The Secure Messaging for Medication Reconciliation Tool (SMMRT) Trial (SMMRT)

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.

Study Overview

• Status: Completed
• Conditions: Drug-Related Side Effects and Adverse Reactions; Adverse Drug Events
• Intervention / Treatment: Other: SMMRT

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.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02130
      • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Veterans age 18 years or older
• Having a VA primary care provider (PCP) at any VA facility in VISN-1
• Planned discharge home (as opposed to another facility)
• Computer and internet access

• Anticipated to be discharged with at least 5 medications.

  • Having a VA PCP will be defined as having seen the provider within the past two years
  • Planned discharge home will be ascertained from the Veteran's nurse; approximately 75% of VA Boston discharges are to home
  • The nurse will also provide number of anticipated discharge medications

Exclusion Criteria:

• Cognitive impairment (as determined by the Callahan screener)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; Usual care delivered at VA Boston
Active Comparator: SMMRT; Receives Usual Care PLUS SMMRT Intervention	Other: SMMRT; Includes My HealtheVet registration and enrollment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Discrepancies	Medication discrepancies (discrepancies between what the patient is taking and what is in the medical record) identified 30 days after hospitalization via telephone interview and review of medical record	30 days after hospitalization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Utilization	Hospital utilization, defined as re-admissions or emergency department utilization, within 30 days of hospital discharge.	30 days

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Amy M Linsky, MD MSc, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Publications and helpful links

General Publications

• Brady JE, Linsky AM, Simon SR, Yeksigian K, Rubin A, Zillich AJ, Russ-Jara AL. The Perceived Effectiveness of Secure Messaging for Medication Reconciliation During Transitions of Care: Semistructured Interviews With Patients. JMIR Hum Factors. 2022 Aug 3;9(3):e36652. doi: 10.2196/36652.

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2018
• Primary Completion (Actual): October 22, 2019
• Study Completion (Actual): June 10, 2020

Study Registration Dates

• First Submitted: June 23, 2015
• First Submitted That Met QC Criteria: June 23, 2015
• First Posted (Estimate): June 25, 2015

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Hospitalization; Medications; Electronic medical records
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: IIR 14-059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Not sharing individual patient data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No