Adverse Drug EventsNCT02026453
Pharmacists and Pharmacy Technicians to Improve Admission Medication History Accuracy
A study testing Pharmacist obtains admission medication history and Pharmacy technician obtains admission medication history in people with Adverse Drug Events, run by Cedars-Sinai Medical Center.
Trial summary
We tested two interventions to improve the accuracy of medication histories obtained at hospital admission. The interventions target elderly and chronically ill patients prone to erroneous medication histories and resultant medication errors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adverse Drug Events
- What is being tested?
- Pharmacist obtains admission medication history and Pharmacy technician obtains admission medication history
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Oct 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
- Accessed via EHR, were: >=10 chronic prescription medications
- History of acute myocardial infarction or congestive heart failure
- Admission from skilled nursing facility
- History of transplant, or active anticoagulant, insulin, or narrow therapeutic index medications.
Who cannot join
- Admitted to pediatric, trauma or transplant services with pharmacists
About this study
We tested two interventions to improve the accuracy of medication histories obtained at hospital admission. The interventions target elderly and chronically ill patients prone to erroneous medication histories and resultant medication errors. For targeted patients, we tested the effect of using pharmacists and pharmacy technicians to obtain an initial medication history. This was studied using a randomized controlled trial of usual care (which involves nurses and physicians) vs usual care + pharmacists vs usual care + pharmacy technicians to obtain an admission medication history.
The overarching hypothesis was that by leveraging pharmacists and pharmacy technicians we can minimize admission medication history errors and related downstream events.
Read the detailed description
Importance: Admission medication history (AMH) errors frequently cause medication order errors and patient harm.
Objective: To quantify AMH error reduction achieved when pharmacy staff obtain AMHs before admission medication orders (AMO) are placed.
Design: Three-arm randomized clinical trial. Setting: Large hospital with community and trainee physicians. Population: 306 enrolled patients with complex medical histories. Interventions: In one intervention arm, pharmacists, and in the second intervention arm, pharmacy technicians obtained initial AMHs prior to admission. They obtained and reconciled medication information from multiple sources. All arms, including the control arm, received usual AMH care. This included common process variation occurring in: accuracy of pre-existing medication histories; nurses' ability to obtain AMHs at hospital admission; and admitting physicians' efforts to verify and order from prior AMHs.
Main Outcomes and Measures: The primary outcome was severity-weighted mean AMH error score. To detect AMH errors, all patients received reference standard AMHs, which were compared with intervention and control group AMHs. AMH errors and resultant AMO errors were independently identified and rated by ≥2 investigators as significant, serious or life-threatening. Each error was assigned 1, 4 or 9 points, respectively, to calculate severity-weighted AMH and AMO error scores for each patient.
- Conditions
- Adverse Drug Events
- Being tested
- Pharmacist obtains admission medication history, Pharmacy technician obtains admission medication history
- Keywords
- Adverse drug events
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist obtains admission medication historyOther
Pharmacy technician obtains admission medication historyOther
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Physicians and nurses obtain admission medication history. |
| Pharmacist obtains home med hx | Experimental | Pharmacist obtains admission medication history, although usual care practices may also continue. Receives: Other: Pharmacist obtains admission medication history |
| Pharm tech obtains home med hx | Experimental | Pharmacy technician obtains admission medication history, although usual care practices may also continue. Receives: Other: Pharmacy technician obtains admission medication history |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Severity-weighted Admission Medication History (AMH) Error Score
The primary outcome was severity-weighted mean admission medication history (AMH) error score which are weighted error counts. Significant, serious, and life-threatening errors count for 1, 4, and 9 points each, respectively. As such, higher scores indicate either more errors or errors of greater severity. The range includes integers starting with 0 (indicating zero errors) up to infinity. To detect AMH errors, all patients received reference standard AMHs, which were compared with intervention and control group AMHs. AMH errors and resultant AMO errors were independently identified and rated by ≥2 investigators as significant, serious or life-threatening.
