Utilization of the TAD Device for Dispensing Pain Medications in Hospice Patients

Not Applicable

Completed

• Conditions: Medication Adherence; Satisfaction, Personal
• Interventions: Device: TAD

• Registration Number: NCT03940534
• Lead Sponsor: Intent Solutions, Inc.

Brief Summary

A novel device, TAD, has been developed to aid adherence to prescribed regimens and may have a roll in hospice pain management. 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.

Detailed Description

This study is a randomized crossover study in which patients will be randomized to start with or without a mobile device assisting the patient or caregiver in using the device. The investigators aim to enroll 20 patients across 3 sites. Each patient is expected to participate in the study for 12 weeks. After the first 2 weeks of participation, the patient will either begin using the mobile device to assist or will stop using the mobile device for the next 2 weeks. after the initial 4 weeks, the patient will choose to continue with or without using the mobile device.

Study Timeline

• Study Start: 2018-03-09
• Primary Completion: 2019-02-26
• Study Completion: 2019-02-26
• Study First Submitted: 2019-04-29
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-06
• Last Update Submitted: 2019-05-06
• Study First Posted: 2019-05-07
• Last Update Posted: 2019-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• any patient taking morphine ER or Oxycontin on one of three hospice home teams

Exclusion Criteria

• pregnancy
• inability to demonstrate competent use of the device
• age less than 18

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Start with Mobile Device	TAD	-
Start without Mobile Device	TAD	-

Primary Outcome Measures

Name	Time	Method
Missed Doses	through study completion, up to 1 year	The number of missed doses that occurred during the study.
Difference from Scheduled Dosing Time	through study completion, up to 1 year	The time difference between when the patient took the dose and the scheduled time of administration.

Secondary Outcome Measures

Name	Time	Method
Physician Satisfaction: scale of 1 to 5	through study completion, up to 1 year	The physician's satisfaction will be measured on a scale of 1 to 5 (from 1 being extremely dissatisfied to 5 being extremely satisfied). Satisfaction will be assessed with the follow questions: 1. Using the mail order pharmacy get your patient their pain medication?; 2. Your patient's ability to use the TAD device to dispense their pain medication?; 3. Your patient's ability to use the mobile device application with the TAD device? (ONLY when using the mobile application); 4. The ability of the device to increase compliance of the pain medication?; 5. The overall experience of using the TAD device?satisfaction will be measured on a scale of 1 to 5 for satisfaction of using the mail order pharmacy, ease of using the device, ease of using the mobile device, the ability of the device to accurately provide the dose, and overall experience with the device.
Patient Satisfaction: scale of 1 to 5	through study completion, up to 1 year	The patient's satisfaction will be measured on a scale of 1 to 5 (from 1 being extremely dissatisfied to 5 being extremely satisfied). Satisfaction will be assessed with the follow questions: 1. Using the mail order pharmacy to receive your pain medication?; 2. Ease of using the TAD device to dispense your pain medication?; 3. Ease of using the mobile device application with the TAD device? (ONLY when using the mobile application); 4. The ability of the device to provide you the dose of pain medication at the correct time?; 5. The overall experience of using the TAD device?
Nurse Satisfaction: scale of 1 to 5	through study completion, up to 1 year	The nurse's satisfaction will be measured on a scale of 1 to 5 (from 1 being extremely dissatisfied to 5 being extremely satisfied). Satisfaction will be assessed with the follow questions: 1. Using the mail order pharmacy get your patient their pain medication?; 2. Your patient's ability to use the TAD device to dispense their pain medication?; 3. Your patient's ability to use the mobile device application with the TAD device? (ONLY when using the mobile application); 4. The ability of the device to increase compliance of the pain medication?; 5. The overall experience of using the TAD device?

Trial Locations

Locations (1)

Haven: Advanced Illness Care; 🇺🇸 Palatka, Florida, United States