Feasibility of Using a Telemedicine Medication Delivery Unit for Older Adults

NCT01430702 | Withdrawn DMC

• 1 other identifier: FY2010-007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Adherence; Medication Nonadherence; Adverse Reaction to Drug

Outcome Measures

Primary Outcomes (1)

• 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).

  30-day

Secondary Outcomes (2)

• medication-reconciliation errors during transition from hospital to home

  30-day

• acceptability and usability of the EMMA® telemedicine medication delivery unit

  30-day

Study Arms (1)

Computerized medication delivery unit

EXPERIMENTAL

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)

Interventions

Computerized medication delivery unit (Electronic Medication Management Assistant (EMMA) DEVICE

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.

Also known as: Electronic Medication Management Assistant (EMMA)

Computerized medication delivery unit

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Medication Adherence; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Chemically-Induced Disorders

Study Officials

• Steven M. Handler, MD, PhD, CMD

  University of Pittsburgh -- of the Commonwealth System of Higher Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2011
• First Posted: September 8, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: April 1, 2012
• Last Updated: January 16, 2013

Record last verified: 2013-01

Locations

US (1)