Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT01600677 |
| Other study ID # |
0031272 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
May 14, 2012 |
| Last updated |
August 18, 2016 |
| Start date |
May 2012 |
| Est. completion date |
May 2013 |
Study information
| Verified date |
August 2016 |
| Source |
University of Pittsburgh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Institutional Review Board |
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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
expenses associated with recruiting, training, and retaining care transition healthcare
professionals; 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 determine the impact of the INRange Systems Electronic
Medication Management Assistant (EMMA) medication delivery unit (MDU) for adults that
require medication assistance in their home immediately following an acute hospitalization
with a diagnosis of a common cardiac condition. As part of this study, we will determine:
(1) Medication adherence rates (# doses/doses scheduled; EMMA (intervention) vs. determined
by manual monthly pill counts at days 1, 45 and 90 (control)); (2) Health service
utilization; (3) Health economic assessment from health plan and societal perspectives; (4)
Medication administration errors; (5) Patient experience and satisfaction; (6) Medication
reconciliation errors (using medication discrepancy tool); (7) 30-day readmission rates; and
(8) Factors related to continued use of the EMMA MDU.
Study Overview and Design: The research study design associated with this proposal is a
randomized controlled trial (RCT) design. The primary endpoint is to compare medication
adherence of adult patients recently hospitalized with a diagnosis of congestive heart
failure who require medication assistance either by receiving usual care (i.e., the control
group; take medications as they had before hospitalization) or by using a medication
delivery unit (i.e., the intervention group; take medications only from the device, which
will always differ from the usual way in which medications were taken prior to
hospitalization).
Study duration: The overall study will last a total of 12 months. Each subject will be
enrolled for a period of 90 days regardless of unit of randomization (i.e., control/usual
care vs. intervention).
Subject Recruitment: One-hundred and sixty patients > 18 years old who are admitted to UPMC
Presbyterian Hospital will be considered as potential study participants. Records of these
patients will be pre-screened within 24 hours of admittance using inclusion and exclusion
criteria that can be assessed without direct patient contact.
Participants who pass the initial/exclusion criteria will be visited by the Research
Assistant following agreement by the patient's attending physician. The Research Assistant
will introduce the goals and design of the study, take informed consent, and complete the
remaining exclusion instruments, MMSE, CAM, the test of the medication delivery unit
interface, and questions regarding subjects' travel and hospice plans.
Detailed Description of Research Activities to be Performed: Following administrative
medical record review by the UPMC Case Manager for review of the inclusion and exclusion
criteria, a potential subject's attending physician will be contacted to review the
patient's study eligibility. If the attending is in agreement with the information collected
by the UPMC Health Plan Case Manager, the patient will be eligible to be consented by the
Research Assistant.
The Research Assistant will then approach the patient to explain the entire research project
and obtain written and oral informed consent. Once informed consent is obtained, an
enrollment questionnaire will be completed, which consists of the following components: 1)
Medication adherence using the MMAS-4 (Morisky 4-Item Self-Report Measure of
Medication-Taking Behavior) and CRN-2 (Cost-related non-adherence); 2) Cognitive status
assessment using the MMSE; 3) Delirium assessment using the CAM; 4) EMMA Medication Delivery
Unit proficiency testing; 5) Demographics and appointment scheduling. If the patient does
not meet any of the additional exclusion criteria contained within the enrollment
questionnaire, the patient will be considered to be enrolled in the study.
Randomization process: Subjects meeting all inclusion and exclusion criteria will randomized
based on the number of medications that are prescribed: > 5 medications (polypharmacy group)
or < 5 medications (non-polypharmacy group). Once a determination that a patient is in the
polypharmacy or non-polypharmacy group, the research assistant will select a sequentially
numbered envelope from either the polypharmacy or non-polypharmacy envelope stack. The
envelope will contain a randomization sequence number that determines if the patient will be
enrolled in the control or intervention group.
Discharge Planning and Transitional Care Control group: For those enrolled in the
intervention group, the UPMC Health Plan will work with RxPartners LTC (wholly owned
subsidiary of UPMC) to perform a medication regimen review and complete a "cost out" for
patients who are expected to leave within 24 hrs. For those enrolled in the control group,
the patient will be discharged from the hospital, but get their medications dispensed
through RXPartners in traditional pill bottles. They will then continue to manage their
medications in the same way that they had been prior to the study which may include taking
medications directly from pill bottles or from a pill-box/reminder system.
