Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256386
Status:
COMPLETED
Last Update Posted:
2006-11-30
First Post:
2005-11-17
Brief Title:
LabAlert Enhancing Medication Safety Through Electronic Interventions to Improve Laboratory Monitoring
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
LabAlert Enhancing Medication Safety Through Electronic Interventions to Improve Medication Safety
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Permanentes 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 patients 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
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None