Trial Outcomes & Findings for Determining the Impact of a Medication Delivery Unit on Medication Adherence of Adults With Common Cardiac Conditions (NCT NCT01600677)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

90-day

Results posted on

2016-08-26

Participant Flow

During the study period, between May 15, 2012 and March 1, 2013, potentially eligible subjects were recruited at UPMC Presbyterian and UPMC Passavant Hospitals. Study eligibility was determined by electronic medical record review and bedside assessment.

Participant milestones

Participant milestones
Measure	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. 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.	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. 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.
Overall Study STARTED	7	4
Overall Study COMPLETED	7	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Computerized Medication Delivery Unit n=7 Participants 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. 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.	Usual Care n=4 Participants 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: 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.	Total n=11 Participants Total of all reporting groups
Age, Continuous	62.5 Years STANDARD_DEVIATION 12.4 • n=5 Participants	71.1 Years STANDARD_DEVIATION 13.5 • n=7 Participants	68.0 Years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 90-day

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

Outcome measures

Outcome measures
Measure	Computerized Medication Delivery Unit n=7 Participants 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. 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.	Usual Care n=4 Participants 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: 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.
Medication Adherence	97.5 percentage of medication adherence Standard Deviation 3.9	87.2 percentage of medication adherence Standard Deviation 15.0

SECONDARY outcome

Timeframe: 90-day

Using the previously validated and reliable medication discrepancy tool (MDT)

Outcome measures

Outcome measures
Measure	Computerized Medication Delivery Unit n=7 Participants 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. 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.	Usual Care n=4 Participants 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: 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.
Medication-reconciliation Errors During Transition From Hospital to Home	0 Participants with errors	0 Participants with errors

SECONDARY outcome

Timeframe: 30 day

Determine the percentage of patients that are readmitted to the hospital within 30 days of discharge

Outcome measures

Outcome measures
Measure	Computerized Medication Delivery Unit n=7 Participants 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. 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.	Usual Care n=4 Participants 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: 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.
Hospital Readmission Rates	0 % readmissions	0 % readmissions

Adverse Events

Computerized Medication Delivery Unit

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steven M. Handler, MD, PhD

UPittsburgh

Phone: 412-864-1878

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place