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Not listed Phase 1 Interventional

Interactive Medication Reconciliation By Secure Messaging

ClinicalTrials.gov ID: NCT01564446

Public ClinicalTrials.gov record NCT01564446. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Interactive Medication Reconciliation by Secure Messaging

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01564446
Recruitment status
Not listed
Study type
Interventional
Phase
Phase 1
Lead sponsor
VA Boston Healthcare System
Federal
Enrollment
152 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2011
Primary completion
Mar 31, 2013
Completion
Jun 30, 2014
Last update posted
Mar 26, 2014

2011 – 2014

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
VA Boston Healthcare System Boston Massachusetts 02130

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01564446, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 26, 2014 · Synced Sep 6, 2026

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