Measured: Attempted to obtain the day after admission
Secondary outcomes (1)
Mean Severity-Weighted Admission Medication Order (AMO) Error Score
The severity-weighted admission medication order (AMO) error score are weighted error counts. Significant, serious, and life-threatening errors count for 1, 4, and 9 points each, respectively. Higher scores indicate either more errors or errors of greater severity. The range includes integers starting with 0 (indicating zero errors) up to infinity. For each AMH error identified, two physicians independently reviewed the relevant medications ordered at hospital admission in the context of the clinical chart. They classified each AMH error as either resulting in no AMO error, or an AMO error of significant, serious, or life-threatening severity. A third physician adjudicated disagreements. In cases where the admitting physician's knowledge of an AMH error was unclear and the orders clinically reasonable, we determined the AMH error did not lead to any AMO error. Because reviewers needed chart access to determine error severity, there was no practicable way to mask study arm.
Measured: Attempted to obtain the day after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionFeb 2014
- Study completionOct 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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adverse Drug EventsStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Josh Pevnick, Cedars-Sinai Medical Center
- Investigators
- Joshua M Pevnick, MD, MSHS, Principal investigator, Cedars-Sinai Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026453
- Sponsor's protocol ID
- KL2TR000122-00032874
- Other IDs
- K23AG049181-01, KL2TR000122
- Status last verified
- Jan 2018
- First submitted
- 31 Dec 2013
- Last updated
- 22 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pevnick JM, Palmer KA, Shane R, Wu CN, Bell DS, Diaz F, Cook-Wiens G, Jackevicius CA. Potential benefit of electronic pharmacy claims data to prevent medication history errors and resultant inpatient order errors. J Am Med Inform Assoc. 2016 Sep;23(5):942-50. doi: 10.1093/jamia/ocv171. Epub 2016 Jan 17.
PubMed 26911817Nguyen CB, Shane R, Bell DS, Cook-Wiens G, Pevnick JM. A Time and Motion Study of Pharmacists and Pharmacy Technicians Obtaining Admission Medication Histories. J Hosp Med. 2017 Mar;12(3):180-183. doi: 10.12788/jhm.2702.
PubMed 28272596Pevnick JM, Nguyen C, Jackevicius CA, Palmer KA, Shane R, Cook-Wiens G, Rogatko A, Bear M, Rosen O, Seki D, Doyle B, Desai A, Bell DS. Improving admission medication reconciliation with pharmacists or pharmacy technicians in the emergency department: a randomised controlled trial. BMJ Qual Saf. 2018 Jul;27(7):512-520. doi: 10.1136/bmjqs-2017-006761. Epub 2017 Oct 6.
PubMed 28986515
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacists and Pharmacy Technicians to Improve Admission Medication History Accuracy
- ClinicalTrials.gov ID
- NCT02026453
- Acronym / sponsor ID
- KL2TR000122-00032874
- Conditions
- Adverse Drug Events
- Keywords
- Adverse drug events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- Jan 2014
- Primary completion
- Feb 2014 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 3 Jan 2014 (estimated)
- Results
- Posted 6 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We tested two interventions to improve the accuracy of medication histories obtained at hospital admission. The interventions target elderly and chronically ill patients prone to erroneous medication histories and resultant medication errors. For targeted patients, we tested the effect of using pharmacists and pharmacy technicians to obtain an initial medication history. This was studied using a randomized controlled trial of usual care (which involves nurses and physicians) vs usual care + pharmacists vs usual care + pharmacy technicians to obtain an admission medication history.
The overarching hypothesis was that by leveraging pharmacists and pharmacy technicians we can minimize admission medication history errors and related downstream events.
Detailed description
Importance: Admission medication history (AMH) errors frequently cause medication order errors and patient harm.
Objective: To quantify AMH error reduction achieved when pharmacy staff obtain AMHs before admission medication orders (AMO) are placed.
Design: Three-arm randomized clinical trial. Setting: Large hospital with community and trainee physicians. Population: 306 enrolled patients with complex medical histories. Interventions: In one intervention arm, pharmacists, and in the second intervention arm, pharmacy technicians obtained initial AMHs prior to admission. They obtained and reconciled medication information from multiple sources. All arms, including the control arm, received usual AMH care. This included common process variation occurring in: accuracy of pre-existing medication histories; nurses' ability to obtain AMHs at hospital admission; and admitting physicians' efforts to verify and order from prior AMHs.
