Interactive Medication Reconciliation By Secure Messaging

NCT01564446 | Unknown Phase 1 DMC

• 1 other identifier: 2580
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

Background and Significance: Adverse drug events (ADE) are the most common of all healthcare associated adverse events. Transitions between inpatient and ambulatory care can lead to ADE and avoidable healthcare utilization affecting up to 20% of patients. Insufficient monitoring has been identified as a particularly common cause of preventable and ameliorable ADE. The Joint Commission for Accreditation of Healthcare Organizations (JCAHO) has called for a process to "accurately and completely reconcile medications across the continuum of care." Inpatient computerized medication reconciliation tools have shown great potential, but little is known about successful medication reconciliation strategies immediately post-discharge. One promising solution to outpatient medication reconciliation is the use of secure electronic communication (SEC) between patients, accessing their personal health record via a web portal, and providers within an electronic health record. Surveys have consistently found that patients want to communicate with their primary care providers via SEC, and SEC is rapidly becoming a standard feature in electronic health records. A SEC-based approach to outpatient medication reconciliation following hospital discharge has the potential to improve patient safety, but important questions must be addressed, including: What information needs to be included in the SEC? What elements of the SEC are essential to its design? How can SEC be best incorporated into the workflow of the primary care office practice? Will patients and physicians find this approach acceptable? To address these questions, we propose a one-year pilot study at VA Boston with the following specific aims: Aim 1: To evaluate the primary care environment's receptivity to secure electronic communication (SEC) for medication reconciliation and design a prototype SEC. We will use qualitative methods to characterize the primary care clinic environment - the physical space and facilities, the workflow, the resources, as well as the knowledge, attitudes and skills of staff and, most importantly, the patients. Specific approaches will include in-depth interviews, direct ethnographic observations, and visualization methods Aim 2. To develop a prototype SEC for medication reconciliation through a participatory design process, involving primary care clinicians, staff and patients working collaboratively with the research team, and to test the usability and acceptability of the prototype SEC among a sample of patients and primary care clinicians. Research and Development Plan: With extensive experience in designing and evaluating health care informatics innovations, we have assembled a multi-disciplinary team with expertise from primary care internal medicine, clinical informatics, health services research, qualitative research, clinical pharmacy, nursing and industrial engineering. This team will carry out a formative evaluation and develop a prototype of a secure electronic message to facilitate medication reconciliation following hospital discharge. The proposed CIMIT project will leverage the resources and expertise of the e-Health QUERI (a national VA program for innovation and evaluation of the VA's e-Health programs) at VA Boston and other participating VA facilities nationwide. The figure below shows a very rough conceptualization of the SEC that will guide the qualitative research and participatory design of the prototype. This project will lay the foundation for a future rigorous evaluation of this approach to medication reconciliation and improving patient safety.

Conditions

Rate of Post-discharge Medication Adherence

Keywords

medication; discharge; adherence; compliance; secure message

Outcome Measures

Primary Outcomes (1)

• post-discharge medication adherence

  The degree to which patients are adhering to the medication regimen prescribed following an inpatient stay.

  one year

Study Arms (1)

secure message regarding post-discharge medication

EXPERIMENTAL

Participants will be sent a secure message to confirm compliance with post-discharge medication.

Other: Participants will receive a internet based secure message confirming adherence to post-discharge medication regimen

Interventions

Participants will receive a internet based secure message confirming adherence to post-discharge medication regimen OTHER

Participants will receive a internet based secure message via My HealtheVet (MHV), The VA's online medical record and secure messaging portal. The message will specify post-discharge prescribed medications and inquire about adherence to these medications.

Also known as: My HealtheVet

secure message regarding post-discharge medication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Staff at Jamaica Plain and West Roxbury VA.
• Trained in use of secure messaging.
• Over 18.
• Receive medical care at the Jamaica Plain or West Roxbury VA.
• Over 18.
• Inpatient at West Roxbury VA.
• Home computer access.

You may not qualify if:

• N/A
• Non-ambulatory
• Not receiving medical care at Jamaica Plain or West Roxbury VA.
• Non-inpatient.
• No home computer access.

Sponsors & Collaborators

• VA Boston Healthcare System: lead
• New England Veterans Engineering Resource Center (VERC): collaborator
• Center for Integration of Medicine & Innovative Technology: collaborator

Study Sites (1)

VA Boston Healthcare System

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Internal Medicine

Study Record Dates

• First Submitted: March 21, 2012
• First Posted: March 27, 2012
• Study Start: April 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: July 1, 2014
• Last Updated: March 27, 2014

Record last verified: 2014-03

Locations

US (1)