Medication AdherenceEMMANCT01430702
Feasibility of Using a Telemedicine Medication Delivery Unit for Older Adults
A study testing Computerized medication delivery unit (Electronic Medication Management Assistant (EMMA) in people with Medication Adherence and Medication Nonadherence, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Medication Adherence, Medication Nonadherence, Adverse Reaction to Drug
- What is being tested?
- Computerized medication delivery unit (Electronic Medication Management Assistant (EMMA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
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- Have a working telephone.
- Be English speaking.
- Have an informal caregiver or support person.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15260
About this study
Official title: Feasibility of Using a Telemedicine Medication Delivery Unit for Older Adults That Require Medication Assistance During Transition Form Hospital to Home
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.
Read the 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.
- Being tested
- Computerized medication delivery unit (Electronic Medication Management Assistant (EMMA)
- Medical subject headings
- Medication Adherence, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized medication delivery unit (Electronic Medication Management Assistant (EMMA)Device
Also called Electronic Medication Management Assistant (EMMA)
The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. The EMMMA 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. The EMMA will remain in the patient's home for a period of 30-days immediately following hospitalization. After 30 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit from the MDU, while addressing the transition period when medication-reconciliation problems are most common.
| Study group | Role | What they receive |
|---|---|---|
| Computerized medication delivery unit | Experimental | Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with a computerized medication delivery unit for use in their homes for the 30-day period following discharge. Receives: Device: Computerized medication delivery unit (Electronic Medication Management Assistant (EMMA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
medication adherence
The investigators will assess adherence by determining the number of regularly scheduled medications taken vs. prescribed (data will come from the EMMA® Report software).
Measured: 30-day
Secondary outcomes (2)
medication-reconciliation errors during transition from hospital to home
Finally, the investigators will measure medication-reconciliation errors using the Medication Discrepancy Tool (MDT).
Measured: 30-day
acceptability and usability of the EMMA® telemedicine medication delivery unit
The investigators will assess acceptability and usability of the EMMA® telemedicine medication delivery unit through a previously validated instrument developed by the The Quality of Life Technology (QoLT) Center at Carnegie Mellon University.
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven M. Handler, MD, PhD, CMD, Principal investigator, University of Pittsburgh -- of the Commonwealth System of Higher Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430702
- Sponsor's protocol ID
- FY2010-007
- Acronym
- EMMA
- Status last verified
- Jan 2013
- First submitted
- 1 Sep 2011
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Using a Telemedicine Medication Delivery Unit for Older Adults That Require Medication Assistance During Transition Form Hospital to Home
- ClinicalTrials.gov ID
- NCT01430702
- Acronym / sponsor ID
- EMMA / FY2010-007
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 8 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computerized medication delivery unit | Experimental | Device: Computerized medication delivery unit (Electronic Medication Management Assistant (EMMA)Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with a computerized medication delivery unit for use in their homes for the 30-day period following discharge. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized medication delivery unit (Electronic Medication Management Assistant (EMMA)Also: Electronic Medication Management Assistant (EMMA)The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. The EMMMA 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. The EMMA will remain in the patient's home for a period of 30-days immediately following hospitalization. After 30 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit from the MDU, while addressing the transition period when medication-reconciliation problems are most common. | Device | Computerized medication delivery unit |
Primary outcome
medication adherence
Time frame: 30-day
The investigators will assess adherence by determining the number of regularly scheduled medications taken vs. prescribed (data will come from the EMMA® Report software).
2 secondary outcomes
medication-reconciliation errors during transition from hospital to home
Time frame: 30-day
acceptability and usability of the EMMA® telemedicine medication delivery unit
Time frame: 30-day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven M. Handler, MD, PhD, CMD principal investigator
University of Pittsburgh -- of the Commonwealth System of Higher Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized medication delivery unit (Electronic Medication Management Assistant (EMMA) in people with Medication Adherence and Medication Nonadherence, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
medication adherence (time frame: 30-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.