NCT02289469

Brief Summary

Medication safety is an important concern in hospital Emergency Departments (EDs), which provide approximately 136 million patient visits annually in the US. An accurate list of the patient's medications is often needed to inform medical decision-making. Moreover, health care facilities are required to provide patients with an accurate, reconciled list of their medications upon completion of the visit. However, for 37-87% of patients in the ED, errors are present in the documented medication list, and patients often leave without an updated list of their medications or a good understanding of their self-care instructions. This increases the risk of harmful adverse drug events. Health disparity populations, who are more likely to seek care in EDs and who more often have difficulty providing a complete medication history, are disproportionately affected. Health information technology has the potential to improve medication safety in this setting. PictureRx is an internet-based platform designed to improve medication management in vulnerable populations. It allows users to generate illustrated medication lists in an easily-understood, patient-centered format, in either English or Spanish. The investigators have developed a process for importing prescription fill data from the Surescripts Medication History service, which covers 96% of US pharmacies, into the PictureRx platform. The investigators are developing a mobile tablet PC-based medication history platform that receives and processes the Surescripts data, as well as prompts verification and additional information about the medication regimen. This trial will assess the effect of the PictureRx medication history platform on the accuracy and efficiency of the medication reconciliation process, as well as patient understanding and satisfaction, in hospital Emergency Departments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
488

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

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

November 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

July 7, 2017

Completed
Last Updated

July 7, 2017

Status Verified

July 1, 2017

Enrollment Period

11 months

First QC Date

November 9, 2014

Results QC Date

February 15, 2017

Last Update Submit

July 5, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Changes/Updates in Medication List

    Participants for whom nurses made updates or corrections to the medication history in electronic health record

    1 day

Secondary Outcomes (1)

  • Patient Understanding

    1 week

Study Arms (2)

PictureRx

EXPERIMENTAL

PictureRx medication history platform

Other: PictureRx medication history platform

Usual care

NO INTERVENTION

Usual medication history process

Interventions

Tablet PC-based tool to take more complete and accurate medication history

PictureRx

Eligibility Criteria

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

You may qualify if:

  • Prescribed one or more prescription medications

You may not qualify if:

  • Too ill to complete informed consent process

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnatti

Cincinnati, Ohio, 45267, United States

Location

Results Point of Contact

Title
Dr. Dane Boyington
Organization
SAI Interactive

Study Officials

  • Dane Boyington, Ph.D.

    PictureRx, LLC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

November 9, 2014

First Posted

November 13, 2014

Study Start

April 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

July 7, 2017

Results First Posted

July 7, 2017

Record last verified: 2017-07

Locations