Medication ReviewNCT02135731
APHID- Primary Care Accuracy Study
A study testing Medication review software with pictures in people with Medication Review, run by Blake Lesselroth at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Review
- What is being tested?
- Medication review software with pictures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veteran with Primary Care appointment at Portland VA
- Three or more medications in medication profile
Who cannot join
- Visual impairment
- Upper extremity neuromuscular impairment
- Cognitive impairment
- Unable to speak and read English
- Never been seen at a VA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: APHID- Sensitivity and Specificity of a Medication Reconciliation Technology - A Primary Care Randomized Controlled Trial
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.
Read the detailed description
The trial compares a paper-based medication adherence questionnaire to an electronic medication adherence questionnaire. Results from each arm will be compared to the ambulatory medication list on file with the clinic and a separate medication review interview conducted by a trained clinician. We intend to compare adherence patterns and medication use discrepancy rates between each approach. This data will help us to determine what strategies work best to solicit an accurate medication history from the patient.
- Conditions
- Medication Review
- Being tested
- Medication review software with pictures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication review software with picturesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Paper | No intervention | Usual care -medication review on paper |
| Computer | Experimental | Medication review software with pictures Receives: Other: Medication review software with pictures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of medication discrepancies from the reference standard
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startFeb 2009
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Medication ReviewStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blake Lesselroth
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, Blake Lesselroth, Portland VA Medical Center
- Investigators
- Blake Lesselroth, MD, MBI, Principal investigator, PVAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135731
- Sponsor's protocol ID
- 08-0308
- Status last verified
- May 2014
- First submitted
- 8 May 2014
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19261949Lesselroth 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.
PubMed 23817905Lesselroth 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.
PubMed 22417821Lesselroth 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.
PubMed 29719884
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APHID- Sensitivity and Specificity of a Medication Reconciliation Technology - A Primary Care Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02135731
- Acronym / sponsor ID
- 08-0308
- Conditions
- Medication Review
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Blake LesselrothUS federal agency
- Study start
- Feb 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 12 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The trial compares a paper-based medication adherence questionnaire to an electronic medication adherence questionnaire. Results from each arm will be compared to the ambulatory medication list on file with the clinic and a separate medication review interview conducted by a trained clinician. We intend to compare adherence patterns and medication use discrepancy rates between each approach. This data will help us to determine what strategies work best to solicit an accurate medication history from the patient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paper | No intervention | –Usual care -medication review on paper |
| Computer | Experimental | Other: Medication review software with picturesMedication review software with pictures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Veteran with Primary Care appointment at Portland VA
- Three or more medications in medication profile
Key exclusion criteria (5 listed)
- Visual impairment
- Upper extremity neuromuscular impairment
- Cognitive impairment
- Unable to speak and read English
- Never been seen at a VA
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 |
|---|---|---|
| Medication review software with picturesThe 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. | Other | Computer |
Primary outcome
Number of medication discrepancies from the reference standard
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2014.
- Background: PubMed 19261949Lesselroth 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.
- Background: PubMed 23817905Lesselroth 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.
- Background: PubMed 22417821Lesselroth 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.
- Derived from this study: PubMed 29719884Lesselroth 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.
Related trials for Medication Review
RecruitingObservational study
A Study to Learn More About the Treatment of People With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Who Received Recombinant ADAMTS13 (rADAMTS13) as Part of the Early Access Program
Thrombotic Thrombocytopenic Purpura (TTP)
Not yet recruiting
Impact of Pharmacotherapy Optimization in Polymedicated Lebanese Older Adults in Primary Health Care Centers
Older Adults (65 Years and Older), Polypharmacy (People Under Treatment With 5 or More Drugs)
Recruiting
An Evaluation of the Impact of Pharmacist Comprehensive Medication Management With Pharmacogenomic Results to Improve Depression Outcomes in Community Pharmacies.
Pharmacogenetics, Depression - Major Depressive Disorder
Active, not recruiting
An Evaluation of the Impact of Pharmacist Personalized Medication Reviews With and Without a Discussion of Pharmacogenomic Results in an Employee Health Program.
Pharmacogenetics, Pharmacogenomic Drug Interaction
Active, not recruitingObservational study
Epidemiology of Antimicrobial-use and Antimicrobial-resistant Infections in Four Hospitals in Thailand
Drug Resistance, Bacterial
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.
Blake Lesselroth, MD, MBI principal investigator
PVAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication review software with pictures in people with Medication Review, run by Blake Lesselroth 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 2 inclusion and 5 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 12 May 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 medication discrepancies from the reference standard (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02135731, which also lists 4 linked publications.
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 12 May 2014.