NCT02482025

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed
3.4 years until next milestone

Study Start

First participant enrolled

November 16, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2020

Completed
5 months until next milestone

Results Posted

Study results publicly available

November 19, 2020

Completed
Last Updated

November 19, 2020

Status Verified

October 1, 2020

Enrollment Period

11 months

First QC Date

June 23, 2015

Results QC Date

October 27, 2020

Last Update Submit

October 27, 2020

Conditions

Keywords

MedicationsHospitalizationElectronic medical records

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Hospital Utilization

    30 days

Study Arms (2)

Usual care

NO INTERVENTION

Usual care delivered at VA Boston

SMMRT

ACTIVE COMPARATOR

Receives Usual Care PLUS SMMRT Intervention

Other: SMMRT

Interventions

SMMRTOTHER

Includes My HealtheVet registration and enrollment

SMMRT

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Cognitive impairment (as determined by the Callahan screener)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Boston, Massachusetts, 02130, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Results Point of Contact

Title
Steven R. Simon, MD
Organization
VA Greater Los Angeles Healthcare System

Study Officials

  • Amy M Linsky, MD MSc

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2015

First Posted

June 25, 2015

Study Start

November 16, 2018

Primary Completion

October 22, 2019

Study Completion

June 10, 2020

Last Updated

November 19, 2020

Results First Posted

November 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Not sharing individual patient data.

Locations