagnosis will be collected as 
descriptive characteristics of each group. The primary endpoint will be measured as time of the dose 
taken compared to time when the dose was scheduled and whether the dose was completely missed or 
not. A missed dose will be greater than 1 hour before or after the scheduled dosing time. Secondary 
endpoints will evaluate patient, nursing, and physician satisfaction from the weekly survey for trends.  
 
Storage of Data 
 
Data collected by Intent Solutions on the primary outcomes will be sent to the primary investigator via 
encrypted email with document password protection. No PHI will be in this data and all data will be 
referenced to the patient’s study identification number. All data will be recorded and stored on a secure 
network drive with limited user access. Additionally, the files containing research data will be password 
protected. All paper surveys which only contain the patient’s assigned study number and PHI will be 
kept in a locked cabinet in a locked office until completion of the study at which point the paper surveys 
will be destroyed in confidential trash.  
 
Risks and Benefits 
 
The only minimal risk to the patient is that the device could malfunction or the patient may not be able 
to properly operate the device. The process for acquiring the medication is noted above and would 
ultimately not prevent the patient from receiving their medication should the device fail. 
 
The potential benefit to the patient is that the device may aid the patient in taking the medication as 
intended by the provider and prevent missed doses.  
 
Informed Consent 
 
Informed consent will be required for every patient to be enrolled. In the case that the patient suffers 
from dementia and/or is otherwise deemed incapable of consenting by review of the medical records, 
the LAR will provide consent. 
 
Cost/Compensation 
 
There is no cost to the patient, and no patient will receive compensation for participation in the study.