Determining the Impact of a Medication Delivery Unit on Medication Adherence of Adults With Common Cardiac Conditions

NCT01600677 | Terminated Results DMC

• 1 other identifier: 0031272
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Medication Adherence; Medication Nonadherence; Adverse Reaction to Drug

Keywords

Experimental; Computerized medication delivery unit

Outcome Measures

Primary Outcomes (1)

• Medication Adherence

  Will be measured by: (number of doses/ doses scheduled; EMMA (intervention) vs. determined by manual monthly pill counts (control))

  90-day

Secondary Outcomes (2)

• Medication-reconciliation Errors During Transition From Hospital to Home

  90-day

• Hospital Readmission Rates

  30 day

Study Arms (2)

Computerized medication delivery unit

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

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

Interventions

Computerized medication delivery unit DEVICE

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.

Also known as: Electronic Medication Management Assistant (EMMA)

Computerized medication delivery unit

Usual care OTHER

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.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18 years of age.
• Admitted during the study period for a nonpsychiatric condition to UPMC Presbyterian Hospital.
• Documented in their medical record with a common cardiac condition.
• Prescribed \> 3 and \< 20 regularly scheduled (i.e., non-PRN) prescription medications.
• 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).
• Reside within a predefined geographic radius of the hospital (specifically, Allegheny, Beaver, Butler, Fayette, Washington or Westmoreland Counties).
• Have a working telephone.
• Be English-speaking.
• Have an informal caregiver or support person.
• Evidence of unintentional medication non-adherence

You may not qualify if:

• Have an active prescription for narcotic analgesic.
• Enrolled in or plan to enroll into hospice care.
• Plans to travel during the next 90 days following discharge for \>/= 14 consecutive 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 service data plan based on physical address.
• Evidence of intentional medication non-adherence.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Presbyterian Hospitl

Pittsburgh, Pennsylvania, 15213, 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

Limitations and Caveats

We terminated the study early after exhausting all possible approaches to increasing participant enrollment.

Results Point of Contact

• Title: Steven M. Handler, MD, PhD
• Organization: UPittsburgh

handler@pitt.edu

412-864-1878

Study Officials

• Steven M. Handler, MD, PhD, CMD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: May 17, 2012
• Study Start: May 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 26, 2016
• Results First Posted: August 26, 2016

Record last verified: 2016-08

Locations

US (1)