Rate of Post-discharge Medication Adherence Clinical Trial
Official title:
Interactive Medication Reconciliation by Secure Messaging
Background and Significance: Adverse drug events (ADE) are the most common of all healthcare
associated adverse events. Transitions between inpatient and ambulatory care can lead to ADE
and avoidable healthcare utilization affecting up to 20% of patients. Insufficient
monitoring has been identified as a particularly common cause of preventable and ameliorable
ADE. The Joint Commission for Accreditation of Healthcare Organizations (JCAHO) has called
for a process to "accurately and completely reconcile medications across the continuum of
care." Inpatient computerized medication reconciliation tools have shown great potential,
but little is known about successful medication reconciliation strategies immediately
post-discharge. One promising solution to outpatient medication reconciliation is the use of
secure electronic communication (SEC) between patients, accessing their personal health
record via a web portal, and providers within an electronic health record. Surveys have
consistently found that patients want to communicate with their primary care providers via
SEC, and SEC is rapidly becoming a standard feature in electronic health records. A
SEC-based approach to outpatient medication reconciliation following hospital discharge has
the potential to improve patient safety, but important questions must be addressed,
including: What information needs to be included in the SEC? What elements of the SEC are
essential to its design? How can SEC be best incorporated into the workflow of the primary
care office practice? Will patients and physicians find this approach acceptable? To address
these questions, we propose a one-year pilot study at VA Boston with the following specific
aims:
Aim 1: To evaluate the primary care environment's receptivity to secure electronic
communication (SEC) for medication reconciliation and design a prototype SEC. We will use
qualitative methods to characterize the primary care clinic environment - the physical space
and facilities, the workflow, the resources, as well as the knowledge, attitudes and skills
of staff and, most importantly, the patients. Specific approaches will include in-depth
interviews, direct ethnographic observations, and visualization methods Aim 2. To develop a
prototype SEC for medication reconciliation through a participatory design process,
involving primary care clinicians, staff and patients working collaboratively with the
research team, and to test the usability and acceptability of the prototype SEC among a
sample of patients and primary care clinicians.
Research and Development Plan: With extensive experience in designing and evaluating health
care informatics innovations, we have assembled a multi-disciplinary team with expertise
from primary care internal medicine, clinical informatics, health services research,
qualitative research, clinical pharmacy, nursing and industrial engineering. This team will
carry out a formative evaluation and develop a prototype of a secure electronic message to
facilitate medication reconciliation following hospital discharge. The proposed CIMIT
project will leverage the resources and expertise of the e-Health QUERI (a national VA
program for innovation and evaluation of the VA's e-Health programs) at VA Boston and other
participating VA facilities nationwide. The figure below shows a very rough
conceptualization of the SEC that will guide the qualitative research and participatory
design of the prototype. This project will lay the foundation for a future rigorous
evaluation of this approach to medication reconciliation and improving patient safety.
Adverse drug events (ADE) are the most common of all healthcare-associated adverse events1
and commonly occur after hospitalization when multiple changes to medication regimens take
place in the context of poor patient education, inadequate information transfer and delayed
continuity of care. Medication reconciliation - i.e., any intentional process to resolve
discrepancies between what medications the patient is taking and what medications the health
care team thinks the patient is taking - has been designated a "National Patient Safety
Goal" since 2005.2-6 Recent studies examining inpatient computerized medication
reconciliation tools and pharmacist-facilitated medication reconciliation programs at
hospital discharge have shown promising results. However, little is known about successful
medication reconciliation strategies following discharge, representing an untapped point of
leverage to improve medication safety.
With recently awarded seed funding, and in collaboration with the Department of Veterans'
Affairs (VA) nationwide Medication Reconciliation Initiative, we are developing an
informatics-based tool for medication reconciliation following hospital discharge by secure,
e-mail-like communication: the Secure Messaging for Medication Reconciliation Tool (SMMRT).
In this proposed study, we plan to pilot the SMMRT prototype through My HealtheVet (MHV),
the VA's secure personal health record and web portal, among 50 Veterans at VA Boston, with
the following two Specific Aims:
Specific Aim 1: Refine the existing SMMRT prototype and integrate it into MHV's secure
messaging web-interface, with authentication of secure two-way communication between patient
and primary healthcare team. We will use a participatory and patient-centered process
involving the primary care clinicians, pharmacists, nurses, other staff members and Veterans
working collaboratively with the research team to establish the usability and acceptability
of the prototype SMMRT.
Specific Aim 2: Pilot the SMMRT prototype, refined through Specific Aim 1, among 50 Veterans
with primary care relationships and hospitalized at our facility. Veterans will be recruited
prior to hospital discharge, enrolled in MHV if necessary, and trained in the use of secure
messaging and specifically the SMMRT tool.
This study will benefit from a recently funded preliminary study (Veterans' Engineering
Resource Center seed funding, $25,000), in enabling us to analyze the primary care
environment's receptivity to SMMRT-based post-discharge medication reconciliation, focusing
on staff activation and education, workflow optimization to incorporate staff and clinicians
managing SMMRT's incoming and outgoing messages, and coordination with MHV staff to ensure
continued successful software integration.
This proposed CIMIT-funded study will lead to a refined and strengthened intervention to
enhance the preliminary use of SMMRT, as well as qualitative results that will constitute
the foundation of an investigator-initiated research proposal alongside a full-scale
implementation of SMMRT into MHV for Veterans nationwide.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research