Pharmacists and Pharmacy Technicians to Improve Admission Medication History Accuracy
Primary Purpose
Adverse Drug Events
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pharmacist obtains admission medication history
Pharmacy technician obtains admission medication history
Sponsored by
About this trial
This is an interventional health services research trial for Adverse Drug Events focused on measuring Adverse drug events
Eligibility Criteria
Inclusion criteria:
- 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.
Exclusion criteria:(supersedes inclusion criteria)
- Admitted to pediatric, trauma or transplant services with pharmacists
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Usual care
Pharmacist obtains home med hx
Pharm tech obtains home med hx
Arm Description
Physicians and nurses obtain admission medication history.
Pharmacist obtains admission medication history, although usual care practices may also continue.
Pharmacy technician obtains admission medication history, although usual care practices may also continue.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02026453
First Posted
December 31, 2013
Last Updated
January 23, 2018
Sponsor
Cedars-Sinai Medical Center
Collaborators
National Institutes of Health (NIH), National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT02026453
Brief Title
Pharmacists and Pharmacy Technicians to Improve Admission Medication History Accuracy
Official Title
Pharmacists and Pharmacy Technicians to Improve Admission Medication History Accuracy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
Collaborators
National Institutes of Health (NIH), National Institute on Aging (NIA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Drug Events
Keywords
Adverse drug events
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
306 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Physicians and nurses obtain admission medication history.
Arm Title
Pharmacist obtains home med hx
Arm Type
Experimental
Arm Description
Pharmacist obtains admission medication history, although usual care practices may also continue.
Arm Title
Pharm tech obtains home med hx
Arm Type
Experimental
Arm Description
Pharmacy technician obtains admission medication history, although usual care practices may also continue.
Intervention Type
Other
Intervention Name(s)
Pharmacist obtains admission medication history
Intervention Type
Other
Intervention Name(s)
Pharmacy technician obtains admission medication history
Primary Outcome Measure Information:
Title
Mean Severity-weighted Admission Medication History (AMH) Error Score
Description
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.
Time Frame
Attempted to obtain the day after admission
Secondary Outcome Measure Information:
Title
Mean Severity-Weighted Admission Medication Order (AMO) Error Score
Description
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.
Time Frame
Attempted to obtain the day after admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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.
Exclusion criteria:(supersedes inclusion criteria)
Admitted to pediatric, trauma or transplant services with pharmacists
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua M Pevnick, MD, MSHS
Organizational Affiliation
Cedars-Sinai Health System
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26911817
Citation
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.
Results Reference
result
PubMed Identifier
28272596
Citation
Nguyen 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 Reference
result
PubMed Identifier
28986515
Citation
Pevnick 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.
Results Reference
result
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Pharmacists and Pharmacy Technicians to Improve Admission Medication History Accuracy
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