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

Primary Purpose

Drug-Related Side Effects and Adverse Reactions, Adverse Drug Events

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SMMRT
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Drug-Related Side Effects and Adverse Reactions focused on measuring Medications, Hospitalization, Electronic medical records

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Usual care

SMMRT

Arm Description

Usual care delivered at VA Boston

Receives Usual Care PLUS SMMRT Intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hospital Utilization
Hospital utilization, defined as re-admissions or emergency department utilization, within 30 days of hospital discharge.

Full Information

First Posted
June 23, 2015
Last Updated
October 27, 2020
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02482025
Brief Title
The Secure Messaging for Medication Reconciliation Tool (SMMRT) Trial
Acronym
SMMRT
Official Title
The Secure Messaging for Medication Reconciliation Tool (SMMRT) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 16, 2018 (Actual)
Primary Completion Date
October 22, 2019 (Actual)
Study Completion Date
June 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug-Related Side Effects and Adverse Reactions, Adverse Drug Events
Keywords
Medications, Hospitalization, Electronic medical records

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care delivered at VA Boston
Arm Title
SMMRT
Arm Type
Active Comparator
Arm Description
Receives Usual Care PLUS SMMRT Intervention
Intervention Type
Other
Intervention Name(s)
SMMRT
Intervention Description
Includes My HealtheVet registration and enrollment
Primary Outcome Measure Information:
Title
Medication Discrepancies
Description
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
Time Frame
30 days after hospitalization
Secondary Outcome Measure Information:
Title
Hospital Utilization
Description
Hospital utilization, defined as re-admissions or emergency department utilization, within 30 days of hospital discharge.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy M Linsky, MD MSc
Organizational Affiliation
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not sharing individual patient data.
Citations:
PubMed Identifier
35921139
Citation
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.
Results Reference
derived

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The Secure Messaging for Medication Reconciliation Tool (SMMRT) Trial

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