NCT02135731

Brief Summary

We are studying patients' abilities to correctly identify the prescription medications they are taking. We are interested in understanding what tools will help patients correctly identify their medications. People participating in this study will be asked to either review a paper printout of their medication list or a computer program with their medications. The program will show the names and pictures of the medications. In either situation, participants will be asked to indicate if they are taking the medications as prescribed. We will then compare reported adherence between each medication review process. Participation may help the program developers improve the product.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2009

Typical duration for not_applicable

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

Study Start

First participant enrolled

February 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2014

Completed
Last Updated

May 12, 2014

Status Verified

May 1, 2014

Enrollment Period

2.8 years

First QC Date

May 8, 2014

Last Update Submit

May 9, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of medication discrepancies from the reference standard

    Baseline

Study Arms (2)

Paper

NO INTERVENTION

Usual care -medication review on paper

Computer

EXPERIMENTAL

Medication review software with pictures

Other: Medication review software with pictures

Interventions

The intervention is a self-service software program that displays each prescription on screen along with an image of the pharmaceutical product. Patients must use response buttons to describe adherence patterns and to advance through the questionnaire items.

Computer

Eligibility Criteria

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

You may qualify if:

  • Veteran with Primary Care appointment at Portland VA
  • Three or more medications in medication profile

You may not qualify if:

  • Visual impairment
  • Upper extremity neuromuscular impairment
  • Cognitive impairment
  • Unable to speak and read English
  • Never been seen at a VA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Portland VAMC

Portland, Oregon, 97239-2999, United States

Location

Related Publications (4)

  • Lesselroth BJ, Felder RS, Adams SM, Cauthers PD, Dorr DA, Wong GJ, Douglas DM. Design and implementation of a medication reconciliation kiosk: the Automated Patient History Intake Device (APHID). J Am Med Inform Assoc. 2009 May-Jun;16(3):300-4. doi: 10.1197/jamia.M2642. Epub 2009 Mar 4.

    PMID: 19261949BACKGROUND
  • Lesselroth BJ, Adams K, Tallett S, Wood SD, Keeling A, Cheng K, Church VL, Felder R, Tran H. Design of admission medication reconciliation technology: a human factors approach to requirements and prototyping. HERD. 2013 Spring;6(3):30-48. doi: 10.1177/193758671300600304.

    PMID: 23817905BACKGROUND
  • Lesselroth BJ, Holahan PJ, Adams K, Sullivan ZZ, Church VL, Woods S, Felder R, Adams S, Dorr DA. Primary care provider perceptions and use of a novel medication reconciliation technology. Inform Prim Care. 2011;19(2):105-18. doi: 10.14236/jhi.v19i2.802.

    PMID: 22417821BACKGROUND
  • Lesselroth BJ, Adams K, Church VL, Tallett S, Russ Y, Wiedrick J, Forsberg C, Dorr DA. Evaluation of Multimedia Medication Reconciliation Software: A Randomized Controlled, Single-Blind Trial to Measure Diagnostic Accuracy for Discrepancy Detection. Appl Clin Inform. 2018 Apr;9(2):285-301. doi: 10.1055/s-0038-1645889. Epub 2018 May 2.

Study Officials

  • Blake Lesselroth, MD, MBI

    PVAMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Portland Patient Safety Center of Inquiry

Study Record Dates

First Submitted

May 8, 2014

First Posted

May 12, 2014

Study Start

February 1, 2009

Primary Completion

December 1, 2011

Study Completion

January 1, 2012

Last Updated

May 12, 2014

Record last verified: 2014-05

Locations