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PictureRx: Improving Medication Safety in Health Disparity Populations

PictureRx: Improving Medication Safety in Health Disparity Populations

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02289469
Enrollment
488
Registered
2014-11-13
Start date
2015-04-30
Completion date
2016-03-31
Last updated
2017-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medication Reconciliation

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.

Interventions

OTHERPictureRx medication history platform

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

Sponsors

University of Cincinnati
CollaboratorOTHER
PictureRx, LLC
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Prescribed one or more prescription medications

Exclusion criteria

* Too ill to complete informed consent process

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Changes/Updates in Medication List1 dayParticipants for whom nurses made updates or corrections to the medication history in electronic health record

Secondary

MeasureTime frameDescription
Patient Understanding1 weekAssessment of patient understanding of their medication regimen using 4 questions: 1. I understand what medicines I am supposed to take. 2. I understand how much medicine I am supposed to take at a time. 3. I understand what time of day to take each of my medicines. 4. I understand what each of my medicines is for. Participants had the following response options: Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree Due to formatting restrictions on this site and the results being nearly identical for each question, only answers to question 1 are reported below.

Countries

United States

Participant flow

Pre-assignment details

A total of 250 patients were enrolled into the intervention group. However, only 244 patients could be matched to suitable controls, and 6 were therefore excluded from the analysis of results. Thus the number of patients recruited was 494 (250 intervention + 244 control), but results are presented for 488 (244 intervention + 244 control).

Participants by arm

ArmCount
PictureRx
Participants in the intervention group interacted with the PictureRx medication history platform on a tablet computer to provide information about their medications and verify their list of prescribed medications
244
Usual Care
Patients in the usual care group were matched on a 1:1 basis with intervention patients, on the basis of having received care in the same area of the Emergency Department by the same nurse. Their medication information was collected in the usual fashion by interview.
244
Total488

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyUnable to match a control60

Baseline characteristics

CharacteristicPictureRxUsual CareTotal
Age, Continuous41 years
STANDARD_DEVIATION 13
41 years
STANDARD_DEVIATION 16
41 years
STANDARD_DEVIATION 15
ESI acuity level
2
32 Participants32 Participants64 Participants
ESI acuity level
3
102 Participants102 Participants204 Participants
ESI acuity level
4
96 Participants97 Participants193 Participants
ESI acuity level
5
14 Participants13 Participants27 Participants
Race/Ethnicity, Customized
American Indian or Alaskan Native
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Asian
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Black or African American
144 Participants151 Participants295 Participants
Race/Ethnicity, Customized
Hispanic
1 Participants13 Participants14 Participants
Race/Ethnicity, Customized
White or Caucasian
94 Participants71 Participants165 Participants
Region of Enrollment
United States
244 Participants244 Participants488 Participants
Sex: Female, Male
Female
136 Participants113 Participants249 Participants
Sex: Female, Male
Male
108 Participants131 Participants239 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 2440 / 244
serious
Total, serious adverse events
0 / 2440 / 244

Outcome results

Primary

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

Time frame: 1 day

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PictureRxNumber of Participants With Changes/Updates in Medication List101 Participants
Usual CareNumber of Participants With Changes/Updates in Medication List43 Participants
Comparison: A chi-square test was used to test for differences in proportions between intervention and control groups.p-value: <0.000195% CI: [16, 31.6]Chi-squared
Secondary

Patient Understanding

Assessment of patient understanding of their medication regimen using 4 questions: 1. I understand what medicines I am supposed to take. 2. I understand how much medicine I am supposed to take at a time. 3. I understand what time of day to take each of my medicines. 4. I understand what each of my medicines is for. Participants had the following response options: Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree Due to formatting restrictions on this site and the results being nearly identical for each question, only answers to question 1 are reported below.

Time frame: 1 week

Population: A convenience sample of 50 intervention patients was contacted by phone approximately 1 week after Emergency Department discharge to rate their understanding of their medication regimen.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
PictureRxPatient UnderstandingDisagree0 Participants
PictureRxPatient UnderstandingStrongly Disagree0 Participants
PictureRxPatient UnderstandingNeutral1 Participants
PictureRxPatient UnderstandingAgree3 Participants
PictureRxPatient UnderstandingStrongly Agree46 Participants
Comparison: Descriptive statistics (counts, frequencies) were used to summarize responses.p-value: <0.01Other

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026