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LabAlert: Enhancing Medication Safety Through Electronic Interventions to Improve Laboratory Monitoring

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00256386
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : November 30, 2006
Garfield Memorial Fund
Information provided by:
Kaiser Permanente

Brief Summary:
Errors and preventable adverse events associated with medication prescription and dispensing are common, and the difference between guideline recommendations and the actual frequency of laboratory monitoring is substantial. This study evaluates three interventions to improve laboratory monitoring at initiation of medication therapy: an electronic medical record reminder to the prescribing clinician (EMR), an automated voice message to the patient (AVM), and a pharmacy team outreach (Pharmacy) compared to usual care (UC).

Condition or disease Intervention/treatment Phase
Safety Device: Electronic Medical Record (EMR) to clinician's in-basket Device: Automated Voice Message (AVM) reminder to patient's phone Procedure: Pharmacy Team phone call-letter followup Not Applicable

Detailed Description:

Many of the medications that clinicians prescribe to prevent or treat disease can result in unanticipated and unintended toxic effects. Many national clinical guidelines recommend baseline and periodic laboratory monitoring to avoid adverse drug events. Our Safety in Prescribing project (SIP) has found many significant gaps in medication safety. Lab Alert will evaluate electronic tools to improve Kaiser Permanente's performance in laboratory monitoring to avoid adverse drug events. We will enroll patients who are taking high-risk medications and who have not received laboratory monitoring. The primary outcome of this 2-year study is the proportion of patients who receive guideline-based laboratory monitoring at 1 and 3 weeks post-intervention.

Fifteen primary care clinics will be randomly assigned to: (1) usual care (UC) (2) electronic message reminder (EMR) (3) automated voice message (AVM) (4) pharmacy outreach team (Pharmacy). The reminders will notify of the patient's need for guideline-specified laboratory testing due to medication use. Using electronic data, patients with PCPs assigned to intervention clinics who are on study-specified medications will be identified and screened for exclusions, to yield 600 patients (200 per intervention group). Patients will be assigned to the treatment groups on the basis of the condition assigned to their usual clinic. After the intervention and observation periods, and using the same time frame and inclusion and exclusion criteria used to identify the patients in the intervention arms, we will retrospectively identify a comparison 200-patient cohort in the usual care clinics. Thus, approximately 800 patients will be included in the study. Baseline, follow-up, and outcome data will be obtained from electronic records.

Study-defined medications will be finalized by the study team and quality committees. These medications are identified based upon previous work and are prescribed with reasonable frequency, commonly have gaps in laboratory monitoring, carry significant risk of toxicity, and are of interest to the participating HMOs because of prior and potential adverse events. We anticipate focusing on baseline monitoring for new prescriptions. New starts will be defined as patients with an index prescription but no other dispense of that medication in the prior 6 months.

Lab Alert will assess the effectiveness of a patient-specific electronic medical record (EMR) in-basket reminder to the primary care provider (PCP) (EMR reminder), an automated recorded voice message to the patient (AVM), pharmacy team outreach (Pharmacy) to increase the proportion of patients receiving all guideline-based laboratory monitoring, when compared to usual care (UC). If any intervention is better than UC, Lab Alert will assess and compare their effectiveness and costs. The study also will evaluate PCP and patient experiences with the intervention in order to refine the interventions in the future.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: LabAlert: Enhancing Medication Safety Through Electronic Interventions to Improve Medication Safety
Study Start Date : January 2004
Study Completion Date : March 2005

Primary Outcome Measures :
  1. The number of patients that complete recommended laboratory monitoring within one week and twenty five days after intervention.
  2. The study will evaluate the time to completion of the recommended labs.
  3. The study will also evaluate PCP and patient experiences with the interventions in order to refine the interventions in the future.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Dispensed one of 12 drugs or classes of drugs where baseline safety laboratory monitoring is recommended and labs have not been completed 6 months prior or 5 days after the dispense of the medication.
  • 18 years of age or older
  • 12-month HMO membership
  • drug benefit coverage
  • has telephone number

Exclusion Criteria:

  • recommended baseline laboratory monitoring completed
  • receives care and/or resides in hospice, nursing home, care outside HMO
  • enrolled in other care management program
  • nonEnglish speaking needing translation services

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00256386

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United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Kaiser Permanente
Garfield Memorial Fund
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Principal Investigator: Adrianne C. Feldstein, MD, MS Northwest Permanente
Publications of Results:
Other Publications:
Freeborn DK PC. Promise and performance in managed care. Greenlick M, Freeborn D, Pope C, editors. 1994. Baltimore, MD, Johns Hopkins University Press.
Feldstein AC, Smith DH, Robertson NR, Kovach CA, Soumerai SB, Simon SR et al. Design and implementation of decision support for outpatient prescribing in an electronic medical record. The Safety in Prescribing study. Advances in Patient Safety: From Research to Implementation. Rockville: Agency for Healthcare Research and Quality, 2005.
Discount usability testing of computer-generated clinical alerts uncovers flaws. Denver, CO: 2003.
Hosmer DWJr, Lemeshow S. Applied survival analysis: Regression modeling of time to event data. New York: Wiley and Sons, 1999.
Raudenbush S, Bryk A, Cheong YF, Congdon R. HLM 5 hierarchical linear and nonlinear modeling. Lincolnwood: Scientific Software International, 2001.

Layout table for additonal information Identifier: NCT00256386    
Other Study ID Numbers: 101-9520 Garfield Mem Trust
First Posted: November 21, 2005    Key Record Dates
Last Update Posted: November 30, 2006
Last Verified: November 2005
Keywords provided by Kaiser Permanente: