Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(Terminated on 2/28/13, low enrollment; last participant med visit 5/13/13.)
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: October 23, 2014
Last verified: October 2014
  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


Enrollment: 17
Study Start Date: May 2012
Study Completion Date: May 2013
Primary Completion Date: February 2013 (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)
Active Comparator: 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
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: NCT01600677

Locations
United States, Pennsylvania
UPMC Presbyterian Hospitl
Pittsburgh, Pennsylvania, United States, 15213
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: October 23, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 27, 2014