Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02482025 |
| Other study ID # |
IIR 14-059 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 16, 2018 |
| Est. completion date |
June 10, 2020 |
Study information
| Verified date |
October 2020 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Medication discrepancies, defined as unintentional differences found between patients'
medical records and patients' reports of the medication they are taking, occur frequently
after hospital discharge, predisposing to adverse drug events (ADEs), emergency department
visits and readmissions. Resolving medication discrepancies - medication reconciliation - is
mandated at every care transition, but little is known about intervention strategies to
improve medication reconciliation in the post-discharge period, when patients may lack prompt
access to primary care and are at high risk for ADEs. To address this gap, the investigators
developed and pilot tested the Secure Messaging for Medication Reconciliation Tool (SMMRT),
with a pharmacist communicating with Veterans to review medications and reconcile
discrepancies after hospital discharge via Secure Messaging (SM), within My HealtheVet (MHV),
VA's patient portal. The objectives of The SMMRT Trial are therefore
To optimize the end-users' experience with SMMRT through usability testing and refinement of
the tool; To conduct a randomized controlled trial (RCT) of usual care vs. usual care plus
MHV Training vs. usual care plus MHV Training plus SMMRT to reduce hospital utilization; To
evaluate how Veterans and staff perceived the impact of SMMRT on routine clinical practices
and, specifically, on Veterans' interactions with their primary care providers.
Description:
Study Procedure of Work Done at Richard L. Roudebush VAMC in Indianapolis
Aim 1 of SMMRT will be conducted at the Human-Computer Interaction & Simulation Laboratory
within the HSR&D Center for Health Information and Communication at the Richard L. Roudebush
VAMC in Indianapolis, IN. The work in Indianapolis will include a formal usability test of
SMMRT to access and improve usability for pharmacists, nurses, and patients. Ten VA
pharmacists, 10 VA nurses, and 10 VA patients will participate in the usability tests in
Indianapolis. They will assess how well the SMMRT interface supports their respective
medication reconciliation tasks. Pharmacists who work for the Roudebush VAMC and have some
responsibility for medication reconciliation in their normal work will be eligible to
participate in the study. Roudebush VAMC nurses who work as part of a Patient Aligned Care
Team (PACT) will be eligible. Eligible patients must be taking at least 5 medications and
must have been discharged from the Roudebush VAMC within the last 30 days. Veterans will be
excluded if they are cognitively impaired, based on the Callahan screener. Patients will be
recruited regardless of prior MHV use. No patients will have previous experience with SMMRT,
as it is a new feature in MHV. Usability testing sessions will be about 30 minutes and will
include audio and video recordings of the computer screen movements and the participant's
face. A standardized script is read to the participants to instruct them to do certain tasks
that will evaluate specific usability issues in the SMMRT. The participants enter reconciled
medications into the SMMRT and the completed work is sent to the research team for analysis.
Although the investigators intend to complete all data collection procedures for Aim 1 at the
Indianapolis VA, the investigators did note in the submitted grant proposal (Section 4.g.1)
that the investigators would recruit (VA) Boston pharmacists for Aim 1 data collection in the
unlikely event that the investigators cannot recruit sufficient numbers from Indianapolis. If
that unlikely contingency arises (i.e., the investigators determine that there is a need to
recruit pharmacists from VA Boston), the investigators will submit an amendment to the VA
Boston IRB with appropriate consent and authorization forms at that time.
Study Procedure of Work at VABHS. The Study has received approval for a Project Modification.
The essential scientific changes of the proposed modification are (1) switching from a
three-arm to a two-arm RCT; (2) changing the main outcome measure from hospital utilization
to medication discrepancies; and (3) reducing the sample size from 1400 to 240 subject. The
second specific aim of the Project will become the following:
Aim 2. To conduct a two-arm RCT to evaluate the effect of SMMRT. This trial will compare
Usual Care (UC) with UC plus the bundled MHV/SMMRT Intervention among Veterans discharged
from the VA Boston Community Living Center (CLC) and from the VA Boston acute inpatient
setting of West Roxbury. The primary outcome measure will be medication discrepancies
detected 30 days after discharge. Secondary outcome measures will be 30-day hospital
utilization (combined readmissions plus emergency department use) and Veterans' self-efficacy
in medication use. The primary hypothesis is that SMMRT will result in a reduction in 30-day
medication discrepancies as compared with UC.
The third specific aim of the Project remains unchanged:
Aim 3. To evaluate the SMMRT intervention for potential future implementation. In
anticipation of future implementation, we will use qualitative methods to identify features
of the intervention that are most and least effective, as well as elements that are most and
least likely to be accepted into clinical practice.
