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Determining the Impact of a Medication Delivery Unit on Medication Adherence of Adults With Common Cardiac Conditions (EMMA-RCT)

This study is currently recruiting participants.
Verified May 2012 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Steven M Handler, MD, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01600677
First received: May 14, 2012
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
  Purpose

The research study is a randomized controlled trial (RCT). The primary endpoint is to compare medication adherence of adult patients recently hospitalized with a diagnosis of common cardiac conditions who require medication assistance either by receiving usual care or by using a medication delivery unit. The overall study will last a total of 12 months. Each subject will be enrolled for a period of 90 days.


Condition Intervention
Medication Adherence
Medication Nonadherence
Adverse Reaction to Drug
 Device: Computerized medication delivery unit
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Determining the Impact of a Medication Delivery Unit on Medication Adherence Immediately Following Hospitalization of Adults With Common Cardiac Conditions

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • medication adherence [ Time Frame: 90-day ] [ Designated as safety issue: No ]
    Will be measured by: (number of doses/ doses scheduled; EMMA (intervention) vs. determined by manual monthly pill counts (control))


Secondary Outcome Measures:
  • medication-reconciliation errors during transition from hospital to home [ Time Frame: 90-day ] [ Designated as safety issue: No ]
    Using the previously validated and reliable medication discrepancy tool (MDT)

  • hospital readmission rates [ Time Frame: 30 day ] [ Designated as safety issue: No ]
    Determine the percentage of patients that are readmitted to the hospital within 30 days of discharge


Estimated Enrollment: 160
Study Start Date: May 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (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 an EMMA MDU for use in their homes for the 90-day period immediately following discharge.
 Device: Computerized medication delivery unit
The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA 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. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common.
Other Name: Electronic Medication Management Assistant (EMMA)
No Intervention: Usual care
Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.
 Other: Usual care
Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients > 18 years of age.
  2. Admitted during the study period for a nonpsychiatric condition to UPMC Presbyterian Hospital.
  3. Documented in their medical record with a common cardiac condition.
  4. Prescribed > 3 and < 20 regularly scheduled (i.e., non-PRN) prescription medications.
  5. Be from and return to a home setting (not to an assisted living or skilled nursing facility, or to a program for all-inclusive care of the elderly, etc).
  6. Reside within a predefined geographic radius of the hospital (specifically, Allegheny, Beaver, Butler, Fayette, Washington or Westmoreland Counties).
  7. Have a working telephone.
  8. Be English-speaking.
  9. Have an informal caregiver or support person.
  10. Evidence of unintentional medication non-adherence

Exclusion Criteria:

  1. Have an active prescription for narcotic analgesic.
  2. Enrolled in or plan to enroll into hospice care.
  3. Plans to travel during the next 90 days following discharge for >/= 14 consecutive days.
  4. Participating in another research protocol.
  5. Have evidence in the chart of a diagnosis of active delirium.
  6. Have evidence in the chart of a diagnosis of dementia.
  7. Have evidence in the chart of legal blindness.
  8. Unable to demonstrate appropriate use of the EMMA medication delivery unit.
  9. Unable to receive ATT wireless service data plan based on physical address.
  10. Evidence of intentional medication non-adherence.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01600677

Contacts
Contact: Steven M. Handler, MD, PhD, CMD 412-648-6060 handler@pitt.edu

Locations
United States, Pennsylvania
UPMC Presbyterian Hospitl Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Steven M. Handler, MD, PhD, CMD     412-648-6060     handler@pitt.edu    
Principal Investigator: Steven M. Handler, MD, PhD, CMD            
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Steven M. Handler, MD, PhD, CMD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Steven M Handler, MD, PhD, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01600677     History of Changes
Other Study ID Numbers: 0031272
Study First Received: May 14, 2012
Last Updated: May 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Experimental; Computerized medication delivery unit

Additional relevant MeSH terms:
Drug Toxicity
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on May 16, 2013