Feasibility of Using a Telemedicine Medication Delivery Unit for Older Adults (EMMA)
Primary Purpose
Medication Adherence, Medication Nonadherence, Adverse Reaction to Drug
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized medication delivery unit (Electronic Medication Management Assistant (EMMA)
Sponsored by
About this trial
This is an interventional supportive care trial for Medication Adherence
Eligibility Criteria
Inclusion Criteria:
- Patients > 65 years of age.
- Admitted during the study period for a nonpsychiatric condition to UPMC Presbyterian Hospital.
- Documented in their medical record at least 1 of 11 diagnoses, including: stroke, congestive heart failure, coronary artery disease, cardiac arrhythmias, chronic obstructive pulmonary disease, diabetes mellitus, spinal stenosis, hip fracture, peripheral vascular disease, deep venous thrombosis, and pulmonary embolism.
- Prescribed > 5 and < 20 regularly scheduled (i.e., non-PRN) prescription medications.
- Be from and return to a home setting (not assisted living, skilled nursing, program for all-inclusive care of the elderly, etc).
- Reside within a predefined geographic radius (i.e., Allegheny, Beaver, Butler, Fayette, Washington or Westmoreland Counties) of the hospital.
- Have a working telephone.
- Be English speaking.
- Have an informal caregiver or support person.
Exclusion Criteria:
- Have an active prescription for narcotic analgesic.
- Enrolled in or plan to enroll into hospice.
- Plans to travel in the next 30 days.
- Participating in another research protocol.
- Have evidence in the chart of a diagnosis of active delirium.
- Have evidence in the chart of a diagnosis of dementia.
- Have evidence in the chart of legal blindness.
- Unable to demonstrate appropriate use of the EMMA medication delivery unit.
- Unable to receive ATT wireless services data plan based on physical address.
Sites / Locations
- UPMC Presbyterian Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Computerized medication delivery unit
Arm Description
Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with a computerized medication delivery unit for use in their homes for the 30-day period following discharge.
Outcomes
Primary Outcome Measures
medication adherence
The investigators will assess adherence by determining the number of regularly scheduled medications taken vs. prescribed (data will come from the EMMA® Report software).
Secondary Outcome Measures
medication-reconciliation errors during transition from hospital to home
Finally, the investigators will measure medication-reconciliation errors using the Medication Discrepancy Tool (MDT).
acceptability and usability of the EMMA® telemedicine medication delivery unit
The investigators will assess acceptability and usability of the EMMA® telemedicine medication delivery unit through a previously validated instrument developed by the The Quality of Life Technology (QoLT) Center at Carnegie Mellon University.
Full Information
NCT ID
NCT01430702
First Posted
September 1, 2011
Last Updated
January 14, 2013
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT01430702
Brief Title
Feasibility of Using a Telemedicine Medication Delivery Unit for Older Adults
Acronym
EMMA
Official Title
Feasibility of Using a Telemedicine Medication Delivery Unit for Older Adults That Require Medication Assistance During Transition Form Hospital to Home
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Withdrawn
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Care transition interventions have been successful in reducing medication-related problems and associated rehospitalization primarily by focusing on medication reconciliation conducted by trained healthcare professionals. Programs to improve the medication reconciliation process have largely been effective, but have limitations including the expense associated with recruiting, training, and retaining care transition healthcare professionals (e.g., nurses and nurse practitioners) the ability to provide services within a finite geographic area, and the retrospective nature of the reconciliation process which usually occurs in the home following hospital discharge. Our short-term objective is to use Pennsylvania Department of Aging resources to assess the feasibility of using a telemedicine medication delivery unit for frail older adults that require medication assistance in their home immediately following an acute hospitalization. As part of this feasibility assessment, the investigators will assess (1) recruitment process and procedures, (2) data collection procedures, (3) resource utilization, (4) drop-out rates, (5) acceptability and usability of the EMMA® telemedicine medication delivery unit, (6) medication adherence, and (7) medication-reconciliation errors during transition from hospital to home.
