Rate of Post-discharge Medication Adherence Clinical Trial
— SMMRTOfficial title:
Interactive Medication Reconciliation by Secure Messaging
| Verified date | March 2014 |
| Source | VA Boston Healthcare System |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Federal Government |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 152 |
| Est. completion date | July 2014 |
| Est. primary completion date | April 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria for Staff and Clinicians: - Staff at Jamaica Plain and West Roxbury VA. - Trained in use of secure messaging. Inclusion Criteria for Veteran pre intervention focus groups: - Over 18. - Receive medical care at the Jamaica Plain or West Roxbury VA. Inclusion Criteria for Veteran intervention sample: - Over 18. - Inpatient at West Roxbury VA. - Home computer access. Exclusion Criteria for Staff and Clinicians: Exclusion Criteria for Veteran pre intervention focus groups - Non-ambulatory - Not receiving medical care at Jamaica Plain or West Roxbury VA. Exclusion Criteria for Veteran intervention sample. - Non-inpatient. - No home computer access. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
| Country | Name | City | State |
|---|---|---|---|
| United States | VA Boston Healthcare System | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| VA Boston Healthcare System | Center for Integration of Medicine & Innovative Technology, Veterans Engineering Resource Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | post-discharge medication adherence | The degree to which patients are adhering to the medication regimen prescribed following an inpatient stay. | one year | Yes |