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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00256386
First Posted: November 21, 2005
Last Update Posted: November 30, 2006
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.
Collaborator:
Garfield Memorial Fund
Information provided by:
Kaiser Permanente
  Purpose
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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: LabAlert: Enhancing Medication Safety Through Electronic Interventions to Improve Medication Safety

Further study details as provided by Kaiser Permanente:

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

Estimated Enrollment: 800
Study Start Date: January 2004
Estimated Study Completion Date: March 2005
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.

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00256386


Locations
United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Kaiser Permanente
Garfield Memorial Fund
Investigators
Principal Investigator: Adrianne C. Feldstein, MD, MS Northwest Permanente
  More Information

Publications:
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Bates DW, Cullen DJ, Laird N, Petersen LA, Small SD, Servi D, Laffel G, Sweitzer BJ, Shea BF, Hallisey R, et al. Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group. JAMA. 1995 Jul 5;274(1):29-34.
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Gandhi TK, Burstin HR, Cook EF, Puopolo AL, Haas JS, Brennan TA, Bates DW. Drug complications in outpatients. J Gen Intern Med. 2000 Mar;15(3):149-54.
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Abookire SA, Karson AS, Fiskio J, Bates DW. Use and monitoring of "statin" lipid-lowering drugs compared with guidelines. Arch Intern Med. 2001 Jan 8;161(1):53-8.
Selby JV, Ettinger B, Swain BE, Brown JB. First 20 months' experience with use of metformin for type 2 diabetes in a large health maintenance organization. Diabetes Care. 1999 Jan;22(1):38-44.
Beach JE, Faich GA, Bormel FG, Sasinowski FJ. Black box warnings in prescription drug labeling: results of a survey of 206 drugs. Food Drug Law J. 1998;53(3):403-11.
Raebel MA, Lyons EE, Andrade SE, Chan KA, Chester EA, Davis RL, Ellis JL, Feldstein A, Gunter MJ, Lafata JE, Long CL, Magid DJ, Selby JV, Simon SR, Platt R. Laboratory monitoring of drugs at initiation of therapy in ambulatory care. J Gen Intern Med. 2005 Dec;20(12):1120-6.
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Balas EA, Weingarten S, Garb CT, Blumenthal D, Boren SA, Brown GD. Improving preventive care by prompting physicians. Arch Intern Med. 2000 Feb 14;160(3):301-8.
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Feldstein AC, Smith DH, Robertson NR, Kovach CA, Soumerai SB, Simon SR, Sittig DF, Laferriere DS, Kalter M. Decision Support System Design and Implementation for Outpatient Prescribing: The Safety in Prescribing Study. In: Henriksen K, Battles JB, Marks ES, Lewin DI, editors. Advances in Patient Safety: From Research to Implementation (Volume 3: Implementation Issues). Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Feb.
Discount usability testing of computer-generated clinical alerts uncovers flaws. Denver, CO: 2003.
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Feldstein A, Elmer PJ, Smith DH, Herson M, Orwoll E, Chen C, Aickin M, Swain MC. Electronic medical record reminder improves osteoporosis management after a fracture: a randomized, controlled trial. J Am Geriatr Soc. 2006 Mar;54(3):450-7.
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Raebel MA, Lyons EE, Chester EA, Bodily MA, Kelleher JA, Long CL, Miller C, Magid DJ. Improving laboratory monitoring at initiation of drug therapy in ambulatory care: a randomized trial. Arch Intern Med. 2005 Nov 14;165(20):2395-401.
Simon SR, Andrade SE, Ellis JL, Nelson WW, Gurwitz JH, Lafata JE, Davis RL, Feldstein A, Raebel MA. Baseline laboratory monitoring of cardiovascular medications in elderly health maintenance organization enrollees. J Am Geriatr Soc. 2005 Dec;53(12):2165-9.

ClinicalTrials.gov Identifier: NCT00256386     History of Changes
Other Study ID Numbers: 101-9520 Garfield Mem Trust
First Submitted: November 17, 2005
First Posted: November 21, 2005
Last Update Posted: November 30, 2006
Last Verified: November 2005

Keywords provided by Kaiser Permanente:
Baseline
Laboratory
Drug


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