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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02026453
Other study ID # KL2TR000122-00032874
Secondary ID K23AG049181-01KL
Status Completed
Phase N/A
First received December 31, 2013
Last updated January 23, 2018
Start date January 2014
Est. completion date October 2016

Study information

Verified date January 2018
Source Cedars-Sinai Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 306
Est. completion date October 2016
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pharmacist obtains admission medication history

Pharmacy technician obtains admission medication history


Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Cedars-Sinai Medical Center National Institute on Aging (NIA), National Institutes of Health (NIH)

References & Publications (3)

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. — View 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 ra — View 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Attempted to obtain the day after admission
Secondary 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. Attempted to obtain the day after admission
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