Medication ReconciliationNCT02289469
PictureRx: Improving Medication Safety in Health Disparity Populations
A study testing PictureRx medication history platform in people with Medication Reconciliation, run by PictureRx, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Reconciliation
- What is being tested?
- PictureRx medication history platform
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prescribed one or more prescription medications
Who cannot join
- Too ill to complete informed consent process
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Medication Reconciliation
- Being tested
- PictureRx medication history platform
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PictureRx medication history platformOther
Tablet PC-based tool to take more complete and accurate medication history
| Study group | Role | What they receive |
|---|---|---|
| PictureRx | Experimental | PictureRx medication history platform Receives: Other: PictureRx medication history platform |
| Usual care | No intervention | Usual medication history process |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (1)
Patient Understanding
Assessment of patient understanding of their medication regimen using 4 questions:
- I understand what medicines I am supposed to take.
- I understand how much medicine I am supposed to take at a time.
- I understand what time of day to take each of my medicines.
- 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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startApr 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Medication ReconciliationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- PictureRx, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cincinnati
- Responsible party
- Sponsor
- Investigators
- Dane Boyington, Ph.D., Principal investigator, PictureRx, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289469
- Sponsor's protocol ID
- 5R44MD004048-04
- Status last verified
- Jul 2017
- First submitted
- 9 Nov 2014
- Last updated
- 7 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PictureRx: Improving Medication Safety in Health Disparity Populations
- ClinicalTrials.gov ID
- NCT02289469
- Acronym / sponsor ID
- 5R44MD004048-04
- Conditions
- Medication Reconciliation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- PictureRx, LLCUniversity, hospital or other
- Collaborators
- University of Cincinnati
- Study start
- Apr 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 Nov 2014 (estimated)
- Results
- Posted 7 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PictureRx | Experimental | Other: PictureRx medication history platformPictureRx medication history platform |
| Usual care | No intervention | –Usual medication history process |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Prescribed one or more prescription medications
Key exclusion criteria (1 listed)
- Too ill to complete informed consent process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PictureRx medication history platformTablet PC-based tool to take more complete and accurate medication history | Other | PictureRx |
Primary outcome
Number of Participants With Changes/Updates in Medication List
Time frame: 1 day
Participants for whom nurses made updates or corrections to the medication history in electronic health record
1 secondary outcome
Patient Understanding
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dane Boyington, Ph.D. principal investigator
PictureRx, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PictureRx medication history platform in people with Medication Reconciliation, run by PictureRx, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Changes/Updates in Medication List (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2017.