Detailed Description
Care transition interventions have been successful in reducing medication-related problems and associated re-hospitalization primarily by focusing on medication reconciliation conducted by trained healthcare professionals. Medication reconciliation is the process of identifying discrepancies in drug regimens prescribed in different care settings or at different time points within the same setting, to inform prescribing decisions and prevent medication-related problems, including medication errors (MEs) and adverse drug events (ADEs). MEs and ADEs are particularly common during and following hospitalization, when multiple changes to a patients' medication regimens may be accompanied by inadequate patient education,\ follow-up, and continuity of care with primary care physicians and case managers. As a result of these problems, as many as 42% of general medical patients experience an ME or ADE after hospital discharge, with disproportionate impacts on older adults with chronic medical conditions. Post-hospital ADEs can be expensive, as12% result in an emergency department evaluation and 5% in readmission, which is associated with a significant increase in healthcare resource utilization and further fragmentation in care.
Programs to improve the medication reconciliation process have largely been effective, but have limitations including the expense associated with recruiting, training, and retaining care transition healthcare professionals (e.g., nurses and nurse practitioners), the ability to provide services within a finite geographic area, and the retrospective nature of the reconciliation process, which usually occurs in the home following hospital discharge. The investigators short-term objective is to use Pennsylvania Department of Aging resources to assess the feasibility of using a telemedicine medication delivery unit for frail older adults that require medication assistance in their home immediately following an acute hospitalization. As part of this feasibility assessment, the investigators will assess several methods and intervention-related components.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Adherence, Medication Nonadherence, Adverse Reaction to Drug
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Computerized medication delivery unit
Arm Type
Experimental
Arm Description
Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with a computerized medication delivery unit for use in their homes for the 30-day period following discharge.
Intervention Type
Device
Intervention Name(s)
Computerized medication delivery unit (Electronic Medication Management Assistant (EMMA)
Other Intervention Name(s)
Electronic Medication Management Assistant (EMMA)
Intervention Description
The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. The EMMMA identifies each medication automatically - no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. The EMMA will remain in the patient's home for a period of 30-days immediately following hospitalization. After 30 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit from the MDU, while addressing the transition period when medication-reconciliation problems are most common.
Primary Outcome Measure Information:
Title
medication adherence
Description
The investigators will assess adherence by determining the number of regularly scheduled medications taken vs. prescribed (data will come from the EMMA® Report software).
Time Frame
30-day
Secondary Outcome Measure Information:
Title
medication-reconciliation errors during transition from hospital to home
Description
Finally, the investigators will measure medication-reconciliation errors using the Medication Discrepancy Tool (MDT).
Time Frame
30-day
Title
acceptability and usability of the EMMA® telemedicine medication delivery unit
Description
The investigators will assess acceptability and usability of the EMMA® telemedicine medication delivery unit through a previously validated instrument developed by the The Quality of Life Technology (QoLT) Center at Carnegie Mellon University.
Time Frame
30-day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients > 65 years of age.
Admitted during the study period for a nonpsychiatric condition to UPMC Presbyterian Hospital.
Documented in their medical record at least 1 of 11 diagnoses, including: stroke, congestive heart failure, coronary artery disease, cardiac arrhythmias, chronic obstructive pulmonary disease, diabetes mellitus, spinal stenosis, hip fracture, peripheral vascular disease, deep venous thrombosis, and pulmonary embolism.
Prescribed > 5 and < 20 regularly scheduled (i.e., non-PRN) prescription medications.
Be from and return to a home setting (not assisted living, skilled nursing, program for all-inclusive care of the elderly, etc).
Reside within a predefined geographic radius (i.e., Allegheny, Beaver, Butler, Fayette, Washington or Westmoreland Counties) of the hospital.
Have a working telephone.
Be English speaking.
Have an informal caregiver or support person.
Exclusion Criteria:
Have an active prescription for narcotic analgesic.
Enrolled in or plan to enroll into hospice.
Plans to travel in the next 30 days.
Participating in another research protocol.
Have evidence in the chart of a diagnosis of active delirium.
Have evidence in the chart of a diagnosis of dementia.
Have evidence in the chart of legal blindness.
Unable to demonstrate appropriate use of the EMMA medication delivery unit.
Unable to receive ATT wireless services data plan based on physical address.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven M. Handler, MD, PhD, CMD
Organizational Affiliation
University of Pittsburgh -- of the Commonwealth System of Higher Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Presbyterian Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Feasibility of Using a Telemedicine Medication Delivery Unit for Older Adults
We'll reach out to this number within 24 hrs