Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pharmacists and Pharmacy Technicians to Improve Admission Medication History Accuracy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Josh Pevnick, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT02026453
First received: December 31, 2013
Last updated: February 5, 2015
Last verified: February 2015
  Purpose

We will test two interventions to improve the accuracy of medication histories obtained at hospital admission. The interventions will target elderly and chronically ill patients prone to erroneous medication histories and resultant medication errors. For targeted patients, we will test the effect of using pharmacists and pharmacy technicians to obtain an initial medication history. This will be 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.

Our overarching hypothesis is that by leveraging pharmacists and pharmacy technicians we can minimize admission medication history errors and related downstream events.


Condition Intervention Phase
Adverse Drug Events
Other: Pharmacist obtains admission medication history
Other: Pharmacy technician obtains admission medication history
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Pharmacists and Pharmacy Technicians to Improve Admission Medication History Accuracy

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Medication History Errors, or Medication Order Errors [ Time Frame: within 48 hours of hospital admission ] [ Designated as safety issue: Yes ]
    The project was originally funded to measure the effect of these interventions on medication history errors. We are currently applying for more funding which would allow us to use the more meaningful, more downstream outcome of medication order errors, and this will become the primary outcome if funding for such is received.


Enrollment: 283
Study Start Date: January 2014
Estimated Study Completion Date: May 2015
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual care
Physicians and nurses obtain admission medication history.
Experimental: Pharmacist obtains home med hx
Pharmacist obtains admission medication history, although usual care practices may also continue.
Other: Pharmacist obtains admission medication history
Experimental: Pharm tech obtains home med hx
Pharmacy technician obtains admission medication history, although usual care practices may also continue.
Other: Pharmacy technician obtains admission medication history

Detailed Description:

At a large university-affiliated hospital, we conducted an IRB-approved, pragmatic randomized trial with informed consent waived.

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; excluded if admitted to pediatric or trauma services or transplant services with pharmacists.

All arms received usual care for patients admitted from the emergency department. This included RNs obtaining AMHs, and natural variation in checking, correcting and ordering from these AMHs by admitting providers. In the two intervention arms, PSPTs and pharmacists obtained initial AMHs. They contacted family, pharmacies,and/or providers to resolve questions. As per prior studies, we obtained reference standard AMHs from all patients (usually one day after admission), and initial AMH errors were independently rated by >=2 pharmacists as significant, serious, or life-threatening. These three error severities were assigned 1, 4, and 9 points, respectively. We calculated weighted error scores for each patient, and mean scores/pt for each arm. We had 80% power to identify arms with higher/lower scores of >=11.2/patient.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Patients were excluded (supersedes inclusion criteria) if admitted to pediatric or trauma services or transplant services with pharmacists.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02026453

Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Joshua M Pevnick, MD, MSHS Cedars-Sinai Health System
  More Information

No publications provided

Responsible Party: Josh Pevnick, Assistant Professor, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02026453     History of Changes
Other Study ID Numbers: KL2TR000122-00032874
Study First Received: December 31, 2013
Last Updated: February 5, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Adverse drug events

ClinicalTrials.gov processed this record on March 03, 2015