Main Outcomes and Measures: The primary outcome was severity-weighted mean AMH error score. To detect AMH errors, all patients received reference standard AMHs, which were compared with intervention and control group AMHs. AMH errors and resultant AMO errors were independently identified and rated by ≥2 investigators as significant, serious or life-threatening. Each error was assigned 1, 4 or 9 points, respectively, to calculate severity-weighted AMH and AMO error scores for each patient.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Physicians and nurses obtain admission medication history. |
| Pharmacist obtains home med hx | Experimental | Other: Pharmacist obtains admission medication historyPharmacist obtains admission medication history, although usual care practices may also continue. |
| Pharm tech obtains home med hx | Experimental | Other: Pharmacy technician obtains admission medication historyPharmacy technician obtains admission medication history, although usual care practices may also continue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Accessed via EHR, were: >=10 chronic prescription medications
- History of acute myocardial infarction or congestive heart failure
- Admission from skilled nursing facility
- History of transplant, or active anticoagulant, insulin, or narrow therapeutic index medications.
Key exclusion criteria (1 listed)
- Admitted to pediatric, trauma or transplant services with pharmacists
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 |
|---|---|---|
| Pharmacist obtains admission medication history | Other | Pharmacist obtains home med hx |
| Pharmacy technician obtains admission medication history | Other | Pharm tech obtains home med hx |
Primary outcome
Mean Severity-weighted Admission Medication History (AMH) Error Score
Time frame: Attempted to obtain the day after admission
The primary outcome was severity-weighted mean admission medication history (AMH) error score which are weighted error counts. Significant, serious, and life-threatening errors count for 1, 4, and 9 points each, respectively. As such, higher scores indicate either more errors or errors of greater severity. The range includes integers starting with 0 (indicating zero errors) up to infinity. To detect AMH errors, all patients received reference standard AMHs, which were compared with intervention and control group AMHs. AMH errors and resultant AMO errors were independently identified and rated by ≥2 investigators as significant, serious or life-threatening.
1 secondary outcome
Mean Severity-Weighted Admission Medication Order (AMO) Error Score
Time frame: Attempted to obtain the day after admission
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26911817Pevnick JM, Palmer KA, Shane R, Wu CN, Bell DS, Diaz F, Cook-Wiens G, Jackevicius CA. Potential benefit of electronic pharmacy claims data to prevent medication history errors and resultant inpatient order errors. J Am Med Inform Assoc. 2016 Sep;23(5):942-50. doi: 10.1093/jamia/ocv171. Epub 2016 Jan 17.
- Results publication: PubMed 28272596Nguyen CB, Shane R, Bell DS, Cook-Wiens G, Pevnick JM. A Time and Motion Study of Pharmacists and Pharmacy Technicians Obtaining Admission Medication Histories. J Hosp Med. 2017 Mar;12(3):180-183. doi: 10.12788/jhm.2702.
- Results publication: PubMed 28986515Pevnick JM, Nguyen C, Jackevicius CA, Palmer KA, Shane R, Cook-Wiens G, Rogatko A, Bear M, Rosen O, Seki D, Doyle B, Desai A, Bell DS. Improving admission medication reconciliation with pharmacists or pharmacy technicians in the emergency department: a randomised controlled trial. BMJ Qual Saf. 2018 Jul;27(7):512-520. doi: 10.1136/bmjqs-2017-006761. Epub 2017 Oct 6.
- Individual participant dataSharing planned: No
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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.
Joshua M Pevnick, MD, MSHS principal investigator
Cedars-Sinai Health System
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist obtains admission medication history and Pharmacy technician obtains admission medication history in people with Adverse Drug Events, run by Cedars-Sinai Medical Center.
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 4 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 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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 6 Oct 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?
Mean Severity-weighted Admission Medication History (AMH) Error Score (time frame: Attempted to obtain the day after admission). 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 NCT02026453, which also lists 3 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 22 Feb 2018.