Intervention group: For those enrolled in the intervention group, the UPMC Health Plan will
work with RxPartners LTC (wholly owned subsidiary of UPMC) to perform a medication regimen
review and complete a "cost out" for patients who are expected to leave within 24 hrs. The
medication regimen review ensures that the currently prescribed medications are available to
RxPartners and can be loaded and dispensed in the EMMA medication delivery unit (MDU). Only
solid form medications of a certain size and shape can be packaged in the required
blister-packs. The cost out procedure ensures that the insurance company will allow a
medication to be filled potentially before the usual refill date (i.e., obtain a new
prescription for a previously prescribed medication that already has an existing supply). We
will also determine if the research study has funds sufficient to cover the
federally-mandated collection of co-pays for newly dispensed medications. If the medication
regimen review is deemed appropriate AND there are sufficient research resources to pay the
patient's co-pay, then the patient will be retained in the study. The patient will then be
asked to complete the EMMA Enrollment Questionnaire to ensure proper communication and
scheduling of medication drops based on the patient's preferences. Finally, the patient will
complete the Emed appointment information and reminder sheet to ensure appropriate in-home
follow-up following discharge.
As part of the previously established medication reconciliation process in use at
Presbyterian Hospital, the final medication list will be faxed to RxPartner's secure fax
server. RxPartners will then dispense, blister pack, load an EMMA medication delivery unit,
and print patient-specific medication information. Once all medications have been loaded,
RxPartners will use their existing courier system to deliver the EMMA MDU and the
patient-specific medication information directly to the patient's home M-F, located in a
predefined geographic radius within 6 hours. RxPartners will also set up the EMMA MDU in the
patient's home, and ensure that it can communicate with the INRange Systems server using its
built-in wireless modem. If it cannot connect for whatever reason, the machine can be
plugged directly into an analog phone line, previously determined to be present.
In summary, all medications being used in this project are medications that have been
prescribed for clinical care by the patients' attending physicians. The only research
portions are the use of the EMMA MDU and the specific research assessments described in this
proposal. All other aspects of this proposal are being done for clinical care.
Follow-up Procedures:
Within 72 hours of hospital discharge, an EMS Care Transition Coach will visit all patients
(regardless of control or intervention assignment) in their home based on their time
preference. The primary goal of the home visit is to reconcile all of the patient's
medication regimens (e.g., pre-hospitalization and post-hospitalization medications,
over-the- counter medications, and medications prescribed to someone else that the patient
is taking).
The Medication Discrepancy Tool will be used between the research team members to
communicate possible problems but will not be given to the patient. For each potential
medication discrepancy, we will directly contact and clarify the medication regimen with the
patient's primary care provider (PCP) or Cardiologist. The coach will also confirm that the
patient will be seen by his or her PCP within 7 days.
Additional follow-up procedures for the control and intervention group are detailed below:
Control group: An EMS Care Transition Coach will perform medication adherence and safety
assessments, as well as home-based prevention and disease management for common cardiac
conditions. Medication adherence will be determined in the control groups at days 1 (along
with medication reconciliation), 45 and 90 (along with the exit-interview) through the use
of a manual pill count procedure. If significant medication safety issues are noted during
the day 45 visit, including improper storage, labeling, administration, and non-compliance
to entire medication regimen, the UPMC Health Plan Case Manager will be contacted to
potentially intervene. At the day 45 visit, the EMS Care Transition Coach will also conduct
home-based prevention and disease management for common cardiac conditions using materials
developed by the American Heart Association (AHA) Answers by Heart Fact Sheets.
Intervention group: At the day 45 visit, the EMS Care Transition Coach will conduct
home-based prevention and disease management for common cardiac conditions using materials
developed by the American Heart Association (AHA) Answers by Heart Fact Sheets.
Additionally, throughout the study the EMMA MDU has the ability to detect medication
adherence in real-time. Therefore, we will program that the EMMA MDU generate an alert email
to the UPMC Health Plan Case Manager who will be assigned to the patient upon discharge.
This is a different UPMC Case Manager then the one that might have seen the patient in the
hospital setting. Case managers are typically assigned to high-risk patients, such as those
that we have enrolled with medication adherence problems. We will operationalize medication
non-adherence as follows: 1) <80% overall medication adherence OR 2) >/= 2 missed doses of
the same medication.
During the course of the study, if a new medication is needed, RxPartners will be
responsible for blister-packing the medication (in the intervention group) or dispensing in
traditional pill bottles, and either couriering it to the patient within 6 hours or
delivering non-urgent medications through overnight-mail.
