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Feasibility of Using a Telemedicine Medication Delivery Unit for Older Adults (EMMA)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01430702
First received: September 1, 2011
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Medication Adherence
Medication Nonadherence
Adverse Reaction to Drug
Device: Computerized medication delivery unit (Electronic Medication Management Assistant (EMMA)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Feasibility of Using a Telemedicine Medication Delivery Unit for Older Adults That Require Medication Assistance During Transition Form Hospital to Home

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • medication adherence [ Time Frame: 30-day ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30-day ] [ Designated as safety issue: No ]
    Finally, the investigators will measure medication-reconciliation errors using the Medication Discrepancy Tool (MDT).

  • acceptability and usability of the EMMA® telemedicine medication delivery unit [ Time Frame: 30-day ] [ Designated as safety issue: No ]
    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.


Enrollment: 0
Study Start Date: September 2011
Study Completion Date: April 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Computerized medication delivery unit
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.
Device: Computerized medication delivery unit (Electronic Medication Management Assistant (EMMA)
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.
Other Name: Electronic Medication Management Assistant (EMMA)

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430702

Locations
United States, Pennsylvania
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15260
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Steven M. Handler, MD, PhD, CMD University of Pittsburgh -- of the Commonwealth System of Higher Education
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01430702     History of Changes
Other Study ID Numbers: FY2010-007
Study First Received: September 1, 2011
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on November 25, 2014