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

Safety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00256386
• Other study ID #: 101-9520 Garfield Mem Trust
• Status: Completed
• Phase: N/A
• First received: November 17, 2005
• Last updated: November 29, 2006
• Start date: January 2004
• Est. completion date: March 2005

Study information

• Verified date: November 2005
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Safety

Intervention

Device:
• Electronic Medical Record (EMR) to clinician's in-basket

• Automated Voice Message (AVM) reminder to patient's phone

Procedure:
• Pharmacy Team phone call-letter followup

Locations

Country	Name	City	State
United States	Kaiser Permanente Center for Health Research	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Garfield Memorial Fund

Country where clinical trial is conducted

United States, 

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* Note: There are 44 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients that complete recommended laboratory monitoring within one week and twenty five days after intervention.
Primary	The study will evaluate the time to completion of the recommended labs.
Primary	The study will also evaluate PCP and patient experiences with the interventions in order to refine the interventions in the future.