Clinical trial NCT01430702: Feasibility of Using a Telemedicine Medication Delivery Unit for Older Adults
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
Overall status: WITHDRAWN
Phase: NA
Conditions: Medication Adherence
Medication Nonadherence
Adverse Reaction to Drug
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2011-09-08
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: medication adherence
timeFrame: 30-day
Secondary outcomes:
measure: medication-reconciliation errors during transition from hospital to home
timeFrame: 30-day
measure: acceptability and usability of the EMMA® telemedicine medication delivery unit
timeFrame: 30-day
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh -- of the Commonwealth System of Higher Education
name: Steven M. Handler, MD, PhD, CMD
role: PRINCIPAL_INVESTIGATOR
References: