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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
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Adverse Drug Events focused on measuring Adverse drug events

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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)
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    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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