The Secure Messaging for Medication Reconciliation Tool (SMMRT) Trial
Condition: Drug-Related Side Effects and Adverse Reactions; Adverse Drug Events
MeSH terms: Drug-Related Side Effects and Adverse Reactions
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): SMMRT
Intervention type(s): Other
Intervention description(s): Includes My HealtheVet registration and enrollment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Medications; Hospitalization; Electronic medical records